9-Octadecenoic acid (Z)-, isooctyl ester, reaction products with glycerol trioleate and sulfur

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 December 1985 to 27 December 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

9-Octadecenoic acid (Z)-, isooctyl ester, reaction products with glycerol trioleate and sulfur

EC Number:

306-111-3

EC Name:

9-Octadecenoic acid (Z)-, isooctyl ester, reaction products with glycerol trioleate and sulfur

Cas Number:

96152-40-8

IUPAC Name:

9-Octadecenoic acid (Z)-, isooctyl ester, reaction products with glycerol trioleate and sulfur

Test material form:

liquid: viscous

Details on test material:

- Physical state: liquid

Test animals

Species:

rabbit

Strain:

other: New Zealand

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, France
- Weight at study initiation: 2.5 kg ± 200 g
- Housing: individual polystyrene cages
- Diet: 150 g complete maintenance food (112 UAR) per rabbit per day
- Water: ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL test material applied to test site

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

6 males were used in the study

Details on study design:

TEST SITE
On the day before test material application, the backs and flanks of each animal were clipped free of fur to bare a 14 cm x 14 cm area. 0.5 mL test material was applied to the test site of each animal, on a surface area of about 6 cm² and then covered with a gauze pad of about 2.5 cm square. The test material and gauze square were held in place with a semi-occlusive patch: 10 cm wide adhesive perforated tape.

REMOVAL OF TEST SUBSTANCE
At the end of the 4 hour exposure period, the coverings were removed and any excess test material wiped from the skin with a gauze pad moistened with deionised water.

SCORING SYSTEM
Skin reactions were scored according to the Draize scale (see "Any other information on materials and methods incl. tables" for further information).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.61

Max. score:

4

Reversibility:

no data

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: No edema observed in any of the animals at any time point

Any other information on results incl. tables

Table 2: Results

	Observation time (h)	Rabbit						Total	Mean
Erythema		1	2	3	4	5	6
	1	1	1	1	1	1	1	6	1.00
	24	1	1	1	1	1	1	6	1.00
	48	1	0	0	1	0	1	3	0.50
	72	1	0	0	0	0	1	2	0.33
Edema	1	0	0	0	0	0	0	0	0
	24	0	0	0	0	0	0	0	0
	48	0	0	0	0	0	0	0	0
	72	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test, the test material did not elicit any reaction in any of the animals during the course of the study that meant the test material required classification as a skin irritant.

Executive summary:

The skin irritation potential of the test material was determined in accordance with standardised guidelines OECD 404 and EU Method B.4. During the study, six rabbits received a single four hour application of 0.5 mL test material and were assessed for the following 72 hours for any signs of skin irritation. Very slight erythema was seen in all animals approximately one and 24 hours after application. Very slight erythema persisted 72 hours after application in two of the animals. Very slight erythema persisted 48 hours application in one animal. There were no other signs of skin irritation noted during the study. No signs of edema were recorded.

Under the conditions of the test, the test material did not elicit any reaction in any of the animals during the course of the study that meant the test material required classification as a skin irritant.