C.I. Acid Yellow 246

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 August 1984 to 15 November 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Test substance: FAT 20306/B
Batch No.: HT 2025/50
Physical properties: powder
Stability: guaranteed by the sponsor for 30 years (2014)
Safety precautions: gloves and face masks
Test material received: July 5, 1984

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
The albino rabbit is the recommended species for skin irritation / corrosion studies.
-Animal Strain: New Zealand white rabbits (KFM-NZW)
-Breeder: Kleintierfarm Maedorin AG, CH-4414 Fuellinsdorf
-Acclimatization period: 5 days
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2-3 kg
- Housing: individually in metal cages
- Diet: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland - and fresh water.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): on a 12 hours light cycle day.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

dist. water

Controls:

yes, concurrent vehicle

Amount / concentration applied:

0.5 g of the test substance was applied to the flank.

Duration of treatment / exposure:

4 hours

Observation period:

viability/mortality: Daily;
Body weights: At the start and end of the test

Number of animals:

3 male rabbits

Details on study design:

An area of about 6 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch bearing 0.5 g of the test substance was applied to the flank. A control gauze patch was applied to the contralateral flank. Both gauze patches were moistened before application with dest. water.

The patches were covered with an occlusive membrane and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).

The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system.

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:

No reactions were observed at 24 hours to 72 hours after removing the bandages. So the test was ended after the 72 hours evaluation without the need for an observation period.

Other effects:

The body weight gain of all rabbits was similar. No acute toxic symptoms were observed in the animal during the test period, and no morality occured due to the results obtained.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20306/B is not irritant in New Zealand White rabbits.

Executive summary:

The test was performed with FAT 20306/B according to OECD guideline 404 to access the primary skin irritation potential when single doses of test substance are placed on the skin of New Zealand White male rabbits. The skin reaction was assessed at 1, 24, 48 and 72 hours intervals after the removal of the dressing, gauze patch and test article. No reactions were observed at 24 hours to 72 hours after removing the bandages. The body weight gain of all rabbits was similar. No acute toxic symptoms were observed in the animal during the test period, and no morality occured due to the results obtained. Based on the results of this test, the test substance is not irritant in New Zealand White rabbits.