2,2-bis(hydroxymethyl)propionic acid

Endpoint summary

Additional information

Genetic toxicity in vitro

Bacterial reverse mutation test

The potential of Bis-MPA (2,2 -dimethylol propionic acid) to cause genetic damage was evaluated in a GLP study conducted according to OECD TG 471 (van Delft, 1998). Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 were tested both in the presence and absence of metabolic activation. There was no evidence of toxicity or mutagenicity up to concentrations of 5000 µg/plate. Therefore it was concluded that Bis-MPA was not mutagenic under the conditions of the study.

In a second GLP study according to OECD Guideline 471 (RTC, 2015) Bis-MPA was examined for the ability to induce gene mutations in Escherichia coli strain WP2 uvrA. It is concluded that Bis-MPA did not induce reverse mutation in Escherichia coli in the absence or presence of S9 metabolism, under the reported experimental conditions.

Mammalian cell gene mutation test

A GLP gene mutation study was performed with Bis-MPA (2,2 -dimethylol propionic acid), according to OECD TG 476 (van Delft, 1998). The potential of the test substance to induce mutations at the TK-locus of L5178Y cells was determined, both in the presence and absence of metabolic activation. Bis-MPA was not found to be cytotoxic or genotoxic, either in the presence or absence of metabolic activation, tested up to a concentration of 10 mM.

Mammalian chromosome aberration test

A GLP chromosome aberration study was performed with Bis-MPA (2,2 -dimethylol propionic acid), according to OECD TG 473 (van Delft, 1998). The study was carried out with Chinese hamster ovary cells, in the presence and absence of metabolic activation, up to a concentration of 1250 µg/ml. Under the conditions of the study, Bis-MPA was found to be non-clastogenic.

Justification for selection of genetic toxicity endpoint
A weight of evidence approach is taken for this endpoint: no key study is identified. Three in vitro studies of genotoxicity are available, all studies report negative results.

Short description of key information:
Bis-MPA (dimethylol propionic acid) was not mutagenic or clastogenic when tested in vitro in a bacterial reverse mutation assay, a mammalian cell gene mutation assay, and a mammalian chromosome aberration test.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Dimethylolpropionic acid was not mutagenic or clastogenic when tested in vitro in a bacterial reverse mutation assay, a mammalian cell gene mutation assay, and a mammalian chromosome aberration test. Classification according to DSD or to Regulation (EC) No 1272/2008 is therefore not required.