Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

An acute toxicity test on invertebrates according to OECD TG. No. 202 and an Algae Growth inhibition test according to OECD TG. No. 201 are available. Both the test were conducted according to GLP.

In both the studies Methylic Adduct exerted a toxic effect on the tested organisms. Basing on the available data the most sensitive trophic level seems to be the Algae but due to technical limitations in the performace of the Algae Growth inhibition test, the study only partially provided meaningful information on the toxicity of Methylic Adduct: the ErC50(24h) value was equal to 0.214 mg/L, no reliable chronic effect levels are obtained from that study.

Basing on the Algae ErC50(24h) and considering that the substance is not ready biodegradable, Methylic Adduct fulfills the classification criteria for Aquatic Chronic Cat.1 hazard class according to EU GHS (CLP) criteria.

Additional information

Methylic Adduct is a volatile substance. The acute toxicity test on invertebrates was conducted in completely closed system according to OECD TG. No. 202 and in compliance with GLP. The EC50(48h) for D.magna was observed to be 7.16 mg/L.

Because of the volatile nature of Methylic Adduct, conducting a fully meaningful Algae Growth inhibition test according to OECD TG. No. 201 was observed to be unfeasible. In fact, the Algae Growth inhibition test in completely sealed system was observed to be technically unfeasible while conducted the study in standard (open) conditions only partially provided meaningul information as after 24 hours from the beginning of the exposure Methylic Adduct was no longer detected in the test media prooving that the entire amount of the Methylic Adduct initially dosed evaporated from the water. Despite such limitations the ErC50(24h) value = 0.214 mg/L obtained in that study is considered reliable and relevant in describing the acute toxicity of Methylic Adduct over a 24 hour-exposure, but due to the early disappearance of the substance from the test system no reliable toxicity effect levels for 48 and 72 hour-exposures are available and no reliable chronic effect levels are obtained from that study.

Basing on the above information Methlytlic Adduct is acutely toxic to the aquatic environment.

Considering the Algae ErC50(24h) = 0.214 mg/L and the lack of biodegradability, Methylic Adduct fulfills the classification criteria for Aquatic Chronic Cat.1 hazard class according to EU GHS (CLP) criteria.