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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:
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

Constituent 1
Chemical structure
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'-sulphonatonaphthylazo)naphthalene-2,7-disulphonate
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:
no data
Body weight:
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.