Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate

Endpoint summary

Description of key information

not eye irritant for rabbits

not skin irritant for 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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

according to guideline

Guideline:

other: Hazardous Substances Regulation, US Federal Hazardous Labelling Act. Sect. 191-11 (February 1965)

Deviations:

not specified

GLP compliance:

not specified

Species:

rabbit

Strain:

Californian

Details on test animals or test system and environmental conditions:

Age: 12-16 weeks
Body weight: average 2.16 kg for males and 2.24 for females.
Source: Hylyne Commercial rabbits Lt
Acclimation: 1 week
Caged singly in an experimental room mainteined at a temperature of 16°C and with a humidity of 50-70%.
Animals were exposed to artificial light for 10 hours daily from 8-18 hours.
Commercial diet, Labsure Christopher Hill Group, was fed ad libitum.
Sterile filtered water was available at all the times.

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

10 g of the test compound was mixed with 12ml of deionised water to make a solution of 20ml.
1 ml of which was applied to each test site on a 2.5cm square gauze pad.
These were couered with aluminium foil secured with "TFanspore" surgical tape. The test sites were then couered by a 6" wide "Coban" self adhesive bandage in order to retain the test substance in close contact with the skin.

Duration of treatment / exposure:

24 hours

Observation period:

72 hours and up to 14 days after treatment

Number of animals:

6, 3 for each sex

Details on study design:

Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10%
of the total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application
of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep
to penetrate the stratum corneum but not to damage the dermis. The left hand sit« remained intact.

Irritation parameter:

erythema score

Basis:

animal: 11,12

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal: 13, 15,14 and 16

Time point:

24/48/72 h

Score:

0.66

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal: 11

Time point:

24/48/72 h

Score:

1.66

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal: 15,12 and 14

Time point:

24/48/72 h

Score:

1.33

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal: 13

Time point:

24/48/72 h

Score:

0.66

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal: 16

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the test results, the tested item is to be considered as non-irritant to the skin of rabbits.

Executive summary:

The primary irritation score was assessed following the Hazardous Substances Regulation, US Federal Hazardous Labelling Act. Sect. 191-11 (February 1965).

The result show no irritation on rabbit skin therefore the tested item is to be considered as non-irritant to skin under CLP classification.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

according to guideline

Guideline:

other: Hazardous Substances Regulation, US Federal Hazardous Labelling Act. Sect. 191-11 (February 1965)

Deviations:

not specified

Principles of method if other than guideline:

The ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A. (sea appendix I).The tested substance is considered to be irritant for the rabbits eyes.

GLP compliance:

no

Species:

rabbit

Strain:

Californian

Details on test animals or tissues and environmental conditions:

Animals age: 12-16 weeks
Average body weights of 2.16 kgs. (SS) and 2.24 kgs.
Source: commercial supplier (Hylyne Commercial Rabbits Ltd.).
Acclimation in the test area for one week prior to the start of the trial.

The rabbits were caged singly in an experimental room maintained at a temperature of 16 C and a relative humidity of 50 - 70%.
Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours.
A commercial diet (Labsure, Christopher Hill Group) was fed ad lib.
Sterile filtered water was available at all times.

Vehicle:

unchanged (no vehicle)

Controls:

other: the right eye serves as control

Amount / concentration applied:

100 mg of the test substance

Duration of treatment / exposure:

30 seconds

Observation period (in vivo):

up to 10 days

Number of animals or in vitro replicates:

3 males / 3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: after 30 seconds the compounds was flushed out of three of the rabbits with 200 ml of warm water.

SCORING SYSTEM: The ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics"
page 51, published by the Association of Food and Drug Officials of the U.S.A.

TOOL USED TO ASSESS SCORE: fluorescein (Fluorets - Smith & Nephew Pharmaceutical Limited) was used as an aid in assessing corneal damage.

Irritation parameter:

cornea opacity score

Basis:

animal: 1 and 3

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 3 days

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.333

Reversibility:

fully reversible within: 2 days

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.333

Reversibility:

fully reversible within: 2 days

Remarks:

waahed eye

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.333

Reversibility:

fully reversible within: 2 days

Remarks:

washed eye

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: 1 and 2

Time point:

24/48/72 h

Score:

2

Reversibility:

fully reversible within: 3 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 3 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #4

Time point:

24/48/72 h

Score:

1.33

Reversibility:

fully reversible within: 3 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #5

Time point:

24/48/72 h

Score:

1.66

Reversibility:

fully reversible within: 3 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 3 days

Irritation parameter:

chemosis score

Basis:

animal: 1, 4 and 5

Time point:

24/48/72 h

Score:

0.33

Reversibility:

fully reversible within: 2 days

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.66

Reversibility:

fully reversible within: 3 days

Irritation parameter:

chemosis score

Basis:

animal: 3 and 6

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal: 1, 3 and 6

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal: 2,4 and 5

Time point:

24/48/72 h

Score:

0.33

Reversibility:

fully reversible within: 2 days

Irritant / corrosive response data:

Conjunctiva:Slight/mild reactions were seen in 3/3 unwashed and 3/3 washed eyes 1 hour after compound application. All the eyes had
improved at 24 hours. At 72 hours 2/3 washed eyes were normal, at 6 days 1/3 washed and 1/3 unwashed eyes were normal. All eyes were normal
at 10 days.

