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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:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from safety assessment reports

Data source

Reference
Reference Type:
review article or handbook
Title:
REPORTS of the Scientific Committee on Cosmetology (seventh series)
Author:
Published by the COMMISSION OF THE EUROPEAN COMMUNITIES; Directorate-General
Year:
1988
Bibliographic source:
Scientific Committee on Cosmetology (seventh series), pg 23 -25, 1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To evaluate the ocular irritation potential of Allura Red AC
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
EC Number:
247-368-0
EC Name:
Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
Cas Number:
25956-17-6
Molecular formula:
C18H16N2O8S2.2Na
IUPAC Name:
disodium 6-hydroxy-5-[(2-methoxy-3-methyl-4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): FD & C Red NO. 40 or Allura Red AC
- IUPAC name: disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- Molecular formula : C18H16N2O8S2.2Na
- Molecular weight: 496.4266 g/mole
- Substance type: Organic
- Physical State: Solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): FD & C Red NO. 40 or Allura Red AC
- IUPAC name: disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- Molecular formula : C18H16N2O8S2.2Na
- Molecular weight: 496.4266 g/mole
- Substance type: Organic
- Physical State: Solid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
not specified

Test system

Vehicle:
water
Controls:
not specified
Amount / concentration applied:
0.1 ml of 1.0% aqueous solution
Duration of treatment / exposure:
no data available
Observation period (in vivo):
no data available
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
no data available
Details on study design:
no data available

Results and discussion

In vitro

Other effects / acceptance of results:
no data available

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: not specified
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No changes were observed, hence Allura Red AC can be considered as not irritating

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
0.1 ml of 1.0% aqueous solution of Allura Red AC did not induce any changes in rabbit eyes. Hence Allura Red AC can be considered not irritating to rabbit eyes.
Executive summary:

An ocular irritation study was carried out to assess the irritation potential of Allura Red AC.0.1 ml of 1.0% aqueous solution of Allura Red AC was instilled into the rabbit eyes and the effects were observed (duration not specified).0.1 ml of 1.0% aqueous solution of Allura Red AC did not any changes in rabbit eyes. Hence Allura Red AC can be considered not irritating to rabbit eyes.