Enter a full short description of the most relevant endpoint data. This includes in principle the summary information that is compiled e.g. in the OECD Full SIDS Summary format or other endpoint summary formats. Provide only the most relevant details, which could be, depending on the cases, the test guideline used, test organism and exposure duration. Normally no reliability score needs to be indicated as it can be assumed that the studies identified are valid (reliability score 1 or 2). If this is not the case (for instance if the reliability of a published study cannot be assigned or if several less valid studies are used for a weight of evidence analysis), the reliability indicators should be specified.

Also several key studies can be referenced as applicable. However, the characterisation of the endpoint data should be kept as concise as possible. Examples of what could be entered here are as follows:

- Melting point: 54.6-55.8 °C at 1,013 hPa

- Water solubility: completely miscible

- pH: 6.9 (80 mg/l water) at 20°C (OECD TG105)

- Oxidation reduction potential: no data available

- Phototransformation in air: T1/2 = 9.32 x 10-2 yr (sensitizer: OH radical) (AOP Win v 1.86)

- Biodegradation in water: screening tests: Not readily biodegradable: 0 - 8% (BOD) in 28 days, 0 - 1% (HPLC) in 28 days (OECD TG 301C)

- Short-term toxicity to fish:

LC50 (96h) < 100 mg/l for Pimephales promelas (OECD TG 203)

LC50 (48h) = 3.2 mg/l for Oryzias latipes (OECD TG 203)

- Acute toxicity:

Dermal: LD50: > 2,000 mg/kg for rat (limit test)

- Genetic toxicity:

In vitro:

Gene mutation (Bacterial reverse mutation assay / Ames test): S. typhimurium TA 100: positive with and without metabolic activation; TA 1535: positive without metabolic activation (equivalent to OECD TG 471)

The field(s) under this heading (if provided) can be optionally completed in order to specify the key parameter(s) that may subsequently be used in the chemical safety assessment, classification and labelling or other. In order to enable the use of any specific software, only a minimum number of structured and hence, searchable fields are provided, in many cases only one.

Key parameters are intended to condense the data summarised in field "Full short description of relevant endpoint data" to one single numeric value or concluding remark (e.g. negative / positive) chosen from a drop-down list. Where a numeric field is provided, only a clear value can be entered, that is, no range and no less than or greater than qualifiers. Conversion to a predefined unit as indicated in the field label (e.g. mg/L) may be required.

If the key value is no clear number, but a range or preceded by <, <=, >, or >=, you may either leave this field empty or make up a value you consider most appropriate for the intended subsequent purpose. The rationale for any user-derived values should be described in field "Discussion" for the sake of transparency. Some non-exhaustive examples of user-derived parameters are as follows:

- Aquatic short-term L(E)C50 >100 mg/L (e.g. because only tested up to water solubility of the substance): it may be appropriate to assume 100 mg/L as worst case value.

- Aquatic long-term LOEC 1 mg/L (>10 and <20% effect): calculate NOEC as LOEC/2 and enter 0.5 mg/L in the field for NOEC.

- Acute oral LD50 >2000 mg/kg b.w. (because no LD50 was achieved in a limit test): enter 2000 mg/kg b.w.

In this rich text field, describe the assessment you have made for the given endpoint. Provide the rationale for the choice of the key study(ies) and the choice of the key parameter that, according to your judgement, characterise the endpoint. This includes a discussion of the key information identified and in some instances of studies which are considered to be unreliable, but give critical results. A discussion as to why they were discarded in favour of other studies should then be included. Vice versa, a weight of evidence analysis based on less reliable data or use of published data, the reliability of which cannot be judged because of limited reporting, should be justified.

If several studies were identified to be relevant for the assessment, discuss possible reasons for differing results if any, e.g. differences in purity / impurities of the test substance used, differences in the methods and test conditions, etc.

Provide an appropriate justification for the classification proposed or, when relevant, for the non-classification of the substance.

Under this main heading, fields are subsumed for identifying the purpose of the record (e.g., "key study"), the type of result (e.g., "experimental study"), data waiving indication (if any), reliability indication, and flags for indicating the regulatory purpose envisaged and/or any confidentiality restrictions. This kind of data characterise the relevance of a study summary and are therefore displayed on top of each Endpoint Study Record. For detailed guidance, refer to chapter D.4.7.7.1 Administrative data.

Indicate the bibliographic reference of the study report or publication the study summary is based on. Always enter the primary reference in the first block of fields (i.e. Sort no. = 1), if there are more than one reference to be cited. Copy this block of fields for specifying any other references related to this record (e.g. report of a preliminary study or other documentation). If results of a study report have been published, indicate the full citation of that publication(s) in addition to the reference of the original study.

Select appropriate indication for data access. Enter "Not applicable" if the summary consists of information that is commonly accessible such as guidance on safe use.

Indicate as appropriate. Note: "yes" should be selected only if "Data submitter is data owner" or "Data submitter has Letter of Access". Options "yes, but willing to share" or "yes, but not willing to share" may be relevant for specific regulatory programmes where the submitter is requested to indicate whether he is willing to share studies (e.g. with vertebrates).

In the supplementary remarks field, include an explanation as appropriate, i.e. justification for denial of sharing the corresponding study or refer to a document attached that provides justification (e.g. "for justification see attached document X")

A cross-reference can be included to indicate that the same study is recorded in another record. Indicate the respective chapter and record ID and enter relevant explanatory text. This may be useful if specific endpoints of a given study are described in another chapter (e.g. results on reproduction toxicity in case of a combined repeated dose / reproduction toxicity study) or if more than one experiment is described by the same study report, but included in separate records.

Check with the relevant guidance document whether all the methodology details must be repeated or whether a cross-reference to the same study in another chapter may suffice.

Note that any such cross-reference may become useless if a record is either printed or exchanged on its own.

Select appropriate test type. Note: This field may be redundant with the information given in field "Guideline", but is considered useful for searching reasons.

Indicate if the experiment was a limit test.

Indicate according to which test guideline the study was conducted. If no test guideline was explicitly followed, but the methodology used is equivalent or similar to a specific guideline, you can indicate so in the "Qualifier" subfield preceding the field "Guideline".

Copy this block of fields for specifying more than one guideline (e.g. US EPA in addition to OECD guideline).

If no guideline was followed, include a description of the principles of the test protocol or estimated method used in the study. Details should be entered in appropriate distinct fields of section MATERIALS AND METHODS if available. Also provide a justification for using this method if appropriate.

If an estimation method was used (to be indicated in field "Test result type") state the equation(s) and/or computer software or other methods applied to calculate the value(s).

Indicate whether the study was conducted following Good Laboratory Practice or not. Select "yes (incl. certificate)" if a GLP certificate of a test facility is available. Select "yes" if a GLP compliance statement is available, but no information on a GLP certificate. You can give an explanation in the supplementary remarks field, e.g. for explaining why GLP was not complied with or for specifying which (national) GLP was followed.

Indicate if the test material used in the study is equivalent to the submission substance identity. If "yes" is selected, the corresponding identity is automatically entered in the subsequent block of fields "Test material identity".

If "no" is selected, identify the test material in the subsequent block of fields "Test material identity". In this case, also make sure that the information entered in field "Study result type" is consistent, i.e. "read-across from supporting substance (structural analogue or surrogate)".

NOTE: If a completed record is used for another submission, you may have to update both fields "Study result type" and "Test material equivalent to submission substance identity".

