Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
no exposure of sediment expected

Sediment (marine water)

Hazard assessment conclusion:
no exposure of sediment expected

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Modified Small Vinyl Ester is a highly viscous prepolymer, which is placed on the market for industrial use only as an approximately 50% solution in a reactive diluent. Modified Small Vinyl Ester solutions are used under controlled conditions to ensure safe use and to avoid release of primarily the reactive diluent to the environment. In case of incidental release to the environment, when exposed to light, Modified Small Vinyl Ester will polymerise to an extremely stable polymer binding all Modified Small Vinyl Ester covalently in the polymer matrix that is highly insoluble in water. The polymer matrix has very low bioavailability to organisms in water. Direct and indirect exposure of water is assessed to be negligible and long-term effects in aqueous species are judged to be unlikely.

Conclusion on classification

Modified Small Vinyl Ester is not classified for the environment. For GHS, the Safety Net Classification (Chronic Category 4) was considered not to be applicable. According to CLP, no safety net classification is required if other scientific evidence exists showing classification to be unnecessary. Such evidence includes chronic toxicity NOECs > water solubility or > 1 mg/L. The only chronic data available is the algae test. In this test, 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 of Modified Small Vinyl Ester at 10 mg/L) This is above 1 mg/L. Therefore it is concluded that no Chronic Category 4 classification is required.