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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report date:
1971

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Human patch test.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate
EC Number:
240-245-2
EC Name:
Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate
Cas Number:
16090-02-1
Molecular formula:
C40H38N12Na2O8S2
IUPAC Name:
disodium 2,2'-ethene-1,2-diylbis{5-[(4-anilino-6-morpholin-4-yl-1,3,5-triazin-2-yl)amino]benzenesulfonate}

Method

Type of population:
general
Subjects:
Number of subjects exposed: 102
Route of administration:
dermal
Details on study design:
TYPE OF TEST USED
Patch test (epicutaneous test).

ADMINISTRATION
- Type of application: occlusive.
- Application: for a total of 10 applications (3 per week).
- Exposure: dressing for 48 hours (72 hours on the weekend).
- Vehicle / solvent: petrolatum.
- Concentrations: 1 % and 5 %.

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: 102
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

There was no evidence of allergenic skin contact sensitization at both concentrations tested.

Applicant's summary and conclusion

Conclusions:
No evidence of allergenic skin contact sensitization at both concentrations tested.
Executive summary:

Procedures

A repeated insult patch test was performed on 102 volunteers. The test substance was dissolved in petrolatum to concentrations of 1 % and 5 % and was applied for a total of 10 applications (3 per week) under occlusive dressing for 48 hours (72 hours on the weekend). This was followed by a rest period and final elicitation on a fresh application site.

Results

There was no evidence of allergenic skin contact sensitization at both concentrations tested.