Benzoic acid, 4-[2-[1-hydroxy-6-[[[[5-hydroxy-6-(2-phenyldiazenyl)-7-sulfo-2-naphthalenyl]amino]carbonyl]amino]-3-sulfo-2-naphthalenyl]diazenyl]-, sodium salt (1:3)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

other: experimental result from similar substance

Adequacy of study:

key study

Study period:

From 12 to 26 march 2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable for assess the endpoint.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Remarks:

This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study.

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 3-[(4-acetamidophenyl)azo]-4-hydroxy-7-[[[[5-hydroxy-6-(phenylazo)-7-sulphonato-2-naphthyl]amino]carbonyl]amino]naphthalene-2-sulphonate

EC Number:

222-348-4

EC Name:

Disodium 3-[(4-acetamidophenyl)azo]-4-hydroxy-7-[[[[5-hydroxy-6-(phenylazo)-7-sulphonato-2-naphthyl]amino]carbonyl]amino]naphthalene-2-sulphonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Amount / concentration applied:

TEST MATERIAL- Amount(s) applied: single application of 0.1 ml (76.6 mg)

Duration of treatment / exposure:

Single application

Observation period (in vivo):

1, 24, 48 amd 72 hours and 7 days after administration

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Irritation parameter:

maximum mean total score (MMTS)

Basis:

animal: All rabbits (65967, 66032 and 66033 males)

Time point:

24/48/72 h

Score:

ca. 10

Reversibility:

fully reversible

Irritant / corrosive response data:

The test material produced moderate conjunctival irritation. Dark red-coloured staining of the lower conjunctival and nictitating membranes and red-coloured staining of the fur around the treated eye were also noted. One treated eye appeared normal at the 72-hour observation and the two remaining treated eyes appeared normal atthe 7-day observation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material did not meet the criteria for classification as irritant according to EU labelling regulations.

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 560.09), The method followed OECD Guidelines for Testing of Chemicals (24 April 2002) No. 405 "Acute Eye Initation/Corrosion" and Method B5 of Commission Directive 2004/73/EC (which constitutes Annex V of Council Directive 67/548/EEC).

The test material did not meet the criteria for classification as irritant according to EU labelling regulations.