Synthetic wollastonite

Bioaccumulation: aquatic / sediment

Link to relevant study record(s)

Reference

Endpoint:

bioaccumulation in aquatic species: algae / cyanobacteria

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance has a low potential to cross biological membranes

other:

Justification for type of information:

In accordance with column 2 of Annex IX Section 9.3.2 of REACH Regulation 1907/2006 bio-accumulation in aquatic species study is required for substances with a high potential for bio-accumulation (e.g. a log Kow greater than 3) and/or a high potential to cross biological membranes. Synthetic wollastonite is an inorganic solid, due to its inherent physicochemical properties bioaccumulation is not expected and there are no concerns regarding toxic effects in any of the (eco-)toxicological studies, short or long-term. As the substance is poorly soluble, low concentrations are expected in the aquatic compartment. Low quantities which might be taken up are considered to be not bioavailable.  It is therefore not expected that bioaccumulation will occur and the study is considered to be scientifically unjustified.

Log Kow result are not available due to the inorganic nature of the substance.

The inorganic nature of Synthetic wollastonite precludes the possibility of metabolic by-products.
There are no concerns regarding toxic effects in any of the (eco-)toxicological studies, short or long term, carried out on the analogues. This would indicate that the substance is unlikely to bioaccumulate within biological tissues.
The substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008.
There is no other evidence of chronic toxicity, as identified specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008.

Reason / purpose for cross-reference:

data waiving: supporting information

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data waiving: supporting information

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data waiving: supporting information

Reason / purpose for cross-reference:

data waiving: supporting information

Reason / purpose for cross-reference:

data waiving: supporting information

Reason / purpose for cross-reference:

data waiving: supporting information

Reason / purpose for cross-reference:

data waiving: supporting information

Description of key information

Synthetic wollastonite is an inorganic solid for which an octanol/water partition coefficient cannot be reliably determined. As the substance is poorly soluble, low concentrations are expected in the aquatic compartment. Low quantities which might be taken up are considered to be not bioavailable.  It is therefore not expected that bioaccumulation will occur and the study is considered to be scientifically unjustified.

Log Kow result are not available due to the inorganic nature of the substance.

The inorganic nature of Synthetic wollastonite precludes the possibility of metabolic by-products.
There are no concerns regarding toxic effects in any of the (eco-)toxicological studies, short or long term, carried out on the analogues. This would indicate that the substance is unlikely to bioaccumulate within biological tissues.
The substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008.
There is no other evidence of chronic toxicity, as identified specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008.