Registration Dossier
Registration Dossier
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EC number: 204-299-0 | CAS number: 119-13-1
Eye irritation
Administrative data
- Endpoint:
- eye 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 405 (Acute Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- other: Japanese white
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 ml, was instilled undiluted into the conjunctival sac of one eye of each animal, and the eye was not rinsed
- Duration of treatment / exposure:
- once not rinsed
- Observation period (in vivo):
- 1 and 4 hours and 1, 2, 3, 6, and 7 days after instillation
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Three male Japanese white rabbits were used to determine the ocular irritation potential of Tocopherol. The test substance, 0.1 ml, was instilled undiluted into the conjunctival sac of one eye of each animal, and the eye was not rinsed. The eyes were evaluated at 1 and 4 hours and 1, 2, 3, 6, and 7 days after instillation according to the Draize scoring system.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: average total score
- Basis:
- mean
- Time point:
- other: 1h, 4h, 24h, 48h, 72h, 6, and 7 days after instillation
- Score:
- 6
- Max. score:
- 110
- Remarks on result:
- probability of weak irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The maximurn score was observed 1 hour after dosing; the average total score at this time was 6.0/110. Tocopherol was a minimal eye irritant.
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