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EC number: 202-696-3 | CAS number: 98-73-7
Repeated dose toxicity: dermal
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:
- 2 009
- 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:
- 1 975
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 substance name:
- 4-tert-butylbenzoic acid
- EC Number:
- 202-696-3
- EC Name:
- 4-tert-butylbenzoic acid
- Cas Number:
- 98-73-7
- Molecular formula:
- C11H14O2
- IUPAC Name:
- 4-tert-butylbenzoic acid
- Test material form:
- other: solution in DMSO
Constituent 1
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.
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