Cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, caprolactam-blocked

Skin irritation / corrosion

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

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

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 homopolymer, caprolactam-blocked

Test animals

Species:

rabbit

Strain:

other: Small white Russian, Chbb-SPF

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: 2.0 - 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

Results

Results 1

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%

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 60 min, 24, 48, 72 hrs

Score:

0

Max. score:

4

Results 3

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.