Registration Dossier
Registration Dossier
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EC number: 428-040-8 | CAS number: 138261-41-3
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).
Persistence (P) Assessment
Imidacloprid is not readily biodegradable according to OECD criteria. Simulation studies conducted in surface water determined a half-life of 10.7 d (re-calculated to 12°C) in a non-sterile, light exposed test system; the DT50 in a non-sterile non-light exposed system was 842.8 d at 12°C. Whereas a half-life of 1271 d at 12°C was determined a sterile system non-light exposed system. A mineralisation rate of 0.2 – 26.2% based on produced CO2 was recorded. In a sediment simulation study conducted according to EPA Subdivision N Pesticide Guideline 162-4 the determined half-life range was 76 to 413 days (re-calculated to 12 °C). The overall mineralisation rate based on CO2 was <2%.
The degradation half-life of Imidacloprid in soil was investigated in studies EPA Pesticide Assessment Guidelines, Subdivision N: § 162-1. The determined half-life was 526.5 d (re-calculated to 12 °C). A mineralisation rate of 6.3 -6.5% was recorded.
Therefore, in a worst-case approach, the substance meets the vP criterion (T1/2 > 180 days in soil) based on REACH legislation Annex XIII in soil. Hence, the substance is assessed as P/vP.
Bioaccumulation (B) Assessment
The substance has a low potential for bioaccumulation based on a log Kow <=3 (Log Kow: 0.7; OECD 117).
Therefore, the substance does not meet the screening criterion for aquatic organisms and is assessed as not B/vB.
Toxicity (T) Assessment
The available acute and chronic effect concentrations are > 0.01 mg/L. Imidacloprid is not classified according to the consolidated version of Regulation (EC) No 1272/2008 as carcinogen, germ cell mutagenic or toxic for reproduction. Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the test substance is not considered to meet the T criterion.
Overall conclusion:
Based on the assessment described above the substance is not PBT.
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