N-Methylolchloracetamid

The German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (MAK Commission) has re-evaluated N-methylolchloroacetamide [2832-19-1] with regard to its carcinogenicity and germ cell mutagenicity classification, its ability to be absorbed through the skin, its sensitization potential and whether an occupational exposure limit value (maximum concentration at the workplace, MAK value) can be derived. Relevant studies were identified from a literature search. The substance is a formaldehyde releaser and is expected to rapidly decompose in aqueous solution. For this reason, local irritation is expected and attributed to the products formaldehyde and chloroacetamide. Carcinogenicity, toxicity and genotoxicity of N-methylolchloroacetamide in the upper respiratory tract or nose, the likely target organs, have not been investigated. The substance has mutagenic and clastogenic potential in vitro, presumably due to the release of formaldehyde. Formaldehyde was classified in Carcinogen Category 4 because it induces tumours in nasal tissue at concentrations that exceed its detoxification capacity. As a formaldehyde releaser, N-methylolchloroacetamide could likewise be classified in Carcinogen Category 4. However, because it is not possible to derive a MAK value for N-methylolchloroacetamide, the substance has been assigned to Carcinogen Category 2 and given the footnote “Prerequisite for Category 4 in principle fulfilled, but insufficient data available for the establishment of a MAK or BAT value”. As there are no data on the systemic bioavailability of N-methylolchloroacetamide and the formaldehyde that is released in tissues, there is no experimental evidence that the formaldehyde reaches the germ cells. Therefore, N-methylolchloroacetamide has been classified in Category 3 B for germ cell mutagens. N-Methylolchloroacetamide has a skin sensitizing potential. Skin contact is not expected to contribute significantly to systemic toxicity.