Registration Dossier
Registration Dossier
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EC number: 947-716-8 | CAS number: -
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
Description of key information
BCF = 222 L/kg (fu =1) in RT- S9 system (Rainbow Trout liver S9 subceluular fraction, fu=1assumes all the material is available for biotransformation)
BCF = 216 L/kg (fu =1) in RT- HEP system (Rainbow Trout Hepatocytes, fu=1assumes all the material is available for biotransformation)
Key value for chemical safety assessment
- BCF (aquatic species):
- 222 L/kg ww
Additional information
The BCF of test item was performed using the in vitro metabolism technology with trout liver S9 sub-cellular fractions (RT-S9) and cryopreserved hepatocytes (RT-HEP)in accordance with OECD guideline 319B/A. The test item was incubated with a particular set of incubation conditions that included time, concentration (μM) and protein concentration (S9 fraction) or cell density (cryopreserved hepatocytes) previously determined during preliminary or range finding incubations.The depletion of the parent compound was analyzed using a GC-MS. The metabolic rate was calculated as described in the testing guideline. Thereafter, the resulted metabolic rate and experimental data of the partition coefficient log Pow were given as input parameters into the in vitro to in vivo extrapolation (IVIVE) model. The BCF-values were calculated to be 222 L/kg (fu=1) and 1051.0 L/kg (fu, modeled) in the RT-S9 system and 216 L/kg (fu=1) and 988 L/kg (fu, modeled) in the RT-HEP system, respectively.
Since BCF values obtained from in vitro studies based on fu=1 appear to be the closest to those observed in in vivo tests (Lapczynski at al., 2018; Laue et at al.,2015). The highest value of 222 L/kg was used for the risk assessment and PBT-assessment. According to section 1 of Annex XIII of the REACH regulation (EC) No 1907/2006the test item was considered as neither bioaccumulative (B) nor very bioaccumulative (vB).
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