Reactive Orange 143

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07February 2012 to 17 February 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): FAT 40854/A TE
- Physical state: Solid
- Storage condition of test material: At room temperature in the dark

Specific details on test material used for the study:

Identification: FAT 40854/A TE
Description: Reddish-brown powder (determined at NOTOX)
Batch: TZ 5719 / BOP 02-11
Content: 46.2 % (4 main constituents)
Test substance storage: At room temperature in the dark
Stability under storage conditions: Stable
Expiry date: 01 April 2016
Hygroscopic: Yes, store in well-sealed container
pH: 5.4 at concentration of >80 g/L
Stability in Water: Stability for at least 6 hours at room temperature
Solubility in Water: More than 80 g/L

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Source: Charles River France, L’Arbresle Cedex, France
- Age at study initiation: at least 6 weeks old.
- Weight at study initiation: at least 1.0 kg.
- Housing: Animals were housed individually in cages with perforated floors.
- Diet: Free access to pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad, Italy). Hay and wooden sticks were abailable during the study period.
- Water: Free access to tap water.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
Environmental controls for the animal room were set to maintain 18 to 24 °C, a relative humidity of 40 to 70 %, approximately 15 room air changes/hour, and a 12-hour light/12-hour dark cycle. Any variations to these conditions were maintained in the raw data and had no effect on the outcome of the study.

IN-LIFE DATES: From: 07- 17 February 2012

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: The test substance was moistened with 0.5 mL water

Controls:

other: Adjacent areas of the untreated skin of each animal served as controls.

Amount / concentration applied:

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

VEHICLE
The test substance was moistened with 0.5 mL water.

Duration of treatment / exposure:

4 hours

Observation period:

14 days.

Number of animals:

3 males.

Details on study design:

The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner one week later, after considering the degree of skin irritation observed in the first animal.

Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm). To facilitate scoring, treated skin areas were re-clipped.
Each animal was treated by dermal application of 0.5 grams of the test substance. The test substance was moistened with 0.5 mL of the vehicle and applied to the skin of one flank, using a metalline patch# of 2x3 cm. The patch was mounted on Micropore tape#, which was wrapped around the abdomen and secured with Coban elastic bandage#.
Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using tap water and watery ethanol (50 % v/v) and/or watery acetone (50 % v/v).

SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system according to OECD 404.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Irritation: Four hours exposure to 0.5 g of FAT 40854/A resulted in very slight erythema in one animal on Day 1. In the other animals, erythema could not be scored on Day 1 based on orange/red staining of the treated skin. No oedema was noted in the treated skin areas of the three rabbits. The skin irritation resolved within 24 hours after exposure in all animals.

Corrosion: There was no evidence of a corrosive effect on the skin.

Other effects:

Coloration / Remnants: Orange/red staining of the treated skin by the test substance was observed during the observation period, which did not hamper the scoring of the skin reactions except for two animals on Day 1. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40854/A is not considered as irritant to rabbit's skin.

Executive summary:

In a GLP-compliant study, primary skin irritation/corrosion study with FAT 40854/A in the rabbit (4-hour semi-occlusive application) was carried out according to OECD No.404 and EU method B4. Three rabbits were exposed to 0.5 grams of FAT 40854/A, moistened with water by application onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure. Exposure to FAT 40854/A resulted in very slight erythema in one animal on Day 1. In the other animals, erythema could not be scored on Day 1 based on orange/red staining of the treated skin. No oedema was noted in the treated skin areas of the three rabbits. The skin irritation resolved within 24 hours after exposure in all animals. There was no evidence of a corrosive effect on the skin. Orange/red staining of the treated skin by the test substance was observed during the observation period, which did not hamper the scoring of the skin reactions except for two animals on Day 1. Based on these results FAT 40854/A is not considered as irritant to rabbit's skin.