Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-[bis(2-hydroxyethyl)amino]-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

other: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Test procedures cannot be subsumed under a testing guideline. The test method is scientifically acceptable, nevertheless the report is not well documented and no many details are included.

Justification for type of information:

Justification for Read Across is detailed in the Category Justification Report attached to the Section 13 of this dossier.

Data source

Reference

Reference Type:

publication

Title:

Fluorescent Whitening Agents. Tests for skin-sensitizing potential.

Author:

Griffith J.F.

Year:

1973

Bibliographic source:

Arch. Dermatol. 107, 728-733

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Human repeated insult patch test.

GLP compliance:

no

Remarks:

Pre GLP.

Test material

Test material information

Constituent 1

Reference substance name:

Tetrasodium 4,4'-bis[[4-[bis(2-hydroxyethyl)amino]-6-(4-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate]

EC Number:

240-521-2

EC Name:

Tetrasodium 4,4'-bis[[4-[bis(2-hydroxyethyl)amino]-6-(4-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate]

Cas Number:

16470-24-9

Molecular formula:

C40H44N12Na4O16S4

IUPAC Name:

tetrasodium 2,2'-ethene-1,2-diylbis[5-({4-[bis(2-hydroxyethyl)amino]-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]

Method

Type of population:

general

Subjects:

- Number of subjects exposed: 72 subjects.

Controls:

The vehicle also was applied as a negative control. No positive control was applied.

Route of administration:

dermal

Details on study design:

TYPE OF TEST USED: repeated insult patch test.

ADMINISTRATION
- Vehicles: soap plus borate.
- Concentration of brightener in vehicle: 3 %.
- Concentration of vehicle applied: in 0.5 % aqueous solution.
- Type of application: occlusive patches
- Applications: series of nine applications, each of 24 hours duration, during a three-week period.
- Challenge: two weeks later the TS application.

EXAMINATIONS
The applciation sites were graded for primary irritation at intervals during the insult patching sequence.

Results and discussion

Results of examinations:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 72
- Number of subjects with irritating reactions: 0

The material did not appear to cause irritation. None of the subjects was sensitized.

Applicant's summary and conclusion

Conclusions:

0 sensitized/72 subjects.
The material did not appear to cause irritation. None of the subjects was sensitized.

Executive summary:

Method

The test material (at 0.5 % aqueous solution of soap plus borate, containing 3 % brightener) was applied under occlusive patches in a series of nine applications (each of 24 hours duration) during a 3 week period to 70 human . Challenge applications were made 2 weeks later.

The vehicle also was applied as a negative control. No positive control was applied. Component concentrations were not listed, but were stated as being within ranges of usual commercial formulations. The test application sites were graded for primary irritation at various intervals.

Results

0 sensitized/72.

The material did not appear to cause irritation. None of the subjects was sensitized.