Registration Dossier
Registration Dossier
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EC number: 204-299-0 | CAS number: 119-13-1
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:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Final Report on the Safety Assessment of Tocopherol, TocopherylAcetate, TocopherylLinoleate, TocopherylLinoleate/Oleate, TocopherylNicotinate, TocopherylSuccinate, DioleylTocopherylMethylsilanol, Potassium Ascorbyl Tocopheryl Phosphate, Tocophersolan
- Author:
- Monice Zondlo Fiume
- Year:
- 2 002
- Bibliographic source:
- International Journal of Toxicology, 21 (Suppl. 3): 51-116, 2002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- α-tocopherol
- EC Number:
- 200-412-2
- EC Name:
- α-tocopherol
- Cas Number:
- 59-02-9
- Molecular formula:
- C29H50O2
- IUPAC Name:
- (2R)-2,5,7,8-tetramethyl-2-[(4R,8R)-4,8,12-trimethyltridecyl]-3,4-dihydro-2H-1-benzopyran-6-ol
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Japanese white
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: The backs of the animals were clipped free of hair 1 day prior to dosing, and the skin on the backs of four of the animals was abraded.
- Vehicle:
- other: 1.0% Tocopherol in "paraffinum liquidum"
- Amount / concentration applied:
- 0.3 ml
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 8
- Details on study design:
- TEST SITE
- Area of exposure: The backs of the animals were clipped free of hair 1 day prior to dosing, and the skin on the backs of four of the animals was abraded. The test material, 0.3 ml, was applied to the back of each animal under an occlusive patch (using "patch-test plaster") for 24 hours. The test sites were scored for irritation 24 and 72 hours after application of the test material.
OBSERVATION TIME POINTS : 24 and 72 hours
SCORING SYSTEM:
- Method of calculation: Draize scoring system
Results and discussion
In vivo
Results
- Irritation parameter:
- other: primary irritation index (PII) according to Draize scoring system
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0.13
- Max. score:
- 8
- Remarks on result:
- probability of weak irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Tocopherol, 1.0%, was a weak primary skin irritant.
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