Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

In Annex IX of Regulation (EC) No 1907/2006, it is laid down that short-term toxicity to terrestrial organisms shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects of the substance and/or relevant degradation products on terrestrial organisms. Column 2 of Annex IX states that studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely.

 

For information, there are no reliable toxicity data for soil-dwelling organisms relating to DMDMH. However, reliable toxicity data for terrestrial organisms is available for DMH, the hydrolysis product of DMDMH. DMDMH readily undergoes hydrolysis to DMH and therefore data are provided for both substances when available. In the case of long-term testing, the data on DMH are considered more relevant for environmental fate and ecotoxicology and are provided in this dossier for information.

 

It can be concluded that short-term toxicity testing of terrestrial organisms is not required based on the unlikely direct or indirect exposure of soil organisms to the DMDMH product or its degradation product (DMH). Based on the unlikely direct exposure to soil organisms, rapid biodegradability in the environment and the additional evidence of no toxicity observed in soil microbes, plants or soil macroinvertebrates in long- and short-term toxicity testing of the breakdown product.