If the identity of the test material used for this study is not included in this block of fields automatically, indicate the identity for one or more appropriate identifiers, e.g. CAS number, CAS name, IUPAC name. Copy this block of fields as appropriate.

If another than the submission substance identity was selected erraneously, go back to field "Test material equivalent to submission substance identity" and select "yes". This will prompt automatic entry of the respective identifiers.

Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Note that any information that can be claimed confidential should be included in the subsequent field "Confidential details on test material".

Explanations:

- Name of test material (as cited in study report): only if different from any other identifiers provided in the preceding fields.

- Molecular formula (if other than submission substance): specify

- Molecular weight (if other than submission substance): specify

- Smiles notation (if other than submission substance): provide if available

- InChl (if other than submission substance): provide if available

- Structural formula attached as image file (if other than submission substance): see Fig.: only if different from submission substance. Indicate Fig. no. if a file is attached in field "Attached document", e.g. state "see Fig. 1".

- Substance type: indicate whether pure active substance, technical product, formulation or other.

- Physical state: indicate "gas", "solid" or "liquid" only if different from submission substance or if substance can occur in different physical states.

- Analytical purity: specify in %

- Impurities (identity and concentrations): specify

- Composition of the test material, percentage of components: specify if applicable

- Isomers composition: specify if applicable

- Purity test date: provide if available

- Lot/batch No.: provide if available

- Expiration date of the lot/batch: provide if available

- Radiochemical purity (if radiolabelling): specify if applicable

- Specific activity (if radiolabelling): specify if applicable

- Locations of the label (if radiolabelling): specify if applicable

- Expiration date of radiochemical substance (if radiolabelling): specify if applicable

- Storage condition of test substance: specify if applicable

- Stability under test conditions: indicate if available

Enter any confidential information on the test material in this separate field. Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Explanations:

- Analytical purity: specify in %

- Impurities (identity and concentrations): specify

- Composition of the test material, percentage of components: specify if applicable

- Purity test date: provide if available

- Lot/batch No.: : provide if available

- Expiration date of the lot/batch: : provide if available

- Isomers composition: specify if applicable

Select name of species. If not available from picklist, select "other" and specify.

Select strain as appropriate. If not available from picklist, select "other" and specify.

Select as appropriate.

Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Explanations:

- Housing: describe housing conditions. Indicate whether individual metabolism cages were used.

- Diet: Describe type of diet (e.g. conventional laboratory diet / caloric restriction) and whether it was provided ad libitum.

- Water: Describe type (e.g. drinking water) and whether it was provided ad libitum.

- IN-LIFE DATES: If required, specify the in-life dates (i.e. the phase of a study following treatment in which the test system is alive/growing).

Select as appropriate. If not available from picklist, select "other" and specify.

Select "unchanged (no vehicle)" if none was used or select vehicle used if any. If not available from picklist, select "other" and specify.

Note that some of the vehicles provided in this list are used for specific routes of administration only.

Select freetext template for the respective route of administration and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Indicate whether the doses or concentrations were analytically verified.

For robust study summaries or as requested by the regulatory programme, include a short description on the method of analysis in the supplementary remarks field. If any problems occurred in any of these procedures, then they should be reported in more detail. If this could have affected the veracity or conclusions of the study, discuss this in field "Rationale for reliability incl. deficiences".

Further route-dependent information to be included:

- For oral studies: State whether the analytical data indicated that the variance between nominal and actual dosage (if diet is route of administration) or concentrations (for drinking water study) was acceptable.

If diet is the route of administration, briefly record when and at what dose levels the dosage analyses were made and include the results (range of values) of (i) Homogeneity analysis, (ii) Stability analysis and (iii) Concentration analysis.It may be appropriate to include a cross-reference to another study in which stability analysis was performed and reported. If so, a justification should also be included briefly explaining the rationale of referring to another study.

- For inhalation studies: State whether the analytical data indicated that the variance between nominal and actual concentrations was acceptable.

- For dermal studies: State whether the analytical data indicated that the variance between nominal and actual concentrations of the test substance in the vehicle was acceptable.

Briefly describe the mating procedure.

Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Indicate duration in days, weeks or months, e.g. "28 days" or "18 months".

Indicate the frequency of the administration of doses to the test animals (e.g., "daily, 7 days each week"). Use of non-standard dosing regime (e.g. a five-day per week regime) should be justified.

Indicate the dose or concentration levels applied and the basis of quantity used. Copy this block of fields if the dose/concentration levels were determined on more than one basis of quantity as appropriate.

Enter value or specify according to dose if different number of animals per dose or test, e.g. "10 in each dose group of FOB".

For robust study summaries or as requested by the regulatory programme, also include a detailed table on the animal assignment in the rich text field "Any other information on results incl. tables". Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the Remarks text (e.g. "... see Table 1").

For a developmental neurotoxicity study it should be noted: The method of animal assignment should have minimized potential problems related to litter effects, i.e., by using one pup/sex/litter (or one measure/litter, e.g., mean body weight for each litter).

When allocating animals to FOB and motor activity testing, the same individual animals should have been evaluated at all scheduled time points.

For the selection of animals and testing paradigms for cognitive (learning and memory) assessment, it is important to ensure that tasks were selected and/or animals allocated so that comparable assessments of learning were made at both times, i.e., shortly after PND 21 and around PND 60. Indicate whether the same or different animals were used for assessments at the weanling and adult ages. In general, the use of separate animals at the two time points is preferred, because for many tasks, initial learning (PND 21) may confound later (PND 60) assessment of learning. If the same animals were used at both times, different tasks would likely have been necessary. The selection of the test for assessing learning should have been adequately justified regardless of whether the same or a different task was used.

Indicate whether and what type of concurrent control groups were used. If not available from picklist, select "other" and specify. Copy field if more than one type of control was used.

Include any details on the study design including a brief description of the rationale for dose selection, animal assignment and selection of satellite groups including the duration of the post-exposure recovery period. As appropriate state study type(s) and briefly describe the results from range-finding or other studies used as basis for dose selection. More comprehensive details may be attached.

Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

For a developmental neurotoxicity study it should be noted: Dose selection rationale should be discussed, including information from the prenatal developmental or two-generation reproduction studies, if applicable. Any pilot study data (including biomarker data, such as cholinesterase activity) or pharmacokinetic data (e.g., milk or blood levels of test substance, or data that established time of peak effect) should be described in detail. If these data were submitted in a separate study report, the methods and results (including detailed tables of analytical results) should be presented in a separate record (include a reference in field "Cross-reference to same study" or "Cross-reference to other study" as applicable); alternatively, they could be appended to this record.

Indicate if and which examinations were performed and the time schedule for those examinations. Also indicate the dose groups that were examined if not all. When tabulating parameters examined, refer to respective table no.

If other observations (e.g. haematology) are reported in another study summary (e.g. repeated dose toxicity), include a note in field "Cross-reference to same study" and refer to that summary.

Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

If specific biochemical determinations were made, provide details on the sampling, the tissues tested (e.g. plasma, whole blood, RBCs, brain (whole brain or regions)) and methodology. When tabulating parameters examined, refer to respective table no.

Use freetext template and delete/add elements as appropriate (e.g. delete items on NTE activity if not applicable). Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Provide details on the neurobehavioural examinations performed and frequency. Use freetext template and delete/add elements as appropriate (e.g. delete items on NTE activity if not applicable). Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Particularly with comprehensive data, include a table in the rich text field "Any other information on results incl. tables" and refer to respective table no., e.g. "see Table 1" (use predefined table if any). Narrative accompanying such tabular data should address the toxicological significance of the results and not repeat what is presented in the table(s).

