Registration Dossier

Diss Factsheets

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:
0.84 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
6
Dose descriptor:
LOAEC
Value:
5.09 mg/m³
AF for dose response relationship:
3
Justification:
LOEC used instead of NOAEC (ECHA guidance R.8)
AF for differences in duration of exposure:
2
Justification:
sub-chronic versus chronic (ECHA guidance R.8)
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not relevant for local effects (ECHA guidance R.8)
AF for other interspecies differences:
1
Justification:
Rats are more susceptible to lung overloading of PSP compared to humans (ECETOC TR No. 122, p.85)
AF for intraspecies differences:
1
Justification:
Rats are more susceptible to lung overloading of PSP compared to humans (ECETOC TR No. 122, p.85-86)
AF for the quality of the whole database:
1
Justification:
default assessment factor for studies performed according to OECD and GLP (ECHA guidance R.8)
AF for remaining uncertainties:
1
Justification:
default assessment factor (ECHA guidance R.8)
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
Overall assessment factor (AF):
1

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

No acute and long-term DNELs for workers exposed via inhalation are derived from animal studies. The animal study on acute inhalation toxicity resulted in a LC50 value of above 6040 mg/m³, the highest tested concentration. Because recommendations on occupational exposure limits for calcium oxide/calcium hydroxide and Portland cement (clinker) are available from SCOEL and ACGIH, these values have been used as DNEL for the acute local and long-term local inhalation exposure route:

STEL (15 min) = 4 mg/m³ respirable dust for short-term exposure and OEL (8 h) = 1 mg/m³ respirable dust for long-term exposure.

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:
0.84 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
6
Dose descriptor:
LOAEC
Value:
5.09 mg/m³
AF for dose response relationship:
3
Justification:
LOAEC used instead of NOAEC (ECHA guidance R.8)
AF for differences in duration of exposure:
2
Justification:
sub-chronic versus chronic (ECHA guidance R.8)
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not relevant for local effects (ECHA guidance R.8)
AF for other interspecies differences:
1
Justification:
Rats are more susceptible to lung overloading of PSP compared to humans (ECETOC TR No. 122, p.85)
AF for intraspecies differences:
1
Justification:
Rats are more susceptible to lung overloading of PSP compared to humans (ECETOC TR No. 122, p.85-86)
AF for the quality of the whole database:
1
Justification:
default assessment factor for studies performed according to OECD and GLP (ECHA guidance R.8)
AF for remaining uncertainties:
1
Justification:
default assessment factor (ECHA guidance R.8)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Value:
4 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
Overall assessment factor (AF):
1

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

No acute and long-term DNELs for workers exposed via inhalation are derived from animal studies. The animal study on acute inhalation toxicity resulted in a LC50 value of above 6040 mg/m³, the highest tested concentration. Because recommendations on occupational exposure limits for calcium oxide/calcium hydroxide and Portland cement (clinker) are available from SCOEL and ACGIH, these values have been used as DNEL for the acute local and long-term local inhalation exposure route:

STEL (15 min) = 4 mg/m³ respirable dust for short-term exposure and OEL (8 h) = 1 mg/m³ respirable dust for long-term exposure.

No DNEL was derived for dermal exposure of workers, since the substance causes local effects due to a pH shift and it is classified as irritating to skin. Dermal absorption is insignificant for inorganic (ionic) elements. Therefore no systemic effects are anticipated to occur from this route of exposure.

The oral exposure route is little appropriate for acute toxicity. From the animal test no DNEL was derived, a LD50 is estimated of above 2000 mg/kg bw. Even for long-term exposure no DNEL is applicable. From the repeated dose toxicity study no indications for a long term toxicity was deemed.