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:

There are two main reasons why the sensitization potential of melamine phosphate can be derived from melamine: First, phosphate is an endogenous substance in the body and present in high concentrations in food and second, both melamine and melamine phosphate are soluble in water and have a simalar log Pow.

Melamine was tested for sensitizing properties in guinea pigs (Seibersdorf 2010). The guinea pig maximization test was performed according to OECD testing guideline 406 and following the principles of GLP. None of the animals were sensitized with the highest dose that could be applied (50% in white petrolatum for epicutaneous application).


Migrated from Short description of key information:
Melamine phosphate is not sensitizing based on the result of the guinea pig maximization test with melamine (GLP, OECD 406) (Seibersdorf 2010).

Respiratory sensitisation

Endpoint conclusion
Additional information:

No experimental data is available regarding respiratory sensitization.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin sensitization under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008.