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Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, and 72h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
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.