Acetic acid, 2-(ethylamino)-2-oxo-, (1R,2S,5R)-5-methyl-2-(1-methylethyl)cyclohexyl ester

Ecotoxicological Summary

Conclusion on classification

Acute and chronic reference values for environmental classification are based on standard test as laid down in Council Regulation (EC) No 440/2008 on “test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)”.

Acute toxicity data for the test item are available for the two trophic levels (daphnia, algae). The lowest EC₅₀for algae growth rate with a 72-h EC₅₀of 7.55 mg/L (based on dissolved test item concentration), observed for the effect in a GLP-conform standard test (EC C.3 / OECD 201) with Pseudokirchneriella subcapitatus (Scheerbaum, 2012). This value is selected as the acute reference value for classification.

The lowest chronic EC₁₀for algae is a 72-h EC₁₀of 3.22 mg/L (based on dissolved test item concentration) for the effect of the test item on growth rate of Pseudokirchneriella subcapitatus (Scheerbaum, 2012). This value was selected as chronic reference value for classification.

Classification according to CLP, i.e. Regulation (EC) No 1272/2008 and 2^ndATP (Regulation (EU) No 286/2011):

Acute (short-term) aquatic hazard:

·        LC₅₀is > 1mg/L

--> No classification for ACUTE AQUATIC HAZARD

Long-term aquatic hazard based on acute and chronic data of the product:

·        EC₁₀ is > 1mg/L

·        readily biodegradable

·        log Pow (2.86) < 4

--> No classification for LONG-TERM AQUATIC HAZARD

Since the substance is not classified in accordance to regulation (EC) 1272/2008 neither an exposure assessment nor a risk characterisation are required in the sense of Regulation (EC) 1907/2006.