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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: data contained in EU risk assessment report of the substance - credibility is assumed. Reference to origin (Shell Research Ltd. London)

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, p. 58, Final Approved Version, July 2009
Reference Type:
study report
Title:
Unnamed
Year:
1975

Materials and methods

Principles of method if other than guideline:
28 d repeated dose dermal toxicity study in rats using different concentrations of the test substance in DMSO
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solution in DMSO

Test animals

Species:
rat
Strain:
other: Carworth Farm E
Sex:
male/female

Administration / exposure

Type of coverage:
other: animals received solutions of the substance topically on shaved skin
Vehicle:
DMSO
Duration of treatment / exposure:
28 d
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 7.5, 15, 30 and 60 mg/kg bw/d
Basis:
no data
No. of animals per sex per dose:
8 males; 8 females

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Growth rates were reduced in males and during the first two weeks in female rats exposed to 30 and 60 mg/kg bw/d resulting in significantly lower final body weight of males of these dose groups. Dose-related significant increases in absolute and relative liver weights were seen in female rats of all dose groups (+11, 23, 27, 30%) and in male rats exposed to 15 mg/kg/d and above (+8, 11, 17%). Increased relative weights of kidneys were observed in two top doses of female rats, and decrease in relative and absolute testes weights were determined for male rats receiving 60 mg/kg/d. Histopathology of the testes revealed a degeneration of germinal epithelium in males exposed to 60 mg/kg/d. No other toxic effect was observed in the liver and the kidneys of the four animals/sex/group examined except an increased basophilia of centrilobular hepatocytes that was considered of uncertain significance. The LOAEL was 7.5 mg/kg bw/d. This study was flawed by the small numbers of test parameters and animals and a poor documentation (summary, 2 tables and 1 figure available).

Applicant's summary and conclusion

Conclusions:
According to the results of this study the dermal LOAEL for the test substance is 7.5 mg/kg.