2,2'-(vinylenedi-p-phenylene)bis[5-methylbenzoxazole]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January from 18th to 25th, 2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

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:

Fluorescent Brightener 002

IUPAC Name:

Fluorescent Brightener 002

Test animals / tissue source

Species:

rat

Strain:

New Zealand White

Test system

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml (67.3 mg) of the test material was administered to the non irrigated eye.

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

Three rabbits

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

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 1

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal:

Time point:

24/48/72 h

Score:

< 2

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

chemosis score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2

Reversibility:

fully reversible within: 48 hrs

Irritant / corrosive response data:

Maximum Group Mean Score was 4.1
Classification: mild irritant (class 4 on a 1-8 SCALE).
The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations Commission Directive 93/21/EEC. No symbol and risk phrase are required.

Any other information on results incl. tables

lndividual scores for ocular irritation

Animal no.	Reaction	Observation at				Mean 24/48/72 hrs
		1 hr	24 hrs	48 hrs	72 hrs
146 male	Corneal opacity	0	0	0	0	0.00
	Iris	0	0	0	0	0.00
	Conjunctival redness	0	0	0	0	0.00
	Conjunctival chemosis	0	0	0	0	0.00
151 male	Corneal opacity	0	0	0	0	0.00
	Iris	0	0	0	0	0.00
	Conjunctival redness	1	1	1	0	0.67
	Conjunctival chemosis	1	1	1	0	0.33
153 male	Corneal opacity	0	0	0	0	0.00
	Iris	0	0	0	0	0.00
	Conjunctival redness	1	0	0	0	0.00
	Conjunctival chemosis	0	0	0	0	0.00

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC 1272/2008)

Conclusions:

Not eye irritating.

Executive summary:

A study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit (SPL Standard Test Method 560.06). The method followed OECD guideline 405 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 (67.3 mg) of the test material was administered to the non irrigated eye of three rabbits. Ocular reactions were observed at 1, 24, 48 and 72 hours after administration.

The Maximum Group Mean Score was 4.1 and the related classification was as mild irritant (class 4 on a 1 -8 SCALE).

Where present, reactions were slight and fully reversible within 72 hours.

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 of the three tested animals.

Therefore, the substance is not an eye irritant.