3-chloro-o-toluidine

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:

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

Test material information

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.