Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Tetrakis(hydroxymethyl)phosphonium chloride, oligomeric reaction products with urea, likeTHPC, is classified as structurally alerting by virtue of its natural electrophilicity. However, THPC is negative in the bacterial reverse mutation assay. THPC was tested and found to be clearly positive in 3 in-vitro tests for genotoxicity: a test for chromosomal aberrations in CHO cells, a test for mutations at the thymidine kinase (TK) locus in mouse lymphoma L5178Y cells, and a test for sister-chromatid exchanges (SCE) in CHO cells. Tetrakis(hydroxymethyl)phosphonium chloride, oligomeric reaction products with urea was found positive for chromosomal aberrations in primary cultivated human lymphcytes (in vitro).

No indications for genotoxicity were found with a close related substance (THPS) in the followingin-vivotests: two tests for micronuclei (MN-PCE) and for chromosomal aberrations (CA) in bone marrow cells of oral treated mice and two tests for micronuclei (MN-PCE) and for chromosomal aberrations (CA) in bone marrow of dermal treated mice.

No indications for genotoxicity were found with Tetrakis(hydroxymethyl)phosphonium chloride, oligomeric reaction products with urea (Proban CC) in the mouse micronucleus test (in vivo).


Justification for selection of genetic toxicity endpoint
No individual study was seleccted, because this conclusion was taken from several tests.

Short description of key information:
WoE: In vitro positive - in vivo negative for the endpoint genetic toxicity.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

conclusive but not sufficient for classification