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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

PNECs were derived based on test data following standard guidelines. All data are considered to be reliable and relevant for the endpoint concerned.

Short-term aquatic data in freshwater are available for three trophic levels for the test item and read-across substance. The most sensitive endpoint was determined to be Daphnia, with a 48 -hour EC50 of 0.568 mg/L (2015). This endpoint was used to derive the PNECs for freshwater, marine water and intermittent releases by assessment factor method, and freshwater sediment, marine sediment and soil by equilibrium partitioning approach.

For derivation of the PNEC for STP, the 30-min EC50 for respiration inhibition of microorganisms was determined to be > 1000 mg/L, the highest concentration tested (1997). A PNEC of 10 mg/L is derived by applying an assessment factor of 100 as the study was conducted according to OECD 209. However, the water solubility for the test item is 6.54 mg/L (2015) and the PNEC for STP exceeds this value.

The test item has low vapour pressure (0.13, 0.17 and 0.58 hPa at 20, 25 and 50°C, respectively (2015)), therefore it is not a precursor to ozone formation and is not expected to be a significant contributor to global warming. The test item is not an ozone depleting substance as defined by the Montreal Protocol and does not contain chemical constituents that would lead to acidification.

A secondary poisoning assessment is not required for this substance as it does not have the potential to cause toxic effects if accumulated in higher organisms, as it is not classified as H360 “May damage fertility or the unborn child”, H361 “Suspected of damaging fertility or the unborn child”, H362 “May cause harm to breastfed children”, H372 “Causes damage to organs through prolonged or repeated exposure” or H373 “May cause damage to organs through prolonged or repeated exposure”, according to ECHA Guidance for environmental exposure assessment (R.16.1.3.2, version 3.0).

Conclusion on classification

Acute aquatic data are available for three trophic levels for the test item and read-across substance. The most sensitive endpoint was determined to be Daphnia, with a 48 -hour EC50 of 0.568 mg/L (2015). Since the effect value is ≤ 1 mg/L, the test item is classified as acute aquatic toxicity category 1 with an M factor of 1, according to CLP Regulation (EC) No 1272/2008 (8th Adaptation to Technical Progress).

Chronic toxicity data are only available for algae. Based on a growth rate EC10 of 1.17 mg/L (2017) and assuming the test item to be rapidly degradable, no chronic aquatic toxicity classification applies. Since an adequate chronic dataset is not available for the test item, classification with the acute data must also be considered. Based on a 48 -hour EC50 of 0.568 mg/L for Daphnia (2015) and a partition coefficient range of 4.60 to 4.78 (2015), the test item is classified with chronic aquatic toxicity category 1. The test item is therefore classified as chronic aquatic toxicity category 1 with an M factor of 1, according to CLP Regulation (EC) No 1272/2008 (8th Adaptation to Technical Progress).