Registration Dossier
Registration Dossier
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EC number: 939-514-3 | CAS number: 1471312-26-1
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:
- key study
- Study period:
- 08 - 11 Jun 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles. The inclusion and exclusion criteria of the volunteers were not listed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
- Type of study / information:
- Epicutaneous patch test in volunteers, single application 48 h patch
- Endpoint addressed:
- skin irritation / corrosion
- Principles of method if other than guideline:
- Volunteers were exposed to the undiluted test substance for 48 hours under occlusive conditions. The skin irritation potential of the test substance was assessed according to the Draize scoring system.
- GLP compliance:
- no
- Remarks:
- no data on GLP
Test material
- Reference substance name:
- Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters
- IUPAC Name:
- Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Analytical purity: 100% (UVCB)
Constituent 1
Method
- Ethical approval:
- not specified
- Details on study design:
- - Number of subjects exposed: 30
- Sex: 9 male, 21 female
- Age: 18-65 years (range)
- Type of application: occlusive, using a Finn chamber
- Test substance concentration: undiluted - Exposure assessment:
- not specified
- Details on exposure:
- TYPE OF EXPOSURE: epicutaneous
TYPE OF EXPOSURE MEASUREMENT: skin irritation
- Site: intact back skin
- Description of patch: 1 cm²
- Volume applied: 0.5 mL
- Testing/scoring schedule: the skin was examined 15 min and 12 hours after patch removal, according to the Draize scoring system
- Control: an untreated site adjacent to the teated site served as the control
EXPOSURE PERIOD:
48 h, single application
POSTEXPOSURE PERIOD:
12 h
Results and discussion
- Results:
- No erythema or edema was observed in any of the subjects at any reading time point.
Applicant's summary and conclusion
- Conclusions:
- Single dermal exposure for 48 hours under occlusive conditions to the undiluted test substance did not result in skin reactions. According to EU classification criteria, no classification for skin irritation is required.
CLP: not classified
DSD: not classified
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