Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Hazard for air
Hazard for terrestrial organisms
Hazard for predators
Additional information
Aquatic toxicity:
Three acute experimental studies and two QSAR predictions are available to assess the aquatic toxicity of the registered substance.
The two experimental studies, performed on aquatic invertebrates Daphnia magna and the algae Desmodesmus subspicatus respectively, were not considered reliable due to major methodological deficiencies and/or insufficient information provided on the methodology used. Therefore, QSAR predictions for these endpoints were performed using iSafeRat® High-Accuracy-Quantitative Structure-Activity Relationship (KREATIS, 2020). Toxic effects were predicted on aquatic invertebrates and algae in acute conditions. For daphnid, the 48h-EC50 value was predicted at 0.76 mg/L. For algae, the 72h-ErC50 value was predicted at 0.20 mg/L.
Finally, the experimental study performed on fish Danio rerio was considered reliable (with restrictions). The 96h-LC50 value was determined at 5.2 mg/L, based on geometric mean measured concentrations.
Environmental fate and pathways:
According to the key ready biodegradability test, the registered substance is readily biodegradable (86.56% biodegradation after 21 days, satisfied the 10-day window validation criterion) and therefore is not persistent in the environment. In addition, with a log Kow value determined experimentally at 4.18, the registered substance is considered to be bioaccumulative according to CLP (>4.0) but not bioaccumulative according to 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 < 1 mg/L, more precisely between 0.1 and 1 mg/L (M-factor = 1);
- no chronic value;
- rapidly biodegradable;
- no experimental BCF data;
- log Kow > 4.0
Based on the above data and according to the CLP Regulation 1272/2008/EC & GHS regulation, the registered substance is classified as Aquatic Acute 1 and Aquatic Chronic 1 for the environment, with a M-factor = 1 (based on acute toxicity values).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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