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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)

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 Kamayaa, Miyuki Ohshita, Kazumi Kabasawa, Kayoko Iwamaa, Kazuyuki Taniguchi, Shuji Tsuda
Year:
2002
Bibliographic source:
Mutation Research 519 (2002) 103–119

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Acute oral toxicity of substance Indigo carmine in ddY mice.
GLP compliance:
no
Test type:
other: No data available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):Indigo carmine- Molecular formula (if other than submission substance):C16H8N2Na2O8S2- Molecular weight (if other than submission substance):466.35 g/mol- Substance type:Organic- Physical state:Solid

Test animals

Species:
mouse
Strain:
other: ddy
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Tokyo Kasei Kogyo Industry Ltd- Age at study initiation: 7 weeks old- Weight at study initiation: No data available- Fasting period before study: No data available- Housing: No data available- Diet (e.g. ad libitum): commercial pellets MF (Oriental Yeast Industries Co., Tokyo, Japan)- Water (e.g. ad libitum): tap water ad libitum- Acclimation period: 1 weekENVIRONMENTAL CONDITIONS- Temperature (°C): 20–24 °C- Humidity (%):No data available- Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): 12 h light–dark cycle.IN-LIFE DATES: From: To: No data available

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
physiological saline
Details on oral exposure:
No data available
Doses:
2000 mg/kg
No. of animals per sex per dose:
4 male
Control animals:
not specified
Details on study design:
No data available
Statistics:
No data available

Results and discussion

Preliminary study:
No data available
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No data available
Clinical signs:
No data available
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 value of substance Indigocarmine is considered to be >2000 mg/kg ddY mice.
Executive summary:

Acute oral toxicity test of Indigocarmine was carried out with ddY mice. Test substance was administered orally to group of four male mice at 2000 mg/kg dose. The acute oral LD50 value of substanceIndigo carmineis considered to be >2000 mg/kgin ddY mice.