Registration Dossier

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: secondary source - similar to guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982

Materials and methods

Principles of method if other than guideline:
Method: other: according to EMS, Toxicol. Appl. Pharmacol. 22, 269-275 (1972): 4 rats/sex/dose/treatmrnt time, killed 6, 24 and 48 hrs after dosing
chromosome aberration frequencies were determined in the bone marrow cells from rats exposed to 2-chlorotoluene administered per os either as acute (single dose) or a subacute (five daily doses) exposure. three doses (300 mg/kg, 100 mg/kg and 30 mg/kg) were investigated and marrow was harvested at various times after treatment with colchicine (according to EMS, Toxicol. Appl. Pharmacol. 22, 269-275 (1972): 4 rats/sex/dose/treatmrnt time, killed 6, 24 and 48 hrs after dosing).
GLP compliance:
yes
Type of assay:
chromosome aberration assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
once
Frequency of treatment:
single dose
Post exposure period:
6, 24 or 48 hours
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 30, 100 or 300 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
24 animals per dose (8 of each killed 6, 24 and 48 hours after dosing)
Control animals:
yes

Examinations

Tissues and cell types examined:
bone marrow cells of rats

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

The test article did not induce significant increases in structural aberration frequency at any of the dose-level/kill-time combinations for either sex, when the dosed animals were compared to the corresponding negative controls.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Executive summary:

Chromosome aberration frequencies were determined in the bone marrow cells from rats exposed to 2-chlorotoluene administered per os either as acute (single dose) or a subacute (five daily doses) exposure. Three doses (300 mg/kg, 100 mg/kg and 30 mg/kg) were investigated and marrow was harvested at various times after treatment with colchicine.

result: negative, 2-chlorotoluene does not induce chromosomal aberrations in rat bone marrow cells in vivo