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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 LD50 study
Author:
Sasaki et al.
Year:
2002
Bibliographic source:
Mutation Research
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

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-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:
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

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.