Reaction mass of Disodium dihydroxy[2-{[5-(hydroxy-kO)-3-methyl-1-(4-sulfophenyl)-1H-pyrazol-4-yl]diazenyl-kN1}benzoato(3-)-kO]chromate(2-) and Sodium hydroxy[2-{[5-(hydroxy-kO)-3-methyl-1-(4-sulfophenyl)-1H-pyrazol-4-yl]diazenyl-kN1}benzoato(3-)-kO]chromate(1-)

Endpoint summary

Description of key information

ACID YELLOW 104 is neither a skin nor an eye irritant.

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:

supporting study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

None

Qualifier:

according to guideline

Guideline:

other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food arid Drug Officials (AFDO).

Principles of method if other than guideline:

None

GLP compliance:

no

Specific details on test material used for the study:

None

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kgs
- Housing: V2A wire cages
- Diet: standard rabbit food ad libitum - NAFAG, Gossau SG
- Water: ad libitum

Type of coverage:

occlusive

Preparation of test site:

other: abraded and intact skin

Vehicle:

other: polyethylene glycol (50 %)

Controls:

not specified

Amount / concentration applied:

0.5 g of the test material were applied to the prepared abraded and intact skin.

Duration of treatment / exposure:

The gauze patches were removed 24 hours after the application.

Observation period:

The reaction of the skin was appraised upon patch removal and after 72 hours later.

Number of animals:

3 male and 3 female

Details on study design:

A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape.

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 and 72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

on intact as well as abraded skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 and 72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

on intact as well as abraded skin

Irritant / corrosive response data:

None

Other effects:

None

None

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20041/A is to be considered as a non-irritant to the skin of rabbits.

Executive summary:

A study was performed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 20041/A, on the skin of the rabbits. The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. FAT 20041/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it. No irritation was found with the intact as well as abraded skin throughout the exposure period. Hence, FAT 20041/A can be classified as a non-irritant to the skin of 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:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

None

Qualifier:

according to guideline

Guideline:

other: Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.

Principles of method if other than guideline:

None

GLP compliance:

no

Specific details on test material used for the study:

None

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2 to 3 kgs
- Housing: housed individually in metal cages, numbered by ear tags
- Diet: standard rabbit food ad libitum - NAFAG, No. 814, Gossau SG
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2° C
- Humidity: 55 +/- 10 %
- Photoperiod (hrs dark / hrs light): 10 hour light cycle day

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

The test material in an amount of 0.1 g was inserted

Duration of treatment / exposure:

The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline.

Observation period (in vivo):

The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit.

Duration of post- treatment incubation (in vitro):

None

Details on study design:

None

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

None

Other effects:

None

Table: Eye irritation – Individual scores

Animal No.	Rinsed/ not rinsed	Corneal opacity	Iris	Conjunctival redness	Chemosis
24 hours
200	not rinsed	0	0	0	2
201	not rinsed	0	0	0	1
202	not rinsed	0	0	0	0
203	rinsed	0	0	0	0
204	rinsed	0	0	0	0
205	rinsed	0	0	0	0
48 hours
200	not rinsed	0	0	0	1
201	not rinsed	0	0	0	0
202	not rinsed	0	0	0	0
203	rinsed	0	0	0	0
204	rinsed	0	0	0	0
205	rinsed	0	0	0	0
72 hours
200	not rinsed	0	0	0	0
201	not rinsed	0	0	0	0
202	not rinsed	0	0	0	0
203	rinsed	0	0	0	0
204	rinsed	0	0	0	0
205	rinsed	0	0	0	0
Day 7
200	not rinsed	0	0	0	0
201	not rinsed	0	0	0	0
202	not rinsed	0	0	0	0
203	rinsed	0	0	0	0
204	rinsed	0	0	0	0
205	rinsed	0	0	0	0

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20041/B can be considered as not an eye irritant.

Executive summary:

The eye irritation potential of the test substance was evaluated in a study conducted according to the proposed guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. The test was performed on 3 male and 3 female adult New Zealand White rabbits. The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. No irritation was seen when the exposed eyes were examined for corneal opacity, effects on iris and conjuntival redness. However mild chemosis was seen in 2 of 6 exposed animals, which was fully reversible within 72 hours. Hence, the scores obtained in this study do not fulfil the classification criteria for eye irritation as required by Regulation (EC) No. 1272/2008. Hence, FAT 20041/B can be considered as not an eye irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin:

A key study was performed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 20041/A, on the skin of the rabbits.The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. FAT 20041/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it. However, abraded skin is an elevated testing condition and the results obtained with abraded skin normally do not have to be taken into account for hazard assessment. According to the EC classification of the results obtained, FAT 20041/A can be classified as non-irritant in albino rabbits.

A study was performed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 20041/A, on the skin of the rabbits.The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. FAT 20041/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it. No irritation was found with the intact as well as abraded skin throughout the exposure period. Hence, FAT 20041/A can be classified as a non-irritant to the skin of rabbits.

Eye:

The eye irritation potential of the test substance was evaluated in a study conducted according to the proposed guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.The test was performed on 3 male and 3 female adult New Zealand White rabbits. The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. No irritation was seen when the exposed eyes were examinedfor corneal opacity, effects on iris and conjuntival redness. However mild chemosis was seen in 2 of 6 exposed animals, which was fully reversible within 72 hours. Hence, the scores obtained in this study do not fulfil the classification criteria for eye irritation as required by Regulation (EC) No. 1272/2008. Hence, FAT 20041/B can be considered as not an eye irritant.

Similarly, other supporting study conducted with FAT 20041/A also supports the conclusion that the substance is not a eye irritant.

Justification for classification or non-classification

Based on the available studies, FAT 20041 does not need to be classified as per the CLP (Regulation 1272/2008) criteria.