Trisodium 4-[[4-chloro-6-[(4-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-[[1-(2,5-dichloro-4-sulphonatophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]benzenesulphonate

Eye irritation

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

Test material information

Constituent 1

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.