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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: data from peer- reviewed journals

Data source

Reference

Reference Type:

publication

Title:

The comet assay with 8 mouse organs: results with 39 currently used food additives

Author:

Yu F. Sasaki, Satomi Kawaguchi, Asako Kamaya, Miyuki Ohshita, Kazumi Kabasawa, Kayoko Iwama, Kazuyuki Taniguchi, Shuji Tsuda

Year:

2002

Bibliographic source:

Mutation Research 519 (2002) 103–119

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 Amaranth

GLP compliance:

not specified

Test type:

other: comet assay

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

Constituent 2

Reference substance name:

trisodium (4E)-3-oxo-4-[(4- sulfonato-1- naphthyl)hydrazono]naphthalene- 2,7-disulfonate

IUPAC Name:

trisodium (4E)-3-oxo-4-[(4- sulfonato-1- naphthyl)hydrazono]naphthalene- 2,7-disulfonate

Constituent 3

Reference substance name:

Amaranth dye

IUPAC Name:

Amaranth dye

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Name of test material (as cited in study report): Amaranth dye
Molecular formula (if other than submission substance): C20H11N2Na3O10S3
Molecular weight (if other than submission substance): 604.47
Smiles notation (if other than submission substance): c1ccc2c(c1)c(ccc2S(=O)(=O)[O])N=Nc3c4ccc(cc4cc(c3O)S(=O)(=O)[O-])S(=O)(=O)[O-].[Na+].[Na+].[Na+]
InChl (if other than submission substance): 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:

Details on test animal
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 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.

Mortality:

no mortality observed

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
Amaranth	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:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

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 Amaranth

Executive summary:

A simple 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 at 20–24◦C with a 12 h light – dark cycle.

 

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.

 

The acute oral LD50 in male DDY mice was determined to be greater than 2000 mg/kg after dosing with Amaranth dye.