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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data are given.

Data source

Reference
Reference Type:
publication
Title:
Toxicological studies on p-tertiary-butyltoluene.
Author:
Hine CH et al.
Year:
1954
Bibliographic source:
AMA Arch Ind Hyg Occup Med 9: 227-244.

Materials and methods

Principles of method if other than guideline:
Draize Test according to
- Draize JH et al (1944). Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes. J Pharm Exp Ther 82:377-390.
- Carpenter CP and Smyth HF Jr (1946). Chemical Burns of the Rabbit Cornea. Am J Ophth 29: 1363-1372.
GLP compliance:
no
Remarks:
pre-GLP study

Test material

Constituent 1
Chemical structure
Reference substance name:
4-tert-butyltoluene
EC Number:
202-675-9
EC Name:
4-tert-butyltoluene
Cas Number:
98-51-1
Molecular formula:
C11H16
IUPAC Name:
1-tert-butyl-4-methylbenzene
Details on test material:
- Name of test material (as cited in study report): p-tertiary-butyltoluene
- Physical state: liquid with distinct odour
- Analytical purity: no data
No further data

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
no further data on animals and environmental conditions

Test system

Type of coverage:
not specified
Preparation of test site:
other: application to intact and abraded skin; no further data
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
no data
Duration of treatment / exposure:
no data
Observation period:
no data
Number of animals:
6
Details on study design:
no further details on study procedure

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
of n=6
Time point:
other: no data
Score:
< 0.5
Reversibility:
no data
Irritant / corrosive response data:
The test substance was found to be only a mild rubefacient, with a skin irritation score of less than 0.5, according to the method of Draize. Erythema was more pronounced in the intact than in the scarified areas, and in only 1/6 animals was there evidence of edema at the site of application.
No further data.
Other effects:
no data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS