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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:
16th September 1991 - 11th December 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid.
Details on test material:
- Name of test material (as cited in study report): Capa 2043
- Physical state: Colourless liquid.
- Analytical purity: 97%
- Lot/batch No.: WAC000392
- Expiration date of the lot/batch: 17th February 2014
- Storage condition of test material: Stored in the dark at room temperature.
Specific details on test material used for the study:
CAPA 203 (2-oxepanone, polymer with 1,4-butanediol)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Olac, Zeist, The Netherlands.
- Age at study initiation: No information provided.
- Weight at study initiation: 2.5 - 3 kg
- Housing: Housed individually in stainless steel wire cages KK 102. Sawdust, woodchips or other extraneous material that might produce skin irritation were excluded.
- Diet: 80 g food, consisting of a standard laboratory diet LKK-20 per day during the acclimatisation period, with food available ad libitum during the testing period.
- Water: Available ad libitum.
- Acclimation period: 11 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 20°C
- Humidity: 55 - 72%
- Air changes: Approximately 16 air changes per hour
- Photoperiod: 12 hours light/12 hours dark

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g


Duration of treatment / exposure:
4 hours
Observation period:
72 hours after patch removal.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6cm2 patch on the back of each rabbit.
- Type of wrap if used: Occlusive wrap.

REMOVAL OF TEST SUBSTANCE
- Washing: The skin was wiped after removal of the patch to remove any remaining test substance.
- Time after start of exposure: 4 hours.

SCORING SYSTEM: Graded according to responses observed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable.
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
A single dermal exposure to CAPA 203 for 4 hours did not cause erythema or oedema in the 3 rabbits on 30 minutes, 24, 48 and 72 hours after removal of the patch.

Any other information on results incl. tables

Individual scores for erythema and oedema

Animal

0.5 hours

24 hours

48 hours

72 hours

Total

Mean

 Erythema

1

0

0

0

0

0

0

 

2

0

0

0

0

0

0

 

3

0

0

0

0

0

0

 

Animal

0.5 hours

24 hours

48 hours

72 hours

Total

Mean

Oedema

1

0

0

0

0

0

0

 

2

0

0

0

0

0

0

 

3

0

0

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
CAPA 203 was not found to be irritating to the skin of rabbits under the conditions of this study and does not require classification for skin irritation.
Executive summary:

To assess the primary skin irritation of CAPA 203 (2 -oxepanone, polymer with 1,4 -butanediol) in rabbits, a study was conducted in accordance with OECD Test Guideline 404 and GLP. A sample of 0.5 g CAPA 203 was applied to the shorn intact skin of three male rabbits and occluded under patches for four hours. Readings of the reactions for erythema and oedema were made at 30 minutes and at 24, 48 and 72 hours after patch removal. CAPA 203 did not cause any signs of skin irritation at any observation time. CAPA 203 was found to be non-irritating under the conditions of this study.