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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

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Administrative data

Link to relevant study record(s)

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Endpoint:
toxicity to soil macroorganisms except arthropods: short-term
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of Annex IX (Section 9.4.1) of REACH Regulation 1907/2006 short-term toxicity testing may be required if direct and indirect exposure of the soil compartment is likely.
The substance consists of amorphous and crystalline silica which when released into the environment are expected to combine indistinguishably with the soil or sediment due to their similarity with inorganic soil/sediment matter and will be subjected to natural processes under environmental conditions (cation exchange, dissolution, sedimentation). It is therefore considered to be essentially a mineral fraction of soil already. For this reason it is considered that the performance of toxicity tests on terrestrial organisms is not scientifically justified.

Testing was carried out on the read-across material Kieselguhr soda ash flux calcined at 3 trophic levels (algae, daphnia and fish) in reliable OECD guideline studies. In each study the L(E)C50s were greater than the solubility of the substance (ie 100% v/v saturated solution).
Based on these results the substance is considered to have no/low toxicity.
Endpoint:
toxicity to soil macroorganisms except arthropods: long-term
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of Annex X (Section 9.4) of REACH Regulation 1907/2006 long-term toxicity testing may be required if the results of the chemical safety assessment indicate the need for further testing.

The substance consists of amorphous and crystalline silica which when released into the environment are expected to combine indistinguishably with the soil or sediment due to their similarity with inorganic soil/sediment matter and will be subjected to natural processes under environmental conditions (cation exchange, dissolution, sedimentation). It is therefore considered to be essentially a mineral fraction of soil already. For this reason it is considered that the performance of long term toxicity tests on terrestrial organisms is not scientifically justified.

Testing was carried out on the read-across material Kieselguhr soda ash flux calcined at 3 trophic levels (algae, daphnia and fish) in reliable OECD guideline studies. In each study the L(E)C50s were greater than the solubility of the substance (ie 100% v/v saturated solution).
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
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

A study with Synthetic wollastonite has not been conducted as there are no concerns in regard to direct and indirect exposure of the soil compartment. The substance is considered to have no or very low toxicity based on a number of studies.


The substance consists of amorphous and crystalline silica which when released into the environment are expected to combine indistinguishably with the soil or sediment due to their similarity with inorganic soil/sediment matter and will be subjected to natural processes under environmental conditions (cation exchange, dissolution, sedimentation). It is therefore considered to be essentially a mineral fraction of soil already. For this reason it is considered that the performance of toxicity tests on terrestrial organisms is not scientifically justified.


Testing was carried out on the read-across material Kieselguhr soda ash flux calcined at 3 trophic levels (algae, daphnia and fish) in reliable OECD guideline studies. In each study the L(E)C50s were greater than the solubility of the substance (ie 100% v/v saturated solution).

Key value for chemical safety assessment

Additional information