Registration Dossier
Registration Dossier
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EC number: 287-487-5 | CAS number: 85536-06-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given. Limited details on test material and methods. No experimental 48 h reading performed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 965
- Report date:
- 1965
Materials and methods
- Principles of method if other than guideline:
- Draize Test in rabbits (according to Draize, J.H., et al. (1944). Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes. J. of Pharm. and Exp. Theapeutics 82(4))
- GLP compliance:
- no
Test material
- Reference substance name:
- Glycerides, C8-18
- EC Number:
- 287-487-5
- EC Name:
- Glycerides, C8-18
- Cas Number:
- 85536-06-7
- Molecular formula:
- Not applicable: Complex UVCB substance
- IUPAC Name:
- Glycerides, C8-18 (even numbered)
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- not specified
- Observation period:
- 72 h
Reading time points: 24 and 72 h - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm on the dorsal site
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: no 48 h data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
- Irritant / corrosive response data:
- No reactions were noted on the intact or abraded skin at 24 and 72 h post-application in any animal.
- Other effects:
- No further local or systemic effects were reported.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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