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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Title 21, Code of Federal Regulations, 191.11.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
(9Z)-N,N-bis(2-hydroxyethyl)octadec-9-enamide
EC Number:
700-972-2
Cas Number:
93-83-4
Molecular formula:
C22H43NO3
IUPAC Name:
(9Z)-N,N-bis(2-hydroxyethyl)octadec-9-enamide
Test material form:
liquid
Details on test material:
No details reported

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Housing: Screen bottom cages
- Diet (e.g. ad libitum): Laboratory chow, ad libitum
- Water (e.g. ad libitum): ad libitum

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: one abraded area and one intact area
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 mL (0.5 g) of the 100% concentration of the test substance.
Duration of treatment / exposure:
24 h
Observation period:
24 and 72 h
Number of animals:
Six
Details on study design:
TEST SITE
- Area of exposure: Backs and flanks of the animals were clipped hair free
- Test substance application: 0.5 mL (0.5 g) of the undiluted test substance was applied in an occlusive patch to the abraded and intact areas of the skin, covered with gauze patch by adhesive-tape.
Duration: 24 h
Scoring criteria: According to Draize classification.
Observations: at 24 and 72 h.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 h
Score:
5.5
Max. score:
8
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: PDII equals average of 24 and 72 h
Irritation parameter:
erythema score
Basis:
animal: 1 to 6
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: similar results for abraded and non-abraded skin
Irritation parameter:
edema score
Basis:
animal: 1 to 6
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: similar results for abraded and non-abraded skin
Irritation parameter:
erythema score
Basis:
animal: 1 to 6
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal: 1 to 6
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: similar results for abraded and non-abraded skin
Irritation parameter:
edema score
Basis:
animal: 1 to 6
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: similar results for abraded and non-abraded skin
Irritation parameter:
edema score
Basis:
animal: 1 to 6
Time point:
48 h
Remarks on result:
not measured/tested
Other effects:
None

Any other information on results incl. tables

Results for the primary skin irritation of the abraded and intact skin at 24 and 72 hrs:

Animal number

24 h

72 h

Abraded

Intact

Abraded

Intact

1

3-2

3-2

3-3

3-3

2

3-2

3-2

3-3

3-3

3

3-2

3-2

3-3

3-3

4

3-2

3-2

3-3

3-3

5

3-2

3-2

3-3

3-3

6

3-2

3-2

3-3

3-3

Scoring was done similar to the Draize system of classification.

Observations: Moderate to severe erythema and defined edema was observed at 24 h and moderate to severe erythema and moderate edema was observed at 72 h on abraded and intact rabbit skin.

The mean primary skin irritation index obtained = 5.50 (mean of erythema and edema scores at 24 and 72 h).

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Under the conditions of the study, the test substance was irritating to skin.
Executive summary:

A study was conducted to assess the irritation potential of the test substance to rabbit skin in accordance with Title 21, Code of Federal Regulations, 191.11. Six animals were treated with undiluted test substance (0.5 mL or 0.5 g). The treated areas were covered with a semi-occlusive gauze patch and taped to maintain the test substance in contact with the skin for 24 h. The degree of erythema and edema was recorded according to the Draize scoring system after 24 and 72 h. Moderate to severe erythema and defined edema was observed at 24 h and moderate to severe erythema and moderate edema was observed at 72 h on the abraded and intact rabbit skin. The mean primary skin irritation index (PII) was 5.5. Under the conditions of the study, the test substance was irritating to skin (Casey, 1976).