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
DNEL related information
DNEL derivation method:
other: based on the OELV for inorganic fluorides and adjusted to the reaction mass
Explanation for the modification of the dose descriptor starting point:

The IOELV for inorganic fluorides of 2.5 mg/m3 as listed in Commission Directive 2000/39/EC is considered to be appropriate for calcium difluoride. The IOELV (equivalent to 5 mg/m3 calcium difluoride) covers all inorganic fluoride salts including the highly soluble salts, and therefore can be considered to be a conservative approach for calcium difluoride, which is of low solubility and low bioavailability following inhalation.

As the reaction mass of calcium fluoride and calcium sulfate and calcium carbonate, contains typically 47% (35 -55% w/w) of the constituent calcium fluoride, the DNEL for the reaction mass can be calculated to be 10 mg/m3.

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
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Explanation for the modification of the dose descriptor starting point:

The reaction mass of calcium fluoride and calcium sulfate and calcium carbonate has no harmonised classification. Moreover, the 3 main constituents of the substance have nor harmonised classification neither self-classification. Consequently, the registered substance is also not self-classified based on the weight of evidence approach  using the reliable data on its main constituents.

As the registered substance is not classified, no risk assessment is needed for human health according to the criteria of the Article 14.4 of the REACH Registration (1907/2006).

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:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: OELV for inorganic fluorides adjusted for the general population and for the reaction mass
Explanation for the modification of the dose descriptor starting point:

As a conservative approach, the DNEL is derived for the main constituent of the reaction mass, Calcium fluoride to take into account potential long-term effects associated with potential exposure to inorganic fluorides. A systemic inhalation DNEL for the general population may be derived by the application of an assessment factor of 5 to the worker DNEL value of 2.5 mg/m3 fluoride (5 mg/m3 calcium difluoride) to take into account the potential greater sensitivity, breathing rate (20 m3/day) and longer potential exposure period (24 hours/day) of the general population. A long-term systemic DNEL value of 0.5 mg/m3 is therefore calculated for the general population. Data indicate that the bioavailability of fluoride from calcium difluoride is low, therefore this value is considered to be sufficiently protective.

As the reaction mass of calcium fluoride and calcium sulfate and calcium carbonate, contains typically 47% (35 -55% w/w) of the constituent Calcium fluoride, the corresponding DNEL for the reaction mass can be calculated to be 1 mg/m3.

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
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:
DNEL (Derived No Effect Level)
Value:
0.04 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: Based on fluoride tolerable total daily intake level, adjusted for the reaction mass composition
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population