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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from Peer-reviewed journal.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Acute Toxicity Studies - LD50
Author:
Gaunt et al.
Year:
1967
Bibliographic source:
Fd Cosmet. Toxtcol
Reference Type:
publication
Title:
Short-term Toxicity
Author:
Creasey et al.
Year:
1969
Bibliographic source:
Fd Cosmet. ToxicoL
Reference Type:
other: authoritative database
Title:
Acute oral toxicity by using test chemical
Author:
U.S. National Library of Medicine
Year:
2018
Bibliographic source:
ChemIDplus
Reference Type:
publication
Title:
Toxicological Evaluation
Author:
WHO
Year:
1981
Bibliographic source:
The Joint FAO/WHO Expert Committee on Food Additives
Reference Type:
review article or handbook
Title:
Acute oral toxicity study of test chemical - LD50
Author:
Gisbert Otterstätter
Year:
1999
Bibliographic source:
Coloring of Food, Drugs, and Cosmetics
Reference Type:
publication
Title:
Repeated oral toxicity study of the test chemical
Author:
Drake et al
Year:
1977
Bibliographic source:
Food and cosmetics toxicology
Reference Type:
publication
Title:
Long-term feeding study
Author:
Gaunt et al.
Year:
1972
Bibliographic source:
Food and Cosmetics Toxicology

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Acute Oral toxicity test was carried out to study the effects of test chemical on rats.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- IUPAC NAME: Tetrasodium 4-acetamido-5-hydroxy-6-({7-sulfonato-4-[(4-sulfonatophenyl)diazenyl]-1-naphthyl}diazenyl)naphthalene-1,7-disulfonate
- Name of test material (as cited in study report): Black PN
- Molecular formula : C28H17N5Na4O14S4
- Molecular weight : 867.6873 g/mol
- Substance type: organic
- Physical state: No data available
- Purity : 83.6%
- Impurities (identity and concentrations): 16.4%

Test animals

Species:
rat
Strain:
other: Carworth Farm Strain E SPF
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Fasting period before study:18 hours
- Diet (e.g. ad libitum): Spillers Small Laboratory Animal Diet was given to animal

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle:5000 mg/kg
- Justification for choice of vehicle: Test substance was soluble in water
Doses:
5000 mg/kg
No. of animals per sex per dose:
Total: 10 animals
5000 mg/kg :5 males and 5 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: no
- Other examinations performed: Clinical signs
Statistics:
Litchfield & Wilcoxon (1949)

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed
Mortality:
No mortality was observed in treated rats at 5000 mg/kg bw.
Clinical signs:
In clinical signs examination, a substantial amount of coloured material was excreted in the faeces.
Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The lethal concentration (LD50) value for acute oral toxicity test was considered to be >5000 mg/kg bw ,when group of 5 male and female Carworth Farm Strain E SPF rats were treated with given test chemical orally.
Executive summary:

Acute oral toxicity study was done in group of 5 male and female Carworth Farm Strain E SPF rats using test material. No mortality was observed at dose 5000 mg/kg bw. In clinical signs examination, substantial amounts of coloured material was excreted in the faeces. Hence, LD50 value was considered to be >5000 mg/kg bw, when rats were treated with test chemical orally.