Registration Dossier

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: OECD guideline not defined. No GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: other: Bone marrow micronucleus test
GLP compliance:
no
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: as prescribed by 1.1 - 1.4

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Duration of treatment / exposure:
2 administrations at an interval of 24 h.
Frequency of treatment:
no data
Post exposure period:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
2 x 177.5 or 355 mg/kg bw
Basis:

No. of animals per sex per dose:
10 animals-negative control.
10 animals - treatment with 2x 177.5 mg/kg.
10 animals - treatment with 2x 355 mg/kg.
Control animals:
yes

Examinations

Tissues and cell types examined:
Polychromatic erythrocytes from bone marrow.

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Vehicle controls validity:
valid

Any other information on results incl. tables

RS-Freetext:
negative

Applicant's summary and conclusion

Executive summary:

Employing the micronucleus test, p-Dichlorobenzene was investigated in male and female mice for a possible clastogenic effect on the chromosomes of bone marrow erythroblasts.

The treated mice recieved two intraperitoneal administrations at an interval of 24 hours.

6 hours after the second administration the femoral marrow was prepared. The doses of p-Dichlorobenzene were 2x 177.5 mg/kg and 2x355 mg/kg.

The animals treated with p-Dichlorobenzene showed no symptoms of toxicity after the administration.

No deaths related to the substance occured.

The ratio of polychromatic to normochromatic erythrocytes was slightly altered in the 2x355 mg/kg group.

No indications of a clastogenic effect of p-Dichlorobenzene were found after treatment with 2x 177.5 mg/kg and 355 mg/kg per os.