Registration Dossier
Registration Dossier
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EC number: 617-898-0 | CAS number: 866462-52-4
Toxicological information
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July/August 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The study was performed in compliance with the following regulations or guidelines:
• OECD Guidelines for Testing of Chemicals No. 471 (1997) "Bacterial Reverse Mutation Test"
• Method B13/14 of Commission Regulation (EC) number 440/2008 of 30 May 2008.
• USA, EPA OCSPP harmonized guideline 870.5100 - Bacterial Reverse Mutation Test
• Japanese Ministry of Economy, Trade and Industry, Japanese Ministry of Health, Labour and Welfare and Japanese Ministry of Agriculture, Forestry and Fisheries
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 617-898-0
- EC Number:
- 617-898-0
- Cas Number:
- 866462-52-4
- Molecular formula:
- C17 H21 N O5
- IUPAC Name:
- 617-898-0
- Test material form:
- solid: particulate/powder
- Details on test material:
- Off white powder
Constituent 1
- Specific details on test material used for the study:
- Batch 18126644
Method
- Target gene:
- Salmonella typhimurium : TA1537 - TA98 - TA1535 - TA100
Escherichia coli : WP2uvrA-
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1537
- Details on mammalian cell type (if applicable):
- obtained from:
• University of California, Berkeley, on culture discs, on 04 August 1995
• British Industrial Biological Research Association, on a nutrient agar plate, on 17 August 1987 - Additional strain / cell type characteristics:
- other: Genotype : his C 3076; rfa-; uvrB-: frame shift mutations
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- The bacteria used in the test were obtained from:
• University of California, Berkeley, on culture discs, on 04 August 1995
• British Industrial Biological Research Association, on a nutrient agar plate, on 17 August 1987 - Additional strain / cell type characteristics:
- other: Genotype : his D 3052; rfa-; uvrB-;R-factor
- Species / strain / cell type:
- S. typhimurium TA 1535
- Details on mammalian cell type (if applicable):
- The bacteria used in the test were obtained from:
• University of California, Berkeley, on culture discs, on 04 August 1995
• British Industrial Biological Research Association, on a nutrient agar plate, on 17 August 1987 - Additional strain / cell type characteristics:
- other: Genotype : his G 46; rfa-; uvrB-: base-pair substitutions
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- The bacteria used in the test were obtained from:
• University of California, Berkeley, on culture discs, on 04 August 1995
• British Industrial Biological Research Association, on a nutrient agar plate, on 17 August 1987 - Additional strain / cell type characteristics:
- other: Genotype : his G 46; rfa-; uvrB-;R-factor
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- The bacteria used in the test were obtained from:
• University of California, Berkeley, on culture discs, on 04 August 1995
• British Industrial Biological Research Association, on a nutrient agar plate, on 17 August 1987 - Additional strain / cell type characteristics:
- other: Genotype : his G 46; rfa-; uvrB-;R-factor
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- The maximum concentration was 5000 μg/plate (the maximum recommended dose level).Eight concentrations of the test item (1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate) were assayed in triplicate against each tester strain, using the direct plate incorporation method.
- Vehicle / solvent:
- Dimethylsulfoxyde
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Remarks:
- triplicate
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Azepan was considered to be non-mutagenic under the conditions of this test.
- Executive summary:
Azepan was considered to be non-mutagenic under the conditions of this test.
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