Disodium [2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

Endpoint summary

Description of key information

FAT 20013 is to be considered as a non-irritant to the skin and eye of rabbits.

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:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: The procedure employed was that prescribed by The Food and Drug Administration of the U.S.A. in The Federal Register (17 September 1964 § 191 .11), a transcript of which is attached as an Appendix to this report.

Deviations:

no

GLP compliance:

no

Specific details on test material used for the study:

Name: FAT 20013/A
Purity: 59 %

Species:

rabbit

Strain:

not specified

Type of coverage:

semiocclusive

Preparation of test site:

other: abraded and intact

Vehicle:

water

Controls:

not required

Amount / concentration applied:

0.5 g of the solid was mixed to a paste with 0.5 ml of water before application to each treatment site.

Duration of treatment / exposure:

24 hours

Observation period:

24 and 72 hours

Number of animals:

6 animals

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

There was no observable response to treatment in any of the six animals at the 24 hours or the 72 hours readings.

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20013/A is to be considered as a non-irritant to the skin of rabbits.

Executive summary:

A study was performed to determine the acute irritation potential of FAT 20013/A, on the skin of the rabbits according to the procedure employed was that prescribed by The Food and Drug Administration of the U.S.A. in The Federal Register (17 September 1964 § 191 .11). Six Albino white rabbits (3 males and 3 females) were shaved and the test substance applied on abraded and intact skin of the animals. 0.5 g of the test substance was mixed with 0.5mL of water to form paste before application to each treatment site. The animals were immobilized with patches secured in place by adhesive tape. The entire trunk of the animal was then wrapped with an impervious material such as rubberized cloth for the 24-hour period of exposure. This material aids in maintaining the test patches in position and retards the evaporation of volatile substances. After 24 hours exposure, the patches were removed, and the resulting reactions were evaluated. No erythema or edema was observed at 24- and 72-hour readings. Based on the findings of this study, FAT 20013 is to be considered 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:

Study completion date: 08 April 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: The procedure employed was that prescribed by The Food and Drugs Administration of the U.S.A. in The Federal Register (17 September 1964 S 191.12), a transcript of which is attached as Appendix 1 to this report.

Deviations:

no

GLP compliance:

no

Specific details on test material used for the study:

Name: FAT 20013/A
Purity: 59 %

Species:

rabbit

Vehicle:

water

Controls:

not required

Amount / concentration applied:

70 mg of FAT 20013/A was instilled into each eye.

Duration of treatment / exposure:

The eyes are examined and the grade of ocular reaction is recorded at 24, 48 and 72 hours.

Observation period (in vivo):

24 hours

Number of animals or in vitro replicates:

Six albino rabbits are used for each test substance.

Details on study design:

SCORING SYSTEM: Scale for scoring Ocular Lesions.
1.Cornea
(A) Opacity-degree of density (area most dense taken for reading)
- No opacity: 0
- Scattered or diffuse area, details of iris clearly visible: 1
- Easily discernible translucent areas, details of iris slightly obscured: 2
- Opalescent areas, no details of iris visible, size of pupil barely discernible: 3
- Opaque, iris invisible: 4

(B) Area of cornea involved
- One quarter (or less) but not zero: 1
- Greater than one quarter but less than half: 2
- Greater than half, but less than three quarters: 3
- Greater than three quarters, up to whole area: 4

AxBx5 Total maximum=80

2.Iris
(A) Values
- Normal: 0
- Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) iris still reacting
to light (sluggish reaction is positive): 1
- No reaction to light, haemorrhage, gross destruction (any or all of these): 2
Ax5 Total maximum=10

3.Conjunctivae
(A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
- Vessels normal: 0
- Vessels definitely injected above normal: 1
- More diffuse, deeper crimson red, individual vessels not easily discernible: 2
- Diffuse beefy red: 3

(B) Chemosis
- No swelling: 0
- Any swelling above normal (includes nictitating membrane): 1
- Obvious swelling with partial eversion of lids: 2
- Swelling with lids about half closed: 3
- Swelling with lids about half closed to completely closed: 4

(C) Discharge'
- No discharge: 0
- Any amount different from normal (does not include small amounts observed" in inner canthus of normal animals): 1
- Discharge with moistening of the lids and hairs just adjacent to lids: 2
- Discharge with moistening of the lids and hairs, and considerable area around the eye: 3
Score (a+b+c)x 2 Total maximum=20

TOOL USED TO ASSESS SCORE: slit lamp

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0.05

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Remarks:

6 animals

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:

0.46

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0.46

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

One animal only gave a "positive" reaction. A temporary corneal opacity was observed in this one animal 24 hours after instillation only. A slight dulling of the normal corneal lustre was observed in one other animal 24 hours after instillation only. Mild conjunctival reactions were observed in all six animals. A maximum group mean reaction of 6 was established on day 1.

