Sodium 4-(2-hydroxynaphth-1-ylazo)-3-methylbenzenesulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

other: experimental result on similar substance

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

211-199-0

EC Name:

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

Cas Number:

633-96-5

Molecular formula:

C16H12N2O4S.Na

IUPAC Name:

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

Test material form:

solid: particulate/powder

Test animals / tissue source

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.

Test system

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.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Reversibility:

fully reversible within: 2 or 3 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.44

Reversibility:

fully reversible within: 2 or 3 days

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.44

Reversibility:

fully reversible within: 2 or 3 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.

Any other information on results incl. tables

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	1,333	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

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

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).

Acid Orange 8 is considered to be not irritant for the rabbits eyes based on the results on similar substance under Regulation 1272/2008.