Registration Dossier
Registration Dossier
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EC number: 816-455-0 | CAS number: 960253-23-0
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistency: Not P/vP
Scentaurus Clean has been demonstrated to be readily biodegradable in an OECD 301F screening study and, therefore, is not persistent.
Bioaccumulation: No firm conclusion can be reached based on the available data
Although Scentaurus Clean has a LogPow of between 5.3 and 6.6 (LogPow of 5.9 for the major component) which is > the 4.5 screening threshold, there is no In vivo Bioconcentration study available for this substance to demonstrate that it is a Bioaccumulative or a Not Bioaccumulative substance.
Bioaccumulation in aquatic species is a requirement of the Annex IX of REACH regulation corresponding to a registration of 100-1000 t/y tonnage band whereas here we are registering the substance for 10-100 t/y tonnage band (corresponding to Annex VIII of REACH regulation).
An OECD 319B In vitro metabolism study has been performed on Scentaurus Clean to assess the In vitro intrinsic clearance rate of Scentaurus Clean when exposed to Rainbow Trout fish liver S9 fractions. The study demonstrated a moderate rate of metabolic turnover yielding extrapolated BCF values of < 2000 L/kg (wet wt.) following application of a recognised IVIVE model. This result suggests that the bioaccumulation potential of Scentaurus Clean in aquatic species is low (IVIVE extrapolated BCF = 308 L/kg (wet wt.)).
Toxicity: No Hazard Identified
In acute aquatic toxicity studies performed, the EC/LC50 values determined were greater than the water saturation concentration for the substance. In the only Chronic aquatic toxicity end-point available, for algae, no inhibition of growth rate was observed at the saturation concentration of the test item.
The substance does not have an environmental classification since the aquatic toxicity studies performed demonstrated that the EC50 values were greater than the highest test concentration tested, which was at or in excess of the water saturation concentration.
The substance is not classified as carcinogenic, mutagenic, toxic for reproduction, toxic for a specific target organ after repeated exposure. There is one long-term toxicity study available (Algal Inhibition) to demonstrate that the substance is not toxic at the water saturation concentration. Other long-term aquatic toxicity studies correspond to requirements of the Annex IX of REACH regulation corresponding to a registration of 100-1000 t/y tonnage band whereas here we are registering the chemical for 10-100 t/y tonnage band (Annex VIII of REACH regulation) and safe use can be demonstrated.
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