Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
44 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
529.68 µg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
52.97 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:
47 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Justification for PNEC soil derivation:

For the soil compartent, test with Earthworm (OECD 222) and nitrifying soil bacteria (OECD 216) are available: NOEC (earth worm, reprod., 56 d) = 59 mg/kg soil dw; EC10 (earth worm, reprod., 56 d) = 39 mg/kg soil dw. -- NOEC (nitrification inhib.; 28 d): 320 mg/kg soil dw; EC50 (nitrification inhib.; 28 d): 566 mg/kg soil dw. A test on toxicity to terrestrial plants is not available: The outcome of the CSA (implicating screening assessment based on equilibrium partitioning) indicates that available long-term toxicity tests on earthworm and soil microorganisms are appropriate to cover information requirements (waiving according to "column 2" in Annex X of REGULATION (EC) No 1907/2006, together with Guidance R.7c, chapter R.7.11.5). Further, in a reliable test according to OECD 201 (algae) neither any effects on growth rate nor biomass could be observed up to the highest concentration of 100 mg/L (concentration analytically verified). Thus, plants may not be the most sensitive trophic level, also with regard to soil. With regard to PNEC-soil derivation, REACH guidance R.10 states the following: “If only one terrestrial test result is available (earthworms or plants), the risk assessment should be performed both of this test result and on the basis of the outcome of the aquatic toxicity data to provide an indication of the risk. As a matter of precaution, the larger PECsoil/PNECsoil ratio determines which further actions should be taken in the framework of the further testing strategy. If additional soil test results are available the assessment factors given in Table R.10-10 should be applied”. As the additional nitrogen transformation test is available for which the NOEC is to be regarded as chronic, according to R.10 an AF of 50 is applied for two chronic NOEC/EC10 values from 2 trophic levels. Because EC10 (earthworm, reproduction, 56 d) is lower compared to the corresponding NOEC, AF 50 is applied to the EC10 of 39 mg/kg soil dw. The resulted PNEC soil would be 780 µg/kg dw.

However, the PNEC soil Screen is calculated using the equilibrium partitioning method (EPM) (derivation following procedures of TGD (R.10 and R.16): PNEC water (freshwater): 0.1 mg/L, Koc: 16.81 (EPA EPI Suite estimate, program PCKOC v1.66, IUCLID sect. 5.4.1), HLC: 0.0193 Pa*m³/mol (EPA EPI Suite estimate, program HENRY v3.10, IUCLID sect. 5.4.2)) resulted value is 47 µg/kg dw, which is more conservative than the PNEC soil calculated based on the soil test (780 µg/kg dw) , is used for the Exposure risk assessment calculations

Conclusion on classification

According to Regulation (EC) No 1272/2008, TCD Alcohol DM is not to be classified as hazardous for the aquatic environment as its acute toxicity is > 100.0 mg/L, the BCF is < 500, and the log Pow is < 4.0.