Registration Dossier
Registration Dossier
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EC number: 939-946-2 | CAS number: -
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
Description of key information
EC50(72h) = 1.08 mg/L, NOEC = 0.111 mg/L, Chlorella vulgaris Beij., Zhen (2016)
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 1.08 mg/L
- EC10 or NOEC for freshwater algae:
- 0.111 mg/L
Additional information
The screening study from Rudolf (2011) was not considered. There is insufficient detail in the report to assess the reliability of these results.The screening studies' results are not reliable or adequate for the purposes of risk assessment or classification.
The study from Zhen (2016) was designed to determine the toxicity of test substance to algae (Chlorella vulgaris Beij.), according to "The guidelines for the testing of chemicals" (HJ/T 153-2004), with reference to OECD 201, and is considered to be the key study and is assigned reliability rating Klimisch 2. The EC50(72) of test item was 1.08 mg/L and the NOEC 0.111 mg/L.
The key study was not performed under OECD GLP, as it was carried out for registration purposes outside the European Economic Area, and does not meet the requirements of Article 13(4). However, the data is considered to be equivalent by meeting the criteria set out in Annex XI, 1.1.2:
1. The key study test data is adequate for the purposes of classification and risk assessment. Algae are not the most sensitives species and do not drive classification or risk assessment, and the substance is classified as the worst-case for aquatic toxicity (Category 1).
2. The key parameters forseen to be investigated have been adequately and reliably covered. The study design is equivalent to OECD 201, and it was carried out under a national quality assurance scheme.
3. The study exposure period of 72h is that required by the OECD guideline method.
4. Adequate and reliable documentation of the study is available in a full study report.
The data provided for this endpoint is considered to be relevant, adequate, reliable and complete for the purposes of classification and risk assessment.
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