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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.006 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.592 mg/L

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
2 316 537 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
231 651 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:
272 730 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

Due to the low water solubility of the substance, aquatic ecotoxicity testing, and thus PNEC derivations, were based on Water Accommodated Fractions (WAFs) of nominal concentrations of the Registration substance and the relevant read-across analogue material.

No PNECs were derived for the air compartment as the physical-chemical properties of the substance (very low V.P) dictate that this is not a relevant compartment for the registration substance.

Conclusion on classification

Registration substance EC 903-162 -9 showed no evidence of toxicity in any of the acute aquatic toxicity studies when tested as a water accomodated fraction, which was considered the most reliable and environmentally relevant method of testing. In light of this data the substance does not require classification for acute aquatic toxicity in accordance with Regulation (EC) No 1272/2008.

However, the CLP regulation also states that a safety net Chronic Aquatic toxicity, Category 4 classification should be applied when:

"Cases when data do not allow classification under the above criteria but there are nevertheless some grounds for concern. This includes, for example, poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility (note 4), and which are not rapidly degradable in accordance with section 4.1.2.9.5 and have an experimentally determined BCF = 500 (or, if absent, a log K ow = 4), indicating a potential to bioaccumulate, which will be classified in this category unless other scientific evidence exists showing classification to be unnecessary. Such evidence includes chronic toxicity NOECs > water solubility or > 1 mg/l, or other evidence of rapid degradation in the environment than the ones provided by any of the methods listed in section 4.1.2.9.5.

Note 4:

‘No acute toxicity’ is taken to mean that the L(E)C 50 (s) is/are above the water solubility. Also for poorly soluble substances, (water solubility < 1 mg/l), where there is evidence that the acute test does not provide a true measure of the intrinsic toxicity. "

While it is considered that for the notification substance, the B criterion is not met, based on properties of the chemistry (MW range) and modelled BCF values generated for main components, the other criteria for this Chronic Category 4 classifiation are met. As there are no experimental data to confirm bioaccumulation potential, a precautionary position is adopted and the safety net classification is applied.