Registration Dossier
Registration Dossier
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EC number: 261-245-9 | CAS number: 58430-94-7
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
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
- Endpoint addressed:
- skin irritation / corrosion
- GLP compliance:
- no
Test material
- Reference substance name:
- 3,5,5-trimethylhexyl acetate
- EC Number:
- 261-245-9
- EC Name:
- 3,5,5-trimethylhexyl acetate
- Cas Number:
- 58430-94-7
- Molecular formula:
- C11H22O2
- IUPAC Name:
- .
Constituent 1
Method
- Ethical approval:
- not specified
- Exposure assessment:
- measured
- Details on exposure:
- TYPE OF EXPOSURE: occlusive patch
TYPE OF EXPOSURE MEASUREMENT: Exposure pads
EXPOSURE LEVELS: concentrated test item
EXPOSURE PERIOD: 24 h
POSTEXPOSURE PERIOD: 48 and 72 h
DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES: one exposure group
Results and discussion
- Results:
- At 24, 48 and 72 hour reading, no skin irritation was observed.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the test article is not irritating to human skin.
- Executive summary:
The purpose of this study was to determine the epicutaneous irritation potential of the test article in humans. A closed patch test was used according to the method of Jadassohn and Bloch. There were 21 sensitive skin people included in the study with a total of 60 people placed on test. The patches were applied to the back or inner side of the upper arm and covered in an airtight manner with bandage material. The patch was removed after 24 hours and the site scored. The site was also scored at 48 and 72 hours.
Under the conditions of this study, the test article is not irritating to human skin. There were no skin reactions noted.
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