Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.025 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.35 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.003 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 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

Air

Hazard assessment conclusion:
no hazard identified

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

Alchisor CAL 145 is characterized as alkenes C13-14 hydroformylation products and a read-across approach has been taken to relate data from the chemically-similar Alchisor CAL 123 substance to Alchisor CAL 145 in order to derive reliable and conservative PNECs.  The PNECfreshwater is based on short-term data for fish and invertebrates and one long-term result for algae with an AF of 1000 applied. The same data, but with an AF of 10000, was applied to derive the PNECmarine. 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. Experimental evidence for mammals indicates that Alchisor CAL 145 is unlikely to present a hazard to mammals and birds, based on read-across from Alchisor CAL 123, and a PNECoral is waived.

Conclusion on classification

The test substance, alkenes C13-14 hydroformylation products, does not warrant environmental classification. It is of low acute toxicity to aquatic organisms with EL50s ranging from 35 to >100 mg/L, however, the substance does not qualify for Chronic Category 3 classification because the substance is rapidly degradable and the single chronic value (NOEL for algae of 25 mg/L) is >1 mg/L. These findings do not warrant classification of Alchisor CAL 145 under the new Regulation (EC) 1272/2008 on classification, labeling 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).