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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
1994

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

Constituent 1
Chemical structure
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

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