2-{(E)-[6-({4-chloro-6-[(4-{[2-(sulfooxy)ethyl]sulfonyl}phenyl)amino]-1,3,5-triazin-2-yl}amino)-1-hydroxy-3-sulfonaphthalen-2-yl]diazenyl}naphthalene-1,5-disulfonic acid

Acute Toxicity: oral

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

Reference

Reference 1

Reference Type:

publication

Title:

Acute Toxicity Studies - LD50

Author:

Gaunt et al.

Year:

1967

Bibliographic source:

Fd Cosmet. Toxtcol

Reference 2

Reference Type:

publication

Title:

Short-term Toxicity

Author:

Creasey et al.

Year:

1969

Bibliographic source:

Fd Cosmet. ToxicoL

Reference 3

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 4

Reference Type:

publication

Title:

Toxicological Evaluation

Author:

WHO

Year:

1981

Bibliographic source:

The Joint FAO/WHO Expert Committee on Food Additives

Reference 5

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 6

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 7

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

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

Test material information

Constituent 1

Reference substance name:

Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate

EC Number:

219-746-5

EC Name:

Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate

Cas Number:

2519-30-4

Molecular formula:

C28H21N5O14S4.4Na

IUPAC Name:

tetrasodium 4-acetamido-5-hydroxy-6-({7-sulfonato-4-[(4-sulfonatophenyl)diazenyl]-1-naphthyl}diazenyl)naphthalene-1,7-disulfonate

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 or test system 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.