Amides, C16-18 and 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

Study period:

From January 9, 1990 to February 14, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to OECD 404 guideline study, but not in compliance with GLP.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

68425-47-8

Cas Number:

68425-47-8

IUPAC Name:

68425-47-8

Constituent 2

Reference substance name:

Amides, soya, N,N-bis(hydroxyethyl)

EC Number:

270-355-6

EC Name:

Amides, soya, N,N-bis(hydroxyethyl)

IUPAC Name:

270-355-6

Test material form:

other: Yellow liquid

Details on test material:

- Name of test material (as cited in study report): Marlamid DF 1818
- Physical state: Yellow liquid
- Composition of test material, percentage of components:
80% soybean oil diethanolamide, 10% glycerin, 5% diethanolamine salt of the fatty acids, 3% sodium salt of the fatty acids, 2% free diethanolamine
- Lot/batch No.: 13

Test animals

Species:

rabbit

Strain:

other: Small White Russian Chbb-SPF

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.5 - 2.8 kg
- Housing: Single animals in steel cages
- Diet (e.g. ad libitum): K4 diet for rabbit, Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): yes
- Acclimation period: 14 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/- 5 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 11-01-1990 To: 05-02-1990

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm3 of product on a 6 cm2 skin surface
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4 h

Observation period:

25 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- % coverage: 100%
- Type of wrap if used: application site covered with gauze. Additional wWrapping with an elastic band.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 4 h


SCORING SYSTEM: OECD 404 method

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: Not applicable

Score:

7

Max. score:

8

Remarks on result:

other: Highly irritating

Irritant / corrosive response data:

No details provided

Other effects:

None

Any other information on results incl. tables

Strong erythema and strong oedema were observed in all animals. Slow recovery occured, under thick scabs. After 25 days, 2/3 animals had fully recovered. In the third animal, scabs were falling away.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, the undiluted test substance was considered to be highly irritating to rabbit skin. Further, according to CLP, the test substance may be considered to be Category 2 skin irritant.

Executive summary:

A study was conducted to assess the irritation potential of amides, C16-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl) to rabbit skin according to OECD Guideline 404. The test substance was applied undiluted to rabbit skin under an occlusive bandage for 4 h, then washed away with warm water. Animals were observed for 25 d.

Strong erythema and strong oedema were observed in all animals. Slow recovery occured, under thick scabs. After 25 d, 2/3 animals had fully recovered. In the third animal, scabs were falling away.

The overall irritation index was 7/8 so that the undiluted test substance can be considered highly irritating to rabbit skin under the conditions of the study. Further, according to CLP, the test substance may be considered to be Category 2 skin irritant.