Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
secondary source
Title:
REPORTS of the Scientific Committee on Cosmetology (seventh series)
Author:
Published by the COMMISSION OF THE EUROPEAN COMMUNITIES; Directorate-General Telecommunications, Information Industries and Innovation
Year:
1988
Bibliographic source:
Scientific Committee on Cosmetology (seventh series), 1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To assess the eye irritation potential of disodium 3-[(2,4-dimethyl-5-sulfonatophenyl)diazenyl]-4-hydroxynaphthalene-1-sulfonate in rabbits
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Ponceau SX
- Molecular formula : C18H16N2O7S2.2Na
- Molecular weight : 480.4276 g/mol
- Smiles notation: [Na+].[Na+].Cc1cc(C)c(cc1N=Nc2cc(c3ccccc3c2O)S(=O)(=O)[O-])S(=O)(=O)[O-]
- InChl :1S/C18H16N2O7S2.2Na/c1-10-7-11(2)16(28(22,23)24)8-14(10)19-20-15-9-17(29(25,26)27)12-5-3-4-6-13(12)18(15)21;;/h3-9,21H,1-2H3,(H,22,23,24)(H,25,26,27);;/q;2*+1/p-2/b20-19+;;
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): disodium 3-[(2,4-dimethyl-5-sulfonatophenyl)diazenyl]-4-hydroxynaphthalene-1-sulfonate
- Common Name: Ponceau SX
- Molecular formula : C18H16N2O7S2.2Na
- Molecular weight : 480.4276 g/mol
- Smiles notation: [Na+].[Na+].Cc1cc(C)c(cc1N=Nc2cc(c3ccccc3c2O)S(=O)(=O)[O-])S(=O)(=O)[O-]
- InChl :1S/C18H16N2O7S2.2Na/c1-10-7-11(2)16(28(22,23)24)8-14(10)19-20-15-9-17(29(25,26)27)12-5-3-4-6-13(12)18(15)21;;/h3-9,21H,1-2H3,(H,22,23,24)(H,25,26,27);;/q;2*+1/p-2/b20-19+;;
- 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:
not specified
Controls:
not specified
Amount / concentration applied:
5% in formulation
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: No data available
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Not irritating

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
Ponceau SX 5% in formulation didnot cause any irritation to rabbit eyes.
Hence, Ponceau SX can be considered not irritating to rabbit eyes.
Executive summary:

An eye irritation study was conducted to assess the irritation potential of Ponceau SX in rabbits. Ponceau SX 5% in formulation was instilled into the eyes of rabbits and observed for signs of irritation (duration not mentioned).

Ponceau SX 5% in formulation didnot cause any irritation to rabbit eyes.

Hence, Ponceau SX can be considered not irritating to rabbit eyes.