- abstract - [Reliability 4] - secondary literature - [Reliability 4] - documentation insufficient for assessment - [Reliability 4] - results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification - [Reliability 1 or 2] - results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification - [Reliability 2, 3 or 4] - results derived from a valid (Q)SAR model, but not (completely) falling into its applicability domain, with adequate and reliable documentation / justification - [Reliability 2 or 3] - results derived from a (Q)SAR model, with limited documentation / justification, but validity of model and reliability of prediction considered adequate based on a generally acknowledged source - [Reliability 2 or 3] - results derived from a valid (Q)SAR model, but not (completely) falling into its applicability domain, and documentation / justification is limited - [Reliability 3 or 4] - results derived from a (Q)SAR model, with limited documentation / justification - [Reliability 4] - other: - guideline study without detailed documentation - [Reliability 2] - guideline study with acceptable restrictions - [Reliability 2] - comparable to guideline study with acceptable restrictions - [Reliability 2] - test procedure in accordance with national standard methods with acceptable restrictions - [Reliability 2] - study well documented, meets generally accepted scientific principles, acceptable for assessment - [Reliability 2] - accepted calculation method - [Reliability 2] - data from handbook or collection of data - [Reliability 2] - significant methodological deficiencies - [Reliability 3] - unsuitable test system - [Reliability 3] - abstract - [Reliability 4] - secondary literature - [Reliability 4] - documentation insufficient for assessment - [Reliability 4] Condition 2: If 'Type of information' = '(Q)SAR': - results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation /
chromosome aberration study in mammalian cells] - EPA OTS 798.5500 (Bacterial DNA Damage or Repair Tests) - [in vitro DNA damage and/or repair study] - EPA OTS 798.5550 (DNA Damage and Repair, Unscheduled DNA Synthesis in Mammalian Cells In Vitro) - [in vitro DNA damage and/or repair study] - EPA OTS 798.5575 (Saccharomyces cerevisiae Mitotic Recombination Assay) - [in vitro DNA damage and/or repair study] - EPA OTS 798.5900 (In Vitro Sister Chromatid Exchange Assay in Mammalian Cells) - [in vitro DNA damage and/or repair study] - JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals - [genetic toxicity in vitro, other] - other: Version / remarks Text (2,000 char.) Display: Basic In this text you can enter any remarks as applicable, particularly: - To include any other title of the test guideline draft used, a subtitle, another version or update number and the year of update (For instance, different titles and/or numbers may exist for a given EU test guideline); - To indicate if the study was performed prior to the adoption of the test guideline specified; - To indicate if the methodology used was based on an extension of the test guideline specified; - To indicate what protocol was followed for methods that allow the optional determination of more than one parameter if this cannot be indicated in a distinct field of the Materials and methods section. Guidance for field condition: Condition: Field active only if 'Qualifier' is not 'no guideline ...' Deviations List sup. (picklist with remarks) Picklist values: - yes - no For robust study summaries or as requested by the regulatory programme, indicate if there are any deviations from the test guideline specified. If Guidance for field condition: Condition: Field active
application: formulated product seed treatment; solution in organic solvent seed treatment. OTHER SPECIFICS Provide any other relevant information needed for characterising the tested material. Specific details on test material used for the (confidential) Text template Display: Basic (Confidential) Freetext template: SOURCE OF TEST MATERIAL - Source and lot/batch No.of test material: - Expiration date of the lot/batch: - Purity test date: RADIOLABELLING INFORMATION (if applicable) - Radiochemical purity: - Specific activity: - Locations of the label: - Expiration date of radiochemical substance: STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL - Storage condition of test material: - Stability under test conditions: - Solubility and stability of the test substance in the solvent/vehicle: - Reactivity of the test substance with the solvent/vehicle of the cell culture medium: TREATMENT OF TEST MATERIAL PRIOR TO TESTING - Treatment of test material prior to testing: - Preliminary purification step (if any): - Final dilution of a dissolved solid, stock liquid or gel: - Final preparation of a solid: FORM AS APPLIED IN THE TEST (if different from that of starting material) TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable) Use this field for reporting specific details on the test material as used for the study if they differ from the starting material specified under 'Test material information'. This can include information on the pre-defined items, but not all or additional ones may be relevant. 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 Programme, Pesticides NAFTA or EU REACH) thereof. If applicable, relevant available information on the following items should be given: SOURCE OF TEST MATERIAL - Source and lot/batch No. of test material - Expiration date of the lot/batch - Purity test date: provide if available RADIOLABELLING INFORMATION - Radiochemical purity - Specific activity - Locations of the label - Expiration date of radiochemical substance
solution in organic solvent seed treatment. OTHER SPECIFICS Provide any other relevant information needed for characterising the tested material. Method Header 2 Target gene Text (2,000 char.) Display: Basic Indicate the target gene (HPRT, XPRT, TK, ATPase, other: specify) only if necessary to characterise the test system. Species / strain Block of fields (repeatable) Start Indicate the species and tester strain(s) used in the type of indicated in the respective field above. Copy this field block for each tester strain. Species / strain / cell type List sup. (picklist with remarks) Display: Basic Picklist values: - S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 - [bacteria] - S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 - [bacteria] - S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 - [bacteria] - S. typhimurium TA 1535 - [bacteria] - S. typhimurium TA 1537 - [bacteria] - S. typhimurium TA 1535 pSK1002 - [bacteria] - S. typhimurium TA 97 - [bacteria] - S. typhimurium TA 98 - [bacteria] - S. typhimurium TA 100 - [bacteria] - S. typhimurium TA 1538 - [bacteria] - S. typhimurium TA 102 - [bacteria] - S. typhimurium, other: - [bacteria] - E. coli WP2 - [bacteria] - E. coli WP2 uvr A - [bacteria] - E. coli WP2 uvr A pKM 101 - [bacteria] - E. coli, other: - [bacteria] - bacteria, other: - [bacteria] - Saccharomyces cerevisiae - [yeast] - yeast, other: - [yeast] - Chinese hamster Ovary (CHO) - [mammalian cell line] Select as appropriate. If not available from picklist, select 'other' and specify.
