Registration Dossier
Registration Dossier
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EC number: 293-036-3 | CAS number: 91050-89-4
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:
- other: Comparable to guideline study with acceptable restrictions. Limited documentation but relevant data given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Adopted 24 April 2002
- Deviations:
- yes
- Remarks:
- limited documentation, limited information on test substance given
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Fatty acids, C8-10, triesters with trimethylolpropane
- EC Number:
- 293-036-3
- EC Name:
- Fatty acids, C8-10, triesters with trimethylolpropane
- Cas Number:
- 91050-89-4
- Molecular formula:
- Not available.
- IUPAC Name:
- tri-esters of octanoic acid and decanoic acid with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol
- Details on test material:
- - Name of test material (as cited in study report): [trade name], Trimethylolpropan-C8/10-ester
- Analytical purity: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: 100 % - Duration of treatment / exposure:
- Group 1: 10 s
Group 2: 72 h (continuous treatment) - Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- Group 1: 4 males
Group 2: 4 males - Details on study design:
- REMOVAL OF TEST SUBSTANCE
Group 1
- Washing: yes
- Time after start of exposure: 10 s
Group 2
- Washing: no
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- No effects on cornea and iris were observed. Slight redness of the conjunctivae was observed both, after 10 s and after continuous treatment. The effects were obvious after 1 and 6 h. After 10 s treatment, the effects were reversible within 48 h. After continuous treatment, redness reversed within 24 h. In addition, exsudation was observed in both treatment groups, being reversible within 24 h (continuous treatment) and 48 h (10 s treatment), respectively. Chemosis was not observed.
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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