Registration Dossier
Registration Dossier
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EC number: 217-057-4 | CAS number: 1732-08-7
Endpoint summary
Administrative data
Description of key information
The key ecotoxicity results for the substance dimethyl pimelate are as follow:
- Aquatic Invertebrates: 48-h EC50 was 73 mg test material/L (lowest acute E(L)C50 value)
- Aquatic algae: 72-h ErC50 was 207 mg test material/L
Based on these results, the lowest acute E(L)C50 is higher than 1 mg/L.
Therefore, the substance would not be classified as acute 1 to aquatic organisms in accordance with the classification of the CLP.
Additional information
Acute toxicities to aquatic invertebrates and algae have been investigated using QSAR models which have been validated to be compliant with the OECD recommendations for QSAR modeling (OECD, 2004). These QSARs allow to predict the endpoint value which would be expected when testing the substance under experimental conditions in a laboratory following OECD 201 and 202 guidelines. To assess the acute toxicity of the substance to daphnids, the criterion predicted was the EC50 (Median Effective Concentration), a statistically derived concentration which is expected to cause immobility in 50% of test animals within a period of 48 hours. To determine the toxicity to algae, the criterion predicted was the ErC50 (Median Effective Concentration for specific growth rate), a statistically derived concentration which is expected to cause 50% inhibition of intrinsic rate of growth of the test system within a period of 72 hours.
Short-term toxicity to fish was not provided in the dataset since the tonnage band (1 -10 tonnes/year) does not require that endpoint.
CLP Classification proposal
It is proposed to compare submission substance dataset to CLP environmental criteria laid down in CLP Regulation (including 2nd Adaptation to Technical Progress, Com Reg No 286/2011).
Acute aquatic hazard: not classified. Reasoning: lowest E(L)C50 higher than 1 mg/L.
Chronic aquatic hazard: not classified. Reasoning: adequate chronic toxicity data are not available, lowest acute E(L)C50 value is between 10 and 100 mg/L, rapidly degradable substance with Log Kow < 4.
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