Registration Dossier

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.