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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute 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. 48, Final Approved Version, July 2009
Reference Type:
study report
Title:
Unnamed
Year:
1975

Materials and methods

Principles of method if other than guideline:
Dermal acute toxicity (LD50) of the test substance determined using rats and rabbits, application percutaneous in DMSO solution or as dry powder
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: 30 % (w/v) solution in DMSO

Results and discussion

Any other information on results incl. tables

The acute single dose percutaneous LD50 value of PTBBA (no data on purity) as a 30% solution in DMSO (w/v) was found to be approximately 300 mg/kg in Carworth Farm E strain (CFE) rats in a study using 2 males and 2 females each at dose levels of 75, 150, 300, and 900 mg/kg bw. After application of 75 mg/kg none of the rats died, after application of 150 mg/kg 0/2 males and 1/2 females died on day 2, after application of 300 mg/kg 2/2 males and 0/2 females died within 4 days, after application of 900 mg/kg all rats died within 4 days. No further information is given (Shell Research Ltd. London, unpublished report 1975).

In studies with New Zealand White rabbits, however, a dermal LD50 value of > 900 mg/kg bw for a 30% solution in DMSO (w/v), and of > 2000 mg/kg bw for the dry powder were determined. The acute single dose percutaneous LD50 value of 4-tert- butylbenzoic acid (no data on purity) as a 30% w/v solution in DMSO was found to be greater than 900 mg/kg, the maximum volume of the most concentrated solution that could be used. The LD50 value of the dry powder was found to be greater than 2000 mg/kg in rabbits. No pathological lesions were found in the tissues of the rabbits exposed to the powdered substance. No further information is given (Shell Research Ltd. London, unpublished report 1975).

Applicant's summary and conclusion

Conclusions:
According to the cited results the LD50 (percutaneous) of the test substance has been determined to be approximately 300 mg/kg in male and female Carworth Farm E strain (CFE) rats.