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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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.