Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 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:
Refer chapter 13 for the detailed analogue justification.

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
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Trisodium 5-[[4-chloro-6-(methylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate
EC Number:
274-417-3
EC Name:
Trisodium 5-[[4-chloro-6-(methylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate
Cas Number:
70210-20-7
Molecular formula:
C26H20ClN7O10S3.3Na
IUPAC Name:
trisodium 5-({4-chloro-6-[methyl(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
Details on test material:
FAT 40034/B

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 h after application of the test compound and for any further period that was considered necessary.
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 h 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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 rabbit
Time point:
24 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 rabbits
Time point:
48 h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 rabbit
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 rabbits
Time point:
24/48/72 h
Score:
0.83
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 rabbits
Time point:
24 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 rabbit
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 rabbit
Time point:
72 h
Score:
0
Max. score:
4

Any other information on results incl. tables

Evaluation of the Eye Reactions: Individual animal score

Cornea

Animal No

Observation time (Hr)

Degree of intensity

Area of cornea involved

Rabbit 11

24

1

1

48

1

1

72

0

0

Rabbit 13

24

0

0

48

0

0

72

0

0

Rabbit 15

24

0

0

48

0

0

72

0

0

Rabbit 12

24

1

1

48

0

0

72

0

0

Rabbit 14

24

0

0

48

0

0

72

0

0

Rabbit 16

24

0

0

48

0

0

72

0

0

 

Iris

Animal No

Observation time (Hr)

Score

Rabbit 11

24

0

48

0

72

0

Rabbit 13

24

0

48

0

72

0

Rabbit 15

24

0

48

0

72

0

Rabbit 12

24

0

48

0

72

0

Rabbit 14

24

0

48

0

72

0

Rabbit 16

24

0

48

0

72

0

 

 

Conjunctiva

Animal No

Observation time (Hr)

Redness

Chemosis

Discharge

Rabbit 11

24

1

0

2

48

1

0

0

72

1

0

0

Rabbit 13

24

1

1

0

48

1

0

0

72

1

0

0

Rabbit 15

24

0

0

0

48

0

0

0

72

0

0

0

Rabbit 12

24

2

1

0

48

2

0

0

72

1

0

0

Rabbit 14

24

1

0

0

48

1

0

0

72

1

0

0

Rabbit 16

24

0

0

0

48

0

0

0

72

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40034/A is considered as non-irritant to the rabbit eyes.
Executive summary:

A study performed to determine the eye irritation potential of FAT 40034/A in New Zealand White rabbits in accordance with the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification. The 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 h, 6 h, 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 h. Based on the study results, FAT 40034/A is considered to be a non-irritant to the eyes.