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:
PNEC soil
PNEC value:
46.69 mg/kg soil dw
Assessment factor:
10
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The toxicity of Alchisor CAL 123, characterized as alkenes, C11-12, hydroformylation products, distillation residues, has been evaluated for this dossier. Study data for Alchisor CAL 123, where available, has been evaluated and considered for assessment. Reliable data was available for short-term toxicity to invertebrates, short-term toxicity to fish, toxicity to algae, and toxicity to microorganisms. No reliable long-term data for fish or invertebrates were available.  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 organisms, but as the substance is unlikely to be directly or indirectly applied to this compartment and is readily biodegradable and is low in toxicity to aquatic organisms and mammals, the PNECs for sediment are waived.

In response to an ECHA compliance check, the registrant sponsored terrestrial toxicity studies of the registered substance including the following: earthworm reproduction test (OECD 222) for long-term toxicity to terrestrial invertebrates; plant seedling emergence and seedling growth (OECD 208) to address long-term toxicity to plants; nitrogen (OECD 216) and carbon (OECD 217) transformation by soil microbes. The lowest toxicity value yielded by the studies was the EC10 value of 466.87 mg/kg for the inhibition of microbial nitrate formation after 28 days. Since multiple long-term toxicity values were generated from the studies, an assessment factor of 10 (ECHA 2008) was used to derive a PNECsoil of 46.69 mg/kg.  

Experimental evidence for mammals indicates that Alchisor CAL 123 is unlikely to present a hazard to mammals and birds and a PNECoral is waived.

Conclusion on classification

The test substance, alkenes, C11-12, hydroformylation products, distillation residues 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 alkenes, C11-12, hydroformylation products, distillation. residues 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).