Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Adequacy of study:
other information

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EC Commission Directive 92/69/EEC Method B12 OECD Guideline No. 474
GLP compliance:
yes
Type of assay:
micronucleus assay

Test animals

Species:
other: Mouse/NMRI BR

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
Corn oil
No. of animals per sex per dose:
Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 500 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 1000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 2000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 2000 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 500 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 1000 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 2000 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 2000 mg/kg; No. of animals: 5; Sacrifice times: 48 hours

Results and discussion

Additional information on results:
Doses producing toxicity:
During the first 1.5 hours after dosing, all animals treated
at 2000 and 1000 mg/kg b.w. showed lethargy and hunched
posture and all animals except one female had a rough coat.
At 2000 mg/kg, one male and one female had closed eyes. All
animals treated with 500 mg/kg were lethargic.

Within 19 hours after dosing, a number of males and females
treated with 2000 mg/kg had a rough coat, hunched posture
and closed eyes. At 1000 mg/kg, one female had a rough coat,
closed eyes and hunched posture. Two males had a rough
coat. All animals at 500 mg/kg had recovered from the
treatment.

Within 44 hours after dosing, all animals had recovered
except one male at 2000 mg/kg, showing signs of hunched
posture and a rough coat.

Observations:
The test material did not cause a significant increase in
the frequency of micronuclei in the polychromatic
erythrocytes of the mice treated in the study.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative