Registration Dossier
Registration Dossier
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EC number: 251-132-2 | CAS number: 32634-68-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- Safety assessment of Dialkyl hydroxysuccinates as used in cosmetics
- Author:
- Cosmetic Ingredient Review Expert Panel
- Year:
- 2 011
- Bibliographic source:
- Cosmetic Ingredient Review, 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize method
- Principles of method if other than guideline:
- To assess the dermal irritation potential of the test chemical in rabbits
- GLP compliance:
- not specified
Test material
- Reference substance name:
- (+)-tartaric acid
- EC Number:
- 201-766-0
- EC Name:
- (+)-tartaric acid
- Cas Number:
- 87-69-4
- Molecular formula:
- C4H6O6
- IUPAC Name:
- (+)-Tartaric acid
- Test material form:
- solid
- Details on test material:
- Name of the test chemical: (2R,3R)-(+)-Tartaric acid
Molecular Weight: 150.09 g/mol
Molecular Formula:C4H6O6
Substance Type:Organic
Physical State: Solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Japanese White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 ml of 1.8% aqueous solution
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24, 48, and 72 h after dosing
- Number of animals:
- 3
- Details on study design:
- no data available
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation observed
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- No Signs of irritation were observed. The Draize score was 0.
Hence, the test chemical was considered to be not irritating to skin. - Executive summary:
The dermal irritation potential of the test chemical was assessed in rabbits.0.5 ml of 1.8% aqueous solution was applied under occlusion to the clipped skin of 3 Japanese White rabbits for 24 hours. The treated skin was observed at1, 24 and 48 hours.
No signs of irritation were observed. The Draize score was 0.
Hence, the test chemical was considered to be not irritating to skin.
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