[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experiment start date - 11 January 2005; Experiment end date - 31 January 2005; Study completion date - 23 February 2005.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

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:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

FAT40819/A TE

IUPAC Name:

FAT40819/A TE

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): FAT 40819/A
- Purity: Approx. 77%
- Lot/batch No.: Red ROE 420 BOP 01/04
- Expiration date: 2 November 2009
- Stability: Stable under storage conditions.
- Storage conditions: At room temperature (range of 20 ± 5 °C), light and moisture (dessiccator) protected.

Specific details on test material used for the study:

Identity: FAT 40819/A
Description: Red brown powder
Batch number: Red ROE 420 BOP 01/04
Purity: approx. 77 %
Stability of test item: Stable under storage condition
Expiry date: 02 November 2009
Stability of test item dilution: Stable in PEG 300 for at least 7 days at room temperature
Storage conditions: At room temperature.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories France, BP 0109, F-69592 L'Arbresle
- Age at treatment: 12 weeks
- Body weight at treatment: 2113 - 2310 g
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Füllinsdorf) and haysticks 4642 (batch no. 38/04, Provimi Kliba AG) were provided for gnawing.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 68/04) provided by Provimi Kliba AG, CH-4303 Kaiseraugst.
- Water: Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.

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:

water

Controls:

no

Amount / concentration applied:

0.5 g test substance moistened with approximately 0.1 mL purified water.

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

1 male, 2 females

Details on study design:

TREATMENT
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 FAT 40819/A was placed on a surgical gauze patch (ca. 4 cm x 4 cm). This gauze patch was applied to the intact skin of the clipped area. The patch was covered with a semi-occlusive 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.

OBSERVATIONS
Viability/Mortality: Daily from acclimatization of the animals to the termination of test.
Clinical signs: Daily from acclimatization of the animals to the termination of test.
Body weights: At start of acclimatization, on the day of application and at termination of observation.

SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004 approximately 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after the removal of the dressing, gauze patch and test item. To allow further examination of the test sites two animals were re-clipped on completion of the 24 hour examination. If evident, corrosive or staining properties of the test item were described and recorded.

Grading of Skin Reactions
ERYTHEMA AND ESCHAR FORMATION
No erythema..................................................................................................................................... 0
Very slight erythema.......................................................................................................................... 1
Well-defined erythema....................................................................................................................... 2
Moderate to severe erythema.............................................................................................................. 3
Severe erythema (beet redness) or eschar formation (injuries in depth preventing erythema) reading.......... 4

OEDEMA FORMATION
No oedema........................................................................................................................... 0
Very slight oedema (barely perceptible)................................................................................... 1
Slight oedema (edges of area well-defined by definite raising)..................................................... 2
Moderate oedema (edges raised approximately 1 mm).............................................................. 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure) ..................4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0.11

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

- Very slight erythema was noted in the male animal one hour after application and in one female at the 24-hour reading. With the exception of staining, no abnormal findings were observed on the treated skin of any animal 48 hours after treatment.
- Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin.

Other effects:

- Slight to moderate red staining of the treated skin produced by the test item was observed from the 1-hour to the 72-hour reading in all animals and persisted up to the 10-day examination in one female.
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
- The body weights of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Test substance is considered to be not irritating or corrosive to the rabbit skin.

Executive summary:

In a GLP-compliant skin irritation study, performed according to OECD guideline 404, the test substance (moistened, 0.5 g) was applied, semi-occlusive, to the skin of three New Zealand White rabbits for 4 hours. After 4 hours, the dressing was removed and the skin was flushed with lukewarm tap water and observations were made for an additional 14 days. The test substance showed an 24/48/72h edema score of 0 and erythema score of 0.11 which was reversible within 48h. Slight red staining was observed on all animals up to 10 days after treatment. No corrosive effects were noted. Also no other clinical signs of test item related effects were observed. Under the conditions of this experiment, the test substance was found to be not irritating or corrosive.