3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-4-en-2-ol

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0.002 mg/L

Assessment factor:

1 000

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

0.019 mg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0 mg/L

Assessment factor:

10 000

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

1 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

0.067 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

0.007 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:

PNEC soil

PNEC value:

0.053 mg/kg soil dw

Extrapolation method:

equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

PNEC oral

PNEC value:

33.3 mg/kg food

Assessment factor:

300

Additional information

Short-term aquatic toxicity data is available for each of the three freshwater trophic levels (fish, daphnia and algae). The observed L(E)C50 values were:

96-hour LC50 for freshwater fish fathead minnow (Pimephales promelas) = 2.3mg/l

48-hour EC50 for freshwater invertebrate daphnia magna = 1.9mg/l

72-hour growth rate EC50 (ECr50) for freshwater algae Pseudokirchneriella subcapitata = 24mg/l

The toxicity to STP microorganisms has been assessed using the activated sludge respiration test. The observed 3-hour EC50 and EC10 were 52.5mg/l and 10.0mg/l respectively.

Long-term toxicity testing is not available for freshwater fish or invertebrates. In accordance with Annex IX of Regulation (EC) No 1907/2006, long-term toxicity testing is not considered to be necessary as the Chemical Safety Assessment (CSA) demonstrates safe use of Ebanol.

No data are available on the toxicity of Ebanol to terrestrial organisms. In accordance with column 2 in Annex IX of REACH (Regulation 1907/2006/EC), studies on terrestrial organisms do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely. In the ECHA "Guidance on information requirements and chemical safety assessment - Chapter R.7c: Endpoint specific guidance" this is further specified. In the case of readily biodegradable substances which are not directly applied to the soil it is generally assumed that the substance will not enter the terrestrial environment and as such no testing of soil organisms is required. As Ebanol is readily biodegradable and is not directly applied to soil, studies on the terrestrial organisms are waived.

In the absence of toxicity data for soil organisms, the PNECsoil has been calculated from the PNECwater using the Equilibrium Partitioning Method (EPM) and incorporated into the CSA to assess indirect exposure to soil organisms. The results of the chemical safety assessment according to Annex I indicate that there is no need to investigate further the effects of the Ebanol on soil organisms.

Conclusion on classification

Environmental classification and labelling of a substance is generally based on data from short-term aquatic toxicity results, the ready biodegradability of the substance and the measured octanol/water partition coefficient. Available adequate chronic toxicity data is also relevant for the assessment of long-term aquatic hazards (Regulation 286/2011/EC).

There is no long-term aquatic toxicity data available for Ebanol. The lowest short-term L(E)C50 was for daphnia with a 48-hour EC50 value of 1.9mg/l. Ebanol is readily biodegradable and has a log Kow of 4.2.

Based on the above data, Ebanol is classified as R51/53 according to Directive 67/548/EEC (DSD) and Aquatic Chronic 2 (H411) according to Regulation 1272/2008/EC & adaptation 286/2011/EC (CLP).