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Toxicological information

Genetic toxicity: in vivo

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes

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.