Sunflower oil, ester with sorbitol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

OECD Guideline 404, adopted 2002.
Council Regulation (EC) No 440/2008 of 30 May 2008

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sunflower oil, ester with sorbitol

EC Number:

306-248-9

EC Name:

Sunflower oil, ester with sorbitol

Cas Number:

96690-53-8

IUPAC Name:

sunflower seed oil sorbitol esters

Test material form:

liquid

Details on test material:

Batch Number: P08/002
Expiry Date: 2010-03-01
Stability of Polyethyleneglycol: stable for hours

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.5ml

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

Four days before treatment, the left flank was clipped with an electric clipper, 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 Hostacerin SFO was placed on a surgical gauze patch (ca. 2.5 cm x 2.5 cm). This gauze patch was applied to the intact skin of the clipped area. The patch was covered with a semiocclusive 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.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: observations in three animals

Time point:

24/48/72 h

Score:

0.78

Max. score:

1

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: observation in three animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Table: Skin irritation scores
Observation Time	Erythema			Oedema
	Animal 1	Animal 2	Animal 3	Animal 1	Animal 2	Animal 3
1h	2	2	1	0	0	0
24h	1	1	1	0	0	0
48h	1	1	1	0	0	0
72h	0	1	0	0	0	0
7 day	0	0	0	0	0	0
10 day	0	0	0	0	0	0
14 day	0	0	0	0	0	0
Mean of 24/48/72h	0.67	1.00	0.67	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The skin irritaiton property of the registration substance in rabbits was investigated according to the Guideline OECD 404. No significant effect was found.

Executive summary:

The skin irritaiton property of the registration substance in rabbits was investigated according to the the Guideline OECD 404. 0.5 ml of the substance was applied on the clipped skin of rabbits for 4 hours. The treatment induced erythema that was reversible within 3 days in two rabbits and within 7 days in one rabbit. No other effect was found. No significant skin irritating property was found.