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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Link to relevant study record(s)

Description of key information

The substance is considered to be easily absorbed, metabolised and eliminated based on the reversible liver and kidney enlargement without histopathology correlates upon subacute oral exposure. This is consistent with the physico-chemical data that shows moderate water solubility and susceptability to acid-catalysed hydrolysis. The substance is considered to be non bioaccumulative.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

The physicochemistry of the substance and its molecular size impose that it will be readily absorbed through the gastro-intestinal tract. This is consistent with the adaptive liver enlargement observed in the subacute and subchronic oral toxicity study. Dermal absorption is also expected to be significant. Inhalative exposure to vapours is not of relevance as the substance has a very low vapour pressure (6.5×10–5Pa at 25°C), but upon exposure to contaminated aerosol particles it will be readily absorbed through respiratory tract. Upon absorption the substance will be rapidly distributed and excreted effectively.

Considering the adaptive liver enlargement observed in the repeated dose toxicity studies, the substance or one of the major components is likely to be subject to hepatic metabolism. This would be consistent with the influence of Arochlor-1254 induced rat liver S9 in the in-vitro clastogenicity study. Involvement of human CYP 1A2 was described for a substance of similar structure, and the analogue rat enzyme is highly inducible upon Arochlor-1254 treatment. Metabolism data is available for a structural analogue supporting the overall assessment of absence of bioaccumulation potential.