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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline and GLP compliant study

Data source

Reference
Reference Type:
other: : Inquiry result from ECHA
Title:
Unnamed
Year:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Directive 84/449/EEC, Method B12 Micronucleus OECD Guideline No. 474
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc
EC Number:
403-360-0
EC Name:
Bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc
Cas Number:
42405-40-3
Molecular formula:
C30H42O6Zn
IUPAC Name:
bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc

Test animals

Species:
other: Mouse, Charles River CD-1

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
Corn oil
No. of animals per sex per dose:
Male: 1000 mg/kg; No of animals: 5; Sacrifice time: 24 hours
Male: 1000 mg/kg; No of animals: 5; Sacrifice time: 48 hours
Male: 1000 mg/kg; No of animals: 5; Sacrifice time: 72 hours

Female: 1000 mg/kg; No of animals: 5; Sacrifice time: 24 hours
Female: 1000 mg/kg; No of animals: 5; Sacrifice time: 48 hours
Female: 1000 mg/kg; No of animals: 5; Sacrifice time: 72 hours

Results and discussion

Additional information on results:
Doses producing toxicity:
Treatment with 1000 mg/kg was clearly toxic for the mice and 6 mice (2 males, 4 females) died within 2 hours of dosing.

There was no significant decrease in the ratio of poly-to normochromatic erythorcytes at any of the three sacrifice times after treatment with the test substance.

Observations:
During the first 2 hours, all animals treated with the test substance showed sluggishness. No other findings were noted.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative