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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.26 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:
0.215 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

A GLP-compliant study according to OECD Guideline 203 with guppies (Poecilia reticulata) was available (Duphar B.V., 1992b). The 96-h LC50 was 560 mg/L in fish.

A GLP-compliant 48-h immobilisation test with Daphnia magna was performed according to OECD Guideline 202 (Duphar B.V., 1992c). The 48-h EC50 was 520 mg/L in Daphnia magna.

For algae a GLP-compliant growth inhibition test was performed according to OECD Guideline 201 (Duphar B.V., 1992d). The 96-h ErC50 was >1,000 mg/L and the 96-h NOErC was 250 mg/L inPseudokirchneriella subcapitata(tested as:Selenastrum capricornutum).

Long-term studies with fish and invertebrates are not available.

For the toxicity of microorganisms, a respiration inhibition study according to GLP and OECD Guideline 209 is available for the structural analogue Polyol IXOL M125(ECT Oekotoxikologie GmbH, 2011).At the nominal limit concentration of 100 mg /L, no inhibition of respiration rate was observed. Therefore, it is concluded that the 3-h EC50 value is > 100 mg/L.

No tests are available with sediment organisms, terrestrial organisms and birds.

Conclusion on classification

According to Directive 67/548/EEC, results of validated structure activity relationships and expert judgment may also be taken into account where appropriate with regard to classification and labelling of substances.

Based on all available data for daphnids, fish and algae, the substance needs not to be classified as the lowest acute effect concentration is higher than 100 mg/L (48-h EC50 of 520 mg/L in Daphnia magna). Although Polyol IXOL B350 is not readily biodegradable, the substance is not expected to bioaccumulate as the log Kow ranges from -0.3 to 3.3, with an average log Kow of 1.29.

According to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, Polyol IXOL B350 does need not to be classified for the environment for the same reasons as stated above.