Indicate details on gross pathological and histopathological examinations. Also indicate those dose groups which were examined.

Use freetext template and delete/add elements as appropriate (e.g. delete items on NTE activity if not applicable). Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Particularly with comprehensive data, include a table in the rich text field "Any other information on results incl. tables" and refer to respective table no., e.g. "see Table 1" (use predefined table if any). Narrative accompanying such tabular data should address the toxicological significance of the results and not repeat what is presented in the table(s).

Specific guidance for acute or subchronic neurotoxicity:

Indicate when and how were animals sacrificed, how many were perfused, what parameters were measured (e.g. brain weight, length and width), what were the procedures for perfusion, what tissues were evaluated, what type of staining was used, how were sections prepared (thickness, embedding media, number of sections). How many animals from each sex and treatment group were evaluated?

Specific guidance for developmental neurotoxicity studies: see freetext template.

Tables are optional, particuarly for postmortem examinations of the offspring and the specific morphometric measures taken.

For developmental neurotoxicity studies, indicate the relevant developmental landmarks and details on postweaning and litter observations. Use freetext template and delete/add elements as appropriate (e.g. delete items on NTE activity if not applicable). Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Specific guidance on DEVELOPMENTAL LANDMARKS: If other developmental landmarks than those specified in the guideline are included in the study report, a detailed description of any developmental landmarks evaluated is MANDATORY, e.g. , e.g., eye opening, pinna unfolding, incisor eruption, etc.

For developmental neurotoxicity studies, provide pharmacokinetic data. If applicable] Measures of [list parameters examined, e.g., test substance and metabolites in milk or in maternal, fetal, or pup blood] were determined in [Provide study identification, source of the animals (e.g., were they part of a range-finding or companion study?). Describe how many animals of each age group at each time point, how often, at what age for offspring. Indicate specifics of sample collection and processing; describe analytical methods used.

Describe any other examinations.

Briefly describe the positive control data cited, and its acceptability for use with the current study.

For positive control data to be acceptable, it must demonstrate the sensitivity of the test method to detect changes in the measured parameters. These data do not have to be from studies using prenatal exposures. However, the laboratory must demonstrate competence in evaluation of effects in neonatal animals perinatally exposed to chemicals and establish test norms for the appropriate age group. For observational measures, the data should demonstrate the ability to detect major neurotoxic endpoints, including limb weakness, paralysis, tremor, and autonomic signs; motor activity positive control data should demonstrate the ability to detect both increases and decreases in motor activity; pathology positive control data should demonstrate the ability to detect central and peripheral nervous system pathology (separate groups may be used to demonstrate each type of pathology, for example, acrylamide for peripheral nervous system pathology and trimethyl tin for central nervous system pathology).

The methods should be completely described, and must be the same as those used in the study being evaluated (for example, the same equipment should be used, motor activity sessions should be of the same duration, the observation arena should be the same, the same sections should be evaluated for neuropathology, using the same types of stains, etc.), and preferably the same personnel should have conducted the testing. The data presentation should be complete enough to evaluate the sensitivity of the method, including individual data and measures of variability. Statistical evaluations used to demonstrate sensitivity should also be the same as those used in the study being evaluated. The number of animals per test group should not be greater than that used in the study under evaluation. Positive control data should also demonstrate inter-observer reliability for the FOB (i.e., the same results should be seen regardless of who is doing the observations). The positive control data should have been collected within a reasonable time frame before the current study, e.g., the last few years. New data should also be collected when observational personnel or other critical laboratory elements change.

List parameters that were analysed and the statistical methods used; include a statement that the Reviewer considers the analyses used to be appropriate. If inappropriate, provide alternative/rationale.

In this field, you can enter any information on materials and methods, for which no distinct field is available, or transfer free text from other databases. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

Note: One rich text editor field each is provided for the MATERIALS AND METHODS and RESULTS section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry.

Record effect levels, based on different endpoints and/or separated for each generation (if applicable) and/or sex. Copy this block of fields as appropriate.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Water consumption may not be specifically requested under the respective test guideline, unless the substance was administered in the drinking water.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Describe the effects by dose level for each of the previous fields answered "yes". If answered "no effects", you may provide any further explanations, e.g. stating that effects were observed, but considered negligible and not of biological or statistical significance (to be explained why).

Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Relate treatment-related findings to any histological findings where appropriate.

Particularly with comprehensive data, include a table in the rich text field "Any other information on results incl. tables" and refer to respective table no., e.g. "see Table 1" (use predefined table if any). Narrative accompanying such tabular data should address the toxicological significance of the results and not repeat what is presented in the table(s).

NOTE: Depending on the regulatory programme some form of a table(s) may be mandatory.

Explanations:

- CLINICAL SIGNS AND MORTALITY: Clinical signs include gross observations for behaviour and appearance ("cage-side observations"). Note when signs were first observed and if they were reversible. For mortalities the cause of death should be indicated.

- WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Water consumption may not be specifically requested under the respective test guideline, unless the substance was administered in the drinking water.

- BIOCHEMISTRY: Provide separate tables for blood and brain cholinesterase activity and, if determined, for other enzyme activities (i.e. NTE for delayed neurotoxicity of organophosphorus substances). Include all data for whole brain (if brain regions were evaluated, also include all data from cortex and hippocampus; for other regions include data from all time points if statistically significant changes were found for a particular region or if changes from baseline of 20% or greater were seen).

- NEUROBEHAVIOUR: Provide separate tables for functional observation battery results, motor activity, auditory startle field and learning and memory testing results as appropriate. Data should be included for all statistically significant findings, and for any findings that could be toxicologically relevant (even if not statistically significant). If significant effects are found, data from all groups, time points, and both sexes should be included for that parameter. Include severity information if there are changes in severity. Duplicate the tables as necessary to include different types of findings (e.g. activity levels, landing foot splay, etc.).

- GROSS PATHOLOGY: Give absolute AND relative brain weights as appropriate.

- NEUROPATHOLOGY: Describe what types of lesions were found. If neuropathological alterations were observed in the high dose group, were lower dose groups sequentially examined? If evidence of neuropathological alterations was seen, was a subjective diagnosis (dose-blind coded re-reading) conducted? If treatment-related lesions were found, include information in a table, including information regarding lesion severity; if no treatment-related lesions were found, include some information in text regarding reported incidence of lesions unrelated to treatment and in control groups.

- OTHER FINDINGS: Describe the results of any other examinations or include a cross-reference in field "Cross-reference to same study" to indicate that specific results of the same study are described in another chapter.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Describe the effects by dose level for each of the previous fields answered "yes". If answered "no effects", you may provide any further explanations, e.g. stating that effects were observed, but considered negligible.

Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Particularly with comprehensive data, include a table in the rich text field "Any other information on results incl. tables" and refer to respective table no., e.g. "see Table 1" (use predefined table if any). Narrative accompanying such tabular data should address the toxicological significance of the results and not repeat what is presented in the table(s).

NOTE: Depending on the regulatory programme some form of a table(s) may be mandatory.

Explanations:

- REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS): Describe the effects by dose level as stated above. Summarise any biologically relevant effects on reproductive performance. Any table included should be based on report content and include any calculated reproductive indices.

