Registration Dossier
Registration Dossier
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EC number: 221-130-6 | CAS number: 3010-02-4
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- , E. coli or S. typhimurium strain TA 102 not tested
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (diethylamino)acetonitrile
- EC Number:
- 221-130-6
- EC Name:
- (diethylamino)acetonitrile
- Cas Number:
- 3010-02-4
- Molecular formula:
- C6H12N2
- IUPAC Name:
- 2-(diethylamino)acetonitrile
- Details on test material:
- - Name of the test substance used in the study report: Diethylaminoacetonitril
- Physical state: Colorless to yellow liquid
- Storage:+ 4 °C to + 6 °C
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- - The Salmonella strains are checked for the following characteristics at regular intervals: deep rough character; UV sensitivity; ampicillin resistance.
- Histidine auxotrophy is automatically checked in each experiment via the spontaneous rate.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S-9 mix
- Test concentrations with justification for top dose:
- Fist Experiment: 0, 20, 100, 500, 2500 and 5000 µg/plate
2nd Experiment: TA 1535; TA 100; TA 1537: 0, 15, 30, 60, 120 and 250 µg/plate; TA 98: 0, 3, 6, 12, 25 and 50 µg/plate
3rd Experiment: 0, 6, 12, 25, 50 and 100 µg/plate - Vehicle / solvent:
- distilled water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, N-methyl-N'-nitro-N-nitrosoguanidine, 4-nitro-o-phenylendiamine, 9-aminoacridine chloride monohydrate
- Remarks:
- With S9: 2-aminoanthracene (all strains), Without S9: N-methyl-N-nitro-N-nitrosoguanidine (TA100, TA 1535), 4-nitro-o-phenylendiamine (TA 98), 9-aminoacridine chloride monohydrate (TA 1537)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: standard plate method and preincubation method
- 1st Experiment (standard plate test with and without S-9 mix)
- 2nd Experiment: (standard plate test with and without S-9 mix)
- 3rd Experiment: (preincubation test with and without S-9 mix)
DURATION
- Preincubation period: 20 min (preincubation test only)
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY: reduced his- background growth, decrease in the number of his+ revertants - Evaluation criteria:
- In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- No increase in the number of his+ revertants was observed both in the standard plate test and in the preincubation test, either without S-9 mix or after the addition of a metabolizing system.
A bacteriotoxic effect (reduced his- background growth, decrease in the number of his+ revertants) was observed depending on the strain and testconditions from about 25 µg - 250 µg/plate onward.
No test substance precipitation was found. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- negative
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