Registration Dossier
Registration Dossier
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EC number: 939-946-2 | CAS number: -
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
EC50(48h) = 0.16 mg/L (0.14 - 0.19 mg/L), Daphnia magna, semi-static, Zhen (2016)
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 0.16 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 acute toxicity of test substance to Daphnia magna under semi-static test conditions, according to "The guidelines for the testing of chemicals" (HJ/T 153-2004), with reference to OECD 202 (2004), and is considered to be the key study, with reliability assigned Klimisch 2. The 48 h-EC50 of test item was 0.16 mg/L (0.14 - 0.19 mg/L, based on the measured concentration).
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. The results of the study determine that aquatic invertebrates are the most sensitive species, and result in the worst-case acute aquatic toxicity classification (Category 1).
2. The key parameters forseen to be investigated have been adequately and reliably covered. The study design is equivalent to OECD 202, and it was carried out under a national quality assurance scheme.
3. The study exposure period of 48h 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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