Registration Dossier
Registration Dossier
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EC number: 203-875-9 | CAS number: 111-49-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 09 MAR 1999 to 18 JUN 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (according to OECD 471).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- not specified
- GLP compliance:
- yes
- Remarks:
- in compliance with US EPA FIFRA (40CFR Part 160) and/or EPA TSCA (49CFR 792) Good Laboratory Practice Standards
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Perhydroazepine
- EC Number:
- 203-875-9
- EC Name:
- Perhydroazepine
- Cas Number:
- 111-49-9
- Molecular formula:
- C6H13N
- IUPAC Name:
- azepane
- Details on test material:
- - Name of test material (as cited in study report): Hexamethyleneimine (HMI)
- Substance type: colorless liquid
- Physical state: fluid
- Analytical purity: 99.5 %
- Impurities (identity and concentrations): water
- Stability under test conditions: the test substance appeared to be stable under the conditions of the study, no evidence of instability was observed.
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- other: S. typhimurium TA97a
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 mix
- Test concentrations with justification for top dose:
- 0, 10, 50, 100, 500, 1000, 2500, 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: sterile water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: TA 97a: 9,10-Dimethyl-1,2-benzanthracene; TA 98, TA 100, TA 1535, E.coli WP2: 2-Aminoanthracene
- Remarks:
- with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: TA 97a: ICR 191 Acridine mutagen; TA 98: 2NF; TA 100, TA 1535: Sodium azide; E.coli WP2: N-Ethyl-N-nitro-N-nitroguanidine
- Remarks:
- without metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: reduction of the microcolony background lawn and concentration-related reduction in the mean number of revertants per plate - Evaluation criteria:
- A test substance was classified as positive (i.e. mutagenic) if the mean number of revertants in any strain at any test substance concentrationw as at least 2 times greater than the mean of concurrent vehicle control and there was a concentration related increase in the mean revertants per plate in the same strain.
A test substance was classified as negative (i.e. not mutagenic) if there were no test substance concentrations with a mean number of revertants that was at least 2 times greater than the mean of concurrent vehicle control and there was no concentration related increase in the mean revertants per plate in that same strain.
Results not meerinig criteria for positive or negative classification were evaluated using scientific judgment and experience and may have been reported equivocal. - Statistics:
- Data for each tester strain were evaluated independently. For each tester strain, the mean number of revertants and the standard deviation at each concentration in the presence and absence of exogenous metabolic activation system were calculated.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at concentration of 1000 µg/plate and higher (without metabolic activation) or in the highest concentration (with metabolic activation)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at concentration of 1000 µg/plate and higher (without metabolic activation) or in the two highest concentrations (with metabolic activation)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at concentration of 1000 µg/plate and higher (without metabolic activation) or in the two highest concentrations (with metabolic activation)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- other: S. typhimurium TA97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at concentration of 1000 µg/plate and higher (without metabolic activation) or in the two highest concentrations (with metabolic activation)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at concentration of 1000 µg/plate and higher (without metabolic activation) or in the two highest concentrations (with metabolic activation)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no precpipitation occurred
COMPARISON WITH HISTORICAL CONTROL DATA: the mean number of revertants scored for the solvent control of each strain was within the laboratory´s historical data range. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The appropriate reference mutagenes for each tester strain showed distinct positive mutagenic effects.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item showed no mutagenic activity in a plate incorporation assay with and without metabolic activation. - Executive summary:
Mutagenic activity of the test item was investigated in Salmonella typhimurium strains TA 1535, TA 97a, TA98 and TA100 as well as Escherichia coli strain WP2 uvrA with (induced rat liver S9 mix) and without metabolic activation at concentrations of 0, 10, 50, 100, 500, 1000, 2500 and 5000 µg/plate using the plate incorporation assay.
The test item did not reveal any mutagenic activity under the conditions tested. The appropriate reference mutagenes showed distinct positive mutagenic effects.
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