Cornea: Slight opacity with damage to the surface epithelium was seen at 1 hour in 3/3 yashed and 3/3 unwashed eyes. 1/3 washed and 1/3
unwashed eyes were normal at 24 hours, 2/3 washed and 1/3 unwashed eyes were normal at 48 hours. All eyes were normal at 72 hours.

Iris: 2/3 unwashed and 1/3 washed eyes showed increased folding at 24 hours only.

Some of the unwashed eyes showed slightly more severe reactions than those of washed eyes.

Irritation parameter	Basis	Time point	Score	Max. score	Reversibility
cornea score	animal #1 Number 11	24, 48 and 72 h	0	80	other: no effect observed
cornea score	animal #2 Number 13	24, 48 and 72 h	1	80	fully reversible within: 3 days
cornea score	animal #3 Number 15 - washed eye	24, 48 and 72 h	0	80	other: no effects observed
cornea score	animal #4 Number 12	24, 48 and 72 h	0,333	80	fully reversible within: 2 days
cornea score	animal #5 Number 14 - washed eye	24, 48 and 72 h	0,333	80	fully reversible within: 2 days
cornea score	animal #6 Number 16 - washed eye	24, 48 and 72 h	0,333	80	fully reversible within: 2 days
conjunctivae score Redness	animal #1 Number 11	24, 48 and 72 h	2	20	fully reversible within: 3 days
conjunctivae score Redness	animal #2 Number 13	24, 48 and 72 h	2	20	fully reversible within: 3 days
conjunctivae score Redness	animal #3 Number 15 - washed eye	24, 48 and 72 h	1	20	fully reversible within: 3 days
conjunctivae score Redness	animal #4 Number 12	24, 48 and 72 h	1,33	20	fully reversible within: 3 days
conjunctivae score Redness	animal #5 Number 14 - washed eye	24, 48 and 72 h	1,66	20	fully reversible within: 3 days
conjunctivae score Redness	animal #6 Number 16 - washed eye	24, 48 and 72 h	1	20	fully reversible within: 3 days
conjunctivae score Chemosis	animal #1 Number 11	24, 48 and 72 h	0,33	20	fully reversible within: 2 days
conjunctivae score Chemosis	animal #2 Number 13	24, 48 and 72 h	0,66	20	fully reversible within: 3 days
conjunctivae score Chemosis	animal #3 Number 15 - washed eye	24, 48 and 72 h	0	20	other: no effects observed
conjunctivae score Chemosis	animal #4 Number 12	24, 48 and 72 h	0,33	20	fully reversible within: 2 days
conjunctivae score Chemosis	animal #5 Number 14 - washed eye	24, 48 and 72 h	0,33	20	fully reversible within: 2 days
conjunctivae score Chemosis	animal #6 Number 16 - washed eye	24, 48 and 72 h	0	20	other: no effects observed
iris score	animal #1 Number 11	24, 48 and 72 h	0	10	other: no effect observed
iris score	animal #2 Number 13	24, 48 and 72 h	0,33	10	fully reversible within: 2 days
iris score	animal #3 Number 15 - washed eye	24, 48 and 72 h	0	10	other: no effect observed
iris score	animal #4 Number 12	24, 48 and 72 h	0,33	10	fully reversible within: 2 days
iris score	animal #5 Number 14 - washed eye	24, 48 and 72 h	0,33	10	fully reversible within: 2 days
iris score	animal #6 Number 16 - washed eye	24, 48 and 72 h	0	10	other: no effect observed

Interpretation of results:

GHS criteria not met

Conclusions:

The tested substance needs to be considered not irritant for rabbits eyes under Regulation 1272/2008.

Executive summary:

The ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A. (sea appendix I).

The tested substance is considered to be not irritant for the rabbits eyes based on the results under Regulation 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Some studies are available both for skin and eye irritation based on the patch-test method described in Hazardous Substances Regulation, US Federal Hazardous Labelling Act. Sect. 191-11 (February 1965)

The results show:

- no eye irritation for observation at 1, 24, 48 and 72 h.

- no skin irritation for observation at 1, 24, 48 and 72 h.

Acid Orange 7 doesn't show any irritating effects and as a consequence it could be stated that is not corrosive or irritant.

Justification for selection of skin irritation / corrosion endpoint:

The study was performed on a tested substance with a higher content of active ingredient.

Justification for selection of eye irritation endpoint:

The study was the most complete and assessed the effect on cornea, iris and conjunctiva.

Justification for classification or non-classification

No classification for skin irritation/corrosion is warranted under CLP Regulation (EC n. 1272/2008)

No classification for eye irritation/corrosion is warranted under CLP Regulation (EC n. 1272/2008)