Registration Dossier
Registration Dossier
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EC number: 229-222-8 | CAS number: 6440-58-0
Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
Description of key information
It can be concluded that short-term toxicity testing of terrestrial organisms is not required based on the unlikely 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 macroinvertebrates based on acute toxicity testing of the breakdown product.
Key value for chemical safety assessment
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 are available for DMH, the hydrolysis product of DMDMH. DMDMH readily undergoes hydrolysis to DMH and therefore data is provided for both substances when available.
Goodband (2007) conducted a reliable (Klimisch 1) GLP compliant study following OECD 207 methods. Earthworms, (Eisenia foetida) at least 2 months old, were exposed to one concentration of DMH, the hydrolysis product of DMDMH (1000 mg/kg) in a limit test for 14 days. The 14-day EC50, based on mortality, was >1000 mg/kg.
It can be concluded that short-term toxicity testing of terrestrial organisms is not required based on the unlikely 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 macroinvertebrates based on acute toxicity testing of the breakdown product.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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