Registration Dossier
Registration Dossier
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EC number: 203-628-5 | CAS number: 108-90-7
Endpoint summary
Administrative data
Description of key information
Experimental studies and HA-QSAR predictions are available to assess the aquatic toxicity of the registered substance in acute and chronic exposure.
Acute toxicity to algae (Desmodesmus subspicatus) was determined according to OECD TG 201. During 72 hours exposure the ErC50 was measured at 11.4 mg/L. Acute toxicity data on aquatic invertebrates and fish were not considered as reliable and they have been waived based on available chronic data.
Reliable data on aquatic effects of the substance are available on three trophic levels (fish, daphnia and algae) for chronic toxicity.
The most sensitive toxicity was observed for chronic toxicity to aquatic invertebrates with an NOEC (21d) of 2.5 mg/L. Regarding chronic toxicity to fish, a 32d-EC10 was determined to be 3.2 mg/L (95% CI: 2.5-4.1 mg/L). The Chronic toxicity of the substance to algae (Desmodesmus subspicatus) was conduted according to OECD Guideline 201 with an ErC10 (72h) measured of 5.8 mg/L.
The effect of the substance towards the growth of activated sludge was investigated according to OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test). The EC50 obtained was 140 mg/L (nominal).
Additional information
According to the criteria of Annex I of the regulation (EC) No 1272/2008 (CLP), the registered substance should not be classified for environment based on available and reliable data in the current dossier (update 2022):
- The substance is not readily biodegradable,
- Lowest acute Toxicity data is obtained with algae: 72h-ErC50=11.4 mg/L
- Lowest chronic toxicity data is obtained with aquatic invertebrates: 21d-NOEC= 2.5 mg/L
The registered substance has an harmonised classification in Annex VI to CLP regulation (1272/2008) as Aquatic Chronic toxicity 2. Based on data available in dossier before the update of 2022, the following chronic data was obtained: 28d-NOEC (ELS)= 4.8 mg/L, 16d-NOEC = 0.32 mg/L (Daphnia magna), 72h-EC10 = 5.8 mg/L (Desmodesmus subspicatus, algae). As daphnids was the most sensitive aquatic organisms, the classification as Aquatic Chronic 2 is based on the chronic study results obtained in Daphnia magna. Chronic study on daphnids (Bobra, 1985) used for classification can not be considered as reliable as this study does not follow a real OECD guideline, it is not GLP and no analytical monitoring was performed.
For the update of the dossier in 2022, all data have been reassessed and new chronic data have been provided to improve the quality of the dossier. Based on reliable data in the dossier, the substance is not classified for acute and chronic toxicity.
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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