Registration Dossier
Registration Dossier
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EC number: 202-196-5 | CAS number: 92-84-2
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
- BCF (aquatic species):
- 660 L/kg ww
Additional information
No bioaccumulation is expected as the log Kow is 3.78 and the log Koc is 3.76. The actual ECHA Guidance as well as the most recent ECETOC-Report state, that a Log Kow < 4.5 is a definitive indicator for non B/vB properties in aquatic systems. According to the ECHA Guidance the uptake of an organic substance is driven by its hydrophobicity. For organic substances with a log Kow value below 4.5 it is assumed that the affinity for the lipids of an organism is insufficient to exceed the B criterion, i.e. a BCF value of 2000 L/kg.
This is supported by the Japanese bioaccumulation study cited in this dossier, in which the applicants come to the conclusion, that phenothiazine is determinated to be non or not highly bioaccumulative. Additional support comes from calculations using the EPI-Suite 4.11 software.
According to ECHA Guidance all available relevant information (testing data and non-testing information) should be taken into account, incl. toxicokinetic studies with mammalians.
There are several studies on the metabolism and the toxicokinetics of phenothiazine in mammals and man, e.g. the study cited in section 7.1.1. According to this study, in man phenothiazine and/or it´s metabolites are excreted totally via faeces and urine within 5 days. This is supported by an older review of the same author (Mitchell et. al., Drug Metabolism Reviews, 13(2), 319-343 (1982)). In this review it is shown, that phenothiazine and/or its metabolites are excreted via the urine and faeces, even so, depending on the species, it may take days or week for nearly total elimination. From this studies it can be concluded, that bioaccumulation in terrestrial animals can be considered to be not relevant.
Therefore a further vertebrate study on the bioaccumulation potential of the substance can not be recommended.
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.
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