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EC number: 603-188-8 | CAS number: 127184-53-6
Eye irritation
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:
- 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:
- 2-oxo-N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3,5-bis({1,3,3-trimethyl-5-[(2-oxoazepane-1-carbonyl)amino]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)azepane-1-carboxamide; 2-oxo-N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3-({1,3,3-trimethyl-5-[(2-oxoazepane-1-carbonyl)amino]cyclohexyl}methyl)-5-({1,3,3-trimethyl-5-[2,4,6-trioxo-3,5-bis(3,3,5-trimethyl-5-{[(2-oxoazepane-1-carbonyl)amino]methyl}cyclohexyl)-1,3,5-triazinan-1-yl]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)azepane-1-carboxamide
- EC Number:
- 603-188-8
- Cas Number:
- 127184-53-6
- Molecular formula:
- Exact identification is not feasible
- IUPAC Name:
- 2-oxo-N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3,5-bis({1,3,3-trimethyl-5-[(2-oxoazepane-1-carbonyl)amino]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)azepane-1-carboxamide; 2-oxo-N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3-({1,3,3-trimethyl-5-[(2-oxoazepane-1-carbonyl)amino]cyclohexyl}methyl)-5-({1,3,3-trimethyl-5-[2,4,6-trioxo-3,5-bis(3,3,5-trimethyl-5-{[(2-oxoazepane-1-carbonyl)amino]methyl}cyclohexyl)-1,3,5-triazinan-1-yl]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)azepane-1-carboxamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- IPDI-Trimer, caprolactam-blocked
Constituent 1
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".
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