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Registration Dossier
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EC number: 938-351-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 404 (Acute Dermal 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
- Species:
- rabbit
- Strain:
- other: Small white Russian
- Details on test animals or test system 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
-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
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: no vehicle
- Controls:
- other:
- Amount / concentration applied:
- - Preparation of test substance: none
- 0.5 g test item, undiluted - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- Post exposure period: 14 days
- Number of animals:
- 3
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Area of exposure: 6 cm2
- Total quantity applied: 0.5 g
- Occlusion: mull patch, polyethylene film, elastic dressing
- Removal of test substance: washing with warm water
- Post exposure period: 14 days
EXAMINATIONS
- Examination time points: 1, 24, 48, 72 hours, 6, 8, 11, and 14 days after patch removal; evaluation based on readings 1-4
- Scoring system: OECD; 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:
- 3.09
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.56
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 2.56
- Edema: 1.11
REVERSIBILITY: not reversible - Other effects:
- sticky residue of test item (1 hour - 6 days), eschars (days 6-14)
Any other information on results incl. tables
no other information
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information
- Conclusions:
- Classification: irritating
- Executive summary:
The acute skin irritation properties of isophorone diisocyanate cyclodimer were estimated according to OECD method 404. A dose of 0.5 ml test item per animal was applied to the clipped, intact dorsal and lateral skin of 3 male rabbits under occlusive conditions. After the 4 -hour exposure period remains of test substance were removed with warm water and skin irritation was assessed using the Draize scale. The average scores at 60 min, 24, 48 and 72 hours after patch removal are as follows: erythema: 2.56, edema: 1.11. The mean irritation index was 3.09. At the end of the post observation period (14 days) eschars were observed. Therefore, under the conditions of this study isophorone diisocyanate cyclodimer is moderately irritating to skin and must be classified as irritating to skin.
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