Registration Dossier
Registration Dossier
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EC number: 701-427-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Additional information
Three studies on short term aquatic toxicity are available for Modified Small Vinyl Ester.
All studies are conducted according to GLP and are in compliance with the validity criteria mentioned in the test guidelines:
OECD 203: Fish acute toxicity test
OECD 202: Daphnia acute toxicity test
OECD 201: Algae acute toxicity test
Study results:
Modified Small Vinyl Ester induced no lethal effects in carp at the water solubility limit. Hence, the 96h-LC50 was above the water solubility limit.
Modified Small Vinyl Ester induced not more than 30% immobility in Daphnia magna at the water solubility limit. Hence, the 48h-EC50 was above the water solubility limit.
Modified Small Vinyl Ester induced not more than 22% growth rate inhibition in algae Pseudokirchneriella subcapitata at the water solubility limit. Hence, the 72h-ERC50 was above the water solubility limit. The NOEC based on growth rate is 10 mg/L. The concentration of bisGMA at 10 mg/L Modified Small Vinyl Ester is above its’ water solubility limit of 0.42 mg/L. The analytical TWA concentration of Monomaleic acid of bisGMA at a nominal Modified Small Vinyl Ester concentration of 10 mg/L is 1.2 mg/L (18% of 6.7 mg/L which is the TWA concentration Modified Small Vinyl Ester at 10 mg/L).
The water solubility limit of Modified Small Vinyl Ester is based on both bisGMA (0.42 mg/l) and the monomaleic adduct of bisGMA (37.6 mg/l), weighted average is 8 mg/l.
Long-term toxicity testing is waived in accordance with REACH Annex IX, section 9.4 column 2, because Modified Small Vinyl Ester is a slightly water soluble, highly viscous prepolymer, which is placed on the market as an approximately 50% solution in an reactive diluent for industrial use only. When exposed to light, Modified Small Vinyl Ester will polymerise and bind all Modified Small Vinyl Ester and most of the reactive diluent covalently in an extremely stable and highly water insoluble polymer with very low bioavailability in water. Modified Small Vinyl Ester is unlikely to reach aqueous environment, thus direct and indirect exposure of aqueous species is unlikely. See the CSA for further details.
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