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EC number: 907-495-0 | CAS number: 198028-14-7
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
Description of key information
Two experimental studies performed on the registered substance are available on the bioaccumulation. Taken together, they both demonstrates that the substance has no potential for bioaccumulation. The key result from the OECD 305 test on zebrafish is a BCF value of 20.6 is well below the threshold of the B/vB criteria of REACH annex XIII.
Key value for chemical safety assessment
- BCF (aquatic species):
- 20.6 dimensionless
Additional information
In the key study, the bioconcentration test was performed using Zebrafish. In the test, fish were exposed to the concentrations of the test substance with 1 and 10 mg/L under semi-static conditions with 48h renewal. BCF values were measured following 28-day exposure period. The water sample of the test substance was analyzed employing UPLC-PDA. The results show that the BCF value (steady state) of the registered substance is 2.43 ~ 15.9 (at 1.00 mg/L) and 4.34 ~ 20.6 (at 10.0 mg/L).
In this key OECD 305 study, the depuration phase have not been integrated into the protocol even if a plateau were reached after 28 days of exposure. However, calculating an experimental BCF only based on the accumulation phase (uptake) is a worst case approach and the conclusion is in phase with the TG OECD 315 supporting study. Even if the concentration in fish may be influenced by fish growth, this aspect has not been investigated in this study. There might be no huge impact considering that the kinetic bioconcentration factor (BCFK) has not been calculated and taken into account (lipid content were also not considered). See the paragraph 20. of the TG OECD 305. This study can be considered with consideration of the supporting study.
A test to determine the bioaccumulation of the test substance in sediment organism (Lumbriculus variegatus) was performed according to the OECD 315 testing guideline and GLP. Rates of accumulation of [14C] 99422018 into L. variegatus were relatively slow with time to achieve 90% of the steady-state concentration being 23 and 55 days of initial exposure and low steady state bioaccumulation factors (BAFk) between 1.3 and 1.7 (fresh weight basis). Elimination rates were equally slow with elimination half-life values of 7-16 days and elimination of 90% of the total radioactive residue within 23-55 days with the higher value probably reflecting variability at the 1 mg/kg concentration.The calculated BAFs values were 1.17-1.37 (wet weight basis) and 2.78-4.13 (dry weight basis). These BAFs can be considered as very low.
Lipid content over the test period was determined as 2.56% based on weight. The biota-sediment accumulation factor (BSAF) expressed on the basis of lipid content were calculated as 0.34-0.45. The higher BSAF obtained was converted into BCF according to the equilibrium partitioning theory (EqP) (Shea 1988, Di Torro et al. 1991 and Kraaij 2001). The BCF obtained was 4.15 L/kg.
According to the REACH document R11 version 3.0 – June 2017 section R.11.4.1.2.4 p.73, both studies can be considered altogether in a Weight of Evidence (WoE) approach to demonstrate that the registered substance has no potential for bioaccumulation.
No trigger values are available for BSAF in sediment for comparison with the PBT criteria. Shea (1988), Di Torro et al. (1991) and Kraaij (2001) have developed a model (the equilibrium partitioning theory) which assumes that if the pore water and the organis carbon are in equilibrium and if if the distribution over organic carbon and pore water can be described by the following constant:
K= Csed/Cpore water
then the BSAF = BCF/K
The BCF obtained were
| Csed (mg equivalent/kg) | Cpore (mg equivalent/L) | Koc | BSAF | BCF (L/kg) | |
| 1 mg/kg dw | 0.645 | 0.07 | 9.21 | 0.45 | 4.15 |
| 10 mg/kg dw | 7.916 | 2.252 | 3.52 | 0.34 | 1.20 |
The highest BCF (worst case) value is used as key value.
Di Toro, D.M., C.S. Zarba, D.J. Hansen et al. 1991. Technical basis for establishing sediment 21 quality criteria for nonionic organic chemicals using equilibrium partitioning. Environ Toxicol Chem 10:1541-1583.
Shea, D. 1988. Developing national sediment quality criteria. Environ Sci Technol 22: 1256-1261.
Kraaij, R. 2001. Sequestration and bioavailability of hydrophobic chemicals in sediment. Utrecht University. Thesis. 104 pp.
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