2H-Azepin-2-one, hexahydro-, polymer with 1,6-diisocyanatohexane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2002-11-12 to 2002-11-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study; GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(2002)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Directive 92/69/EEC, B.4

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Copolymer of hexahydro-2H-azepin-2-one and 1,6-diisocyanatohexane

EC Number:

607-997-7

Cas Number:

26776-30-7

Molecular formula:

Exact identification is not feasible

IUPAC Name:

Copolymer of hexahydro-2H-azepin-2-one and 1,6-diisocyanatohexane

Test material form:

liquid: viscous

Details on test material:

90 % Hexamehylendiisocyanate, oligomeric, caprolactam blocked
10 % Solvesso

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS: 
- Source: Charles River Deutschland (Germany)
- Sex: male
- Age: at least 6 weeks old
- Controls: untreated skin surrounding the application area
- Diet: ad libitum, Altromin special diet for rabbits
- Water: ad libitum, tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours dark
- Air changes (per hr): 15 per hour

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml test substance, undiluted

Duration of treatment / exposure:

4 hour(s)

Observation period:

Postexposure period: 72 hours (Because no effects have been observed the period of observation is not 14 days but 72 hours.)

Number of animals:

3 males

Details on study design:

ADMINISTRATION/EXPOSURE
- Area of exposure: dorsal area of trunk, shaved 24 hours in advance,  approx. 10 x 15 cm2
- Preparation of test substance: 0.5 ml undiluted
- Occlusion: metalline patch (2x3 cm) held in place by semi-occlusive non-irritating  tape dressing
- Duration: 4 h , after application was removed, skin was cleaned with water
EXAMINATIONS
- Examination time points: 60 minutes, 24, 48, and 72 hours after patch removal
- Scoring system: Draize (0-4 possible scores each for erythema/eschar  and for edema)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 60 min, 24 hrs, 48 hrs, 72 hrs

Score:

0.3

Max. score:

8

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

AVERAGE SCORE
- Erythema: 0.30
- Edema: 0.30
REVERSIBILITY: fully reversible within 48 h

Other effects:

Under the test conditions the animals showed very slight erythema and very slight oedema in the treated skin-aeras. The skin irritation had resolved within 48 hours after exposure in all animals.

Any other information on results incl. tables

no other information

Applicant's summary and conclusion

Conclusions:

Under the test conditions three male rabbits showed very slight erythema and very slight oedema in the treated skin-aeras after exposure to 2H-Azepin-2-one, hexahydro-, polymer with 1,6 diisocyanatohexane (90 % active ingredient in solvent). The skin irritation had resolved within 48 hours after exposure in all animals. Therefore, the test item is not irritating to skin.

Executive summary:

The acute skin irritation properties of 2H-Azepin-2-one, hexahydro-, polymer with 1,6 diisocyanatohexane were estimated according to OECD Guideline 404. A dose of 0.5 ml test item (90 % in solvent) per animal was applied to the shaved, intact dorsal skin of 3 male rabbits under semi-occlusive conditions. After the 4 -hour exposure period the patch was removed and the resulting reactions were examined. Observations were made 1, 24, 48 and 72 hours after exposure. The three male rabbits showed very slight erythema and very slight oedema in the treated skin-areas at 1 hour and 24 hours after exposure. The skin irritation had resolved within 48 hours in all animals. Sticky remnants of the test substance were present on the skin on day 1 and 2 and dry remnants were present on days 3 and 4. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured.

Under the conditions of this study the test item is not irritating to skin.