Registration Dossier
Registration Dossier
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EC number: 202-797-2 | CAS number: 99-88-7
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guidelinestudy and GLP in Japanese, relevant tables available
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 4-isopropylaniline
- EC Number:
- 202-797-2
- EC Name:
- 4-isopropylaniline
- Cas Number:
- 99-88-7
- Molecular formula:
- C9H13N
- IUPAC Name:
- 4-(propan-2-yl)aniline
- Test material form:
- not specified
- Details on test material:
- content 99.6 %
Constituent 1
Test animals
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- standard conditions
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- animals received orally 0, 60, 120, 249 mg/kg bw p-isopropylaniline diluted in corn oil twice 24 hours apart
- Duration of treatment / exposure:
- twice 24 hours apart
- Frequency of treatment:
- twice 24 hours apart
- Post exposure period:
- at least up to 3 hours after the second application
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 60, 120, 240 mg/kg bw
Basis:
other: twice 24 hours apart
- No. of animals per sex per dose:
- 5/sex/group
- Positive control(s):
- cyclophosphamid monohydrat
Examinations
- Tissues and cell types examined:
- mammalian erythrocytes
- Details of tissue and slide preparation:
- according to guideline
- Statistics:
- yes; according to Kastenbaum and Bowman; student's t-test; Williams' test
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- 1-3 hours post first application of 240 mg/kg bw: decrease in locomotor activity, ataxia
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
- Executive summary:
According to OECD TG 474 and GLP isopropylanilin was tested for the induction of micronuclei in rats. Male and female rats received 0, 60, 120, 240 mg/kg bw p-isoproylanilin twice 24 hours appart. The test substance was diluted in corn oil which served as negative control. As positive control cyclophosphamid monohydrate was included. At least 3 hours after the last application animals were killed for evaluation. According to the conditions of this test p-isopropylanilin did not induce micronuclei. The positive control was functional.
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