Registration Dossier
Registration Dossier
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EC number: 451-060-3 | CAS number: 122886-55-9
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT/vPvB assessment was performed on the constituent of this mono-constituent substance. The identified impurities are structurally sufficiently similar that they will have similar PBT/vPvB properties. The whole substance approach is thus justified.
P/vP: In a ready biodegradation study according to OECD TG 301B, a maximum of 21% biodegradation was observed. Based on this information alone, no definitive conclusion can be reached. The substance is however considered to be potentially vP (and P).
B/vB: At very high log Kow, the linear relationship between log BCF and log Kow is no longer valid and the BCF decreases with increasing log Kow due to limited bioavailability. According to REACH guidance R.11, a (calculated) log Kow of >10 is generally taken as an indicator of reduced bioconcentration. The EPISuite calculated log Kow value for the substance is 9.3 i.e. slightly lower than the cut-off log Kow of 10. Therefore, the following additional information is considered in the assessment of bioaccumulation. The EPISuite calculated BCF values for the substance, based on the log Kow of 9.3, are 266 L/kg (regression-based estimate) and 434 L/kg (Arnot-Gobas model assuming a biotransformation rate of zero). The bioavailability of the substance is assessed to be very low based on the very low water solubility of the substance (<3.03 µg/L), together with its relatively high molecular weight (509 g/mol) and a calculated Dmax average of 2.4 nm (i.e. >1.7 nm). This limited bioavailability is further substantiated by a complete absence of toxicological effects in the entire (eco-)toxicological dataset available for the substance. Based on these arguments, the substance is considered as not B/vB.
T: In acute tests with 3 trophic levels, no effects were observed at the maximum solubility of the test substance in medium. No chronic effects were observed in a study with algae. Furthermore, the substance is not classified as carcinogen, mutagenic or toxic for reproduction (CMR) and there is no other evidence of chronic toxicity (STOT RE). However, as only one chronic study is available (algae) and no information is available on the most sensitive species, no conclusion on T can be reached.
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