concentration, humidity level, temperature, if applicable: Additional strain / cell type characteristics List sup. (picklist with remarks) Display: Basic Picklist values: - DNA polymerase A deficient - acetyltransferase proficient - acetyltransferase deficient - nitroreductase deficient - p53 proficiency for cell - not applicable - other: - not specified For robust study summaries, indicate additional strain characteristics (e.g. only if necessary to characterise the test system. Otherwise, leave this subfield empty. Species / strain Block of fields (repeatable) End Cytokinesis (if used) Text (2,000 char.) Display: If a cytokinesis blocking substance (e.g. cytoB) was used, indicate its identity and its concentration and duration of cell exposure. Metabolic activation List (picklist) Display: Basic Picklist values: - with - with and without - without - not applicable - not specified Indicate whether metabolic activation was applied or not. Select 'not applicable' for mammalian cell lines when no exogenous metabolic system is required. Metabolic activation system Text template Display: Basic Freetext template: Type and composition of metabolic activation system: - source of S9 - method of preparation of S9 mix - concentration or volume of S9 mix and S9 in the final culture medium - quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability) For robust study summaries, specify metabolic activation system, if any. Indicate the type and composition of and acceptability criteria for the metabolic activation system used. Alternatively or in addition refer to appropriate table(s), which can be uploaded in the rich text field “Any other information on materials and methods incl. tables”. Use predefined table 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
Positive control substance List multi. list with remarks) Display: Basic Picklist values: - 2-acetylaminofluorene - triethylenemelamine - 3-methylcholanthrene - 4-nitroquinoline-N-oxide - 7,12-dimethylbenzanthracene - 9,10-dimethylbenzanthracene - 9-aminoacridine - 2-nitrofluorene - sodium azide - monomeric acrylamide - N-dimethylnitrosamine - N-ethyl-N-nitro-N-nitrosoguanidine - benzo(a)pyrene - congo red - colchicine - cumene hydroperoxide - cyclohexylamine - cyclophosphamide - cytosine arabinoside - ethylmethanesulphonate - ethylnitrosurea - furylfuramide - methylmethanesulfonate - mitomycin C - streptonigrin - vinblastine - other: - not specified If applicable, indicate which substance(s) was/were used as positive control(s). Multiple items can be selected. If different substances were used for tests with and without metabolic activation or for different tester strains or for the different treatment harvest schedules, include a remark in subfield 'Remarks'. If other than the reference substance(s) specified in the test guidelines was/were used, include a brief justification. Final concentration, conditions and durations of treatment and recovery periods. Note that the list of substances provided is not exhaustive. Remarks Text (255 char.) Display: Basic Enter any remarks related to the recorded controls as appropriate. Controls of fields (repeatable) End Details on test system and experimental conditions Text template Display: Detailed Freetext template: NUMBER OF REPLICATIONS: - Number of cultures per concentration (single, duplicate, triplicate) - Number of independent experiments 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
Display: Basic - not examined - not specified - other: Untreated negative controls validity List sup. (picklist with remarks) Display: Basic Picklist values: - valid - not valid - not applicable - not examined - not specified - other: Indicate whether test with untreated controls, if applicable (i.e. no vehicle and no test substance) is True negative controls validity List sup. (picklist with remarks) Display: Basic Picklist values: - valid - not valid - not applicable - not examined - not specified - other: Indicate whether test with true negative control(s) (i.e. substances with lack of genotoxicity) is valid. Positive controls validity List sup. (picklist with remarks) Display: Basic Picklist values: - valid - not valid - not applicable - not examined - not specified - other: Indicate whether test with positive control(s), i.e. substance(s) with known genotoxicity, is valid. Test results Block of fields (repeatable) End Additional information on results Text template Display: Detailed Freetext template: TEST-SPECIFIC CONFOUNDING FACTORS - Data on pH: - Data on osmolality: - Possibility of evaporation from medium: - Water solubility: - Precipitation and time of the determination: - Definition of acceptable cells for analysis: - Other confounding effects: RANGE-FINDING/SCREENING STUDIES (if applicable): Enter any additional information that could be relevant for evaluating this study summary. Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report.
remarks' and 'Executive summary' allow rich text entry. Attached background material Block of fields (repeatable) Start Attach any background document that cannot be inserted in any rich text editor particularly image files (e.g. an image of a structural formula). Copy this block of fields for attaching more than one file. Attached document Attachment (single) Display: Basic Upload file by clicking the upload icon. As appropriate, enter any additional information, e.g. language. The file name is displayed after uploading the document. Remarks Text (255 char.) Display: Basic As appropriate, include remarks, e.g. a description of the content of the attached document if the file name is not self-explanatory. Attached background material Block of fields (repeatable) End Attached full study report Attachment (multiple) Display: Basic If required, an electronic copy of the full study report can be attached as WORD, pdf or other document type. Illustration Image upload Display: Basic Upload file by clicking the upload icon. As appropriate, enter any additional information, e.g. language. The file name is displayed after uploading the document. Applicant's summary and conclusion Header 1 Key result Read-only Display: Basic This read-only field displays the key results flagged in the corresponding results table(s), if any.