Registration Dossier
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EC number: 926-564-6 | CAS number: 1179964-22-7
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
Description of key information
As requested by ECHA in a Decision an OECD 305 study was conducted as dietary exposure study. The study was GLP documented. Rainbow trout (O. mykiss) were used as test organisms. Since no bioaccumulation of the test item was observed and in order to be sure not to miss a late bioaccumulation event the uptake phase lasted 36 days. However, no bioaccumulation was determined for none of the 5 constituents. Most measurements were < LOD and some data points < LOQ. Since no bioaccumulation had occurred it was decided to skip the depuration phase and to terminate the study.
In conclusion, the OECD 305 dietary exposure study revealed that none of the 5 UVCB constituents with log Kow > 4.5 accumulated in fish and thus, the test substance is not bioaccumulative.
In addition, the bioaccumulation behaviour of this substance was assessed using QSAR estimations of reaction educts as well as reaction products.
Both give that the BCF can be expected in the range of 3.16 – 379, supporting the classification as none bioaccumulative.
Key value for chemical safety assessment
- BCF (aquatic species):
- 379 dimensionless
Additional information
No bioaccumulation was observed in a GLP and OECD 305 Guideline compliant fish bioaccumulation study on performed on request of ECHA.
In addition, bioaccumulation was evaluated based on QSAR estimation of reaction educts (propylene oxyde, n-butyl-glycidyl ether) and an experimental study of tetrabrom-bisphenol A, as well as with reaction products (smallest and largest reaction product molecule).
---Educts: QSAR estimation showed negligible bioaccumulation potential BCF = 3.16 for propylene oxyde, n-butyl-glycidyl ether and a low experimental BCF <= 170 for tetrabrom-bisphenol A .
--- Products: The smallest and the largest reaction product molecule were used for QSAR estimation and showed a low BCF = 379.
QSAR estimations and the experimental study are assumed to be appropriate for risk assessment as well as classification purposes. The highest BCF = 379 was taken forward to the risk assessment. Based on this highest BCF the substance does clearly not fulfill the B and vB criterion of the PBT assessment, in particular, as the substance also does not fulfill the T criterion. It is very unlikely that an experimental study would provide relevant new information that is significantly different from the result described above and that risk assessment or classification would have to be updated. Therefore, and in order to avoid unnecessary animal testing a study on the bioaccumulation behavior of the substance is not justified and no study proposal is submitted.
The available data are sufficient for assessment.
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