Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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EC number: 270-659-9 | CAS number: 68475-76-3 A complex combination of finely divided inorganic particles separated from the exit gases formed during the manufacture of Portland cement. The flue dust consists of uncalcined raw materials along with partially calcined materials. Some Portland cement clinker is usually included. The major constituents of kiln dust are calcium carbonate, clays, shales, quartz and sulfate salts. The following materials may also be present:@Dolomite@Ca(OH)2@Feldspars@CaSO4@Fly ash@KCl@Iron oxides@K2CO3@CaF2@K2SO4@CaO@Na2SO4@Glasses of SiO2, Al.s@Portland cement chemicals [659
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:
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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