Rape oil, reaction products with diethanolamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted on the structural analogue amides, C18(unsatd.), N,N-bis(hydroxyethyl) in accordance with Title 21, Code of Federal Regulations, 191.11.

Cross-reference

Reason / purpose for cross-reference:

reference to same 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.

Principles of method if other than guideline:

None

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

N,N-bis(2-hydroxyethyl)oleamide

EC Number:

202-281-7

EC Name:

N,N-bis(2-hydroxyethyl)oleamide

Cas Number:

93-83-4

Molecular formula:

C22H43NO3

IUPAC Name:

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

Constituent 2

Reference substance name:

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

IUPAC Name:

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

Details on test material:

- Name of test material (as cited in study report): Varamide A-7

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 aread 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

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72 h

Score:

5.5

Max. score:

8

Reversibility:

no data

Remarks on result:

other: irritating to the skin (mean of erythema and edema scores at 24 and 72 h).

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)

Remarks:

Migrated information irritating to the skin Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the test substance had an irritant effect on the skin and was classified as a irritating according to the definitions given in the U.S. Federal Hazardous Substances Act. The Draize system of classification, which is separate from the Federal Register test, would regard the test substance as a severe irritant to the skin. Further, according to CLP criteria (EC 1272/2008) , the test substance may be considered to be Category 2 skin irritant as the mean scores of erythema and edema were >2.3 after 72 h.

Executive summary:

A study was conducted to assess the skin irritation potential of test substance, amides, C18 -unsatd., N,N-bis(hydroxyethyl) to the rabbit skin in accordance with Title 21, Code of Federal Regulations, 191.11.

Six animals were treated with undiluted 0.5 mL (0.5 g) of the test substance. The treated areas were covered with a semi-occlusive gauze patch and taped to maintain the test substance in contact with the skin for a duration of 24 h. The degree of erythema and edema were recorded according to 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 meanprimary skin irritation index (PII) was 5.5.

Under the test conditions, the test substance had an irritant effect on the skin and was classified as a irritating according to the definitions given in the U.S. Federal Hazardous Substances Act. The Draize system of classification, which is separate from the Federal Register test, would regard the material as a severe irritant to the skin. Further, According to CLP criteria (EC 1272/2008), the test substance may be considered to be Category 2 skin irritant as the mean scores of erythema and edema were >2.3 after 72 h.