Chromate(3-), [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)][3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-7-nitro-1-naphthalenesulfonato(3-)]-, sodium

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From February 07 to 17, 2005.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Justification for Read Across is detailed in the endpoint summary and it is further detailed in the report attached to the IUCLID section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar substance 01

Molecular formula:

n.a

IUPAC Name:

Similar substance 01

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Amount / concentration applied:

A single application of 0.1 ml (51.3 mg) of the test material was administered to the non irrigated eye of three rabbits.

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3 rabbits

Details on study design:

Ocular reactions were recorded 1, 24, 48 and 72 hours after administration.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #97, #104, #105

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: #97, #104, #105

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #97, #104, #105

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #97, #104, #105

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

The test material produced iridial inflammation and minimal to moderate conjunctival irritation. All treated eyes appeared normal at the 72-hour observation.
Maximum Group Mean Score: 12.7. Mild irritant (Class 4 on A 1-8 scale)

Any other information on results incl. tables

Individual Scores and Individual Total Scores for Ocular Irritation

Rabbit Number and Sex	97 Male					104 Male					105 Male
	IPR = 2					IPR = 3					IPR = 0+
Time After Treatment	1 hour	24 hours	48 hours	72 hours	Mean 24, 48 and 72 hrs	1 hour	24 hours	48 hours	72 hours	Mean 24, 48 and 72 hrs	1 hour	24 hours	48 hours	72 hours	Mean 24, 48 and 72 hrs
CORNEA
E = Degree of Opacity	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
F = Area of Cornea Involved	0	0	0	0	/	0	0	0	0	/	0	0	0	0	/
Score (E x F) x 5	0	0	0	0		0	0	0	0		0	0	0	0
IRITIS
D	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0
Score (D x 5)	0	0	0	0	/	5	0	0	0	/	5	0	0	0	/
CONJUNCTIVAE
A = Redness	1 Sf	1 Sf	1 Sf	0 Sf	0.7	2 Sf	1 Sf	1 Sf	0 Sf	0.7	1 Sf	1 Sf	1 Sf	0 Sf	0.7
B = Chemosis	1	0	0	0	0	2	1	1	0	0.7	2	1	0	0	0.3
C = Discharge	1 Re	1Re	0	0	/	2 Re	1 Re	1 Re	0	/	2	1	1	0	/
Score (A + B + C) x 2	6	4	2	0		12	6	6	0		10	6	4	0
Total Score	6	4	2	0		17	6	6	0		15	6	4	0

IPR = Initial pain reaction

+ = One drop of local anaesthetic instilled into both eyes 1 to 2 minutes before treatment

Sf = Black staining of the fur around the treated eye

Re = Black residual test material

Applicant's summary and conclusion

Interpretation of results:

other: Not classified as eye irritant according to the CLP Regulation (EC) No. 1272/2008.

Conclusions:

Not irritating.

Executive summary:

Method

The study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit (SPL Standard Test Method 560.09). The method followed OECD Guidelines for Testing of Chemicals (24 April 2002) No. 405 "Acute Eye Irritation/Corrosion" and Method B5 of Commission Directive 20041731EC (which constitutes Annex V of Council Directive 67/548IEEC).

A single application of 0.1 ml (51.3 mg) of the test material was administered to the non irrigated eye of three rabbits. Ocular reactions were recorded 1, 24, 48 and 72 hours after administration.

Results

The test material produced iridial inflammation and minimal to moderate conjunctival irritation. All treated eyes appeared normal at the 72-hour observation.

Maximum Group Mean Score: 12.7

Mild irritant (Class 4 on A 1-8 scale).

Conclusion

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all animals.

Therefore the substance does not meet the criteria to be classified as eye irritating.

In conclusion, the test item can be not classified as irritating, according to the CLP Regulation (EC 1272/2008).