Registration Dossier
Registration Dossier
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EC number: 233-226-5 | CAS number: 10094-45-8
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistency assessment
Studies on the ready biodegradability of (Z)-N-octadecyldocos-13-enamide (CAS No. 10094-45-8) are not available. Therefore data of the analogue substance N-octadecylstearamide (CAS No. 13276-08-9) were used as read across. The ready biodegradability of N-octadecylstearamide was investigated in five tests. The substance is only partly biodegradable in water according to a OECD guideline studies but not readily biodegradable.
Moreover, biodegradability properties of (Z)-N-octadecyldocos-13-enamide have been investigated by performing simulation tests as followed:
- water/sediment simulation testing (OECD 308, at 12 °C) and
- soil simulation testing (OECD 307, at 12 °C)
Both studies indicate that there is very weak biodegradation in both soil and water/sediment system with a half-life of 6630 days in the water sediment/system and there was no significant decline in the four soils under aerobic conditions. Thus, the substance fulfills the P and vP criteria.
Bioaccumulation assessment
Evidence of non-B / non-vB properties
Criteria based on Annex XIII of REACH
-Not B / vB based on BCF <= 2000 L/kg: Arnot-Gobas BCF & BAF Methods (assuming a biotransformation rate of zero):
Estimated Log BCF (upper trophic) = -0.049 (BCF = 0.893 L/kg wet-wt)
Estimated Log BAF (upper trophic) = -0.038 (BAF = 0.9168 L/kg wet-wt)
Other evidence of non-B / non-vB properties
The substance is highly unsoluble in water and has a high adsorption potential. Thus, a significant uptake of the substance by aquatic organisms through the water phase is not expected. Considering this, one can assume that the availability of the substance in the aquatic environment is generally very low. Nonetheless, for the very same reasons, the dietary route would be more appropriate for testing.
Therefore, a biomagnification of the substance through the food chain has been investigated via an OECD 305 (dietary exposure). The study leads to the conclusion that a rapid elimination of the substance from the fish’s tissue occurs quickly (growth corrected half-life of 0.46 days) and the normalized biomagnification factor was estimated to be <0.1. Therefore it is not expected that the substance accumulates in the food chain.
Conclusion on B / vB properties: not B/vB
Toxicity assessment
All available aquatic studies do not indicate toxicity. In addition, the substance is not classified according to Regulation (EC) No 1272/2008 for any human health hazard. Thus, the criteria are not met and the substance is not classified as "T".
In conclusion, the substance is not PBT / vPvB.
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