Disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 June 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances. Labelling Act Sect. 191.1.2 (February 1965), with slight modification.

Deviations:

not specified

Principles of method if other than guideline:

None

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]

EC Number:

276-882-8

EC Name:

Disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]

Cas Number:

72828-69-4

Molecular formula:

C47H42N10O12S4.2Na

IUPAC Name:

disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

A yellow powder, labelled FAT 21'015/A.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Animals:
Healthy New Zealand White rabbits (Porton strain) aged 9-15 weeks with average body weights of 2.6.0 kgs. (M) and 2.58 kgs. (F), bred on the premises and maintained under a semi-barrier system. Six rabbits (3 M and 3 F) were acclimatised in the test area for one week prior to the start of the trial.

Husbandry:
The rabbits were caged singly in an experimental room maintained at a temperature of 20 °C. (+/- 1°) 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 irradiated diet (Styles-Oxoid) was fed ad lib. Sterile filtered water was available at all times.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

100 mg of the test compound were instilled into the conjunctival sac of the left eye. The right eye served as a control.

Duration of treatment / exposure:

The eyelids were then held closed for 1 second after the application of test material. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute.

Observation period (in vivo):

The rabbits were examined 1, 24, 48 and 72 h after application of the.test compound and for any further period that was considered necessary.

Number of animals or in vitro replicates:

Six rabbits (3 males and 3 females).

Details on study design:

The test was carried out in accordance with the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances. Labelling Act Sect. 191.1.2 (February 1965), with slight modification. The eyes of the experimental animals were examined and found normal prior to the test. 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 warm water for 1 minute. The rabbits were examined 1, 24, 48 and 72 hours after application of the.test compound and for any further period that was considered necessary. 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.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

6 animal

Time point:

24/48/72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 48h

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

6 animal

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

6 animal

Time point:

24/48/72 h

Score:

1.8

Max. score:

3

Reversibility:

fully reversible within: 6 d

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

6 animal

Time point:

24/48/72 h

Score:

1.6

Max. score:

4

Reversibility:

fully reversible within: 6 d

Irritant / corrosive response data:

A very slight to moderate conjunctival reaction was noted in all treated eyes one hour after application of the compound. This had subsided slightly by 24 hours, and thereafter continued to do so slowly until all eyes were normal by day 10. A corneal reaction consisting of damage to the superficial epithelium was noted in 2/3 unwashed and 1/3 washed eyes. This was still present at 24 h in 1/3 unwashed eyes. There was very little difference in reactions between washed and unwashed eyes.

Other effects:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 21015/A is considered to be a non-irritant to the eyes.

Executive summary:

A key study was performed to determine the eye irritation potential of FAT 21015/A in rabbits. Six rabbits were used for this purpose. A very slight to moderate conjunctival reaction was noted in all treated eyes one hour after application of the compound. This had subsided slightly by 24 hours, and thereafter continued to do so slowly until all eyes were normal by day 10. A corneal reaction consisting of damage to the superficial epithelium was noted in 2/3 unwashed and 1/3 washed eyes. This was still present at 24 h in 1/3 unwashed eyes. There was very little difference in reactions between washed and unwashed eyes. However the mean scores for corneal opacity, iris, conjuctival redness and chemosis of individual animals did not fulfill the CLP criteria for classification. Hence, FAT 21015/A is considered to be a non-irritant to the eyes.