N-(2-carboxyethyl)-N-octyl-β-alanine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18-28 September 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed in compliance with GLP and according to OECD guideline 404.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

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 (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate

EC Number:

305-318-6

EC Name:

Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate

Cas Number:

94441-92-6

Molecular formula:

C14H26NO4.Na

IUPAC Name:

sodium 3-[(2-carboxyethyl)(2-ethylhexyl)amino]propanoate

Test material form:

other: Liquid

Details on test material:

- Name of test material:sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate
- Physical state: liquid (colorless)
- Analytical purity: confidential information
- Composition of test material, percentage of components: confidential information
- Lot/batch No.: confidential information
- Expiration date of the lot/batch: confidential information
- Storage condition of test material: Room temperature, in the dark, container: plastic flask.
- Other: Date received 10 September 2007

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gérome, Linxe.
- Age at study initiation: 12 weeks
- Weight at study initiation:2.42-2.68 kg
- Housing: Individual box
- Diet (e.g. ad libitum): ad libitium
- Water (e.g. ad libitum): ad libitium
- Acclimation period: 5 days
- Other: Albino rabbits, female

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23 °C
- Humidity (%): 31-55 %
- Photoperiod (hrs dark / hrs light): (12/12)

Test system

Type of coverage:

semiocclusive

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 mL

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after removal of the patches

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm2 on an undamaged skin area of one flank of each animal.
- Type of wrap if used: patch with strip of surgical adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing: treated area was rinsed with distilled water
- Time after start of exposure: 4 hours

SCORING SYSTEM: scored in accordance with OECD404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No cutaneous reactions (erythema and oedema) were observed (1, 24, 48 and 72 hours).

Other effects:

No other effects were observed

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The skin irritating potential of the substance was investigated in a dermal skin irritating study which was performed in accordance with OECD404 and under GLP conditions. Based on the result the test item does not need to be classified in accordance with the criteria outlined in Annex I of 67/548/EEC and Annex VI of 1272/2008?EC, under the conditions of this study.

Executive summary:

The skin irritating potential of sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate was investigated in a dermal skin irritating study which was performed in accordance with OECD404 and under GLP conditions. The test material was applied to the shorn skin of 3 (female) New Zealand White albino rabbits at a dose of 0.5 mL under semi-occlusive dressing during 4 hours. No cutaneous reactions (erythema and oedema) were observed. Based on these results, the test substance does not need to be classified in accordance with the criteria outlined in Annex I of 67/548/EEC and Annex VI of 1272/2008?EC, under the conditions of this study.