2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium salt

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 LD50 study

Author:

Sasaki et al.

Year:

2002

Bibliographic source:

Mutation Research

Reference 2

Reference Type:

review article or handbook

Title:

Reaxys summary

Author:

Reaxys database

Year:

2016

Bibliographic source:

Reaxys by Reed Elsevier Properties SA,2016

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To determine the acute oral toxicity of the test chemical.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 3-hydroxy-4-(4'-sulphonatonaphthylazo)naphthalene-2,7-disulphonate

EC Number:

213-022-2

EC Name:

Trisodium 3-hydroxy-4-(4'-sulphonatonaphthylazo)naphthalene-2,7-disulphonate

Cas Number:

915-67-3

Molecular formula:

C20H14N2O10S3.3Na

IUPAC Name:

trisodium 3-hydroxy-4-[(4-sulfonato-1-naphthyl)diazenyl]naphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Details on test material:

- IUPAC Name of test material: trisodium 3-hydroxy-4-(4'-sulphonatonaphthylazo)naphthalene-2,7-disulphonate
- Common Name: Amaranth dye
- Molecular formula: C20H11N2Na3O10S3
- Molecular weight: 604.47
- Smiles notation: c1ccc2c(c1)c(ccc2S(=O)(=O)[O])N=Nc3c4ccc(cc4cc(c3O)S(=O)(=O)[O-])S(=O)(=O)[O-].[Na+].[Na+].[Na+]
- InChl: 1S/C20H14N2O10S3.3Na/c23-20-18(35(30,31)32)10-11-9-12(33(24,25)26)5-6-13(11)19(20)22-21-16-7-8-17(34(27,28)29)15-4-2-1-3-14(15)16;;;/h1-10,23H,(H,24,25,26) (H,27,28,29)(H,30,31,32);;;/q;3*+1/p-3
- Substance type: Organic
- Physical state: Solid

Test animals

Species:

mouse

Strain:

other: DDY

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
Source: Japan SLC Co., Shizuoka, Japan
Age at study initiation: 7 weeks
Weight at study initiation: no data
Fasting period before study: no data
Housing: no data
Diet (e.g. ad libitum): commercial pellets MF (Oriental Yeast Industries Co., Tokyo, Japan), ad libitum
Water (e.g. ad libitum): Tap Water, ad libitum
Acclimation period: 1 week of acclimatization

ENVIRONMENTAL CONDITIONS
Temperature (°C): The animal room was kept at 20–24°C.
Humidity (%): No data
Air changes (per hr): No data
Photoperiod (hrs dark / hrs light): 12 h Light – dark cycle.

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

physiological saline

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 0.5 × LD50 or the limit dose of 2000 mg/kg.

Doses:

0.5 × LD50 or the limit dose of 2000 mg/kg.

No. of animals per sex per dose:

4 - 5 male mice

Control animals:

not specified

Details on study design:

no data

Statistics:

no data

Results and discussion

Preliminary study:

no data

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality was observed

Mortality:

no mortality observed at dose 2000 mg/kg bw.

Clinical signs:

other: no data

Gross pathology:

no data

Other findings:

no data

Any other information on results incl. tables

Table 1: Acute Oral Toxicity study results

 

Test chemical	Vehicle	Source*	LD50** mg/kg
TEST CHEMICAL	Saline	T	>2000

 

*T = Tokyo Kasei Kogyo Industry Ltd., Tokyo, Japan;

** In order to set appropriate doses for the assay, we determined approximate LD50 by simple acute toxicity experiments on four–five animals. When no death was observed at 2000 mg/kg, the LD50 was defined as >2000 mg/kg.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Conclusions:

A simple acute oral toxicity experiment was conducted prior to Comet assay in male DDY mice.When no death was observed at 2000 mg/kg, the LD50 was defined as >2000 mg/kg. The acute oral LD50 in male DDY mice was determined to be greater than 2000 mg/kg after dosing with test chemical.

Executive summary:

Acute oral toxicity experiment was conducted prior to Comet assay in male DDY mice. Male ddY mice were obtained from Japan SLC Co., Shizuoka, Japan, at 7 weeks of age and used after 1 week of acclimatization. They were fed commercial pellets MF (Oriental Yeast Industries Co., Tokyo, Japan) and tap water ad libitum throughout the acclimatization period and the experiment. The animal room was kept at 20–24°C with a 12 h light – dark cycle. In order to set appropriate doses for the assay, the approximate LD50 was determined by simple acute toxicity experiments on four–five animals. When no death was observed at 2000 mg/kg, the LD50 was defined as >2000 mg/kg. The acute oral LD50 in male DDY mice was determined to be greater than 2000 mg/kg after dosing with test chemical.