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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin 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 404 (Acute Dermal 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 homopolymer, caprolactam-blocked

Test animals

Species:
rabbit
Strain:
other: Small white Russian, Chbb-SPF
Details on test animals and environmental conditions:
TEST ANIMALS: 
- Strain: Small white Russian, Chbb-SPF
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: male
- Weight at study initiation: 2.0 - 2.3 kg
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

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: water
Controls:
not required
Amount / concentration applied:
0.5 g test item was wetted with 0.5 ml water
Duration of treatment / exposure:
4 hour(s)
Observation period:
Post exposure period: 6 days
Number of animals:
3 males
Details on study design:
ADMINISTRATION/EXPOSURE 
- Area of exposure: 6 cm2
- Total quantity applied: 0.5 g wetted with 0.5 ml water
- Occlusion: mull patch, polyethylene film, elastic dressing
- Removal of test substance: The test material had turned solid and stuck  to the skin together with the patch, thus some force had to be exerted  carefully. After rinsing with water, some small particles remained on the  skin. 
EXAMINATIONS
- Examination time points: 1, 24, 48, 72 hours and 6 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: 60 min, 24, 48, 72 hrs
Score:
0
Max. score:
8
Remarks on result:
other: none of the three rabbits showed any test item related changes; test substance: IPDI homopolymer, caprolactam-blocked, approx. 100%
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 60 min, 24, 48, 72 hrs
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 60 min, 24, 48, 72 hrs
Score:
0
Max. score:
4
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 0.0
- Edema: 0.0
Other effects:
no other effects

Any other information on results incl. tables

no further results

Applicant's summary and conclusion

Conclusions:
Under the present test conditions, none of the three male rabbits exposed for 4 hours to 500 mg cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, caprolactam-blocked (IPDI homopolymer, caprolactam-blocked) per patch and animal (occlusive condition) showed any test item-related changes at the examination time-points 60 minutes, 24, 48 and 72 hours after patch removal. Therfore, cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, caprolactam-blocked is not irritating to skin.
Executive summary:

The acute skin irritation properties of cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, caprolactam-blocked (IPDI homopolymer, caprolactam-blocked) were estimated according to OECD Guideline 404. A dose of 500 mg test item per animal was applied to the shaved, intact dorsal skin of 3 male rabbits under occlusive conditions. The test substance was administered undiluted, wetted with water. After the 4 -hour exposure period the patch was removed and the resulting reactions were examined. The average scores at 60 min, 24, 48 and 72 hours after patch removal are as follows: erythema/eschar: 0, edema: 0. Therefore, cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, caprolactam-blocked is not irritating to skin.