Amines, N-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, N-(hydroxyethyl) derivs.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well reported and carried out study according to guideline/standards

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amines, N-(C16-18 (even numbered) and C18-unsatd. alkyl) trimethylenedi-, ethoxylated(NLP)

EC Number:

800-029-6

Cas Number:

1290049-56-7

Molecular formula:

Not applicable

IUPAC Name:

Amines, N-(C16-18 (even numbered) and C18-unsatd. alkyl) trimethylenedi-, ethoxylated(NLP)

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Details on test material:

Name: DINORAMOX S3
Batch no.: 96102808
Appearance: thick light brown paste
Date of receipt: 31 December 1998
Storage: room temperature protected from light
Purity: 99.86%
Expiry date: January 2000

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, Prouzel, France
- Age at study initiation: no info
- Weight at study initiation: 2.9 kg
- Housing: polystyrene cage
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30-70
- Air changes (per hr): ca. 12
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 16 To: 18 March 1999

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:

3 min on left flank, 4 h on right flank

Observation period:

2 days

Number of animals:

1

Details on study design:

TEST SITE
- Area of exposure: 6 cm2 gauze patch was used
- % coverage: no info
- Type of wrap if used: adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): after removal of the dressing of the 3-min exposure
- Time after start of exposure: 3 min


SCORING SYSTEM:
EVALUATION OF SKIN REACTIONS
Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar
formation (injuries in depth) 4

Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by
definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and
extending beyond area of exposure) 4

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

other: 24 and 48 h

Score:

4

Max. score:

4

Reversibility:

other: animal killed after 2 days because of necrosis

Irritant / corrosive response data:

After a 3-minute exposure: No cutaneous reactions were observed at the 1-hour reading. A severe erythema (grade 4) and a
severe oedema (grade 4), together with cutaneous necrosis, were noted on days 2 and 3.
After a 4-hour exposure: A well-defined erythema (grade 2) and a slight oedema (grade 2) were noted at the 1-hour reading. A
severe erythema (grade 4) and a severe oedema (grade 4), together with cutaneous necrosis, were observed on days 2 and 3.

Other effects:

As the substance showed corrosive properties the animal was killed for ethical reasons two days after application. The study was considered complete.

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Remarks:

Migrated information

Conclusions:

Because a 3-min exposure resulted in necrotic effects 1 and 2 days after application, but not at 1 h after application, the test
material is considered corrosive to rabbit skin, and should be classified in Category 1B according to OECD-GHS.

Executive summary:

At the request of CECA S.A., Paris-la-Defense, France, the potential of the test substance DINORAMOX S3 (batch No. 96102808) to induce skin irritation was evaluated in rabbits according to OECD (No. 404, 17th July 1992) and EC (92169lEEC. B.4, 31st July 1992) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations. The study design was established according to available information on the test substance and the above guidelines. The test substance was applied in a first assay for a period of 3 minutes and 4 hours to one male New Zealand White rabbit. A single dose of 0.5 ml of the undiluted test substance was applied to the closely-clipped skin of one flank. The test substance was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour, 24 and 48 hours after removal of the dressing. As the test substance showed corrosive properties in this first assay, the animal was killed for ethical reasons 2 days after application. The study was considered complete and the test substance was not evaluated on other animals. After a 3-min exposure: No cutaneous reactions were observed at the 1 -hour reading. A severe erythema and a severe oedema, together with cutaneous necrosis, were noted on days 2 and 3. After a 4 -hour exposure: A well-defined erythema and a slight oedema were observed at the 1-hour reading. A severe erythema and a severe oedema, together with cutaneous necrosis, were noted on days 2 and 3. Under these experimental conditions and according to the classification criteria laid down in OECD-GHS, the test substance DINORAMOX S3 (batch No. 96102808) should be considered as corrosive (Category 1B) when applied topically to rabbit skin.