Registration Dossier
Registration Dossier
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EC number: 239-405-4 | CAS number: 15373-31-6
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1988
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: short summary of test results, no substance puritiy given, only tested at a concentration of 10 %
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
- Type of study / information:
- human patch test results
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A human patch test was performed on human volunteers.
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,2,3-trimethylcyclopent-3-enylacetonitrile
- EC Number:
- 239-405-4
- EC Name:
- 2,2,3-trimethylcyclopent-3-enylacetonitrile
- Cas Number:
- 15373-31-6
- Molecular formula:
- C10H15N
- IUPAC Name:
- 2-(2,2,3-trimethylcyclopent-3-en-1-yl)acetonitrile
Constituent 1
Method
- Ethical approval:
- not applicable
- Details on study design:
- The test material was tested on 43 subjects, 23 of which had eczema.
- Exposure assessment:
- estimated
- Details on exposure:
- TYPE OF EXPOSURE: patch test
TYPE OF EXPOSURE MEASUREMENT: Exposure pads
EXPOSURE LEVELS: 10 % suspension
EXPOSURE PERIOD: 24 h
POSTEXPOSURE PERIOD: skin reactions were evaluated after patch removal and 24 hours thereafter.
Results and discussion
- Results:
- The preparation was tolerated by all persons without pathological findings.
Applicant's summary and conclusion
- Conclusions:
- The test material at a concentration of 10 % did not cause skin irritation in the human patch test.
- Executive summary:
The test material was tested for its potential to cause skin irritation in the human patch test. The concentration of the substance was 10 % (suspension in white petrolatum). The test area on the body was the shoulderblade. As testing patch Leukosilk was used. The time of exposition was 24 hours and skin reactions were evaluated 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. The preparation was tested on 43 persons (18 male, 25 female). 23 persons had eczema of various kinds. As a result, no skin reactions were observed and therefore the material was considered to not cause skin irritation.
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