Numerical Scores awarded to the ocular reactions elicited by FAT 20013/A:

Animal Number	Region of eye		Day
			1	2	3	4	7	14	21
1	Cornea		0	0	0	0	0	0	0
	Iris		0	0	0	0	0	0	0
	Conjuctivae		4	0	0	0	0	0	0
	TOTAL		4	0	0	0	0	0	0
2	Cornea		0	0	0	0	0	0	0
	Iris		0	0	0	0	0	0	0
	Conjuctivae		6	0	0	0	0	0	0
	TOTAL		6	0	0	0	0	0	0
3	Cornea		0	0	0	0	0	0	0
	Iris		0	0	0	0	0	0	0
	Conjuctivae		2	2	0	0	0	0	0
	TOTAL		2	2	0	0	0	0	0
4	Cornea		5	0	0	0	0	0	0
	Iris		0	0	0	0	0	0	0
	Conjuctivae		6	4	2	2	2	2	0
	TOTAL		11	4	2	2	2	2	0
5	Cornea		0	0	0	0	0	0	0
	Iris		0	0	0	0	0	0	0
	Conjuctivae		6	2	0	0	0	0	0
	TOTAL		6	2	0	0	0	0	0
6	Cornea		0	0	0	0	0	0	0
	Iris		0	0	0	0	0	0	0
	Conjuctivae		8	2	2	0	0	0	0
	TOTAL		8	2	2	0	0	0	0
Total Score			37	16	4	2	2	2	0
Mean / rabbit			6	3	<1	<1	<1	<1	0

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20013/A is considered to be a non-irritant to the eyes.

Executive summary:

In a study performed according to The Food and Drugs Administration of the U.S.A. in The Federal Register (17 September 1964 S 191.12), to determine the eye irritation potential of FAT 20013A, the test substance was instilled in the eyes of 3 male and 3 female rabbits and observations for irritation were recorded at the time points of 1 hour, 6 hours, 1 day, 2 days, 3 days, 4 days, 7 days, 14 days and 21 days. Corneal opacity, Iris, Conjuctivae and chemosis score was reported to be 0.05, 0, 0.46, 0.46 respectively, indicating a very weak irritation potential. One animal only gave a "positive" reaction. A temporary corneal opacity was observed in this one animal 24 hours after instillation only. A slight dulling of the normal corneal lustre was observed in one other animal 24 hours after instillation only. Mild conjunctival reactions were observed in all six animals. A maximum group mean reaction of 6 was established on day 1. Based on these findings, FAT 20013/A is considered to be a non-irritant to the eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

A study was performed to determine the acute irritation potential of FAT 20013/A, on the skin of the rabbits according to the procedure employed was that prescribed by The Food and Drug Administration of the U.S.A. in The Federal Register (17 September 1964 & 191 .11). Six Albino white rabbits (3 males and 3 females) were shaved and the test substance applied on abraded and intact skin of the animals. 0.5 g of the test substance was mixed with 0.5mL of water to form paste before application to each treatment site. The animals were immobilized with patches secured in place by adhesive tape. The entire trunk of the animal was then wrapped with an impervious material such as rubberized cloth for the 24-hour period of exposure. This material aids in maintaining the test patches in position and retards the evaporation of volatile substances. After 24 hours exposure, the patches were removed, and the resulting reactions were evaluated. No erythema or edema was observed at 24- and 72-hour readings.

Based on the findings of this study, FAT 20013 is to be considered as a non-irritant to the skin of rabbits.

Eye irritation:

In a study performed according to The Food and Drugs Administration of the U.S.A. in The Federal Register (17 September 1964 S 191.12), to determine the eye irritation potential of FAT 20013A, the test substance was instilled in the eyes of 3 male and 3 female rabbits and observations for irritation were recorded at the time points of 1 hour, 6 hours, 1 day, 2 days, 3 days, 4 days, 7 days, 14 days and 21 days. Corneal opacity, Iris, Conjuctivae and chemosis score was reported to be 0.05, 0, 0.46, 0.46 respectively, indicating a very weak irritation potential. One animal only gave a "positive" reaction. A temporary corneal opacity was observed in this one animal 24 hours after instillation only. A slight dulling of the normal corneal lustre was observed in one other animal 24 hours after instillation only. Mild conjunctival reactions were observed in all six animals. A maximum group mean reaction of 6 was established on day 1. Based on these findings, FAT 20013/A is considered to be a non-irritant to the eyes.

Justification for classification or non-classification

Based on the above stated assessment, FAT 20013 is to be considered as a non-irritant to the skin and eye of rabbits, hence no classification is warranted according to CLP (Regulation (EC) No 1272/2008).