Sodium 4-[4-[[2-methyl-4-[[(p-tolyl)sulphonyl]oxy]phenyl]azo]anilino]-3-nitrobenzenesulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December from 04th to 13rd, 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

The complete study report is not available, thus some details about test conditions are missing.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2001

Report date:

2001

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:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acid Orange 067

IUPAC Name:

Acid Orange 067

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Amount / concentration applied:

0.1 ml (93 mg) of the test material as administered to the non irrigated eye.

Duration of treatment / exposure:

4 hours

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

Three rabbits

Details on study design:

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 2/3

Time point:

24/48/72 h

Score:

< 1

Results 2

Irritation parameter:

iris score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 1

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2

Results 4

Irritation parameter:

chemosis score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2

Irritant / corrosive response data:

Maximum Group Mean Score: 14.3, mild irritant (class 4 on 1-8 scale)

Individual reactions included orange coloured staining of the eye and fur surrounding the eye, translucent corneal opacity, iridial inflammation and minimal to moderate conjunctival irritation.

Any other information on results incl. tables

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

	68 male			Mean 24/48/72 hrs	85 male			Mean 24/48/72 hrs	86 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	0	0	0	0.00	2	2	1	1.67	0	0	0	0.00
Iridial Inflammation	0	0	0	0.00	1	1	0	0.67	0	0	0	0.00
Conjunctival Redness	1	0	0	0.33	2	2	1	1.67	1	1	0	0.67
Conjunctival Chemosis	0	0	0	0.00	2	2	0	1.33	0	0	0	0.00

Individual Scores for Ocular Irritation

	68 male				85 male					86 male
Time After Treatment	1hr	24 hrs	48 hrs	72 hrs	1hr	24 hrs	48 hrs	72 hrs	7 days	1hr	24 hrs	48 hrs	72 hrs
Degree of Comeal Opacity (E)	0	0	0	0	0S	2S	2	1	0	0S	0	0	0
Area of Corneal Opacity (F)	0	0	0	0	0	2	2	1	0	0	0	0	0
Score (ExF)x5	0	0	0	0	0	20	20	5	0	0	0	0	0
Iridial Inflammation (D)	0	0	0	0	0S	1S	1	0	0	0S	0	0	0
Score (Dx5)	0	0	0	0	5	5	5	0	0	0	0	0	0
Conjunctival Redness (A)	1S	1	0	0	1S	2S	2	1	0	1S	1	1	0
Conjunctival Chemosis (B)	0	0	0	0	1	2	2	1	0	0	0	0	0
Conjunctival Discharge (C)	1Sf	0Sf	0Sf	0Sf	2Sf	3Sf	2Sf	1Sf	0	1Sf	0Sf	0Sf	0Sf
Score (A+B+C)x2	4	2	0	0	8	14	12	6	0	4	2	2	0
Total Score	4	2	0	0	8	39	37	11	0	4	2	2	0

S = orange caloured staining

Sf = orange staining of the fur around the eye

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC) No 1272/2008

Conclusions:

Not classified, according to the CLP Regulation (EC) 1272/2008

Executive summary:

A study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit. The method followed OECD Guidelines No. 405 and Method B5 of Commission Directive 92/69/EEC. A single application 0.1 ml (93 mg)of the test material was administered to the non irrigated eye of three rabbits. Ocular effects were recorded 1, 24, 48 and 72 hours and 7 days after administration.

Individual reactions included orange coloured staining of the eye and fur surrounding the eye, translucent corneal opacity, iridial inflammation and minimal to moderate conjunctival irritation.

Maximum Group Mean Score: 14.3, mild irritant (class 4 on 1-8 scale)

Conclusion

The mean values from grading 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 at least two of three tested animals.

Therefore, the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC) No 1272/2008.