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Diss Factsheets

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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented GLP-Study according to OECD Guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes (incl. QA statement)
Type of assay:
micronucleus assay

Test material

Constituent 1
Reference substance name:
3-Chlor-2-methylanilin
IUPAC Name:
3-Chlor-2-methylanilin

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld
- Age at study initiation: 8 Weeks
- Weight at study initiation: males ca. 34.7 g (30-38 g), females ca. 28 g (23-33 g)
- Assigned to test groups randomly: yes, under following basis: randomization schedule 93.844 and 93.845
- Fasting period before study:
- Housing: air-conditioned rooms in macrolon cages (type 3), on softwood granulate in groups of 5 animals
- Diet (e.g. ad libitum): rat/mice Altromin 1324 (Altromin-GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 50+/-20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
- Vehicle(s)/solvent(s) used: sesame oil
- Concentration of test material in vehicle: 8%
- Amount of vehicle (if gavage or dermal): 10 ml/kg BW
Frequency of treatment:
Once
Post exposure period:
12, 24 and 48 h
Doses / concentrations
Remarks:
Doses / Concentrations:
800 mg/kg bw
Basis:
nominal in diet
No. of animals per sex per dose:
5
Control animals:
yes
Positive control(s):
Cyclophosphamide (Endoxan (R) Batch No. 060798))

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
All animals survived after application of 800 mg per kg bodyweight. The following signs of toxicity were observed: uncoordinated gait, forward crawling, prone position, palpbreal fissure narrow, reduced placing reflex, spontaneous activity decreased, coat bristling, cyanosis. 12 h after application all animals were free of clinical signs of toxicity. The dissection of the animals revealed no test substance related macroscopic findings. ....
The incidence of micronucleated polychromatic and normochromatic erythrocytes in the dose groups of 3-Chlor-2-methylanilin was within the normal range of the negative control groups. .....
Summarizing it can be stated that administration of 3-chlor-2-methylanilin did not lead to substancial increase of micronucleated polychromatic erythrocytes and is not mutagenic in the micronucleus test.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
3-chlor-2-methylanilin is not mutagenic in the micronucleus test.