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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
review article or handbook
Title:
Scientific Opinion on the safety and efficacy of indigo carmine (E 132) for cats and dogs and ornamental fish
Author:
EFSA Journal
Year:
2015
Bibliographic source:
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), European Food Safety Authority (EFSA), Parma, Italy; EFSA Journal 2015; 13(5):4108

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as per mentioned below
Principles of method if other than guideline:
study is performed by using In vivo( Draize test) method
GLP compliance:
no

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- Substance type:Organic- Physical state:Solid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data available

Test system

Vehicle:
water
Controls:
not specified
Amount / concentration applied:
0.2mL of 10% aqueous solution
Duration of treatment / exposure:
Twice daily for five days per week for four weeks
Observation period (in vivo):
72 hours after the last administration
Number of animals or in vitro replicates:
Six rabbits
Details on study design:
No data available

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 Hr
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Substance is not an eye irritant
Irritant / corrosive response data:
Slight transient irritation is produced which is reversible, hence indigo carmine is not irritating to the eye.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Slight transient irritation is produced which is reversible, hence indigo carmine is not irritating to the eye.
Executive summary:

In the given study Indigo carmine was tested for eye irritation in albino rabbits using Draize test, produced slight transient irritation ,when 0.2mL of 10% aqueous solutionwas applied twice daily for five days per week for four weeks to the eye of six rabbits. Three days after the last administration, there were no signs of eye irritation in any of the treated animals. This indicates that Indigo carmine is not an eye irritant.