(1-methyl-1,2-ethanediyl)bis[oxy(methyl-2,1-ethanediyl)] diacrylate

Biodegradation in water and sediment: simulation tests

Additional information

Water:

According to Regulation (EC) 1907/2006, Annex IX, Section 9.2.1.2, column 2, a simulation study on ultimate degradation in surface water does not need to be conducted if the substance is readily biodegradable. TPGDA and all of the constituents of the registration item are predicted to sufficiently degrade in the environment (Cray Valley, rep. no.: 638/004, 1997). Additionally, no one out of the four main ingredients is considered to persist in the environment, neither in sediment, soil or water (IUCLID Ch. 5.2.1). Moreover, based on modeled data relevant degradation products present in concentration of ≥ 0.1% (equivalent to quantity setting in OASIS CATALOGIC: ≥0.001 [mol/mol parent]) do neither fulfill the PBT criteria (not PBT) nor the vPvB criteria (not vPvB). The remaining “non-specified constituents” sum up to a typical concentration of approximately 6.0 % (w/w). According to GC analytics, more than 45 peaks contribute to this part of the composition of the registration item. Though it is virtually not possible to identify each single peak and assess the respective substance(s) individually, a generic assessment of the environmentally relevant properties of these ingredients may be applied. Multifunctional acrylates are synthesized from alcohols and acrylic acid. As a consequence, the resulting products – including the “non-specified constituents” – are made of the same, similar chemistry. As shown by the evidence provided above, this chemistry basically is subject to ultimate biotic degradation: in none of the four main constituents, a potential metabolite that may be generated from the degradation of these compounds was identified. Therefore, from a scientific perspective, it is extremely likely that also the degradation of the chemically similar “non-specified constituents” of the registration item will not lead to the formation of a persistent metabolite. The raw materials used as well as the conditions of the reaction chosen during manufacture are targeted to produce 2-{2-[2-(acryloyloxy)-1-methylethoxy]-1-methylethoxy}-1-methylethyl acrylate. Side-products beyond the main constituents discussed above are expected to slightly vary in chain lengths and/or branching, but are not anticipated to significantly differ in terms of structural elements – if at all. Therefore, also these structures are deemed degradable by the same metabolic pathways. Consequently, there is no concern that (part of) the UVCB may persist in the environment.Moreover, the structural related acrylate DPGDA, which differs only in a slightly shorter chain length is readily biodegradable (90 - 100% DOC removal, BASF AG, rep. no.: 02/0368/21/1, 2003). In Analogy to DPGDA it can be expected that TPGDA is ultimately biodegradable under environmental conditions. Therefore, no biodegradation studies in surface water will be provided.

Sediment:

According to Regulation (EC) 1907/2006, Annex IX, Section 9.2.1.2, column 2, a simulation study on ultimate degradation in sediment does not need to be conducted if the substance is readily biodegradable. TPGDA and all of the constituents of the registration item are predicted to sufficiently degrade in the environment (Cray Valley, rep. no.: 638/004, 1997). Additionally, no one out of the four main ingredients is considered to persist in the environment, neither in sediment, soil or water (IUCLID Ch. 5.2.1). Moreover, based on modeled data relevant degradation products present in concentration of ≥ 0.1% (equivalent to quantity setting in OASIS CATALOGIC: ≥0.001 [mol/mol parent]) do neither fulfill the PBT criteria (not PBT) nor the vPvB criteria (not vPvB). The remaining “non-specified constituents” sum up to a typical concentration of approximately 6.0 % (w/w). According to GC analytics, more than 45 peaks contribute to this part of the composition of the registration item. Though it is virtually not possible to identify each single peak and assess the respective substance(s) individually, a generic assessment of the environmentally relevant properties of these ingredients may be applied. Multifunctional acrylates are synthesized from alcohols and acrylic acid. As a consequence, the resulting products – including the “non-specified constituents” – are made of the same, similar chemistry. As shown by the evidence provided above, this chemistry basically is subject to ultimate biotic degradation: in none of the four main constituents, a potential metabolite that may be generated from the degradation of these compounds was identified. Therefore, from a scientific perspective, it is extremely likely that also the degradation of the chemically similar “non-specified constituents” of the registration item will not lead to the formation of a persistent metabolite. The raw materials used as well as the conditions of the reaction chosen during manufacture are targeted to produce 2-{2-[2-(acryloyloxy)-1-methylethoxy]-1-methylethoxy}-1-methylethyl acrylate. Side-products beyond the main constituents discussed above are expected to slightly vary in chain lengths and/or branching, but are not anticipated to significantly differ in terms of structural elements – if at all. Therefore, also these structures are deemed degradable by the same metabolic pathways. Consequently, there is no concern that (part of) the UVCB may persist in the environment.Moreover, the structural related acrylate DPGDA, which differs only in a slightly shorter chain length is readily biodegradable (90 - 100% DOC removal, BASF AG, rep. no.: 02/0368/21/1, 2003). In Analogy to DPGDA it can be expected that TPGDA is ultimately biodegradable under environmental conditions. Therefore, no biodegradation studies in sediment will be provided.