Sodium 8-phenylamino-5-(4-(3-sulphonatophenylazo)-1-naphthylazo)naphthalenesulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, test procedure in accordance with OECD 406 methods, meets generally accepted scientific principles, acceptable for assessment. Not GLP compliant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Hazardous substance Labelling Act Sect. 191-12 (february 1965)

Deviations:

yes

Remarks:

slight modifications

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 8-phenylamino-5-(4-(3-sulphonatophenylazo)-1-naphthylazo)naphthalenesulphonate

EC Number:

222-111-5

EC Name:

Sodium 8-phenylamino-5-(4-(3-sulphonatophenylazo)-1-naphthylazo)naphthalenesulphonate

Cas Number:

3351-05-1

Molecular formula:

C32H23N5O6S2.2Na

IUPAC Name:

disodium 8-(phenylamino)-5-[(1E)-2-{4-[(1E)-2-(3-sulfonatophenyl)diazen-1-yl]naphthalen-1-yl}diazen-1-yl]naphthalene-1-sulfonate

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Healthy New Zealand White rabbits (Porton strain) aged 12-16 weeks with average body weights of 2.70 kgs. (males ) and 2.58 kgs (females) bred on the premises and maintained under a semi-barrier system. Six rabbits (3 males and 3 females) were acclimatised 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 20°C. (_+1°) and a relative humidityof 50-70%. Animals ware exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours. A commercial irradiated diet(Styles-Oxoid) was fed ad lib. Sterile filtered water was available at all times.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the right eye served as control

Amount / concentration applied:

100 mg of the test compound were instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second. The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with approximately200 ml. of warm water.

Duration of treatment / exposure:

30 seconds

Observation period (in vivo):

up to 16 days

Number of animals or in vitro replicates:

6 (3 males and 3 females)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: all animals

Time point:

other: 1 h

Score:

1

Reversibility:

fully reversible within: 6 days

Results 2

Irritation parameter:

iris score

Basis:

animal: 11,13

Time point:

24 h

Score:

1

Reversibility:

fully reversible within: 10 days

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: all animals

Time point:

other: 1 h

Score:

2

Reversibility:

fully reversible within: 15 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal: 11,15,16

Time point:

other: 1 h

Score:

1

Reversibility:

fully reversible within: 10 days

Results 5

Irritation parameter:

chemosis score

Basis:

animal: 13,14

Time point:

other: 1 h

Score:

2

Reversibility:

fully reversible within: 10 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal: 14

Time point:

other: 1 h

Score:

3

Reversibility:

fully reversible within: 10 days

Results 7

Irritation parameter:

conjunctivae score

Remarks:

Discharge

Basis:

animal: all animals

Time point:

other: 1 h

Score:

3

Reversibility:

fully reversible within: 6 days

Results 8

Irritation parameter:

chemosis score

Time point:

24/48/72 h

Remarks on result:

positive indication of irritation

Results 9

Irritation parameter:

conjunctivae score

Time point:

24/48/72 h

Remarks on result:

positive indication of irritation

Results 10

Irritation parameter:

iris score

Time point:

24/48/72 h

Remarks on result:

positive indication of irritation

Results 11

Irritation parameter:

cornea opacity score

Time point:

24/48/72 h

Remarks on result:

positive indication of irritation

Any other information on results incl. tables

 

Time	Rabbit no.	11	13	15	12	14	16
1 h	Cornea Opacity	1	1	1	1	1	1
	Iris
	Conjunctivae Redness Chemosis Discharge	2 1 3	2 2 3	2 1 3	2 3 3	2 2 3	2 1 3

 

Time	Rabbit no.	11	13	15	12	14	16
1 day	Cornea Opacity	1	1		1	1	1
	Iris	1	1
	Conjunctivae Redness Chemosis Discharge	2 2 2	2 3 3	2 1	2 3 2	2 2 1	2 1

 

Time	Rabbit no.	11	13	15	12	14	16
3 days	Cornea Opacity	1	1		1		1
	Iris	1	1
	Conjunctivae Redness Chemosis Discharge	3 2 1	3 2 2	1	3 2 2	2 1	3

 

Time	Rabbit no.	11	13	15	12	14	16
6 days	Cornea Opacity	1
	Iris	1	1
	Conjunctivae Redness Chemosis Discharge	2 1	2 2	1	2 1	1	1

 

Time	Rabbit no.	11	13	15	12	14	16
10 days	Cornea Opacity
	Iris
	Conjunctivae Redness Chemosis Discharge		1		1

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

irritant for the eye

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 irritant for the rabbits eyes.