Registration Dossier
Registration Dossier
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EC number: 215-138-9 | CAS number: 1305-78-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation 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:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- Dose descriptor:
- other: IOELV
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- Dose descriptor starting point:
- other: IOELV
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:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
No acute and long-term DNEL for workers exposed via inhalation are derived from animal studies, because indicative occupational exposure limit values (IOELV) for calcium dihydroxide and calcium oxide have been established by the European Commission (Commission Directive (EU) 2017/164 of 31 January 2017). These limits, based on the recommendations of the Scientific Committee on Occupation Exposure Limits (SCOEL) are STEL (15 min) = 4 mg/m³ respirable dust for short-term exposure to prevent local sensory irritation due to the irritation potential of the substance, and 8 -h TWA = 1 mg/m³ respirable dust for long term exposure to prevent local sensory irritation and decrease of lung function parameters as critical effects. No further assessment factors are applied to the IOELVs.
General Population - Hazard via inhalation 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:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- Dose descriptor:
- other: IOELV
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- Dose descriptor starting point:
- other: IOELV
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:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- medium hazard (no threshold derived)
Additional information - General Population
For the oral route, no DNELs are derived in view of the role of calcium as an essential mineral nutrient. An upper intake level (UL) has been derived by the Scientific Committee on Food as 2500 mg/d for calcium. This value is sufficiently protective both with respect to acute and long-term exposure.
No acute and long-term DNEL for exposure of general population via inhalation are derived from animal studies, because indicative occupational exposure limit values (IOELV) for calcium dihydroxide and calcium oxide have been established by the European Commission (Commission Directive (EU) 2017/164 of 31 January 2017). These limits, based on the recommendations of the Scientific Committee on Occupation Exposure Limits (SCOEL) are STEL (15 min) = 4 mg/m³ respirable dust for short-term exposure to prevent local sensory irritation due to the irritation potential of the substance, and 8 -h TWA = 1 mg/m³ respirable dust for long term exposure to prevent local sensory irritation and decrease of lung function parameters as critical effects. These indicative exposure limits are considered as sufficiently protective also for the general population and are therefore proposed to be adopted. No further assessment factors are applied to the IOELVs.
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