Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

One study is recorded for this endpoint and was chosen as a key study. The delayed contact hypersensitivity of sodium hypophosphite was assessed using the murine Local Lymph Node Assay . This study was conducted in compliance with the principles of Good Laboratory Practices and performed according to the OECD guideline 429 and the EU Method B.42.

Results showed no cutaneous reactions and no increase in ear thickness. No lymphoproliferation was noted. Over the range of sodium hypophosphite tested concentrations (2.5% to the maximal practicable concentration of 50%), the Stimulation Index (SI) varied from 1.01 to 1.79.

Under these test conditions, sodium hypophosphite was considered as not sensitising.


Migrated from Short description of key information:
The potential of sodium hypophosphite to induce delayed contact hypersensitivity was investigated using the murine Local Lymph Node Assay (LLNA)(OECD 429 , EU B 42 method, GLP) . The test item was found to be non-sensitising.

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
There is no reported case of respiratory sensitisation in humans.

Justification for classification or non-classification

Skin sensitisation:

In accordance with column 2 of REACH annex VII point 8.3, the murine Local Lymph Node Assay (LLNA) (OECD guideline 429) is the first-choice method for in vivo testing of skin sensitisation. Hence, the results of the reported study were used as a basis for  classification. According to the criteria laid down in EU regulation (EC) n°1272/2008 (CLP) and EU Directive 67/548/EEC, sodium hypophosphite is not classified for skin sensitisation.