Registration Dossier
Registration Dossier
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EC number: 202-675-9 | CAS number: 98-51-1
Skin irritation / corrosion
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:
- 1 954
- 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
- 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
Constituent 1
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
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