Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986-03-07 to 1986-03-13
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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
IPDI-Trimer, caprolactam-blocked

Test animals / tissue source

Species:
rabbit
Strain:
other: Small white Russian, Chbb-SPF
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: female
- Weight at study initiation: 2.4 - 2.6 kg
- Controls: untreated eye
Environmental conditions:
- Room temperature: 20°C (+/- 1°C)
- Hhumidity: 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: untreated eye
Amount / concentration applied:
undiluted
Amount applied: 0.1 g
Duration of treatment / exposure:
72 hour(s)
Observation period (in vivo):
Postexposure observation period: 6 days
Number of animals or in vitro replicates:
3 females
Details on study design:
ADMINISTRATION/EXPOSURE 
- Vehicle: none
- rinsed after 72 h
- Postexposure observation period: 6 days
EXAMINATIONS
- Ophtalmoscopic examination: 60 min, 24, 48, 72 hours, and 6 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:
8
Max. score:
110
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.56
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0.56
- Iris: 0.33
- Conjunctivae (Redness): 0.67
- Conjunctivae (Chemosis): 0.11
- Overall irritation score: 8
REVERSIBILITY: complete within 72 hours
Other effects:
no other effects

Any other information on results incl. tables

no other results

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, caprolactam-blocked (IPDI homopoymer, caprolactam blocked) showed slightly eye irritating effects in rabbits, which do not meet criteria according to EC Regulation 1272/2008 to be classified as "irritant to eyes".

Executive summary:

A study was performed to examine eye irritating effects of cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, caprolactam-blocked (IPDI homopoymer, caprolactam blocked) according to OECD TG 405. An amount of 0.1 g of the undiluted test substance was instilled into the conjunctival sac of the right eye of each of three female rabbits, and the untreated left eye served as control. The fluorescein test was performed 72 hours after instillation and thereafter the treated eyes were rinsed with warm NaCl solution. The eye reactions were monitored until the changes observed have completely subsided, however not for more than 21 days after application. Eye irritation index was assessed using Draize scale.

The test was evaluated as follows (average of evaluation at 24, 48 and 72 hours respectively): cornea: 0.56, iris: 0.33, conjunctivae: redness: 0.67 and chemosis: 0.11 (mean scores on Draize scale). All irritating effects were fully reversible within 72 hours. Therefore, under the conditions of this study Cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, caprolactam-blocked showed slightly eye irritating effects in rabbits, which do not meet criteria according to EC Regulation 1272/2008 to be classified as "irritating to eyes".