Registration Dossier
Registration Dossier
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EC number: 212-728-8 | CAS number: 860-22-0
Acute Toxicity: oral
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:
- 2 002
- 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
- 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
- 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
Constituent 1
Constituent 2
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.
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