1-phenylazo-2-naphthol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Justification for type of information:

Data is from study report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Principles of method if other than guideline:

Acute oral toxicity study of Sudanorange R (fest ) in rats

GLP compliance:

not specified

Test type:

other: No data

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-phenylazo-2-naphthol

EC Number:

212-668-2

EC Name:

1-phenylazo-2-naphthol

Cas Number:

842-07-9

Molecular formula:

C16H12N2O

IUPAC Name:

1-[(E)-2-phenyldiazen-1-yl]naphthalen-2-ol

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): C. I. Solvent Yellow 14
- Molecular formula (if other than submission substance): C16H12N2O
- Molecular weight (if other than submission substance): 248.284 g/mole
- Substance type: Organic

Specific details on test material used for the study:

- Name of test material (as cited in study report):C. I. Solvent Yellow 14
- Molecular formula : C16H12N2O
- Molecular weight: 248.284 g/mole
- Substance type: Organic
- Physical state: Solid
- Purity :98%
- Impurities (identity and concentrations): 2%

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5%

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10000 mg/kg/day
- Amount of vehicle (if gavage): 5-35% suspension
- Justification for choice of vehicle: 0.5% aqueous CMC preparation
- Lot/batch no. (if required): No data available
- Purity: No data available

MAXIMUM DOSE VOLUME APPLIED: No data available

DOSAGE PREPARATION (if unusual): 5-35% suspension in 0.5% aqueous CMC preparation

Doses:

10000 mg/kg bw

No. of animals per sex per dose:

No data available

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data available
- Necropsy of survivors performed: yes
- Other examinations performed: Mortality was examined.

Statistics:

No data available

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other:

Remarks:

No mortality observed

Mortality:

No mortality was observed in treated rat at 10000 mg/kg bw

Clinical signs:

skin, feces and urine orange discolored were observed in treated rats.

Body weight:

No data available

Gross pathology:

No data available

Other findings:

No data available

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

LD50 was considered to be > 10000 mg/kg bw when rats were treated with 1-phenylazo-2-naphthol (Sudanorange R) as a 5-35% suspension in 0.5% aqueous CMC preparation orally by gavage.

Executive summary:

In a acute oral toxicity study, rats were treated wtih 1-phenylazo-2-naphthol (Sudanorange R) in the concentration of 10000 mg/kg bw as a 5-35% suspension in 0.5% aqueous CMC preparation orally by gavage and observed for 14 days. No mortality was observed in treated rat at 10000 mg/kg bw and skin, feces and urine orange discolored were observed in treated rats. Therefore, LD50 was considered to be > 10000 mg/kg bw when rats were treated with 1-phenylazo-2-naphthol (Sudanorange R) as a 5-35% suspension in 0.5% aqueous CMC preparation orally by gavage.