Sodium 4-(2-hydroxynaphth-1-ylazo)-3-methylbenzenesulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: experimental result on similar substance

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate

EC Number:

211-199-0

EC Name:

Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate

Cas Number:

633-96-5

Molecular formula:

C16H12N2O4S.Na

IUPAC Name:

Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Imported from Ciba-geigy Limited, Basle, CH
Age: 6-7 weeks
Body weight: 157 g male / 141 g female
Rats were caged singly and kept in a room maintaned at a temperature of 21°C.
Animals were subjected to 12 hours artificial light and 12 hours darkness in each 24 hours period.
A commercial auotoclavable pelleted diet (Labsure CRM rat and mouse nuts) was fed ad libitum.
Water filtered at 0.45 micron was available at all times.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5% in water

Details on oral exposure:

16.72% suspension in 0.5% CMC / water

Doses:

3830 mg/kg bw (30 ml/kg of solution)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

post-observation period 14 days

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 830 mg/kg bw

Mortality:

No data

Clinical signs:

other: Orange staining of urine was seen from one hour and of the faeces from 2 hours up to 3 days post dose. All animals were normal from 4 days until the study terminated on day 14.

Gross pathology:

No abnormalities

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The tested item was found to be non-toxic for oral exposure with a LD50 > 5000 mg/kg bw.

Executive summary:

The acute oral toxicity of Acid Orange 7 in rats of both sexes was assessed with this test following OECD 401 guidelines.
The LD50 value was > 5000 mg/kg corresponding to a NOAEL of 5000 mg/kg.