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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Marine water

Hazard assessment conclusion:
no hazard identified

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

 Environmental fate and pathways

Degradation

Not readily biodegradable (28% in 28 d, OECD 301 F)

Bioaccumulation

All (Q)SAR models consistently predicted very low BCF values of maximally 28.18 L/kg, resulting in a low potential for bioaccumulation.

 

Ecotoxicity

Aquatic short-term toxicity

- Fish: LL50 (96 h) > 100 mg/L (nominal, OECD 203, O. mykiss)

- Aquatic invertebrates: Long-term test will be available (OECD 211 test already commissioned). This information will be submitted later based on ECHA communication/decision number TPE-D-2114565572-44-01/F. Reasons for this delay are summarized in the statement attached in IUCLID section 13.2 (Timelines for Ecotoxicity (and Associated Analytical Chemistry) Testing of Fatty acids, Montan-Wax, Stearyl Esters (CAS 68308-30-5)).

- Aquatic algae: EL50 (72 h) > 100 mg/L (nominal, OECD 201, P. subcapitata)

 

Aquatic long-term toxicity

Fish

Long-term fish test will be available (OECD 210 test already commissioned)

This information will be submitted later based on ECHA communication/decision number TPE-D-2114565572-44-01/F. Reasons for this delay are summarized in the statement attached in IUCLID section 13.2 (Timelines for Ecotoxicity (and Associated Analytical Chemistry) Testing of Fatty acids, Montan-Wax, Stearyl Esters (CAS 68308-30-5)).

Aquatic invertebrates

Long-term aquatic invertebrate test will be available (OECD 211 test already commissioned)

This information will be submitted later based on ECHA communication/decision number TPE-D-2114565572-44-01/F. Reasons for this delay are summarized in the statement attached in IUCLID section 13.2 (Timelines for Ecotoxicity (and Associated Analytical Chemistry) Testing of Fatty acids, Montan-Wax, Stearyl Esters (CAS 68308-30-5)).

Aquatic algae

NOELR (72 h) ≥ 100 mg/L (nominal, OECD 201, P. subcapitata)

              

Conclusion on CLP

Based on the available data, neither short-term nor long-term effects to aquatic organisms were recorded and the substance is not rapidly biodegradable. Since no bioaccumulation is expected based on estimated BCF values, environmental fate and toxicokinetic considerations, the substance is not classified and labelled for environmental hazards according to the consolidated version of Regulation (EC) No 1272/2008 and further amendments (ATPs).

 

This conclusion will be reevaluated, based on the results of the already commissioned long-term tests with invertebrates (OECD 211) and fish (OECD 210). The results will be submitted later based on ECHA communication/decision number TPE-D-2114565572-44-01/F. Reasons for the delay are summarized in the statement attached in IUCLID section 13.2 (Timelines for Ecotoxicity (and Associated Analytical Chemistry) Testing of Fatty acids, Montan-Wax, Stearyl Esters (CAS 68308-30-5)).