Butyl carbamate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From February 09, 1988 to February 10, 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Butyl carbamate

EC Number:

209-751-0

EC Name:

Butyl carbamate

Cas Number:

592-35-8

Molecular formula:

C5H11NO2

IUPAC Name:

butyl carbamate

Test material form:

solid

Details on test material:

organic

Specific details on test material used for the study:

- Butylurethan
- Purity: approx. 94% (impurities: 5.5% dibutyl carbonate, 0.6% n-butanol).
- 500 mg carbamic acid butyl ester (mixed into a paste with 0.18 mL polyethylene glycol 400).

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Weight: 2.9 - 3.3 kg
Age: 3 - 5 months
Room temperature: 20 +/- 3°C; Humidity: 50 +/- 20%
Light/dark period: 12/12h
Food: Altromin 2123 Haltungsdiat (ad libitum); Water: deionized (ad libitum)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Remarks:

depilated

Vehicle:

other: Polyethylene glycol 400

Amount / concentration applied:

500 mg in 0.18 mL (PEG 400).

Duration of treatment / exposure:

4 hours

Observation period:

1/2, 1, 24, 48 and 72 hours after removal of the adhesie dressing

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 1 and 2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 30 min to 24 h

Score:

1

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 48 and 72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal: 1, 2 and 3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

From 30 minutes to 24 hours after removal of the patch, one animal showed very mild erythema.
As of 48 hours after patch removal, none of the animals had signs of irritation.

Applicant's summary and conclusion

Conclusions:

Under the study conditions, the test substance was considered to be not irritating to rabbit skin.

Executive summary:

A study was conducted to determine the skin irritation/corrosion potential of the test substance (94% purity) in rabbit according to to OECD Guideline 404 and EU Method B.4. Three New-Zealand White rabbits were exposed to 500 mg (in 0.18 mL PEG 400) for 4 h (semi-occlusive coverage on shaved skin). At the end of the exposure period, the bandage was removed and the skin carefully cleaned with warm water. Effects were recorded at 30 and 60 minutes, then after 24, 48 and 72 h. From 30 min to 24 h after removal of the patch, one animal showed very mild erythema. As of 48 h after patch removal, none of the animals had signs of irritation (in terms of erythema, scab formation and oedema). Under the study conditions, the test substance was considered to be not irritating to rabbit skin (Kreiling and Jung, 1988).