Registration Dossier
Registration Dossier
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EC number: 938-351-5 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-12-17 to 1985-12-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate homopolymer, uretdione type
- EC Number:
- 938-351-5
- Molecular formula:
- residual C12H18N2O2, otherwise C24H36N4O4 (dimer) and higher species
- IUPAC Name:
- 3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate homopolymer, uretdione type
- Details on test material:
- Isophorone diisocyanate oligomer (uretdione type) of Hüls AG
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Small white Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Strain: Small white Russian, Chbb-SPF
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: male
- Weight at study initiation: 2.3 - 2.4 kg
- Controls: untreated eye
-Environmental conditions:
- room temperature: 20°C (+/- 1°C);
- humidity: 60% (+/- 5%);
- Air change: 15 times/hour;
- Light: 12 hour light/dark rhythm;
- feed: K4 complete feed for rabbits (Ssniff, Soest, Germany);
- water: tap water ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: identical animals, left eyes
- Amount / concentration applied:
- Amount applied: 0.1 g undiluted
- Duration of treatment / exposure:
- 72 hour(s)
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Vehicle: none
- Washing: rinsed after72 hours
- Postexposure observation period: 2 weeks
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, 6, 8, 11, and 14 days after treatment
- Tool used to assess score: sodium fluorescein / ophthalmic lamp / visual inspections
- Scoring system: Draize (1959); evaluation: VCI notes on safety data sheet and Appendix VI of 79/831/EEC
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 3
- Max. score:
- 110
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.89
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- AVERAGE SCORE - Cornea: 0.0 - Iris: 0.0 - Conjunctivae (Redness): 0.89 - Conjunctivae (Chemosis): 0.0 - Overall irritation score: 3.0/110
REVERSIBILITY: complete within 6 days - Other effects:
- OTHER EFFECTS: The substance stuck on the cornea. Loss of hair was observed at the treated eyes.
Any other information on results incl. tables
no other information
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Draize (1959); Appendix VI of 79/831/EEC
- Conclusions:
- Classification: not irritating
- Executive summary:
Determination of eye irritating index was conducted following OECD method No.405. An amount of 0.1 g of the undiluted test substance was instilled into one eye of each 3 male rabbits, and the untreated contralateral eye served as control. The eyes were rinsed 72 hours after application of test item. The animals were observed for a period of 14 days after application. The substance stuck on the cornea. Loss of hair was observed at the treated eyes. Eye irritation index was assessed using the Draize scale. The test was evaluated as follows (average of evaluations at 24, 48 and 72 hours respectively): cornea: 0, iris: 0, conjunctivae: redness:0.89, chemosis: 0.0 (mean scores on Draize scale). Therefore, isophorone diisocyanate cyclodimer was considered to be not irritating to eyes.
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