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EC number: 229-222-8
CAS number: 6440-58-0
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 microbes based on long-term toxicity testing of the breakdown product.
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 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.
product is not supposed to be directly applied to soil and indirect
exposure of terrestrial organisms is unlikely since the test substance
and its degradation product (DMH) are readily biodegraded in the aquatic
environment and STP processes. Therefore no short-term tests on
terrestrial organisms are required in accordance with Annex IX of
Regulation (EC) No 1907/2006.
information, there are no reliable short-term toxicity data for plants
relating to DMDMH. However,
reliable long-term toxicity data for terrestrial organisms are 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
(2007) conducted a reliable (Klimisch 1) GLP compliant study following
OECD 216 methods. Soil microbes were exposed to one concentration of DMH
(1000 mg/kg) in a limit test for 28 days. The
28-day EC50, based on inhibition of microbial nitrogen transformation
activity, was >1000 mg/kg and the NOEC was 1000 mg/kg.
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 microbes based on long-term 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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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