Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
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: data is contained in the EU risk assessment report of the substance - credibility is assumed. Reference to origin (RCC-CCR)

Data source

Referenceopen allclose all

Reference Type:
other: EU risk assessment report
Title:
No information
Author:
Federal Institute for Occupational Safety and Health, Division for Chemicals and Biocides Regulation, Germany
Year:
2009
Bibliographic source:
European Union Risk Assessment Report, 4-tert-butylbenzoic acid, CAS No: 98-73-7, EINECS No: 202-696-3, 4.1.2.7 Mutagenicity, p.66-67, Final Approved Version, July 2009
Reference Type:
study report
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
GLP compliance:
not specified
Type of assay:
chromosome aberration assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat

Results and discussion

Any other information on results incl. tables

This in vivo chromosomal aberration test with rats was negative for single oral gavage doses of 600 (males) or 300 (females) mg/kg bodyweight.

Treatment led to toxic reactions in both genders and lethal effects in males (2/6). Pretests on toxicity demonstrated that in males lethal effects were observed for doses of 900 mg/kg (1/2) and 1000 mg/kg (1/2); in females lethal effects were observed for doses of 500 mg/kg (1/2), 600 mg/kg (1/2) and 800 mg/kg (2/2). A weak reduction of mitotic indices was observed at 24 h sampling in females (6.76 % in treated males, 5.02 % treated females vs. 7.24 % in control group).

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
The in vivo chromosomal aberration test with rats was negative.