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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECETOC Guidance on Assessment factors
Overall assessment factor (AF):
3
Explanation for the modification of the dose descriptor starting point:
Not applicable, original study is by inhalation
AF for dose response relationship:
3
Justification:
Effect level reported in epidemiological study regarded as LOAEL
AF for differences in duration of exposure:
1
Justification:
Effect level in epidemiological study based on long-term exposure
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable, DNEL based on human data
AF for other interspecies differences:
1
Justification:
Not applicable, DNEL based on human data
AF for intraspecies differences:
1
Justification:
Default factor for intraspecies differences human data in accordance with ECETOC Guidance
AF for the quality of the whole database:
1
Justification:
Four weight of evidence studies were provided which together give sufficient quality of the database.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: ECETOC Guidance on Assessment Factors
Overall assessment factor (AF):
3
Dose descriptor:
NOAEC
AF for dose response relationship:
3
Justification:
Effect level reported in epidemiological study regarded as LOAEL
AF for differences in duration of exposure:
1
Justification:
Effect level in epidemiological study based on long-term exposure
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable, DNEL based on human data
AF for other interspecies differences:
1
Justification:
Not applicable, DNEL based on human data
AF for intraspecies differences:
1
Justification:
Default factor for intraspecies differences human data in accordance with ECETOC Guidance
AF for the quality of the whole database:
1
Justification:
Four weight of evidence studies were provided which together give sufficient quality of the database.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

A Weight of Evidence approach was followed to determine the repeated dose toxicity of Silicic acid, calcium salt, and included two epidemiological studies with Wollastonite workers, a subchronic (1 -yr) inhalation study with rats, and health surveillance data of a production plant. As the epidemiological studies give information on chronic exposure to humans, the DNEL was derived based on one of these studies.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECETOC Guidance on Assessment Factors
Overall assessment factor (AF):
6
AF for dose response relationship:
3
Justification:
Effect level reported in epidemiological study regarded as LOAEL
AF for differences in duration of exposure:
1
Justification:
Effect level in epidemiological study based on long-term exposure
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable, DNEL based on human data
AF for other interspecies differences:
1
Justification:
Not applicable, DNEL based on human data
AF for intraspecies differences:
2
Justification:
Default factor for worker to general population, in accordance with ECETOC guidance
AF for the quality of the whole database:
1
Justification:
Four weight of evidence studies were provided which together give sufficient quality of the database.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: ECETOC Guidance on Assessment Factors
Overall assessment factor (AF):
6
AF for dose response relationship:
3
Justification:
Effect level reported in epidemiological study regarded as LOAEL
AF for differences in duration of exposure:
1
Justification:
Effect level in epidemiological study based on long-term exposure
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable, DNEL based on human data
AF for other interspecies differences:
1
Justification:
Not applicable, DNEL based on human data
AF for intraspecies differences:
2
Justification:
Default factor for worker to general population, in accordance with ECETOC guidance
AF for the quality of the whole database:
1
Justification:
Four weight of evidence studies were provided which together give sufficient quality of the database.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

A Weight of Evidence approach was followed to determine the repeated dose toxicity of Silicic acid, calcium salt, and included two epidemiological studies with Wollastonite workers, a subchronic (1 -yr) inhalation study with rats, and health surveillance data of a production plant. As the epidemiological studies give information on chronic exposure to humans, the DNEL was derived based on one of these studies.