C.I. Acid Yellow 246

Endpoint summary

Description of key information

The test substance is not considered to be irritating to the skin as well eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

no

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

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.

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.

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

not specified

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)

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

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.

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

2

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation:

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.

 

Eye Irritation:

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 occured. 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.

Justification for classification or non-classification

Based on the findings in the skin and eye irritation study, the test substance does not considered to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 to be irritating to the skin as well eyes.