Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Remarks:
- Predates Regulation EC No. 863/2016.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Justification for type of information:
- Guideline study under GLP, prior to passage of Regulation EC No. 863/2016.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. FHSA, 16 CFR 1500.42
- Version / remarks:
- Federal Hazardous Substances Act
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 6 animals used
- Principles of method if other than guideline:
- Similar to OECD 405
- GLP compliance:
- yes
Test material
- Reference substance name:
- Trihexyl O-acetylcitrate
- Cas Number:
- 24817-92-3
- Molecular formula:
- C26 H46 O8
- IUPAC Name:
- Trihexyl O-acetylcitrate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Purity 97%
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Observation period (in vivo):
- 72 h from the beginning of the exposure
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not generally done, but any eyes may be washed with sodium chloride solution U.S.P or equivalent after the 24 h reading
- Time after start of exposure: not before 24 h
SCORING SYSTEM: Draize, et al., 1944, as listed in 16 CFR 1500.42.
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 8
- Max. score:
- 110
- Irritation parameter:
- other: conjunctival redness
- Basis:
- other: 4/6 animals
- Time point:
- 24 h
- Score:
- 8
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Slight reddening of the conjunctivae were noted in 4 of 6 rabbits within 6 hours of instillation. In three rabbits, the reddening persisted through 24 h, but had cleared by 48 h. According to the study directors, a positive ocular irritation reaction was not observed in any of the rabbits tested. None of the following changes was observed: chemosis, iritis or corneal opacity or denudation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance was not irritating in a guideline in vivo study, according to the U.S. FHSA. Classification is not indicated according to Regulation EC No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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