Dodecanal

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0.004 mg/L

Assessment factor:

100

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

0.035 mg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0 mg/L

Assessment factor:

1 000

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

10 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

1.41 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

0.141 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:

no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:

PNEC soil

PNEC value:

0.278 mg/kg soil dw

Extrapolation method:

equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

PNEC oral

PNEC value:

313 mg/kg food

Assessment factor:

90

Additional information

Short-term aquatic toxicity data are available for each of the three freshwater trophic levels (fish, daphnia and algae). There were no toxic effects at the limit of solubility. In order to avoid unnecessary chronic testing the highest measured soluble concentration (or solubility limit) was used to derive aquatic PNECs. This was determined to be 0.42 to 0.53 mg/L in the daphnia study and 0.35 mg/L in the algal study. Measured test item specific concentrations are not available in fish study. The solubility of the test item in pure water is 1.3mg/L but it is not uncommon for solubility limits to be lower in aquatic toxicity testing media. Taking a conservative approach, the lowest solubility limit of 0.35mg/L was used to derive PNEC. According to ECHA guideline R.10, page 20, a long-term aquatic toxicity test with invertebrates is required if the aquatic PECs are exceeding the threshold value of 1/100th of the water solubility. Therefore, an AF of 100 was applied to the solubility limit of 0.35mg/L to derive PNEC aqua (freshwater). In line with ECHA guidance R.10, the assessment factors applied to derive PNECaqua (marine) and PNECaqua (intermittent) were respectively, 10 x higher (AF=1000) and 10 x lower (AF=10) than the AF used for PNECaquatic freshwater.

PNEC_STP can be calculated via biodegradation endpoints using the concentration where no toxicity to microorganisms was observed. This can be considered the NOEC. In this case, no toxicity was observed at the test concentration of 100mg/l. An assessment factor of 10 should be used when evaluation PNEC_STP in this way. Therefore PNEC_STP= 10 mg/l

PNEC secondary poisoning was derived from the available information on reprotox (NOAEL = 1409.7 mg/kg bw/day) by multipling by 20 (rattus norvegicus > 6 weeks) to convert to concentration (NOEC) and dividing by an assessment factor of 90 (subchronic) in accordance with ECHA guidance R.10-8.

For Soil and sediment PNECs, wet weight PNECs were calculated with using equilibrium partitioning as described in Guidance R.10 & R.16, conversion to dry weight was performed with factor of 4.6 (1.13 soil)

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 dodecanal. Short-term aquatic toxicity data are available for each of the three freshwater trophic levels (fish, daphnia and algae). No toxic effects up to the limit of solubility were observed. Dodecanal is readily biodegradable and has a log Kow of 4.9.

Based on the measured log Kow value of 4.9, dodecanal is considered to have the potential to bioconcentrate for classification purposes. However, since no acute toxicity was recorded at the highest attainable test concentrations and the substance is readily biodegradable, dodecanal is not classified as hazardous to the aquatic environment according to Regulation 1272/2008/EC & adaptation 286/2011/EC (CLP) or according to Directive 67/548/EEC (DSD).