Registration Dossier
Registration Dossier
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EC number: 202-150-4 | CAS number: 92-36-4
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: genome mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP and Guideline study. Well documented.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 4-(6-methylbenzothiazol-2-yl)aniline
- EC Number:
- 202-150-4
- EC Name:
- 4-(6-methylbenzothiazol-2-yl)aniline
- Cas Number:
- 92-36-4
- Molecular formula:
- C14H12N2S
- IUPAC Name:
- 4-(6-methyl-1,3-benzothiazol-2-yl)aniline
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd. Manston , Kent
- Age at study initiation: 5-8 wks
- Weight at study initiation: 23-30 (male), 20-26 (female)
- Assigned to test groups randomly: yes
- Fasting period before study:
- Housing: groups of five by sex in solid floor polypropylene cage with saw dust bedding.
- Diet (e.g. ad libitum): Rat and mouse expanded diet no. 1, special diet services ltd. Witham, Essex, U.K.
- Water (e.g. ad libitum): drinking water
- Acclimation period: min. 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 44-46
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: arachis oil supplied by Philip Harris Scientific
- Concentration of test material in vehicle: 100 / 200 mg/ml (Range finding), 50-200 mg/l (Main study)
- Lot/batch no. (if required): Co/730
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
2000 mg/kg
Basis:
nominal conc.
Oral an IP, Range finding study and Main Study
- Remarks:
- Doses / Concentrations:
1000 mg/kg
Basis:
nominal conc.
Oral an IP, Range finding study and Main Study
- Remarks:
- Doses / Concentrations:
500 mg/kg
Basis:
nominal conc.
Main Study
- No. of animals per sex per dose:
- 5
- Control animals:
- other: vehicle and positive controls
- Positive control(s):
- cyclophosphamide
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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