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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Although info about the batch of the tested substance is delivered, no info about its purity is given; statement that the study was performed in accordance with GLP guidelines but no provision of a certificate; info about the vehicle/application of the substance lacks some information details. The study was performed in accordance with an official guideline. The methodology, evaluation of the results and the results themselves are well documented.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: E.E.C. Directive 84/449/EEC appendix V B4
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
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
Details on test material:
- Name of test material (as cited in study report): ACIDE P-TERTIOBUTYLBENZOIQUE, Acide p.tertiobutylbenzoique (acide P.T.B.B.) lot 8802217
- supplier: Société Francaise Hoechst, Tour Roussel Hoechst, Cédex 03, 92080 Paris La Défense, France.

Test animals

Species:
rabbit
Strain:
other: "New-Zealand albino rabbits"
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Abbaye de Bellefontaine (49122 Bégrolles-en-Mauges, France)
- Sex: all males
- weight on day of treatment: 2.5 +/- 0.1 kg
- identification of individuals by ear-tags

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Controls:
other: on each animal was a control site and a test site
Duration of treatment / exposure:
4 h
Observation period:
up to 72 h
Number of animals:
6

Results and discussion

Any other information on results incl. tables

Summary of results:

No cutaneous reaction was observed one hour, 24, 48 and 72 hours after the removal of the dressing. The scoring was at all times "0" concerning erythema and eschar formation as well as oedema formation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
According to the results of the study the test substance showed no cutaneous reactions (after 1, 24, 48 and 72 hours) on the rabbits skin and can therefore be considered as not irritating to the skin.