Amides, C18-unsatd., N,N-bis(hydroxyethyl)

Skin irritation / corrosion

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:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Title 21, Code of Federal Regulations, 191.11.

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

(9Z)-N,N-bis(2-hydroxyethyl)octadec-9-enamide

EC Number:

700-972-2

Molecular formula:

C22H43NO3

IUPAC Name:

(9Z)-N,N-bis(2-hydroxyethyl)octadec-9-enamide

Test material form:

not specified

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:

6

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

Irritation parameter:

erythema score

Basis:

animal: 1 to 6

Time point:

48 h

Remarks on result:

not measured/tested

Results 5

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

Results 6

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

Results 7

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 study conditions, the test substance was irritating to skin.

Executive summary:

A study was conducted to assess the irritation potential of the test substance, C18-unsatd. DEA, 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 were observed at 24 h and moderate to severe erythema and moderate edema were seen at 72 h on the abraded and intact skin. The mean primary irritation index (PII) was 5.5. Under the study conditions, the test substance was irritating to skin (Casey, 1976).