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Toxicological information

Eye irritation

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Administrative data

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

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

Constituent 1
Chemical structure
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 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

Resultsopen allclose all
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.

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 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

Applicant's summary and conclusion

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.