Trisodium 4-[[1-hydroxy-6-[[[[5-hydroxy-6-(phenylazo)-7-sulphonato-2-naphthyl]amino]carbonyl]amino]-3-sulphonato-2-naphthyl]azo]benzoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data from peer- reviewed journals

Data source

Reference

Reference Type:

review article or handbook

Title:

A Review of the Toxicity of Twelve Fluorescent Dyes Used for Water Tracing

Author:

P.L Smart

Year:

1984

Bibliographic source:

The NSS Bulletin, Volume 46 Number 2: 21-33 - October 1984, A publication of the National Speleological Society

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the ocular irritation potential of Pyranine

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 8-hydroxypyrene-1,3,6-trisulphonate

EC Number:

228-783-6

EC Name:

Trisodium 8-hydroxypyrene-1,3,6-trisulphonate

Cas Number:

6358-69-6

Molecular formula:

C16H10O10S3.3Na

IUPAC Name:

trisodium 8-hydroxypyrene-1,3,6-trisulfonate

Test material form:

solid: particulate/powder

Details on test material:

Name of test material (as cited in study report): Solvent Green 7 also known as Pyranine
Molecular formula : C16H10O10S3.3Na
Molecular weight : 524.385088 g/mol
Smiles notation : c12c3c4c(cc(c3ccc2c(S([O])(=O)=O)cc(c1cc4)S([O])(=O)=O)O)S([O])(=O)=O.[Na+].[Na+].[Na+]
InChl: 1S/C16H10O10S3.3Na/c1711512(27(18,19)20)8341014(29(24,25)26)613(28(21,22)23)9217(11)15(8)16(9)10;;;/h16,17H,(H,18,19,20)(H,21,22,23)(H,24,25,26);;;/q;3*+1/p3
Substance type: Organic
Physical State: Solid

Specific details on test material used for the study:

Name of test material (as cited in study report): Solvent Green 7 also known as Pyranine
Molecular formula : C16H10O10S3.3Na
Molecular weight : 524.385088 g/mol
Smiles notation : c12c3c4c(cc(c3ccc2c(S([O])(=O)=O)cc(c1cc4)S([O])(=O)=O)O)S([O])(=O)=O.[Na+].[Na+].[Na+]
InChl: 1S/C16H10O10S3.3Na/c1711512(27(18,19)20)8341014(29(24,25)26)613(28(21,22)23)9217(11)15(8)16(9)10;;;/h16,17H,(H,18,19,20)(H,21,22,23)(H,24,25,26);;;/q;3*+1/p3
Substance type: Organic
Physical State: Solid

Test animals / tissue source

Species:

other: mammals

Strain:

not specified

Details on test animals or tissues and environmental conditions:

no data

Test system

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

no data

Duration of treatment / exposure:

no data

Observation period (in vivo):

no data

Number of animals or in vitro replicates:

no data

Details on study design:

no data

Results and discussion

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:

No signs of irritation observed

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

Pyranine was observed to be non – irritating to eyes. Since there was no evidence of substantial toxicity, it was considered that Pyranine can be used safely for the angiography in the human eye.

Executive summary:

In an ocular irritation study conducted on mammals (species - not mentioned), Pyranine was observed to be non – irritating to eyes.Since there was no evidence of substantial toxicity, it was considered that Pyranine can be used safely for the angiography in the human eye.