Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Environmental fate & pathways

Bioaccumulation: aquatic / sediment

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
bioaccumulation in aquatic species: fish
Study period:
Biodegradation in water: sediment simulation testing
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance has a low potential to cross biological membranes
Principles of method if other than guideline:
QSAR calculation by US EPA On-Line EPI Suite™ v4.11 model BCFBAF v3.01 (attached QSAR Prediction Reporting Format, QPRF)
GLP compliance:
no
Key result
Type:
BCF
Value:
>= 7.7 - <= 23.3 L/kg
Remarks on result:
other: QSAR estimation based on structures present in the UVCB substance
Validity criteria fulfilled:
not applicable
Remarks:
QSAR estimation
Conclusions:
BCF value range is estimated to be >=7.7 - <=23.3 L/kg
Executive summary:

The substance is estimated to not be bioacumullative based on the calculation conducted with US EPA On-Line EPI Suite™ v4.11 model BCFBAF v3.01.
Based on the evaluation of the constituents of the UVCB substance, the BCF value range is estimated to be BCF >=7.7 - <=23.3 L/kg.

Description of key information

A key study evaluating the substances octanol-water partition coefficient using the HPLC method concluded that the substance has a log kow of 3.56. Resulting in the substance screening as being not potentially Bioaccumulative/very Bioaccumulative (≤ 4.5). The substance is estimated to not be bioaccumulative based on the calculation conducted with US EPA On-Line EPI Suite™ v4.11 model BCFBAF v3.01. Based on the evaluation of the constituents of the UVCB substance, the BCF value range is estimated to be BCF >=7.7 - <=23.3 L/kg.

Additional information derived from the acute toxicity studies, as well as a 28-day repeated oral dose and reproductive/developmental toxicity studies indicate of lack of toxicologically relevant effects associated with the test substance when administered orally. Therefore insinuating that the bioavailability should be considered to be low via the oral route for animals.         

Based on the available information, the substance cannot be adequately defined as bioaccumulative. It should be noted that a further study under the requirements of the Japanese METI scheme is currently in progress in Japan. The dossier will be spontaneously updated with these results upon completion.

Key value for chemical safety assessment

BCF (aquatic species):
23.3 L/kg ww

Additional information