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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according OECD guideline, GLP, well documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, C8-10, Me esters
EC Number:
287-636-4
EC Name:
Fatty acids, C8-10, Me esters
Cas Number:
85566-26-3
Molecular formula:
C9-11H18-22O2
IUPAC Name:
Fatty acids, C8-10 (even numbered), Me esters
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Edenor ME C6-10 (later found to be more C8-10 fatty acid methyl ester containing)
- Substance type: fattyacid methylester
- Physical state: yellow liquid

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Age at study initiation: adult
- Weight at study initiation: 2465.0 g
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21°C
- Humidity (%): 45-50%
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5ml
- Concentration (if solution): undiluted
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
4 male
Details on study design:
TEST SITE
- Area of exposure: 2.5cm x 2.5 cm
- Type of wrap if used: cotton lobe plus plastic foil

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1#2#3#4
Time point:
other: 24,48,72h
Score:
2.16
Max. score:
4
Reversibility:
fully reversible within: 14d
Irritation parameter:
edema score
Basis:
animal: #1#2#3#4
Time point:
other: 24,48,72h
Score:
1.25
Max. score:
4
Reversibility:
fully reversible within: 10days

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information CLP Criteria used for interpretation of results: EU
Conclusions:
Based on this result the substance has not to be labeled as irritating to skin according to EU GHS EC 1272/2008.
Based on the study results the test substance has to be classified as Xi, R38: Irritating to skin according to DSD.
Executive summary:

The substance Edenor ME C6-10 was tested for its primary skin irritation under occlusive conditions on the shaved back skin of 4 rabbits (Method: Off.J.Europ. Commun. 27, L 251, 1984, p. 106 - 108 and Guidelines for Testing of Chemicals. Section 4, No 404, OECD).

 

After a contact time of 4 hours the skin reactions were evaluated 1,24,48 and 72 hours as well as on day 8, 10 and 14 after termination of exposure. Slight to moderate skin reactions were observed.

Under the experimental conditions described in this report, the mean score for erythema was 2.16 (2.6, 2.3, 2.0, 1.6) and for oedema 1.25 (1.3, 1.3, 1.6, 0.6). These reactions disappeared totally within fourteen days.

Based on this result the substance has not to be labeled as irritating to skin according to EU GHS EC 1272/2008.

Based on the study results the test substance has to be classified as Xi, R38: Irritating to skin according to DSD.