Registration Dossier
Registration Dossier
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EC number: 446-630-3 | CAS number: 181587-01-9
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistence (P) Assessment
The substance is not readily biodegradable in accordance with the definition given in the OECD Guidelines for the Testing of Chemicals. Simulation studies in soil conducted according to GLP and EU Council Directive 91/414/EEC as amended by Commission Directive 95/36/EC, and US EPA Subdivision N Pesticide guideline 162-1, obtained DT50 values in five different soils ranging from 22.4 - 236.4 days (recalculated to 12 °C). 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 vP/P.
Therefore, the substance does meet the P criterion and is considered as persistant (P) or very persistant (vP).
Bioaccumulation assessment
Results of a study reveal that ethiprole does not show significant accumulation in aquatic organisms. Due to rapid depuration, the potential for biomagnification through the food chain is low as indicated by a study according to OECD 305 B and GLP. The depuration half-life of the substance in fish ranged from 31 to 35.5 h and its bioconcentration factor (BCF) was found to range from 8.92 to 10.24. Thus, the substance has a low potential for bioaccumulation in fish. The log Kow of the substance with a value of 2.9 is below 4.5.
The available information indicates that the substance has a very low potential for bioconcentration and will not accumulate in any significant levels in aquatic organisms.
Therefore, the substance does not meet the B criterion.
Toxicity assessment
From the ecotoxicity perspective the toxicity criterion is met for the substance with a lowest NOEC of 0.01 mg/L (long term fish) being at the ecologically relevant NOEC triggers of 0.01 mg/L.
The substance is classified for specific target organ toxicity after repeated exposure (STOT RE 2) based on the effects on liver and thyroid gland in a sub-chronic toxicity study with rats.
Therefore, the substance is T.
Summary and overall conclusions on PBT or vPvB properties
Overall conclusion:
Based on the assessment described in the subsections above the submission substance is not a PBT / vPvB substance.
Justification:
According to Annex XIII of the REACH Regulation (EC) No 1907/2006, a PBT substance has to meet all three of the criteria for persistence, bioaccumulation and toxicity, as listed in part 1 of Annex XIII, and a vPvB substance has to meet all criteria for persistence and bioaccumulation, as listed in part 2 of Annex XIII. Based on the relevant data provided and discussed, the substance is not identified as PBT or as a vPvB substance.
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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