Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

There no data available on phosphonic ester residue with respect to genetic toxicity.

Phosphonic ester residue contains monomethyl phosphonate, phosphonic acid, and Dimethylphosphonate, and salt of pyrophosphoric acid. and phosphate which were not further specified.

There are no data on genetic toxicity available with monomethylphosphonate or phosphonic acid

Dimethylphosphonate

Overall, the available in vitro data indicate that dimethyl phosphonate has mutagenic and clastogenic potential.

The available in vivo data are limited to the bone marrow and the results are conflicting with one study indicating clastogenicity. Dimethyl phosphonate should be regarded as having genotoxic potential in vivo (UNEP 2006)

There are no data with salt of pyrophosphoric acid and phosphate which are not further specified

OVERALL EVALUATION ON MUTAGENICITY

There are no data on genetic toxicity of phosphonic ester residue.

According to GHS/CLP regulation 1272 / 2008 section 3.5.3 classification criteria for mixtures: A mixture shall be classified as a mutagen when at least one ingredient has been classified as a Category 1A, Category 1B or category 2 mutagen and is present at or above 1% (genertic concentration limit) This requirement is fulfilled with dimethylphosphonate which accounts for 11 % in phophonic ester residue

Dimethylphosphonate has mutagenic and clastogenic potential in vitro and should be regarded as having genotoxic potential in vivo (UNEP 2006). Dimethylphosphonate is classified by the producer with R68 = .possible risk of irreversible effects according to Regulation 67/548/EWG resp according to Regulation(EC) 1272/2008 (GHS/CLP) allocated to MutCat 2 , H341 = .suspected of causing genotoxic effects.


Endpoint Conclusion:

Justification for classification or non-classification

According to Regulation (EC) 1972/2008 GHS/CLP section 3.5.3.1.1. a mixture containing an ingriedient (Dimethylhydrogenphosphit) as described above ( R68 or mut Cat 2, H341) with content more than 1 % in the mixture, this mixture has to be allocated to category 2 of mutagenic substances with Hazard Statement 341: suspected of causing genetic defects