Trisodium 5-[[4-chloro-6-(methylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

None

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

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. 191.12 (February 1965)

Deviations:

not specified

Principles of method if other than guideline:

None

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

EC Number:

276-911-4

EC Name:

Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

Cas Number:

72829-25-5

Molecular formula:

C27H22ClN7O10S3.3Na

IUPAC Name:

trisodium 5-({4-chloro-6-[ethyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(2-sulfonatophenyl)diazenyl]naphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Specific details on test material used for the study:

None

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 10-15 weeks with average body weights of 2.65 kg (Males) and 2.53 kg (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.

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 h. 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:

not specified

Amount / concentration applied:

100 mg of the test compound (equivalent to 0.1 ml in volume) was applied.

Duration of treatment / exposure:

30 seconds

Observation period (in vivo):

The rabbits were examined 1, 6, 24, 48 and 72 hours after application of the test compound and for any further period that was considered necessary.

Duration of post- treatment incubation (in vitro):

None

Number of animals or in vitro replicates:

3 males and 3 females

Details on study design:

The eyes of the experimental animals were examined and found normal prior to the test. 100 mg of the test compound (equivalent to 0.1 ml in volume) 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 30 ml of warm water.

The rabbits were examined 1, 6, 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", published by the Association of Food and Drug Officials of the UCS.A.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.17

Max. score:

1

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24/48/72 h

Score:

0.83

Max. score:

2

Reversibility:

fully reversible within: 10 days

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.11

Max. score:

2

Reversibility:

fully reversible within: 48h

Results 4

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

mean

Time point:

24/48/72 h

Score:

0.11

Max. score:

3

Reversibility:

fully reversible within: 48h

Results 5

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritant / corrosive response data:

None

Other effects:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40034 is considered to be a non-irritant to the eyes.

Executive summary:

In a study performed to determine the eye irritation potential of FAT 40034, test substance was instilled in the eyes of 3 male and 3 female rabbits and observations for irritation were recorded at the time points of 1 hour, 6 hours, 1 day, 2 days, 3 days, 6 days and 10 days. One hour after application of the test compound there was slight opacity and ulceration of the cornea in 3/6 animals (unwashed eyes) and a conjunctival reaction in 6/6. The corneal changes had healed by day 3 and the conjunctivae were normal, apart from slight injection of vessels in one animal, by day 6. Staining of the cornea was visible up to 48 hours. Based on these findings, FAT 40034 is considered to be a non-irritant to the eyes.