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EC number: 926-564-6
CAS number: 1179964-22-7
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
Both give that the BCF can be expected in the range of 3.16 – 379,
supporting the classification as none bioaccumulative.
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
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 =
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
The available data are sufficient for assessment.
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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