- VIABILITY (OFFSPRING): Describe, for each generation and sex, the effects at the different doses, i.e. mean litter size and viability (survival) results from pups during lactation. Also describe anogenital distance results, if measured.

- SEXUAL MATURATION (OFFSPRING): Describe the effects by dose level as stated above. Summarize any biologically relevant effects on vaginal opening and balanopreputial separation. Describe findings on sexual maturation.

- DEVELOPMENTAL LANDMARKS (OFFSPRING): For developmental neurotoxicity studies, describe the effects at the different doses in the supplementary remarks field.

- OTHER FINDINGS: Describe the results of any other examinations.

In this field, you can enter any other remarks on results. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

Note: Both the "Materials and methods" section and "Results" section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry.

In this field, you can enter any overall remarks or transfer free text from other databases. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

Note: One rich text editor field each is provided for the MATERIALS AND METHODS and RESULTS section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry.

Attach any background document that cannot be inserted in any rich text editor field, particularly image files (e.g. an image of a structural formula).

Copy this block of fields for attaching more than one file.

If required, an electronic copy of the full study report can be attached as WORD, pdf or other document type, which will not be integrated in any report, but must be handled as separate files.

Note: In the export administration you can indicate whether the attached files should be included in the data export or not.

Enter any conclusions if applicable.

If required by the respective national/regional programme, briefly summarise the relevant aspects of the study including the conclusions reached. If a specific format is prescribed, upload the respective freetext template if available from the drop-down list or copy it from the corresponding document.

Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

A Cross-reference to other study or other studies can be included which are considered relevant in the interpretation of the test results, e.g. for supporting the conclusion that an effect observed was not substance-related. Indicate the respective chapter(s) and record ID(s) and enter relevant explanatory text.

Such cross-references may be useful if it is considered relevant to discuss other results at the summary level of a single study. It should be noted that the overall appraisal of results from different studies is normally done in the hazard or risk assessment.

Note that any such cross-reference may become useless if a record is either printed or exchanged on its own.

Enter a full short description of the most relevant endpoint data. This includes in principle the summary information that is compiled e.g. in the OECD Full SIDS Summary format or other endpoint summary formats. Provide only the most relevant details, which could be, depending on the cases, the test guideline used, test organism and exposure duration. Normally no reliability score needs to be indicated as it can be assumed that the studies identified are valid (reliability score 1 or 2). If this is not the case (for instance if the reliability of a published study cannot be assigned or if several less valid studies are used for a weight of evidence analysis), the reliability indicators should be specified.

Also several key studies can be referenced as applicable. However, the characterisation of the endpoint data should be kept as concise as possible. Examples of what could be entered here are as follows:

- Melting point: 54.6-55.8 °C at 1,013 hPa

- Water solubility: completely miscible

- pH: 6.9 (80 mg/l water) at 20°C (OECD TG105)

- Oxidation reduction potential: no data available

- Phototransformation in air: T1/2 = 9.32 x 10-2 yr (sensitizer: OH radical) (AOP Win v 1.86)

- Biodegradation in water: screening tests: Not readily biodegradable: 0 - 8% (BOD) in 28 days, 0 - 1% (HPLC) in 28 days (OECD TG 301C)

- Short-term toxicity to fish:

LC50 (96h) < 100 mg/l for Pimephales promelas (OECD TG 203)

LC50 (48h) = 3.2 mg/l for Oryzias latipes (OECD TG 203)

- Acute toxicity:

Dermal: LD50: > 2,000 mg/kg for rat (limit test)

- Genetic toxicity:

In vitro:

Gene mutation (Bacterial reverse mutation assay / Ames test): S. typhimurium TA 100: positive with and without metabolic activation; TA 1535: positive without metabolic activation (equivalent to OECD TG 471)

The field(s) under this heading (if provided) can be optionally completed in order to specify the key parameter(s) that may subsequently be used in the chemical safety assessment, classification and labelling or other. In order to enable the use of any specific software, only a minimum number of structured and hence, searchable fields are provided, in many cases only one.

Key parameters are intended to condense the data summarised in field "Full short description of relevant endpoint data" to one single numeric value or concluding remark (e.g. negative / positive) chosen from a drop-down list. Where a numeric field is provided, only a clear value can be entered, that is, no range and no less than or greater than qualifiers. Conversion to a predefined unit as indicated in the field label (e.g. mg/L) may be required.

If the key value is no clear number, but a range or preceded by <, <=, >, or >=, you may either leave this field empty or make up a value you consider most appropriate for the intended subsequent purpose. The rationale for any user-derived values should be described in field "Discussion" for the sake of transparency. Some non-exhaustive examples of user-derived parameters are as follows:

- Aquatic short-term L(E)C50 >100 mg/L (e.g. because only tested up to water solubility of the substance): it may be appropriate to assume 100 mg/L as worst case value.

- Aquatic long-term LOEC 1 mg/L (>10 and <20% effect): calculate NOEC as LOEC/2 and enter 0.5 mg/L in the field for NOEC.

- Acute oral LD50 >2000 mg/kg b.w. (because no LD50 was achieved in a limit test): enter 2000 mg/kg b.w.

In this rich text field, describe the assessment you have made for the given endpoint. Provide the rationale for the choice of the key study(ies) and the choice of the key parameter that, according to your judgement, characterise the endpoint. This includes a discussion of the key information identified and in some instances of studies which are considered to be unreliable, but give critical results. A discussion as to why they were discarded in favour of other studies should then be included. Vice versa, a weight of evidence analysis based on less reliable data or use of published data, the reliability of which cannot be judged because of limited reporting, should be justified.

If several studies were identified to be relevant for the assessment, discuss possible reasons for differing results if any, e.g. differences in purity / impurities of the test substance used, differences in the methods and test conditions, etc.

Provide an appropriate justification for the classification proposed or, when relevant, for the non-classification of the substance.

Under this main heading, fields are subsumed for identifying the purpose of the record (e.g., "key study"), the type of result (e.g., "experimental study"), data waiving indication (if any), reliability indication, and flags for indicating the regulatory purpose envisaged and/or any confidentiality restrictions. This kind of data characterise the relevance of a study summary and are therefore displayed on top of each Endpoint Study Record. For detailed guidance, refer to chapter D.4.7.7.1 Administrative data.

Indicate the bibliographic reference of the study report or publication the study summary is based on. Always enter the primary reference in the first block of fields (i.e. Sort no. = 1), if there are more than one reference to be cited. Copy this block of fields for specifying any other references related to this record (e.g. report of a preliminary study or other documentation). If results of a study report have been published, indicate the full citation of that publication(s) in addition to the reference of the original study.

Select appropriate indication for data access. Enter "Not applicable" if the summary consists of information that is commonly accessible such as guidance on safe use.

Indicate as appropriate. Note: "yes" should be selected only if "Data submitter is data owner" or "Data submitter has Letter of Access". Options "yes, but willing to share" or "yes, but not willing to share" may be relevant for specific regulatory programmes where the submitter is requested to indicate whether he is willing to share studies (e.g. with vertebrates).

In the supplementary remarks field, include an explanation as appropriate, i.e. justification for denial of sharing the corresponding study or refer to a document attached that provides justification (e.g. "for justification see attached document X")

A cross-reference can be included to indicate that the same study is recorded in another record. Indicate the respective chapter and record ID and enter relevant explanatory text. This may be useful if specific endpoints of a given study are described in another chapter (e.g. results on reproduction toxicity in case of a combined repeated dose / reproduction toxicity study) or if more than one experiment is described by the same study report, but included in separate records.

