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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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
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

Constituent 1
Chemical structure
Reference substance name:
Disodium 5,5'-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate
EC Number:
212-728-8
EC Name:
Disodium 5,5'-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate
Cas Number:
860-22-0
Molecular formula:
C16H10N2O8S2.2Na
IUPAC Name:
disodium 3,3'-dioxo-1,1',3,3'-tetrahydro-2,2'-biindole-5,5'-disulfonate
Constituent 2
Reference substance name:
Indigo carmine
IUPAC Name:
Indigo carmine
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 or test system 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:
other: 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.