Registration Dossier

Diss Factsheets

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:
1986
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

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

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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