Trisodium bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonato(3-)]chromate(3-)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From December 17th, 2001 to January 28th, 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Acid Violet 090

IUPAC Name:

Acid Violet 090

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 ml (85 mg) of the test material was administered to the non inigated eye.

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

Three rabbits (1 female and 2 males)

Details on study design:

SCORING SYSTEM
Ocular reactions were recorded 1, 24, 48 and 72 hours, 7, 14 and 21 days after administration.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

>= 1 - < 3

Reversibility:

fully reversible

Results 2

Irritation parameter:

iris score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

>= 2

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

>= 2

Reversibility:

fully reversible

Irritant / corrosive response data:

Maximum Group Mean Score: 41.0; at least a moderate irritant (class 5 ona 1- 8 scale).

The test material produced scattered or diffuse to translucent corneal opacity, iridial inflammation and moderate to severe conjunctival irritation. Other ocular effects noted were petechial haemorrhage of the nictitating membrane or haemorrhage of the nictitating and lower conjunctival membranes.

Any other information on results incl. tables

Individual and Mean Scores for Cornear lris and Conjunctivae for EU Labelling Regulations

	33 Female			Mean 24/48/72 hrs	18 Male			Mean 24/48/72 hrs	25 Male			Mean 24/48/72 hrs
Time After Treatment	24 hrs	48 hrs	72 hrs		24 hrs	48 hrs	72 hrs		24 hrs	48 hrs	72 hrs
Degree of Comeal Opacity	2S	2S	1	1.7	1	1	1	1.0	1S	2S	2S	1.7
Iridial Inflammation	1S	1S	1	1.0	1	1	1	1.0	1S	1S	1S	1.0
Conjunctival Redness	2S	2S	2H	2.0	2SPt	2S	2	2.0	3S H*	3S H*	2S H*	2.7
Conjunctival Chemosis	2	2	2	2.0	3	2	1	2.0	3	3	2	2.7

Individual Scores for Ocular Irritation

	33 Female							18 Male						25 Male
Time After Treatment	1hr	24 hrs	48 hrs	72 hrs	7 dy	14 dy	21 dy	1hr	24 hrs	48 hrs	72 hrs	7 dy	14 dy	1hr	24 hrs	48 hrs	72 hrs	7 dy	14 dy	21 dy
Degree of Comeal Opacity (E)	?s	2S	2S	1	0	0	0	?s	1	1	1	0	0	?s	1S	2S	2S	1S	1	0
Area of Corneal Opacity (F)	?s	2	1	1	0	0	0	?s	4	3	2	0	0	?s	4	4	3	2	1	0
Score (ExF)x5	0-80	20	10	5	0	0	0	0-80	20	15	10	0	0	0-80	20	40	30	10	5	0
Iridial Inflammation (D)	?s	1S	1S	1	0	0	0	?s	1	1	1	1	0	?s	1S	1S	1S	1S	1	0
Score (Dx5)	0-10	5	5	5	0	0	0	0-10	5	5	5	5	0	0-10	5	5	5	5	5	0
Conjunctival Redness (A)	?s	2S	2S	2H	1H	1H	0	?s	2SPt	2S	2	1	0	?s	3S H*	3S H*	2S H*	2 H*	1	0
Conjunctival Chemosis (B)	2	2	2	2	0	0	0	2	3	2	1	1	0	2	3	3	2	1	1	0
Conjunctival Discharge (C)	3Sf	3Sf	2Sf	1Sf	0Sf	0Sf	0Sf	3Sf	3Sf	2	1	0Sf	0Sf	3Sf	3Sf	3Sf	2Sf	1Sf	0Sf	0Sf
Score (A+B+C)x2	10-16	14	12	10	2	2	0	10-16	16	12	8	4	0	10-16	18	18	12	8	4	0
Total Score	10-106	39	27	20	2	2	0	10-106	41	32	23	9	0	10-106	43	63	47	23	14	0

IPR = initial pain reaction

?s = purple/pink caloured staining prevented evalualion

S = purple/pink caloured staining

Sf = purple/pink caloured staining of the fur

H* = two areas of haemorrhage, approximately 2 mm x 2 mm in size, on edge of the nictitating membrane and lower conjunctival membrane

Pt = Petechial haemorrhage over the nictitating membrane

Applicant's summary and conclusion

Interpretation of results:

other: Eye Irrit. 2 (H319) according to the CLP Regulation (EC 1272/2008)

Conclusions:

Eye irritant

Executive summary:

The study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbits (SPL Standard Test Method 560.07). The method followed OECD Guidelines for Testing of Chemicals (1987) No. 405 "Acute Eye Irritation/Corrosion" and Method B5 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

A single application of 0.1 ml (85 mg) of the test material was administered to the eye of three rabbits. Ocular reactions were recorded 1, 24, 48 and 72 hours, 7, 14 and 2l days after administration.

Maximum Group Mean Score: 41.0; at least a moderate irritant (class 5 ona 1- 8 scale). The test material produced scattered or diffuse to translucent corneal opacity, iridial inflammation and moderate to severe conjunctival irritation. Other ocular effects noted were petechial haemorrhage of the nictitating membrane or haemorrhage of the nictitating and lower conjunctival membranes.

The mean values from gradings at 24, 48 and 72 hours were:

- cornea score was equal/higher than 1 and lower than 3 in all the animals tested;

- iris score was equal to 1 in all rabbits;

- redness and oedema scores were equal/higher than 2 in all rabbits.

All the reactions resulted to be reversible within 21 days.

Conclusion

The test material meets the criteria for classification as eye irritant, category 2 (H319) of the CLP Regulations EC 1272/2008.