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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: Well documented article from a peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Contact dermatitis and contact sensitization among enamellers and decorators in the ceramics industry
Author:
Motolese A, Truzzi M, Giannini A and Seidenari S
Year:
1993
Bibliographic source:
Contact Dermatitis 1993: 28: 59-62

Materials and methods

Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
126 enamellers and 64 decorators from 5 factories underwent dermatological and allergological examination using occupational test series in order to evaluate the prevalence of dermatitis and contact sensitization, and to identify the most important sensitizing substances. Sodium tripolyphosphate was one of the substances tested.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentasodium triphosphate
EC Number:
231-838-7
EC Name:
Pentasodium triphosphate
Cas Number:
7758-29-4
Molecular formula:
H5O10P3.5Na
IUPAC Name:
pentasodium triphosphate
Details on test material:
- Name of test material (as cited in study report): Sodium tripolyphosphate

Method

Type of population:
occupational
Subjects:
- Number of subjects exposed:
- Sex: 119 females and 71 males
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test


ADMINISTRATION
- Concentrations: To establish dilutions of sodium triployphosphate, 100 subjects undergoing standard patch testing were also patch tested with concentrations of 1 and 2%.
-Description of patch: Patch tests were applied with Finn Chambers (Epitest, Finland) on Scanpor tape (Norgesplaster, Norway)
- Removal of test substance: Removed after 2 days
- Testing/scoring schedule: 1 day after removal


Results and discussion

Results of examinations:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 1/190

Any other information on results incl. tables

No skin reactions to patch tests performed with sodium tripolyphosphate at different concentrations were observed in the subjects undergoing standard patch testing and no positive reactions to one or more allergens specific to the ceramics industry were discovered in healthy volunteers. (table 1).

Table 1: No. sensitizations to sodium tripolyphosphate used in the ceramics industry in enamellers and decorators:

Sodium tripolyphosphate

Total

190 (100%)

Enamellers

126 (100%)

Decorators

(100%)

1

1

0

Applicant's summary and conclusion