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Administrative data

Description of key information

Acute oral toxicity:
The acute oral LD50 value of substance Indigocarmine is considered to be >2000 mg/kg ddY mice.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Reference:
Composition 0
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 information:
Composition 1
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
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
Preliminary study:
No data available
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Data is from peer reveiw journal.

Additional information

Acute Oral Toxicity:

Peer reviewed articles were viewed to determine the acute oral toxicity of the test compound C.I. Acid blue 74 (CAS no 860-22-0). The studies are summarized as below:

 

Acute oral toxicity testwas performed by Yu F. Sasaki et al, 2002 forIndigo carminewas carried out withddY 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/kg in ddY mice.

 

From review article (Richard J. Lewis, Sr., 2012) acute oral toxicity test was conducted on rat administered indigo carmine by oral route.LD50 value was found to be 2000 mg/kg. In acute oral toxicity test of chemical indigo carmine administered orally to rat.

 

From Danish (Q)SAR Database predicted data, The acute oral LD50 value of substance Indigo carmine is considered to be 3500 mg/kg in rat and 5200 mg/kg in mouse.

 

From review article of Acute oral toxicity of chemical Indigo carmine (Food additives handbook, 1989)test was conducted on rat administered indigo carmine by oral route.LD50 value was found to be >3000 mg/kg. In acute oral toxicity test of chemical indigo carmine administered orally to rat

 

From EFSA Journal (2014) Scientific Opinion on the re-evaluation of Indigo Carmine (E 132) as a food additive,The acute oral median lethal dose (LD50) of indigo carmine in rat was found to be 2000mg/kg and mice was found to be 2500mg/kg. Acute oral toxicity of indigo carmine to rat and mouse by oral route indicates that indigo carmine does not exhibits acute toxicity by the oral route.

 

From RTECS handbook (2015), theAcute oral toxicity test of(delta(sup 2,2')Biindoline) 5,5' disulfonic acid, 3,3'dioxo, disodium salt(Indigo Carmine) was conducted in rat. The acute oral LD50 value of substance(delta(sup 2,2')Biindoline) 5,5' disulfonic acid, 3,3'dioxo, disodium salt is considered to be 2000 mg/kg in rat and 2500 mg/kg in mouse..Acute oral toxicity of indigo carmine to rat and mouse by oral route indicates that indigo carmine does not exhibits acute toxicity by the oral route.

 

Based on the key study used, its relative supporting data and as per the CLP classification, the test material does not classify as an acute oral toxicant.

Justification for selection of acute toxicity – oral endpoint
The acute oral LD50 value of substance Indigocarmine is considered to be >2000 mg/kg ddY mice.

Justification for classification or non-classification

Acute oral toxicity:

Based on the key study used, its relative supporting data and as per the CLP classification, the test material does not classify as an acute oral toxicant.