Check with the relevant guidance document whether all the methodology details must be repeated or whether a cross-reference to the same study in another chapter may suffice.

Note that any such cross-reference may become useless if a record is either printed or exchanged on its own.

Select appropriate test type.

Indicate if the experiment was a limit test.

Indicate according to which test guideline the study was conducted. If no test guideline was explicitly followed, but the methodology used is equivalent or similar to a specific guideline, you can indicate so in the "Qualifier" subfield preceding the field "Guideline".

Copy this block of fields for specifying more than one guideline (e.g. US EPA in addition to OECD guideline).

If no guideline was followed, include a description of the principles of the test protocol or estimated method used in the study. Details should be entered in appropriate distinct fields of section MATERIALS AND METHODS if available. Also provide a justification for using this method if appropriate.

If an estimation method was used (to be indicated in field "Test result type") state the equation(s) and/or computer software or other methods applied to calculate the value(s).

Indicate whether the study was conducted following Good Laboratory Practice or not. Select "yes (incl. certificate)" if a GLP certificate of a test facility is available. Select "yes" if a GLP compliance statement is available, but no information on a GLP certificate. You can give an explanation in the supplementary remarks field, e.g. for explaining why GLP was not complied with or for specifying which (national) GLP was followed.

Indicate if the test material used in the study is equivalent to the submission substance identity. If "yes" is selected, the corresponding identity is automatically entered in the subsequent block of fields "Test material identity".

If "no" is selected, identify the test material in the subsequent block of fields "Test material identity". In this case, also make sure that the information entered in field "Study result type" is consistent, i.e. "read-across from supporting substance (structural analogue or surrogate)".

NOTE: If a completed record is used for another submission, you may have to update both fields "Study result type" and "Test material equivalent to submission substance identity".

If the identity of the test material used for this study is not included in this block of fields automatically, indicate the identity for one or more appropriate identifiers, e.g. CAS number, CAS name, IUPAC name. Copy this block of fields as appropriate.

If another than the submission substance identity was selected erraneously, go back to field "Test material equivalent to submission substance identity" and select "yes". This will prompt automatic entry of the respective identifiers.

Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Note that any information that can be claimed confidential should be included in the subsequent field "Confidential details on test material".

Explanations:

- Name of test material (as cited in study report): only if different from any other identifiers provided in the preceding fields.

- Molecular formula (if other than submission substance): specify

- Molecular weight (if other than submission substance): specify

- Smiles notation (if other than submission substance): provide if available

- InChl (if other than submission substance): provide if available

- Structural formula attached as image file (if other than submission substance): see Fig.: only if different from submission substance. Indicate Fig. no. if a file is attached in field "Attached document", e.g. state "see Fig. 1".

- Substance type: indicate whether pure active substance, technical product, formulation or other.

- Physical state: indicate "gas", "solid" or "liquid" only if different from submission substance or if substance can occur in different physical states.

- Analytical purity: specify in %

- Impurities (identity and concentrations): specify

- Composition of the test material, percentage of components: specify if applicable

- Isomers composition: specify if applicable

- Purity test date: provide if available

- Lot/batch No.: provide if available

- Expiration date of the lot/batch: provide if available

- Radiochemical purity (if radiolabelling): specify if applicable

- Specific activity (if radiolabelling): specify if applicable

- Locations of the label (if radiolabelling): specify if applicable

- Expiration date of radiochemical substance (if radiolabelling): specify if applicable

- Storage condition of test substance: specify if applicable

- Stability under test conditions: indicate if available

Enter any confidential information on the test material in this separate field. Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Explanations:

- Analytical purity: specify in %

- Impurities (identity and concentrations): specify

- Composition of the test material, percentage of components: specify if applicable

- Purity test date: provide if available

- Lot/batch No.: : provide if available

- Expiration date of the lot/batch: : provide if available

- Isomers composition: specify if applicable

Select name of species. If not available from picklist, select "other" and specify.

Select strain as appropriate. If not available from picklist, select "other" and specify.

Select as appropriate.

Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Explanations:

- Housing: describe housing conditions. Indicate whether individual metabolism cages were used.

- Diet: Describe type of diet (e.g. conventional laboratory diet / caloric restriction) and whether it was provided ad libitum.

- Water: Describe type (e.g. drinking water) and whether it was provided ad libitum.

- IN-LIFE DATES: If required, specify the in-life dates (i.e. the phase of a study following treatment in which the test system is alive/growing).

Select as appropriate. If not available from picklist, select "other" and specify.

Select "unchanged (no vehicle)" if none was used or select vehicle used if any. If not available from picklist, select "other" and specify.

Note that some of the vehicles provided in this list are used for specific routes of administration only.

Select freetext template for the respective route of administration and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Indicate whether the doses or concentrations were analytically verified.

For robust study summaries or as requested by the regulatory programme, include a short description on the method of analysis in the supplementary remarks field. If any problems occurred in any of these procedures, then they should be reported in more detail. If this could have affected the veracity or conclusions of the study, discuss this in field "Rationale for reliability incl. deficiences".

Further route-dependent information to be included:

- For oral studies: State whether the analytical data indicated that the variance between nominal and actual dosage (if diet is route of administration) or concentrations (for drinking water study) was acceptable.

If diet is the route of administration, briefly record when and at what dose levels the dosage analyses were made and include the results (range of values) of (i) Homogeneity analysis, (ii) Stability analysis and (iii) Concentration analysis.It may be appropriate to include a cross-reference to another study in which stability analysis was performed and reported. If so, a justification should also be included briefly explaining the rationale of referring to another study.

- For inhalation studies: State whether the analytical data indicated that the variance between nominal and actual concentrations was acceptable.

- For dermal studies: State whether the analytical data indicated that the variance between nominal and actual concentrations of the test substance in the vehicle was acceptable.

Indicate duration in days, weeks or months, e.g. "28 days" or "18 months".

Indicate the frequency of the administration of doses to the test animals (e.g., "daily, 7 days each week"). Use of non-standard dosing regime (e.g. a five-day per week regime) should be justified.

Indicate the dose or concentration levels applied and the basis of quantity used. Copy this block of fields if the dose/concentration levels were determined on more than one basis of quantity as appropriate.

Enter value or specify according to dose if different number of animals per dose, e.g. "10 in each dose group of main study; 10 f and 5 m in interim sacrifice group". Also specify number of animals in recovery group if applicable.

For robust study summaries or as requested by the regulatory programme, also include a detailed table on the animal assignment in the rich text field "Any other information on results incl. tables". Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the Remarks text (e.g. "... see Table 1").

Note: Specific tables may be required. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Indicate whether and what type of concurrent control groups were used. If not available from picklist, select "other" and specify. Copy field if more than one type of control was used.

Include any details on the study design including a brief description of the rationale for dose selection, animal assignment and selection of satellite groups including the duration of the post-exposure recovery period. As appropriate state study type(s) and briefly describe the results from range-finding or other studies used as basis for dose selection. More comprehensive details may be attached.

Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Indicate if and which examinations were performed and the time schedule for those examinations. Also indicate the dose groups that were examined if not all. As appropriate include detailed table(s) in the rich text field "Any other information on results incl. tables". Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the Remarks text (e.g. "... see Table 1").

If other observations (e.g. haematology) are reported in another study summary (e.g. repeated dose toxicity), include a note in field "Cross-reference to same study" and refer to that summary.

Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Indicate if and which examinations were performed. Also indicate the dose groups that were examined if not all. Note if not all collected tissues were examined. As appropriate include detailed table(s) in the rich text field "Any other information on results incl. tables". Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the Remarks text (e.g. "... see Table 1").

Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Indicate if and which examinations were performed and give details on the method and test protocoll, the dose groups and number of animals examined.

Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Indicate if and which examinations were performed and give details on the method and test protocoll, the dose groups and number of animals examined. Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Example of brief description of protocol: "Spleen IgM antibody response to a T-dependent antigen, sheep erythrocytes (sRBC) - Day 4 response: Animals were exposed to the test substance or positive control for 28 days, then injected intravenously to sheep erythrocytes on day 25. On day 29 (peak day of IgM response), the animals were sacrificed, spleens were removed and weighed, then spleen cells were prepared on day 30. The primary response to sheep erythrocytes was measured using a modified hemolytic plaque assay (Jerne, N.K., et al., Plaque forming cells: Methodology and Theory. Transpl. Rev. 18:130-191, 1974). Cell counts were performed and the number of cells/spleen, AFC/spleen and AFC/106 spleen cells were determined."

Example of brief description of protocol for Enzyme-Linked Immunosorbent Assay (ELISA): "The effects of test substance on antibody response to antigen were determined by an ELISA using methods described by Temple et al. (1995). Test animals were dosed with test material for ... days. Animals were exposed to sheep erythrocytes on day...IgM titers in serum were determined ... days after immunization. "

Indicate if and which examinations were performed and give details on the method and test protocoll, the dose groups and number of animals examined. Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Describe cell harvest and culture and proliferation measurement ((3H) thymidine) incorporation, etc.

Indicate if and which examinations were performed and give details on the method and test protocoll, the dose groups and number of animals examined.

Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Example of brief description of protocol: "Following ... days of exposure to test material or positive control, the effects of test substance on spontaneous cytotoxic activity were determined by incubating splenocytes from treated and control animals with 51Cr-labeled YAC-1 lymphoma cells (target cell). Following a 4-hour incubation period, the amount of radiolabel released from target cells was determined (measure of NK cytolysis)."

Indicate if and which examinations were performed and give details on the method and test protocoll, the dose groups and number of animals examined.

Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Example of brief description of protocol: "On day 30, a single cell suspension was prepared from each spleen and incubated in flat bottom microtiter plates (RPMI media supplemented with 10% fetal bovine serum and 5x10-5 2-mercaptoethanol). The spleen cells were cultured in either non-treated or anti-CD3-treated wells (100 µL of 1 µg/mL anti-CD3) and incubated at 4°C overnight. Prior to harvest on day 3, the cells were pulsed with 3H-thymidine for 18-24 hours."

Example of brief description of protocol for enumeration total B cells, total T cells and T cell subpopulations: "Following ... days of dosing, single cell preparations from each spleen were seeded at 1x106 cells/well into a 96-well microtiter plate. Phenotypic analysis of total B cell, T cell, and T cell subpopulations were conducted using monoclonal antibody conjugates to fluorescein isothiocyanate (FITC) or phycoerythrin (PE). The specific monoclonal antibodies used were: OX19 conjugated to PE to enumerate total T-cells (CD5+), OX38 conjugated to FITC to enumerate CD4+ cells (T helper cells) and OX8 conjugated to FITC to enumerate CD8+ cells (T suppressor/cytotoxic cells). For both the CD4+ and CD8+ cells, a double label with OX19 was used. OX33 conjugated to FITC was used to enumerate CD45+ (B lymphocytes). Following the initial staining with antibody and washing with staining buffer, the DNA specific fluorescent stain propidium iodide (PI) was added to each well as a viability stain. Following a 5 minute incubation with PI, the cells were washed once with staining buffer and then enumerated on a Coulter Epics XL-MCL Flow Cytometer. At least 5,000 cells were counted for each sample."

Describe any other examinations.

Briefly describe the positive control data cited, and its acceptability for use with the current study. Criteria for acceptability include the positive demonstration of sensitivity of the test methods to detect changes in the measured parameters.

List parameters that were analysed and the statistical methods used; include a statement that the Reviewer considers the analyses used to be appropriate. If inappropriate, provide alternative/rationale.

In this field, you can enter any information on materials and methods, for which no distinct field is available, or transfer free text from other databases. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

Note: One rich text editor field each is provided for the MATERIALS AND METHODS and RESULTS section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry.

Record effect levels, based on different endpoints and/or separated for for males and females. Copy this block of fields as appropriate.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Water consumption may not be specifically requested under the respective test guideline, unless the substance was administered in the drinking water.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Indicate whether any treatment-related effects were observed. In below field "Details on results", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

Describe the effects by dose level for each of the previous fields answered "yes". If answered "no effects", you may provide any further explanations, e.g. stating that effects were observed, but considered negligible and not of biological or statistical significance (to be explained why).

Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Relate treatment-related findings to any histological findings where appropriate.

Particularly with comprehensive data, include a table in the rich text field "Any other information on results incl. tables" and refer to respective table no., e.g. "see Table 1" (use predefined table if any). Narrative accompanying such tabular data should address the toxicological significance of the results and not repeat what is presented in the table(s).

NOTE: Depending on the regulatory programme some form of a table(s) may be mandatory.

Explanations:

- CLINICAL SIGNS AND MORTALITY: Describe the effects by dose level as stated above. Clinical signs include gross observations for behaviour and appearance ("cage-side observations"). Note when signs were first observed and if they were reversible. For mortalities the cause of death should be indicated.

- BODY WEIGHT AND WEIGHT GAIN: Describe the effects by dose level as stated above.

- FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Describe the effects by dose level as stated above.

- FOOD EFFICIENCY: Describe the effects by dose level as stated above.

- WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Describe the effects by dose level as stated above. Water consumption may not be specifically requested under the respective test guideline, unless the substance was administered in the drinking water.

- OPHTHALMOSCOPIC EXAMINATION: Describe the effects by dose level as stated above.

- HAEMATOLOGY: Describe the effects by dose level as stated above.

- CLINICAL CHEMISTRY: Describe the effects by dose level as stated above.

- URINALYSIS: Describe the effects by dose level as stated above.

- GROSS PATHOLOGY: Describe the effects by dose level as stated above. Give absolute and relative organ weights as appropriate and relate to any histological changes. Limit text to integration of findings and highlights and refer to respective table no. (use predefined table if any).

- CELL VIABILITIES: Describe the effects by dose level as stated above. Specify organ (spleen, thymus, bone marrow) and describe the effects at the different doses.

- HUMORAL IMMUNITY EXAMINATIONS: Describe the effects by dose level as stated above.

- SPECIFIC CELL-MEDIATED IMMUNITY: Describe the effects by dose level as stated above.

- NON-SPECIFIC CELL-MEDIATED IMMUNITY: Describe the effects by dose level as stated above.

- OTHER FUNCTIONAL ACTIVITY ASSAYS: Describe the effects by dose level as stated above.

- OTHER FINDINGS: Describe the results of any other examinations or include a cross-reference in field "Cross-reference to same study" to indicate that specific results of the same study are described in another chapter.

In this field, you can enter any other remarks on results. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

Note: Both the "Materials and methods" section and "Results" section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry.

