Registration Dossier
Registration Dossier
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EC number: 221-639-3 | CAS number: 3173-53-3
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Reference Type:
- publication
- Title:
- Screening-Level Hazard Characterization, Sponsored Chemical Cyclohexyl isocyanate, Supporting Chemical Cyclohexanamine
- Author:
- U.S.EPA
- Year:
- 2 010
- Bibliographic source:
- U.S. Environmental Protection Agency Hazard Characterization Document
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Remarks:
- no information on GLP in the data source
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Cyclohexyl isocyanate
- EC Number:
- 221-639-3
- EC Name:
- Cyclohexyl isocyanate
- Cas Number:
- 3173-53-3
- Molecular formula:
- C7H11NO
- IUPAC Name:
- isocyanatocyclohexane
1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Metabolic activation system:
- 30% Rat S9, 10% Hamster S9, 30% Hamster S9
- Test concentrations with justification for top dose:
- 0, 1, 3.3, 10, 20, 33, 50, 67, 100, 150, 200 and 333 µg/plate
- Vehicle / solvent:
- dimethyll sulfoxide
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-Aminoanthracene, 4-Nitro-O-Phenylenediamine
- Details on test system and experimental conditions:
- The number of samples = 3, unless samples marked toxic or contaminated were excluded from mean and SEM calculations
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 2-Aminoanthracene, 4-Nitro-O-Phenylenediamine
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 2-Aminoanthracene, 9-Aminoacridine
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 2-Aminoanthracene, 2-Nitrofluorene
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 2-Aminoanthracene, Sodium Azide
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 2-Aminoanthracene, Sodium Azide
Applicant's summary and conclusion
- Conclusions:
- Salmonella typhimurium
strains TA97, TA98, TA100, TA1535 and TA1538 were exposed to cyclohexyl isocyanate at
concentrations ranging from 0 to 333 µg/plate in the presence and absence of metabolic
activation. Positive controls were included. Cyclohexyl isocyanate was found to be equivocal
for mutagenicity in this assay.
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