4-tert-butylbenzoic acid

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

Reference

Reference 1

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 2

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

Test material information

Constituent 1

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

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.