In this field, you can enter any overall remarks or transfer free text from other databases. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

Note: One rich text editor field each is provided for the MATERIALS AND METHODS and RESULTS section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry.

Attach any background document that cannot be inserted in any rich text editor field, particularly image files (e.g. an image of a structural formula).

Copy this block of fields for attaching more than one file.

If required, an electronic copy of the full study report can be attached as WORD, pdf or other document type, which will not be integrated in any report, but must be handled as separate files.

Note: In the export administration you can indicate whether the attached files should be included in the data export or not.

Enter any conclusions if applicable.

If required by the respective national/regional programme, briefly summarise the relevant aspects of the study including the conclusions reached. If a specific format is prescribed, upload the respective freetext template if available from the drop-down list or copy it from the corresponding document.

Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

A Cross-reference to other study or other studies can be included which are considered relevant in the interpretation of the test results, e.g. for supporting the conclusion that an effect observed was not substance-related. Indicate the respective chapter(s) and record ID(s) and enter relevant explanatory text.

Such cross-references may be useful if it is considered relevant to discuss other results at the summary level of a single study. It should be noted that the overall appraisal of results from different studies is normally done in the hazard or risk assessment.

Note that any such cross-reference may become useless if a record is either printed or exchanged on its own.

Enter a full short description of the most relevant endpoint data. This includes in principle the summary information that is compiled e.g. in the OECD Full SIDS Summary format or other endpoint summary formats. Provide only the most relevant details, which could be, depending on the cases, the test guideline used, test organism and exposure duration. Normally no reliability score needs to be indicated as it can be assumed that the studies identified are valid (reliability score 1 or 2). If this is not the case (for instance if the reliability of a published study cannot be assigned or if several less valid studies are used for a weight of evidence analysis), the reliability indicators should be specified.

Also several key studies can be referenced as applicable. However, the characterisation of the endpoint data should be kept as concise as possible. Examples of what could be entered here are as follows:

- Melting point: 54.6-55.8 °C at 1,013 hPa

- Water solubility: completely miscible

- pH: 6.9 (80 mg/l water) at 20°C (OECD TG105)

- Oxidation reduction potential: no data available

- Phototransformation in air: T1/2 = 9.32 x 10-2 yr (sensitizer: OH radical) (AOP Win v 1.86)

- Biodegradation in water: screening tests: Not readily biodegradable: 0 - 8% (BOD) in 28 days, 0 - 1% (HPLC) in 28 days (OECD TG 301C)

- Short-term toxicity to fish:

LC50 (96h) < 100 mg/l for Pimephales promelas (OECD TG 203)

LC50 (48h) = 3.2 mg/l for Oryzias latipes (OECD TG 203)

- Acute toxicity:

Dermal: LD50: > 2,000 mg/kg for rat (limit test)

- Genetic toxicity:

In vitro:

Gene mutation (Bacterial reverse mutation assay / Ames test): S. typhimurium TA 100: positive with and without metabolic activation; TA 1535: positive without metabolic activation (equivalent to OECD TG 471)

In this rich text field, describe the assessment you have made for the given endpoint. Provide the rationale for the choice of the key study(ies) and the choice of the key parameter that, according to your judgement, characterise the endpoint. This includes a discussion of the key information identified and in some instances of studies which are considered to be unreliable, but give critical results. A discussion as to why they were discarded in favour of other studies should then be included. Vice versa, a weight of evidence analysis based on less reliable data or use of published data, the reliability of which cannot be judged because of limited reporting, should be justified.

If several studies were identified to be relevant for the assessment, discuss possible reasons for differing results if any, e.g. differences in purity / impurities of the test substance used, differences in the methods and test conditions, etc.

Under this main heading, fields are subsumed for identifying the purpose of the record (e.g., "key study"), the type of result (e.g., "experimental study"), data waiving indication (if any), reliability indication, and flags for indicating the regulatory purpose envisaged and/or any confidentiality restrictions. This kind of data characterise the relevance of a study summary and are therefore displayed on top of each Endpoint Study Record. For detailed guidance, refer to chapter D.4.7.7.1 Administrative data.

Indicate the bibliographic reference of the study report or publication the study summary is based on. Always enter the primary reference in the first block of fields (i.e. Sort no. = 1), if there are more than one reference to be cited. Copy this block of fields for specifying any other references related to this record (e.g. report of a preliminary study or other documentation). If results of a study report have been published, indicate the full citation of that publication(s) in addition to the reference of the original study.

Select appropriate indication for data access. Enter "Not applicable" if the summary consists of information that is commonly accessible such as guidance on safe use.

Indicate as appropriate. Note: "yes" should be selected only if "Data submitter is data owner" or "Data submitter has Letter of Access". Options "yes, but willing to share" or "yes, but not willing to share" may be relevant for specific regulatory programmes where the submitter is requested to indicate whether he is willing to share studies (e.g. with vertebrates).

In the supplementary remarks field, include an explanation as appropriate, i.e. justification for denial of sharing the corresponding study or refer to a document attached that provides justification (e.g. "for justification see attached document X")

A cross-reference can be included to indicate that the same study is recorded in another record. Indicate the respective chapter and record ID and enter relevant explanatory text. This may be useful if specific endpoints of a given study are described in another chapter (e.g. results on reproduction toxicity in case of a combined repeated dose / reproduction toxicity study) or if more than one experiment is described by the same study report, but included in separate records.

Check with the relevant guidance document whether all the methodology details must be repeated or whether a cross-reference to the same study in another chapter may suffice.

Note that any such cross-reference may become useless if a record is either printed or exchanged on its own.

Indicate the type of effects studied. As appropriate, include further specification in the supplementary remarks field.

In the supplementary remarks field, include any relevant remarks, e.g. indicate which data point or findings the special study was intended to address if applicable. If the results recorded are part of a study recorded in another record/section (e.g. Repeated dose toxicity), include a note in field "Cross-reference to same study" and refer to that summary.

Indicate if study was in vivo or in vitro test. If in vitro test, describe study design in field "Any other information on materials and methods incl. tables". If a specific template for in vitro assays is provided include the data in that template instead.

If the study recorded gives useful information on one or several of the classic endpoints, select the endpoint(s) addressed from the picklist. Copy this field as appropriate.

Indicate according to which test guideline the study was conducted. If no test guideline was explicitly followed, but the methodology used is equivalent or similar to a specific guideline, you can indicate so in the "Qualifier" subfield preceding the field "Guideline".

Copy this block of fields for specifying more than one guideline (e.g. US EPA in addition to OECD guideline).

If no guideline was followed, include a description of the principles of the test protocol or estimated method used in the study. Details should be entered in appropriate distinct fields of section MATERIALS AND METHODS if available. Also provide a justification for using this method if appropriate.

If an estimation method was used (to be indicated in field "Test result type") state the equation(s) and/or computer software or other methods applied to calculate the value(s).

Indicate whether the study was conducted following Good Laboratory Practice or not. Select "yes (incl. certificate)" if a GLP certificate of a test facility is available. Select "yes" if a GLP compliance statement is available, but no information on a GLP certificate. You can give an explanation in the supplementary remarks field, e.g. for explaining why GLP was not complied with or for specifying which (national) GLP was followed.

Indicate if the test material used in the study is equivalent to the submission substance identity. If "yes" is selected, the corresponding identity is automatically entered in the subsequent block of fields "Test material identity".

