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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: Annnex V (in vivo micronucleus)
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: 25 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 25 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 100 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 100 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 250 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 250 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 25 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 25 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 100 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 100 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 250 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 250 mg/kg; No. of animals: 5; Sacrifice times: 48 hours

Results and discussion

Test results
Toxicity:
yes
Remarks:
Doses producing toxicity: No deaths occurred. Animals dosed with 250 mg/kg showed ataxia, tremours, lethargy and restlesness. No clinical signs were observed in animals from the 25 or 100 mg/kg dose groups.
Additional information on results:
Observations:
In females dosed with 250 mg/kg statisitcally significant
increases in the frequency of micronucleated polychromatic
erythrocytes of 3-fold and 2.9 fold over vehicle control
values were observed at the 24 and 48-hour tome points,
respectvively. These increase were observe outside of the
historical control range for vehicle controls. There were no
increases in the frequency of micronucleated polychromatic
erythrocytes in males treated with 250 mg/kg or animals of
either sex treated with 25 or 100 mg/kg notified substance.
Negative and positive control substances gave the expected
responses.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): positive