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Registration Dossier
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EC number: 931-312-3 | CAS number: 53880-05-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-03-09 - 2002-05-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study; GLP study without deviation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers
- EC Number:
- 500-125-5
- EC Name:
- 3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers
- Cas Number:
- 53880-05-0
- Molecular formula:
- residual C12H18N2O2, otherwise C36H54N6O6 (trimer) and higher species
- IUPAC Name:
- 3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate homopolymer
- Reference substance name:
- 3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate homopolymer, isocyanurate type
- EC Number:
- 931-312-3
- Cas Number:
- 53880-05-0
- Molecular formula:
- residual C12H18N2O2, otherwise C36H54N6O6 (trimer) and higher species
- IUPAC Name:
- 3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate homopolymer, isocyanurate type
- Details on test material:
- Isophorone diisocyanate (IPDI) homopolymer "Desmodur Z 4470 MPA/X" of Bayer AG, purity not reported, 70 % solution in
1-Methoxypropylacetate-2/Xylol (1:1);
Batch No. 2.4/1-6;
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Number of animals: 3 male rabbits
- Source: LPT, Löhndorf (Germany)
- Initial Age: approx. 3.5 months
- Weight at study initiation: 1.7 - 2.0 kg
- Diet: ssniff K-H
- Water: ad libitum
ENVIRONMENTAL CONDITIONS:
- Housing: seperately in cages
- Temperature: 20 °C +/- 3 °C
- Humidity: 55% +/- 15%
- Photoperiod (hrs dark/hrs light): 12 hours/day
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: identical animal, left eye
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml/animal - Duration of treatment / exposure:
- not rinsed; no removal of test substance
- Observation period (in vivo):
- - Ophthalmoscopic examination with a slit lamp: prior to the administration and 1, 24, 48 and 72 hours after administration; 24 hours after
administration, the eyes were treated additionally with fluorescein and examined.
- Scoring system: Draize - Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- Based on most recent guidelines, the eye reactions are monitored until the changes observed have completely subsided, however not more than
21 days after application. Animals that do reveal any lesions anymore for 24 hours following the first 72 hours of observation are sacrificed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: corneal opacity was observed in animal no.one 1 hour after instillation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: The iris was not effected after instillation of test substance.
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: The iris was not effected after instillation of test substance.
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: The iris was not effected after instillation of test substance.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: conjunctival redness was observed in all animals 1 hour after instillation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: conjunctival redness was observed in all animals 1 hour after instillation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: conjunctival redness was observed in all animals 1 hour after instillation; in animal no. 3 until 24 hours after instillation.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: conjunctival chemosis was observed in all animals 1 hour after instillation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: conjunctival chemosis was observed in all animals 1 hour after instillation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: conjunctival chemosis was observed in all animals 1 hour after instillation; test substance: IPDI homopolymer, 70 % solution in 1-Methoxypropylacetate-2/Xylol (1:1)
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0.11
- Iris: 0
- Conjunctivae (Redness): 0.11
- Conjunctivae (Chemosis): 0 - Other effects:
- There were no systemic intolerance reactions.
The fluorescein test performed 24 hours after instillation revealed corneal staining in animal no. 3 (1/4 of the surface).
Any other information on results incl. tables
no further remarks
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study IPDI homopolymer (approx. 70% in vehicle) showed only slightly eye irritating effects in rabbits, which do not meet
criteria according to EU Directive 67/548/EEC to be classified as "irritant to eyes". - Executive summary:
A study was performed to examine eye irritating effects of IPDI homopolymer according to OECD TG 405. An amount of 0.1 ml of the test substance (approx. 70% in solvent) was instilled into the conjunctival sac of the right eye of each of three male Himalayan rabbits, and the untreated left eye served as control. The eyes remained unrinsed and there was no removal of test substance. The eye reactions were monitored until the changes observed have completely subsided, however not for more than 21 days after application.
Under the present test conditions, IPDI homopolymer caused the following effects: Corneal opacity (grade 1) was observed in animal no. one 1 hour and in animal three 24 hours after instillation. The fluorescein test performed 24 hours after instillation revealed corneal staining in animal no. 3 (1/4 of the surface). Conjunctival redness (grade 1 and 2) was observed in all animals 1 hour after instillation, in animal no. 3 until 24 hours after instillation. Conjunctival chemosis (grade 1 and 2) was observed in all animals 1 hour after instillation. The iris was not effected after instillation of the test substance. There were no systemic intolerance reactions.
Therefore, under the conditions of this study IPDI homopolymer (approx. 70% in solvent) showed only slightly eye irritating effects in rabbits, which do not meet criteria according to EU Directive 67/548/EEC to be classified as "irritant to eyes".
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