Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.002 mg/L
Assessment factor:
5
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
0 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
no exposure of sediment expected

Sediment (marine water)

Hazard assessment conclusion:
no exposure of sediment expected

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no exposure of soil expected

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Ziegler Bottoms are characterized as comprising of two primary constituents; icosan-1-ol and docosan-1-ol. Together these constituents represent a structural class of components (alcohols) that constitute approximately 82% of the composition of Ziegler Bottoms. In accordance with the OECD SIDS Report for Long Chain Alcohols (2006) the measured aquatic invertebrate long-term toxicity data for ¿C15 (21-day Daphnia NOECrepro = 0.0078 mg/l) is used as the basis for deriving the aquatic PNEC for Ziegler Bottoms. It is also concluded in the SIDS Report that "for substances of chain length greater than C15, no long-term effects would be expected". The RCRs derived using this approach are only indicative limits, not true values, as they are above the limit of solubility for the constituents of the Ziegler Bottoms. The freshwater and marine PNECs for Ziegler Bottoms are conservative, but indicative, values. There was a paucity of toxicity data for sediment and soil organisms, but as the substance is unlikely to be directly or indirectly applied to these compartments and is readily biodegradable and is low in toxicity to aquatic organisms and mammals, the PNECs for sediment and soil are waived. However, values are presented using the equilibrium partitioning method, for completeness. Experimental evidence for mammals indicates that Ziegler Bottoms is unlikely to present a hazard to mammals and birds and a PNECoral is waived.

Conclusion on classification

The test substance Ziegler Bottoms, characterised as comprising of two primary constituents; icosan-1-ol and docosan-1-ol, is of low acute toxicity to aquatic organisms with most LC50¿s for aquatic organisms being reported as greater than 100 or 1000 mg/L. Algal studies, using QSAR, report EC50 of >0.001 and a short-term fish study (Wetton, 1996) has a LC50 of greater than 0.4 mg//L. However, these toxicity values are greater than the limit of solubility (predicted value of 0.0011 mg/L) and Ziegler Bottoms are not considered to be toxic to aquatic organisms above their limit of solubility. As a consequence, these findings do not warrant classification of Ziegler Bottoms under the new Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) do not warrant classification under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations (DSD/DPD).