Trisodium 4-amino-5-hydroxy-3-[[4-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]phenyl]azo]-6-[(4-sulphonato-1-naphthyl)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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Principles of method if other than guideline:

In order to evaluate the eye irritation of the test substance, a single dose was applied into the eyes of six rabbits. After the exposure for each animal one eye was rinsed and the other one was not rinsed. The degree of eye irritation/corrosion was evaluated by scoring lesions of conjunctiva, cornea, and iris, at specific intervals of 24, 48, 72 hours and 7 days.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 4-amino-5-hydroxy-3-[[4-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]phenyl]azo]-6-[(4-sulphonato-1-naphthyl)azo]naphthalene-2,7-disulphonate

EC Number:

279-093-7

EC Name:

Trisodium 4-amino-5-hydroxy-3-[[4-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]phenyl]azo]-6-[(4-sulphonato-1-naphthyl)azo]naphthalene-2,7-disulphonate

Cas Number:

79135-92-5

Molecular formula:

C36H25N8Na3O12S3

IUPAC Name:

trisodium 4-amino-5-hydroxy-3-[[4-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]phenyl]azo]-6-[(4-sulphonato-1-naphthyl)azo]naphthalene-2,7-disulphonate

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Test system

Vehicle:

not specified

Controls:

no

Duration of treatment / exposure:

single application

Observation period (in vivo):

24, 48, 72 h and 7 d

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
One eye was rinsed and the other one was not rinsed.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3, #5, #6

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: rinsed eye

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal: #4

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: rinsed eye

Results 3

Irritation parameter:

iris score

Basis:

animal: #1, #2, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: rinsed eye

Results 4

Irritation parameter:

iris score

Basis:

animal: #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: rinsed eye

Results 5

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

not fully reversible within: 7 d

Remarks on result:

other: rinsed eye

Results 6

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: #2, #4

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: rinsed eye

Results 7

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: #3, #5, #6

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: rinsed eye

Results 8

Irritation parameter:

chemosis score

Basis:

animal: #1, #3, #5, #6

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: rinsed eye

Results 9

Irritation parameter:

chemosis score

Basis:

animal: #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: rinsed eye

Results 10

Irritation parameter:

chemosis score

Basis:

animal: #4

Time point:

24/48/72 h

Score:

0.67

Max. score:

1

Reversibility:

not fully reversible within: 7 d

Remarks on result:

other: rinsed eye

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP Regulation (EC 1272/2008)

Conclusions:

The test substance was found to be not irritant when applied to intact rabbit eye.

Executive summary:

The substance was tested for eye irritation according to an internal method: a single dose was applied into the eyes of six rabbits. After the exposure for each animal one eye was rinsed and the other one was not rinsed. The degree of eye irritation/corrosion was evaluated by scoring lesions of conjunctiva, cornea, and iris, at specific intervals of 24, 48, 72 hours and 7 days.

Considering the rinsed eye, under this study conditions the substance resulted in no effects on cornea and iris (mean scores 0) except in animal #4 (mean cornea score 0.33) and in animal #3 (mean iris score 0.33). Three animals (#3, #5 and #6) showed no effects on conjunctivae (redness and chemosis mean scores 0). Effects on conjunctivae were observed in the other three animals: redness mean scores were 1.33 and 1 in animal #1 and animals #4 and #2 respectively; chemosis mean scores were 0, 1 and 0.67 in animals #1, #2 and #4 respectively. Higher scores on cornea, iris and conjunctivae were observed in the unrinsed eye.

At the end of the observation period (7 days) all the irritation effects were fully reversible except from conjunctivae redness and chemosis scores that were observed in animal #1 and in animal #4 respectively (grade 1 after 7 days for both effects). In these both cases, a decreasing trend of observed values occurred during the 7-day study period. This trend was also observed in the worst case for the unrinsed eye of the same two animals. Furthermore, the trend towards lower conjunctival scores was found in all other animals. Therefore, it is reasonable to think that reversibility within 21 days should occur even if at the present study it was not possible to observe the fully reversibility of all the effects within the 7-day study period.