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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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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:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD 475 B.11 Mutagenicity - mammalian bone marrow chromosome aberation test
GLP compliance:
yes
Type of assay:
other: in vivo mammalian bone marrow cytogenetic test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test batch:No.: 003/2006

Test animals

Species:
other: mouse strain ICR male

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
olive oil
No. of animals per sex per dose:
Male: 125 mg/kg; No. of animals: 7; Sacrifice time: 24 hours
Male: 250 mg/kg; No. of animals: 7; Sacrifice time: 24 hours
Male: 500 mg/kg; No. of animals: 7; Sacrifice time: 24 hours
Male: 1000 mg/kg; No. of animals: 7; Sacrifice time: 24 hours

Results and discussion

Test results
Toxicity:
yes
Remarks:
Doses producing toxicity: The animals tolerated the highest tested dose 500 mg/kg body weight without toxic symptoms. Dose 1000 mg/kg had letal effect after 24 hours.
Additional information on results:
Observations:
Cytogenic analysis of mouse bone marrow cells which were
impacted in vivo with tested substance in doses 125, 250,
500 mg/kg body weight during 24 hours showed that no one of
these doses increase statistically significantly neither the
percentage of cells with aberrations nor the number of
aberation per cell.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative