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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:
16/09/1991 - 19/09/1991
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
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
ε-Caprolactone, oligomeric reaction products with 2,2'-oxydiethanol
EC Number:
500-092-7
EC Name:
ε-Caprolactone, oligomeric reaction products with 2,2'-oxydiethanol
Cas Number:
36890-68-3
Molecular formula:
C6H10O2x.C4H8O3
IUPAC Name:
ε-Caprolactone, oligomeric reaction products with 2,2'-oxydiethanol
additive 1
Chemical structure
Reference substance name:
Glycerol
EC Number:
200-289-5
EC Name:
Glycerol
Cas Number:
56-81-5
Molecular formula:
C3H8O3
IUPAC Name:
glycerol
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Test animals were obtained from Harlan Olac, Zeist, The Netherlands.
- Weight at study initiation: 2.5 – 3.0 kg
- Housing: Rabbits were individually housed in stainless steel wire cages KK 102. Sawdust, woodchips or other extraneous material that might produce eye irritation were excluded
- Diet and Water - Test animals received 80g food (a standard laboratory diet LKK-20, Hope farms, Woerden, The Netherlands) per day during the acclimatization period of 11 days. During the experiment they had free access to food and water
- Acclimation period: A period of 11 days

ENVIRONMENTAL CONDITIONS
- Temperature : 19- 20°C
- Humidity: 55-72%
- Air changes (per hr): Approximately 16 air changes per hour
- Photoperiod: Artificial light from 7 a.m. till 7 p.m.
- Radio- sound on 24 hours per day

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied (volume or weight with unit): 0.5 g


Duration of treatment / exposure:
4 hours
Observation period:
30-60 minutes and at 24, 48 and 72 hours after patch removal
Number of animals:
3 male
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: Occlusive Blenderm tape and secured in place by adhesive tape. The animals fitted with Elizabethan collars in order to prevent disturbance of the application

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4hrs
- The skin was wiped to remove any remaining test substance

OBSERVATION TIME POINTS
At 30-60 minutes and at 24, 48 and 72 hours

SCORING SYSTEM:
Erythema and Eschar Formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema 4

Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1mm) 3
Severe oedema (raised more than 1mm and extending beyond area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No dermal irritation was observed
Other effects:
No adverse local or systemic effects were observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the test material produced no dermal irritation effects. The test material is considered to be non-irritating to the skin. The test material does not require a classification as irritant to the skin according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP)
Executive summary:

In this dermal irritation study performed according to the OECD guideline No. 404, and in compliance with GLP, 0.5 g of CAPA 304 was applied on the clipped skin of 3 New Zealand White male rabbits.

The patches were sustained by occlusive Blenderm tape and secured in place by adhesive tape. The animals were fitted with Elizabethan collars in order to prevent disturbance of the application for 4 hours. After this period, the collars and patches were removed and the skin was wiped to remove any remaining test substance.

Animals were then observed 30-60 minutes and at 24, 48 and 72 hours after patch removal for oedema and erythema and skin irritation was assessed. The mean scores calculated for each individual animal tested for erythema and oedema at 24, 48 and 72 hours was 0. No dermal irritation was observed.

 Under the test conditions, the test material is not classified as a skin irritant according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).