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)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: experimental result from similar substance

Adequacy of study:

key study

Study period:

From 20 march to 10 april 2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test acceptable for the assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

GLP compliance:

no

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 type:

fixed dose procedure

Limit test:

yes

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

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

arachis oil

Details on oral exposure:

VEHICLEDose of test material was administrated as a suspension in arachis oil BP at a dose level of 2000 mg/kg body weight

Doses:

Single oral dose of 2000 mglkg,

No. of animals per sex per dose:

4 females

Details on study design:

- Duration of observation period following administration: 14 days - Necropsy of survivors performed: yes; all animals were subjected to gross necropsy.- Other examinations performed: Clinical signs and body weight development were monitored during the study.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

discriminating dose

Effect level:

ca. 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Estimated

Mortality:

There were no deaths.

Clinical signs:

other: No signs of systemic toxicity were noted during the study.

Other findings:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System Category - Unclassified).The test material was considered to have no significant acute toxic risk if swallowed and did not meet the criteria for classification according to EU labelling regulations Commission Directive 2001/59/EC for classification and labelling of dangerous substances.

Executive summary:

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD strain rat (SPL Standard Test Method 518.04). The method followed the OECD Guidelines for the Testing of Chemicals No 420 "Acute Oral Toxicity - Fixed Dose Method" (adopted l7 December 2001). The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System Category - Unclassified)