Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Biometabolism of Green S and Indigo Carmine through Cecal Microflora of Rats
Author:
Sudhir Singh1, Mukul Das and Subhash K. Khanna 2
Year:
1993
Bibliographic source:
Biochemical and Biophysical Research Communications, Vol. 195, No. 1, 1993

Materials and methods

Objective of study:
metabolism
Test guideline
Qualifier:
equivalent or similar to
Guideline:
other:
Principles of method if other than guideline:
In Vitro Metabolism of Indigo Carmine in Wistar male rats Cecal Microflora
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Indigo Carmine - Molecular formula (if other than submission substance): C16H8N2O8S2.2Na- Molecular weight (if other than submission substance): 466.3572 g/mole - Substance type: Organic- Physical state: Powder - Impurities (identity and concentrations): No data available
Radiolabelling:
not specified

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Industrial toxicology research center, Lucknow animal breeding colony. - Age at study initiation: No data available - Weight at study initiation: 160 ± 20 g- Fasting period before study: Overnight - Housing: No data available - Diet (e.g. ad libitum):Pellet diet, ad libitum- Water (e.g. ad libitum): Water, ad libitum- Acclimation period: No data available ENVIRONMENTAL CONDITIONS- Temperature (°C): No data available - Humidity (%):No data available - Air changes (per hr): No data available - Photoperiod (hrs dark / hrs light): No data available IN-LIFE DATES: From: To: No data available

Administration / exposure

Route of administration:
other: incubation
Vehicle:
other: nutrient broth
Details on exposure:
1 mg of Indigo Carmine was mixed with rat caecum extract (0.2 ml) in a total of 2.3 ml of nutrient broth.
Duration and frequency of treatment / exposure:
6 and 18 hr
Doses / concentrations
Remarks:
Doses / Concentrations:1 mg
No. of animals per sex per dose:
1
Control animals:
yes
Positive control:
No data available
Details on study design:
Content of caecum was suspended in a steriilized nutrient broth containing 0.5 % each of glucose, peptone and yeast extract in 0.1 M phosphate buffer pH 7.0 to give 10 % v/v suspension. The reaction was stopped at different time interval by 0.2 ml of methanol. The comparative degradation pattern of Indigo Carmine was estimated at different time interval and expressed as degradation index 50 (DI 50) value i.e. the time period required to degrade 50 % of the original Indigo Carmine concentarion present in the incubation system.
Details on dosing and sampling:
No data available
Statistics:
No data available

Results and discussion

Preliminary studies:
No data available
Main ADME results
Type:
metabolism
Results:
4 fluorescent metabolite spots were detected

Toxicokinetic / pharmacokinetic studies

Details on absorption:
No data available
Details on distribution in tissues:
No data available
Details on excretion:
No data available

Metabolite characterisation studies

Metabolites identified:
no
Details on metabolites:
4 fluorescent metabolite spots were detected with maximum degradation of 72. 6 % after 6 and 18 hrs.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): low bioaccumulation potential based on study resultsIndigo Carmine expected to have Low bio-accumulation potential based on study results.
Executive summary:

In a vitro biometabolism study, Wistar male rats caecum extract were treated with Indigo Carmine in the concentration of 1 mg and comparative degradation patternwas estimated at different time interval and expressed as degradation index 50 (DI 50) value i.e. the time period required to degrade 50 % of the original Indigo Carmine concentarion present in the incubation system. 4 fluorescent metabolite spots were detected with maximum degradation of 72.6 % after 6 and 18 hours. Indigo Carmine showed faster degradation with DI 50 value of 54 min.Therefore, On the basis of given result Indigo Carmine expected to have Low bio-accumulation potential based on study results.