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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
10 µg/L

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
8.9 mg/L
Assessment factor:
10

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
2.45 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:
4.91 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
6.67 mg/kg food
Assessment factor:
300

Additional information

Conclusion on classification

The environmental classification of Fatty acids, tall-oil, reaction products with formaldehyde and (Z)-N-9-octadecenyl-1,3-propanediamine is currently not harmonized according to the CLP Regulation (EC) 1272/2008 and the Dangerous Substance Directive 67/548/EC.

Based on available acute toxicity data, the lowest valid effect concentration for freshwater aquatic organisms is > 1 mg/L (unbounded EC50 value for daphnia magna).

The substance is not readily biodegradable; its logKow is in a range between 1.4 and 6.5 (Brekelmans, 2013). Log Kow measurements (Brekelmans, 2013) revealed that the vast majority of the components in the substance (75% at neutral pH and 83% at pH 2) showed a log Kow>6.5. Based on available data the substance should not be classified for Acute toxicity (as the lowest value is unbounded EC50 > 1 mg/L). As the NOEC for algae is < 1 mg/L (0.99 mg/L; no other long-term studies are available) the substance should be classified for chronic toxicity, following section 4.1.2.6, table 4.1.0 b (iii) of the CLP Regulation. Based on the same criteria the substance should be classified with R51 (Toxic to aquatic organisms) and R53 (May cause long-term adverse effects in the aquatic environment) under the Dangerous Substance Directive 67/548/EC (see Annex VI section 5.2.1.2) as the DSD does not consider algae data for showing the absence of chronic toxicity. The substance has a low water solubility and is rated high for persistence. The substance however is expected to have low potential for bioaccumulation based on estimated BCFs.