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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Fluorescent Whitening Agents. Tests for skin-sensitizing potential.
Author:
Griffith et al.
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:
see details in remarks on material and methods: human repeat insult patch test (HRIPT)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): FWA-8

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 66 with 1% and 73 with 10%
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(S) USED: patch test (epicutaneous test)


ADMINISTRATION
- Type of application: occlusive
- Vehicle / solvent: 0.5% aqueous solution of a detergent mixture
- Concentrations: 10%

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: 66 or 73
- Number of subjects with equivocal reactions: 0
- 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