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Administrative data

Endpoint:
acute toxicity: inhalation
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 inhalation toxicity study of 1-phenylazo-2-naphthol (Sudanorange R) in rats
GLP compliance:
not specified
Test type:
fixed concentration procedure
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): 1-phenylazo-2-naphthol (Sudanorange R)
- 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:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
air
Remark on MMAD/GSD:
No data available
Details on inhalation exposure:
200 L of air / h are passed through a 5 cm high layer of the product.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
8 h
Remarks on duration:
for 3,10 and 30 min and 1,3 and 8 hours
Concentrations:
200 L
No. of animals per sex per dose:
12
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 8 hours
Statistics:
No data available

Results and discussion

Preliminary study:
No data available
Effect levels
Sex:
not specified
Dose descriptor:
LC50
Effect level:
> 200 000 mg/m³ air
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
other: No mortality observed
Mortality:
No mortality observed in treated rats at 200000 mg/m3
Clinical signs:
other: No data available
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available

Any other information on results incl. tables

Mortality x / y deceased / exposed animals

Exposure time

3'

10'

30'

1 h

3 h

8h

Steam

 

 

 

 

 

 

Volatile constituents

 

 

 

 

 

 

Staub

 

 

 

 

 

0/12 R

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
LC50 was considered to be > 200000 mg/m3 of air when rats were exposed with 1-phenylazo-2-naphthol (Sudanorange R) by inhalation route.
Executive summary:

In a acute inhalation toxicity study, rats were expose with 1-phenylazo-2-naphthol (Sudanorange R) in the concentration of 200000 mg/m3 / h inhaled through a 5 cm high layer of the product and observed for 8 hours. No mortality was observed in treated rat at 200000 mg/m3 / h. Therefore, LC50 was considered to be > 200000 mg/m3 of air when rats were exposed with 1-phenylazo-2-naphthol (Sudanorange R) by inhalation route.

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