4-[(2,5-dichlorophenyl)azo]-3-hydroxy-2-naphthoic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-[(2,5-dichlorophenyl)azo]-3-hydroxy-2-naphthoic acid

EC Number:

257-484-3

EC Name:

4-[(2,5-dichlorophenyl)azo]-3-hydroxy-2-naphthoic acid

Cas Number:

51867-77-7

Molecular formula:

C17H10Cl2N2O3

IUPAC Name:

4-[(2,5-dichlorophenyl)diazenyl]-3-hydroxy-2-naphthoic acid

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

red powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

24, 48 and 72 hours

Number of animals:

3

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48, 72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible

Any other information on results incl. tables

Red-coloured staining was noted at all treated skin sites throughout the study. This did not affect evaluation of skin reactions.

Very slight erythema was noted at all treated skin sites one hour after patch removal and at two treated skin sites at the 24 -hour observation.

No evidence of skin irritation was noted at one treated skin site at the 24 -hour observation or the remaining two treated skin sites at the 48 -hour observation.

individual skin reactions

skin reaction	observation time	scores - animals			total
		1	2	3
erythema	1 hour	1	1	1	3
	24 hours	1	0	1	2
	48 hours	0	0	0	0
	72 hours	0	0	0	0
oedema	1 hour	0	0	0	0
	24 hours	0	0	0	0
	48 hours	0	0	0	0
	72 hours	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material did not meet the criteria for classification as irritant or corrosive according to the EU labeling regulations Commission Directive 2001/59/EC.

The test material produced a primary irritation index of 0.3 and was classified as a mild irritant to rabit skin according to the Draize classification scheme. No corrosive effects were noted.