Registration Dossier
Registration Dossier
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EC number: 268-407-8 | CAS number: 68083-58-9
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Remarks:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Remarks:
- only abstract available
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
- Type of study / information:
- Human Patch Test
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Human patch test with 5% 1,3-dimethyl-3-phenylbutyl acetate in vaseline: 24-hour occluded patch test in 50 subjects.
Test material
- Reference substance name:
- 1,3-dimethyl-3-phenylbutyl acetate
- EC Number:
- 268-407-8
- EC Name:
- 1,3-dimethyl-3-phenylbutyl acetate
- Cas Number:
- 68083-58-9
- Molecular formula:
- C14H20O2
- IUPAC Name:
- 4-methyl-4-phenylpentan-2-yl acetate
- Test material form:
- liquid
Constituent 1
Method
- Details on study design:
- The test concentration of the substance was a 5% suspension in white petrolatum. The test area on the body was the shoulderblade. The test was performed by the patch skin test. As testing patch Leukosilk was used. The time of exposition was 24 hours. The reaction to the test was examined immediately after removal of the testing patch and 24 hours later. The Interpretation of the test reaction was based on the criteria of the International Contact Dermatitis Research Group.
Results and discussion
- Results:
- The preparation of the test item was tolerated by all 50 persons (22 male, 28 female) without pathological findings.
Applicant's summary and conclusion
- Conclusions:
- Results: not skin irritating at 5% (0/50)
- Executive summary:
Human patch test with 5% test item in vaseline, 24 -hour occluded patch test in 50 subjects, resulted in no skin reactions.
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