3-chloroaniline

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: scientifically acceptable and sufficient documented

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)

Principles of method if other than guideline:

In a bone marrow micronucleus evaluations, male F344/N rats received three intraperitoneal injections of m-chloroaniline dissolved in corn oil at 24-hour intervals. The total dosing volume was 0.4 mL. Solvent control rats were injected with corn oil only; the positive control animals received injections of 25 mg/kg cyclophosphamide. Twenty-four hours after the final injection, the animals were killed and smears of the bone marrow cells obtained from the femurs were prepared. Air-dried smears were fixed and stained; 2,000 polychromatic erythrocytes (PCEs) were scored for frequency of micronucleated cells in each of five animals per dose group. In addition, the percentage of PCEs among the total erythrocyte population in the bone marrow was scored for each dose group as a measure of toxicity.

GLP compliance:

yes

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

3-chloroaniline

EC Number:

203-581-0

EC Name:

3-chloroaniline

Cas Number:

108-42-9

Molecular formula:

C6H6ClN

IUPAC Name:

3-chloroaniline

Test material form:

other: liquid

Details on test material:

m-chloroaniline, a pale yellow liquid, was identified by infrared spectroscopy; each spectrum was consistent with a literature reference (Aldrich Library of FT-IR Spectra, 1985) and with that expected for the chemical structure. Gas chromatography indicated a purity greater than 99%.
Boiling Point: 230.5°C
Density at 22°C: 1.210
Vapor pressure: <0.1 mmg Hg at 30°C
Solubility: practically insoluble in water, soluble in organic solvents

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male

Administration / exposure

Route of administration:

intraperitoneal

Duration of treatment / exposure:

three intraperitoneal injections at 24-hour interval

Frequency of treatment:

three intraperitoneal injections at 24-hour interval

Post exposure period:

twenty-four hours after the final injection, the animals were killed

Doses / concentrations

Remarks:

Doses / Concentrations:
25 or 1000 mg/kg bw
Basis:
actual ingested

No. of animals per sex per dose:

5 animals per dose

Control animals:

yes, concurrent vehicle

Examinations

Tissues and cell types examined:

bone marrow cells of F344/N rats

Results and discussion

Test results

Sex:

male

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Results from the in vivo rat bone marrow micronucleus tests with m-chloroaniline were negative. In the single trial performed with male rats, only two dose groups survived, but these were sufficient for a valid test; no significant increase in the number of micronucleated erythrocytes was observed in rats.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative

Executive summary:

In a bone marrow micronucleus evaluations, male F344/N rats received three intraperitoneal injections of m-chloroaniline dissolved in corn oil at 24-hour intervals. The total dosing volume was 0.4 mL. Solvent control rats were injected with corn oil only; the positive control animals received injections of 25 mg/kg cyclophosphamide. Twenty-four hours after the final injection, the animals were killed and smears of the bone marrow cells obtained from the femurs were prepared. Air-dried smears were fixed and stained; 2,000 polychromatic erythrocytes (PCEs) were scored for frequency of micronucleated cells in each of five animals per dose group. In addition, the percentage of PCEs among the total erythrocyte population in the bone marrow was scored for each dose group as a measure of toxicity.

The results from the in vivo rat bone marrow micronucleus tests with m-chloroaniline were negative.