3-ETHYL-5,5-DIMETHYL-GAMMA BUTYROLACTONE

Ecotoxicological Summary

Additional information

Two acute experimental studies and two QSAR predictions are available to assess the aquatic toxicity of the registered substance.

For aquatic invertebrates, the experimental study, performed on Daphnia magna, was not considered reliable due to major methodological deficiencies. Therefore, a QSAR prediction for this endpoint was performed using iSafeRat® High-Accuracy-Quantitative Structure-Activity Relationship (KREATIS, 2020a) and the 48h-EC50 value, used as key data, was predicted at 88 mg/L.

For algae, the experimental study, performed on Desmodesmus subspicatus, was considered reliable. In this study, the 72h-ErC50 value based on growth rate was greater than 100 mg/L, the limit test concentration. However, in order to obtain a quantitative toxicity value, a QSAR prediction was performed using iSafeRat® High-Accuracy-Quantitative Structure-Activity Relationship (KREATIS, 2020b). The 72h-ErC50 value, used as key data, was predicted at 130 mg/L.

 

The registered substance is not readily biodegradable and therefore, in the absence of other studies (e.g. readily/enhanced/simulation biodegradability tests), is considered potentially persistent (P) or very persistent (vP) in the environment.

However, with an experimental log Kow value at 1.20, the registered substance is not considered to be bioaccumulative according to CLP (< 4.0) and PBT criteria (< 4.5).

Conclusion on classification

No existing harmonised classification in CLP Regulation Annex VI.

Environmental classification and labelling of a substance is based on data from short-term aquatic toxicity results, and long-term aquatic toxcity results if available, the ready biodegradability of the substance and an experimentally determined BCF (or if absent the measured octanol/water partition coefficient).

 

Data available :

- lowest E(L)C50 value at 88 mg/L;

- no EC10/NOEC value;

- not rapidly biodegradable;

- no experimental BCF data;

- log Kow < 4.0

 

Short-term aquatic toxicity data is available for two trophic levels (daphnia and algae). Since EC50 values are > 1 mg/L, the substance is not classified for short-term hazards to the aquatic environment.

Chronic aquatic toxicity data is not available. Therefore, the long-term hazard has been assessed based on two types of information: the acute aquatic toxicity data (lowest value for daphnia with a 48 hr EC50 at 88 mg/L, so > 10 and < 100 mg/L) and environmental fate data (log Kow < 4.0 but not rapidly biodegradable), which results in a Chronic 3 classification.

Thus, based on the above data and according to the CLP Regulation 1272/2008/EC & adaptation, the registered substance is classified as Aquatic Chronic 3 (H412) for the environment.

Based on the above data and according to the GHS Regulation, the registered substance is classified as Aquatic Acute 3 and Aquatic Chronic 3  for the environment.