Disodium [N-(2-chlorophenyl)-2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997

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:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

Directive 92/69/EC

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

423-100-1

EC Name:

-

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

100 mg
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

Not specified

Observation period (in vivo):

21 days

Details on study design:

SCORING SYSTEM: Draize’s

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.67

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: Max. duration: 7 h; Max. value at end of observation period: 0 (related to all animals)

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: Max. duration: 7 h; Max. value at end of observation period: 0 (related to all animals)

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: Max. duration: 7 h; Max. value at end of observation period: 0 (related to all animals)

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: Max. duration: 3 h; Max. value at end of observation period: 0 (related to all animals)

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: Max. duration: 3 h; Max. value at end of observation period: 0 (related to all animals)

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: Max. duration: 3 h; Max. value at end of observation period: 0 (related to all animals)

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: Max. duration: 3 h; Max. value at end of observation period: 0 (related to all animals)

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: Max. duration: 3 h; Max. value at end of observation period: 0 (related to all animals)

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: Max. duration: 3 h; Max. value at end of observation period: 0 (related to all animals)

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

not specified

Remarks on result:

other: Max. duration: 1 h; Max. value at end of observation period: 0 (related to all animals)

Results 11

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

not specified

Remarks on result:

other: Max. duration: 1 h; Max. value at end of observation period: 0 (related to all animals)

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

not specified

Remarks on result:

other: Max. duration: 1 h; Max. value at end of observation period: 0 (related to all animals)

Irritant / corrosive response data:

Reversibility of any observed effect: changes not fully reversible within 21 days

Other effects:

COLORATION: Extensive persistent staining of the cornea, conjunctivae, iris and sclera was observed in all animals up to study termination.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

The substance is classified as serious eye damage due to its persistent and severe effects on the eye.

Executive summary:

An in vivo test was conducted to assess the eye irritating effects of the test material Green KK 80884 (EC 423-100-1) according to EU Method B.5 (directive 92/69/EC). Three individuals of New Zealand white rabbit were tested with the selected dose of 100 mg and the effects were recorded according to the Draize’s scoring system for the first 24, 48 and 72 hours after treatment: a positive response was observed for all the considered parameters and staining of cornea, conjunctiva, iris and sclera was observed in all the animals and persisted until day 21.
Therefore, due to its severe irritating effects and the persistent staining, Green KK 80884 (EC 423-100-1) was considered an eye irritant and labelled with EU risk phrase R41: risk of serious damage to eyes, moderate but persistent eye lesions, eye corrosion).