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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
no emission to STP expected

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.013 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:
0.015 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

This substance is not dangerous, and does not need an exposure assessment under REACH. PNECs were derived for use in exposure-based waiving chronic and soil ecotox studies listed in Annex IX. Using available ecotoxicological data, the PNECs were calculated to be 0.0001192 mg/L for Freshwater and 0.00001192 mg/L for Marine Water.  For the calculation of the Freshwater and Marine water PNECs; a 21-day NOEC value of 0.00596 mg/L was obtained from PTPA media solubility and toxicity results from a read-across study with Daphnia magna from category member PTBA. Because three acute studies (fish, daphnia and algae) and two chronic studies (algae and daphnia) were available, and the chronic studies were conducted on the organism with the most sensitve acute toxicity (Daphnia), an AF of 50 was applied to the Daphnia chronic NOEC.  An assessment factor of 500 was applied to the freshwater NOEC to derive the PNECmarine. For the freshwater (intermittent) PNEC, the lowest of three acute values, the 48-hr EC50 of > 0.00284 mg/L for Daphnia magna, was used with an AF of 100 to obtain a value of 0.0000284 mg/L  For Grassland and Agricultural soil, no testing results were available.  The EPM method applied to the Freshwater PNEC was used to derive soil PNECs.  Using the estimated Koc of 110,000 L/kg, the PNEC for Grassland and Agricultural soil was determined to be 0.136 mg/kg based on wet weight and 0.154 mg/kg based on dry weight.  The dry weight value was then divided by a further factor of 10 because the log Kow is  > 5.  The final PNECsoil is  0.0154 mg/kg dw.  Similarly, the PNEC sediment values for freshwater and marine systems were extrapolated using the equilibrium partitioning method (EPM) with the PNECfreshwater and PNECmarine to obtain values of 0.131 and 0.0131 mg/kg dw, respectively. The PNECoral was calculated using read-across of a 28-day repeated dose study of another category member on rat.  No effect were observed at the highest dose tested (1000 mg/kg day).

Conclusion on classification

Hazardous to the aquatic environment - acute/short-term: conclusive but not sufficient to classify. No acute toxicity at the limit of water solubility.

Hazardous to the aquatic environment - long-term: conclusive but not sufficient to classify. Not chronically toxic at limit of water solubility. Not persistent in aquatic environment.

M-factor chronic: not applicable.

Hazardous to the ozone layer: conclusive but not sufficient to classify. PTPA is not listed in the Montreal Protocol on Substances that Deplete the Ozone Layer. It does not contain reactive halogens (chlorine or bromine) that could play a role in ozone depletion. PTPA is not hazardous to the ozone layer.

DSD endpoints environment: not classified. No acute toxicity at the limit of water solubility. Not persistent in the aquatic environment.