C.I. Acid Yellow 246

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 September 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 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

not specified

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
Purity: approx. 96 %
Physical properties: powder
Stability: guaranteed by the sponsor for 30 years (2014)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
The rabbits were recognized by the international guideline as the recommended test system. Total number of animals are 3 males.
- Animal Strain: New Zealand white rabbits (KFM-NZW)
- Breeder: Kleintierfarm Maedorin AG, CH-4414 Fuellinsdorf
- 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.
- Acclimation period: 5 days

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 g of FAT 20306/B was placed into the conjunctival sac of the right eye of each animal

Duration of treatment / exposure:

no data

Observation period (in vivo):

The body weight was recorded at start and on day 3 and 7 of the test .
The animals were checked daily for systemic symptoms and mortality.

Number of animals or in vitro replicates:

3 male rabbits

Details on study design:

0.1 g of FAT 20306/B was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material. The left eye remained untreated and served as a control. The ocular reactions were evaluated 24, 48, and 72 hours after the instillation of FAT 20'306/B according to the OECD scoring system. A slit-lamp was used to facilitate the evaluation.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

1.66

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0.77

Max. score:

4

Reversibility:

fully reversible within: 3 days

Results 5

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 7 d

Score:

0

Max. score:

13

Irritant / corrosive response data:

Because reactions were observed within 72 hours after instillation of the test compound, the observation period was extended to 7 days to determine the reversibility of the eye reactions. The eye reactions observed were reversible until the end of the observation period on day 7.

Other effects:

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

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20306/B shows only slight irritation to the rabbit eye.

Executive summary:

The study was performed to access the primary eye irritation potential of FAT 20306/B according to OECD guideline 405. Three male New Zealand White rabbits were exposed a single dose of test substance (0.1 g per animal) placed in the eyes of rabbits. The reaction was assessed at 1, 24, 48 and 72 hours intervals after administration. No acute toxic symptoms were observed in the animal during the test period, and no morality occurred. The mean values of the readings 24 to 72 hours after application are under the threshold of significance, thus FAT 20306/B is not considered as eye irritant to rabbit.