If "no" is selected, identify the test material in the subsequent block of fields "Test material identity". In this case, also make sure that the information entered in field "Study result type" is consistent, i.e. "read-across from supporting substance (structural analogue or surrogate)".

NOTE: If a completed record is used for another submission, you may have to update both fields "Study result type" and "Test material equivalent to submission substance identity".

If the identity of the test material used for this study is not included in this block of fields automatically, indicate the identity for one or more appropriate identifiers, e.g. CAS number, CAS name, IUPAC name. Copy this block of fields as appropriate.

If another than the submission substance identity was selected erraneously, go back to field "Test material equivalent to submission substance identity" and select "yes". This will prompt automatic entry of the respective identifiers.

Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Note that any information that can be claimed confidential should be included in the subsequent field "Confidential details on test material".

Explanations:

- Name of test material (as cited in study report): only if different from any other identifiers provided in the preceding fields.

- Molecular formula (if other than submission substance): specify

- Molecular weight (if other than submission substance): specify

- Smiles notation (if other than submission substance): provide if available

- InChl (if other than submission substance): provide if available

- Structural formula attached as image file (if other than submission substance): see Fig.: only if different from submission substance. Indicate Fig. no. if a file is attached in field "Attached document", e.g. state "see Fig. 1".

- Substance type: indicate whether pure active substance, technical product, formulation or other.

- Physical state: indicate "gas", "solid" or "liquid" only if different from submission substance or if substance can occur in different physical states.

- Analytical purity: specify in %

- Impurities (identity and concentrations): specify

- Composition of the test material, percentage of components: specify if applicable

- Isomers composition: specify if applicable

- Purity test date: provide if available

- Lot/batch No.: provide if available

- Expiration date of the lot/batch: provide if available

- Radiochemical purity (if radiolabelling): specify if applicable

- Specific activity (if radiolabelling): specify if applicable

- Locations of the label (if radiolabelling): specify if applicable

- Expiration date of radiochemical substance (if radiolabelling): specify if applicable

- Storage condition of test substance: specify if applicable

- Stability under test conditions: indicate if available

Enter any confidential information on the test material in this separate field. Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Explanations:

- Analytical purity: specify in %

- Impurities (identity and concentrations): specify

- Composition of the test material, percentage of components: specify if applicable

- Purity test date: provide if available

- Lot/batch No.: : provide if available

- Expiration date of the lot/batch: : provide if available

- Isomers composition: specify if applicable

Select as appropriate. For in vitro tests, indicate the species used as source of the test system. If not available from picklist, select "other" and specify.

NOTE: Although species "human" is provided in the picklist for specifying the source of in vitro test systems as applicable, human data should be reported in an appropriate subsection of section "Exposure related observations".

Select as appropriate. If not available from picklist, select "other" and specify.

Select as appropriate.

Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Explanations:

- Housing: describe housing conditions. Indicate whether individual metabolism cages were used.

- Diet: Describe type of diet (e.g. conventional laboratory diet / caloric restriction) and whether it was provided ad libitum.

- Water: Describe type (e.g. drinking water) and whether it was provided ad libitum.

- IN-LIFE DATES: If required, specify the in-life dates (i.e. the phase of a study following treatment in which the test system is alive/growing).

Select as appropriate. If not available from picklist, select "other" and specify.

Select "unchanged (no vehicle)" if none was used or select vehicle used if any. If not available from picklist, select "other" and specify.

Note that some of the vehicles provided in this list are used for specific routes of administration only.

Select freetext template for the respective route of administration and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Indicate whether the doses or concentrations were analytically verified.

For robust study summaries or as requested by the regulatory programme, include a short description on the method of analysis in the supplementary remarks field. If any problems occurred in any of these procedures, then they should be reported in more detail. If this could have affected the veracity or conclusions of the study, discuss this in field "Rationale for reliability incl. deficiences".

Further route-dependent information to be included:

- For oral studies: State whether the analytical data indicated that the variance between nominal and actual dosage (if diet is route of administration) or concentrations (for drinking water study) was acceptable.

If diet is the route of administration, briefly record when and at what dose levels the dosage analyses were made and include the results (range of values) of (i) Homogeneity analysis, (ii) Stability analysis and (iii) Concentration analysis.It may be appropriate to include a cross-reference to another study in which stability analysis was performed and reported. If so, a justification should also be included briefly explaining the rationale of referring to another study.

- For inhalation studies: State whether the analytical data indicated that the variance between nominal and actual concentrations was acceptable.

- For dermal studies: State whether the analytical data indicated that the variance between nominal and actual concentrations of the test substance in the vehicle was acceptable.

Indicate duration in days, weeks or months, e.g. "28 days" or "18 months".

Indicate the frequency of the administration of doses to the test animals (e.g., "daily, 7 days each week"). Use of non-standard dosing regime (e.g. a five-day per week regime) should be justified.

Indicate observation period (in days, weeks, months) after last exposure to the test material. Specify, if there are differences for treatment and recovery groups or other individual groups.

Indicate the dose or concentration levels applied and the basis of quantity used. Copy this block of fields if the dose/concentration levels were determined on more than one basis of quantity as appropriate.

Enter value or specify according to dose if different number of animals per dose, e.g. "10 in each dose group of main study; 10 f and 5 m in interim sacrifice group". Also specify number of animals in recovery group if applicable.

For robust study summaries or as requested by the regulatory programme, also provide a detailed table on the animal assignment and refer to respective table no. (use predefined table if any).

Indicate whether and what type of concurrent control groups were used. If not available from picklist, select "other" and specify. Copy field if more than one type of control was used.

Include details on the study design as appropriate.

Include details on the examinations performed.

Briefly describe the positive control data cited, and its acceptability for use with the current study. Criteria for acceptability include the positive demonstration of sensitivity of the test methods to detect changes in the measured parameters.

In this field, you can enter any information on materials and methods, for which no distinct field is available, or transfer free text from other databases. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

Note: One rich text editor field each is provided for the MATERIALS AND METHODS and RESULTS section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry.

Describe the results.

If the results recorded are part of a study recorded in another record/section (e.g. Repeated dose toxicity), include a note in field "Cross-reference to same study" and refer to that summary.

In this field, you can enter any other remarks on results. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

Note: Both the "Materials and methods" section and "Results" section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry.

In this field, you can enter any overall remarks or transfer free text from other databases. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

Note: One rich text editor field each is provided for the MATERIALS AND METHODS and RESULTS section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry.

Attach any background document that cannot be inserted in any rich text editor field, particularly image files (e.g. an image of a structural formula).

Copy this block of fields for attaching more than one file.

If required, an electronic copy of the full study report can be attached as WORD, pdf or other document type, which will not be integrated in any report, but must be handled as separate files.

Note: In the export administration you can indicate whether the attached files should be included in the data export or not.

Enter any conclusions if applicable.

If required by the respective national/regional programme, briefly summarise the relevant aspects of the study including the conclusions reached. If a specific format is prescribed, upload the respective freetext template if available from the drop-down list or copy it from the corresponding document.

Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

A Cross-reference to other study or other studies can be included which are considered relevant in the interpretation of the test results, e.g. for supporting the conclusion that an effect observed was not substance-related. Indicate the respective chapter(s) and record ID(s) and enter relevant explanatory text.

Such cross-references may be useful if it is considered relevant to discuss other results at the summary level of a single study. It should be noted that the overall appraisal of results from different studies is normally done in the hazard or risk assessment.

Note that any such cross-reference may become useless if a record is either printed or exchanged on its own.