Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Tetrakis(hydroxymethyl) phosphonium chloride (THPC), oligomeric reaction products with urea is considered to be cytotoxic and corrosive by its intrinsic chemical reactivity (see IUCLID chapter7.3.1: Pascic 2006 + Gray, 2011). Test data with the polymer or the treated fabric are negative, but test results with structurally closely related compounds (THPC 80%, THPS 75% as well as Proban CC= 65% THPC-urea oligomere) are conclusive and sufficient for classification as skin sensitising.

read across from data/evidence based expert jugement: THPC is considered a skin sensitiser based on two other existing data: a 20% THPC aqueous solution was found positive for skin sensitisation Tuffnell (1992) and a 75% THPS aqueous solution was found positive for skin sensitisation (Guest, 1994) both by means of the GPMT (Magusson&Kligman).


Migrated from Short description of key information:
In accordance with section 8.3 column 2 of Annex VII, the sensitization study is not necessary as the substance is classified to be corrosive to skin. Further there is enough weight of evidence from supporting data with structurally closely related substances (THPC, THPS) and an assessment of Proban CC (another trade name) from a reliable secondary source to conclude that classification of the endpoint is necessary.

Justification for selection of skin sensitisation endpoint:
The substance is classified to be corrosive to skin. Further there is enough evidence from supporting data with structurally closely related substances (THPC, THPS) and an assessment of Proban CC (another trade name) from a reliable secondary source to conclude that classification of the endpoint is necessary.
Tetrakis(hydroxymethyl) phosphonium chloride, oligomeric reaction products with urea is classified for skin sensitisation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

The test substance has very low vapor pressure and no significant inhalation exposure is expected. The substance is an salt and manufactured and marketed in form of an aqueous solution. The use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and no inhalation test or resiratory sensitisation test was performed. No respiratory sensitisation did occur under intended conditions of handling and use (contiunous observation at workplaces in manufacturing site as well as in textile treatment plant).


Migrated from Short description of key information:
Not tested.

Justification for selection of respiratory sensitisation endpoint:
inhalation exposure consideration; experience from manufacturing and application.

Justification for classification or non-classification