Registration Dossier
Registration Dossier
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EC number: 919-489-5 | CAS number: -
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:
- 1985
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 2003
Materials and methods
- Type of study / information:
- study with volunteers
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test substance was tested on human volunteers, some exhibiting eczema of various kinds.
- GLP compliance:
- no
Test material
- Reference substance name:
- Reaction mass of (2E)-Tridec-2-enenitrile and (2Z)-Tridec-2-enenitrile and (3E)-Tridec-3-enenitrile and (3Z)-Tridec-3-enenitrile
- EC Number:
- 919-489-5
- Molecular formula:
- C13H23N
- IUPAC Name:
- Reaction mass of (2E)-Tridec-2-enenitrile and (2Z)-Tridec-2-enenitrile and (3E)-Tridec-3-enenitrile and (3Z)-Tridec-3-enenitrile
1
Method
- Ethical approval:
- not applicable
- Details on study design:
- The preparation (1 % in vaseline) was tested on 50 persons (20 male, 30 female). 39 persons had eczema of various kinds. Therefore the test was conducted under especially 'hard' conditions.
- Exposure assessment:
- measured
- Details on exposure:
- TYPE OF EXPOSURE: patch skin test
TYPE OF EXPOSURE MEASUREMENT: Exposure pads
EXPOSURE LEVELS: 1 % suspension in vaseline
EXPOSURE PERIOD: 24 h
POSTEXPOSURE PERIOD: Examinations were carried out immediately after removal of the testing patch and 24 h later.
Results and discussion
- Results:
- The preparation was tolerated by all persons without pathological findings.
Applicant's summary and conclusion
- Conclusions:
- The test substance was not irritating to human skin at a concentration of 1 %.
- Executive summary:
A study (Symrise 1985180) is available which was conducted to assess the skin irritating properties of the test substance applied at a concentration of 1 % in vaseline. Among the 50 volunteers, 39 persons were known to have eczema. The test substance preparation was applied to skin sites on the shoulderblades and occluded for 24 h. Skin reactions were evaluated immediately after removing the patches and 24 hours thereafter. As a result, no reactions were observed. Thus, the test substance at a concentration of 1 % was shown to be irritating to skin.
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