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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.61
Max. score:
4
Reversibility:
no data
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.

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