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Diss Factsheets

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:
1986
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

Constituent 1
Chemical structure
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

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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