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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January from 10th to 13th, 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 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal 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

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: intact skin

Controls:

yes, concurrent no treatment

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4-hour

Observation period:

72 hours

Number of animals:

Three rabbits

Details on study design:

OBSERVATION TIME POINTS
Skin reactions were recorded 1, 24, 48 and 72 hours after administration.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2.3

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2.3

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Primary Initation Index: 0
Yellow staining of the test site was recorded at the 1 and 24-hour observations which did not affect the evaluation of skin respotrses.

Any other information on results incl. tables

Individual skin reactions following 4 -hour exposure period

Animal no.	Reaction	Observation at				Mean 24/48/72 hrs
		1 hr	24 hrs	48 hrs	72 hrs
41 Male	Erythema	0	0	0	0	0
	Oecdma	0	0	0	0	0
40 Male	Erythema	0	0	0	0	0
	Oecdma	0	0	0	0	0
43 Male	Erythema	0	0	0	0	0
	Oecdma	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Not skin irritating

Executive summary:

A study was performed to assess the irritation of the test material to the skin of the New Zealand White rabbit (SPL Standard Test Method 540.05). The method followed OECD guideline 404 and method B4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

A single, 4-hour semi-occluded application (500 mg) of the test material was administered to the intact skin of three rabbits. Skin reactions were recorded 1, 24, 48 and 72 hours after administration.

No erythema or oedema was noted, thus scores of skin reactions in all animals were 0. Yellow staining of the test site was recorded at the 1 and 24-hour observations which did not affect the evaluation of skin responses.

Conclusion

Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions, thus the test item is not a skin irritant.