Mixture of mono-, di- and triesters obtained with isooctadecanoic acid and hydrogenated castor oil

Skin irritation / corrosion

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: GLP-Study according to OECD Guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Salacos HCISV-L

IUPAC Name:

Salacos HCISV-L

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Details on test material:

- Name of test material (as cited in study report): Salacos HCISV-L
- Substance type: organic
- Physical state: liquid
- Analytical purity: not stated
- Lot/batch No.: 40314
- Expiration date of the lot/batch: 02-May-2003
- Stability under test conditions: stable under storage conditions
- Storage condition of test material: in the original container, at room temperature (range 17-23 °C), away from direct light

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Domes, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: 12 weeks
- Weight at study initiation: 1956 - 2316 g
- Housing: individually
- Diet: standard, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: not stated

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

1h, 24 h, 48 h, 72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 4 cm * 4 cm
- % coverage: not stated
- Type of wrap if used: surgical gauze, semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with luke warm water
- Time after start of exposure: 4h

SCORING SYSTEM: standard scoring system as layed down in 92/69/EEC

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

animal: #2,3

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

see results table

Other effects:

no other effects observed

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based upon the classification criteria, the substance is considererd to be not irritating on rabbit skin.

Executive summary:

The primary skin irritation potential of SALACOS HCISV-L was investigated by topical semi-occlusive application of 0.5 ml to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 0.33, 0.00 and 0.00, respectively and the mean oedema score was 0.00 for all three animals.

The application of SALACOS HCISV-L to the skin resulted in mild signs of irritation such as erythema. This effect was reversible an dwas no longer evident 48 hours after treatment. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals.

Thus, the test item did not induce significant or irreversible damage to the skin.