Reaction mass of 6-(2-ethyl-6-methylanilino)-5-(4-{4-[ethyl(3-sulfobenzyl) amino] phenylazo} phenylazo)-4-hydroxynaphthalene-2-sulfonic acid, sodium and/or disodium salt(s) and 6-(2-ethyl-6-methylanilino)-5-(4-{4-[ethyl(4-sulfobenzyl) amino] phenylazo} phenylazo)-4-hydroxynaphthalene-2-sulfonic acid, sodium and/or disodium salt(s)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acid Navy RN-2682

IUPAC Name:

Acid Navy RN-2682

Test material form:

solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

No rinse after application.

Observation period (in vivo):

1, 24, 48, 72 h after administration as well as 7 and 10 d.

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible within: 7 d

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible within: 10 d

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 10 days

Other effects:

No clinical signs of systemic toxicity were observed and no mortality occurred.

No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals. Due to a moderate black staining of the test item, the cornea as well as the conjunctivae and the sclerae were not assessable 1 hour after instillation. When assessable, no local reactions
were observed in the cornea. However, a slight swelling (chemosis) was noted in two animals at the 1-hour evaluation which persisted up to the 24-hour reading in all three animals. A slight to moderate reddening of the conjunctivae was noted in the three animals 24 hours after treatment,
which persisted as slight up to the 48- or 72- hour reading or up to test day 7 in all animals, respectively.
Furthermore, all animals expressed a moderate reddening of the sclerae 24 hours post treatment which persisted as slight up to 48 or 72 hours in both females, respectively.
Moderate ocular discharge was noted in all animals 1 hour after instillation which persisted as slight up to the 24- hour reading in two animals. No abnormal findings were observed in the treated eye of any animal 10 days after treatment, the end of the observation period for all animals.

A moderate black staining produced by the test item was observed in all animals at the 1-hour evaluation and persisted as slight up to the 48 or 72 hours.

No corrosion of the cornea was observed at any of the reading times.

Applicant's summary and conclusion

Interpretation of results:

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