Registration Dossier
Registration Dossier
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EC number: 476-160-4 | CAS number: 54807-34-0
Endpoint summary
Administrative data
Description of key information
Additional information
Hydrolysis:
The hydrolysis study has been performed on DMH (Dimethyl Hydantoin) and has been used for read-across purposes. The results of the study demonstrated that DMH was not hydrolyzed in aqueous media at a pH of 5 and 9. At a pH of 7 hydrolysis of DMH was minimal, resulting in very long half-lives. At pH 7, half-life is 3194 days in TRIS Buffer at 25°C and at pH 7 in HEPES Buffer 1715 days.
Biodegradability:
A readily biodegradability test in accordance with GLP and OECD Guideline 301 B was performed on the chemical NaDMH. NaDMH attained 85% degradation after 28 days and is therefore considered readily biodegradable. Additionally a read-across study on the analogue chemical DMH attained 88% degradation after 28 days and this also was considered readily biodegradable.
Biodegradation in water and sediment:
A biodegradation study in water and sediment was not carried out on the chemical NaDMH, three studies were however carried out on the analogue chemical DMH and are to be considered for the purposes of read-across. The studies provided show that DMH was steadily degraded at 20 °C in the absence of light giving whole system and aqueous phase DT50 values of 13 to 24 days and DT90 values of 42 to 79 days. After 17 weeks, 65% of initial radioactivity was mineralised to CO2.
Degradation-biotic:
According to Annex IX section 9.2.1.3 of Regulation No. 1907/2006 “Further biotic degradation testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicated the need to investigate further the degradation of the substance and its degradation products”. Adequate information on the degradation of DMH is available which shows that it is readily biodegradable and therefore no further testing for this endpoint is proposed.
Bioaccumulation:
The bioaccumulation study has been performed on DMH (Dimethyl Hydantoin) and has been used for read-across purposes. Concentrations of radioactivity in edible and non-edible tissues of bluegill exposed to 14C-DMH at 1.0 ppm were lower than the limit of quantitation therefore DMH did not bioconcentrate in fish tissue (BCF < 1.79).
Adsorption/desorption:
The adsorption/desorption study has been performed on DMH (Dimethyl Hydantoin) and has been used for read-across purposes. Based on the range of Koc values DMH (Koc >23.4 - <147; logKoc >1.37 - <2.17) was considered as having a high mobility in soil.
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