Reaction mass of N,N-ethanediylbis- Hexadecanamide, N-[2-[(1-oxohexadecyl)amino]ethyl]-Octadecanamide, Hexadecanoic acid, 12-hydroxystearic acid, reaction products with ethylenediamine, N,N-ethanediylbis-Octadecanamide and Octadecanoic acid, 12-hydroxystearic acid, reaction products with ethylenediamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

With the exception that the test item was put on a surgical gauze patch of approximately 4 cm x 4 cm (instead of 6 cm²) to guarantee a good contact and uniform distribution of the test item on the skin, the study procedures described in this report meet or exceed the requirements of the following guidelines:
OECD Guidelines for Testing of Chemicals, Section 4, number 404 "Acute Dermal Irritation / Corrosion", adopted April 24, 2002.
Commission Directive 2004/73/EC, B.4. "Acute Toxicity: Dermal Irritation/Corrosion", April 29, 2004.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of N,N-ethanediylbis- Hexadecanamide, N-​[2-​[(1-​oxohexadecyl)​amino]​ethyl]​-Octadecanamide, Hexadecanoic acid, 12-​hydroxystearic acid, reaction products with ethylenediamine, N,N-ethanediylbis-Octadecanamide and Octadecanoic acid, 12-​hydroxystearic acid, reaction products with ethylenediamine

EC Number:

906-763-4

Molecular formula:

not applicable, mixture of substances

IUPAC Name:

Reaction mass of N,N-ethanediylbis- Hexadecanamide, N-​[2-​[(1-​oxohexadecyl)​amino]​ethyl]​-Octadecanamide, Hexadecanoic acid, 12-​hydroxystearic acid, reaction products with ethylenediamine, N,N-ethanediylbis-Octadecanamide and Octadecanoic acid, 12-​hydroxystearic acid, reaction products with ethylenediamine

Test material form:

other: Nearly white solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Netherlands BV
- Age at study initiation: 14 - 15 weeks (male); 13 - 15 weeks (females)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Füllinsdorf) and haysticks 4642 (batch no. 77/05, Provimi Kliba AG) were provided for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 85/05) provided by Provimi Kliba AG, CH-4303 Kaiseraugst.
- Water (e.g. ad libitum): Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: 24-MAY-2006 to 28-MAY-2006

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 24.05. To: 01.06.2006

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Amount / concentration applied:

0.5 g (per animal) of the test item was weighed as delivered by the Sponsor and then moistened with approximately 0.5 mL of purified water before application. The pH of the test item was measured before the study initiation date. A formulation of a 1 % (w/w) solution was prepared. The pH was found to be 5 - 6. According to Commission Directive 2004/73/EC, B.4. and OECD Guidelines 404, a test item needs not to be tested if the pH-value is less than 2 or greater than 11.5, owing to its predictable corrosive properties.

Duration of treatment / exposure:

Four days before treatment, the left flank was clipped with an electric clipeer, exposing an area of approximately 100 cm² (10 cm x 10 cm). The skin of the animals was examined one day before treatment, and regrown fur of all animals was clipped again. Animals with overt signs of skin injury or marked irritation which may have interfered with the interpretation of the results were not used in the test. On the day of treatment, 0.5 g of the test item was placed on a surgical gauze patch (ca. 4 cm x 4 cm). This gauze patch was applied to the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape. The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.

Observation period:

The skin reaction was assessed at approximately 1, 24, 48 and 72 hours after exposure (removal of the dressing, gauze patch and test item).

Number of animals:

Number of animals per test: 3 (Animals of both sexes were used)
Age of treatment: 14-15 weeks (male); Male No. 58
13-15 weeks (females); Female Nos. 59 and 60

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

IRRITATION:
The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.

COLORATION:
No staining produced by the test item of the treated skin was observed.

CORROSION:
Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin.

Other effects:

VIABILITY/MORTALITY/CLINICAL SIGNS:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.

BODY WEIGHTS:
The body weights of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating to rabbit skin

Conclusions:

Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 2001), the test item is considered to be "not irritating" to rabbit skin.

Executive summary:

The primary skin irritation potential of the substance was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing.

The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.

The application of the substance to the skin resulted in no signs of irritation. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.

Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 2001), the test substance is considered to be "not irritating" to rabbit skin.