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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 915-037-6 | CAS number: -
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:
- 4 mg/m³
DNEL related information
- DNEL derivation method:
- other: OEL general inhalable dust
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:
- no hazard identified
Additional information - workers
The surface composition of silicocalcium differs from the bulk composition. The surface was found to be covered by silicon-, calcium-, iron- and aluminium rich oxide phases. No manganese or titanium present in the bulk material was detected in the outermost surface layer.
Main elements released from silicocalcium in different fluids are silicon and calcium. The release is significantly higher in acidic fluids than observed at neutral conditions. The release of other elements like aluminium and iron present in silicocalcium is usually low, and for instance aluminium is released only in very acidic environment.
The significant exposure scenario for silicocalcium is the occupational inhalation exposure. To derive a proper DNEL, read-across from amorphous silica is used. The released amount of calcium is seen insignificant because of its ubiquitous presence in tissues.
DNEL values for both the inhalable and the respirable CaSi particles are derived because of the fact that the dustiness properties are likely to vary.
A NOAEL of 1.3 mg/m3(representing respirable particles) has been identified in animal tests with synthetic amorphous silicas (Reuzel et al. 1991). This can be taken as a starting point for the derivation of an inhalation DNEL forCaSi (respirable fraction). For the DNEL calculation, no allometric scaling between humans and rats shall be done in the case of local effects but the value should be corrected for differences in respiratory rates between rats and humans. This results in a starting point of 0.9 mg/m3 (1.3 mg/m3×6.7/10). ECETOC has suggested an assessment factor of 1 to be used for interspecies differences and a factor of 3 for interindividual differences in the case of local respiratory tract effects (ECETOC 2003). Application of these factors (1×3) to 0.9 mg/m3results in a DNEL of 0.3 mg/m3 for respirablefraction. This DNEL of 0.3 mg/m3 for respirable dust derived above is likely to be well on the safe side because of the small particle size and high particle surface area of synthetic amorphous silica used in these studies, which are likely to contribute the effects seen in the study by Reuzel et al. (1991). The derived value is similar to the current (2010) German MAK-value for silica fume.
However, since silicocalcium dust is likely to consist mainly on inhalable particles with only minority of respirable particles, also a DNEL for inhalabledust is suggested. Because of the apparent nontoxicity of silicocalcium, it is recommended that inhalable dust levels are controlled below 4 mg/m3, which is the recommendation by German MAK commission (DFG 2010) for inhalable general dust and represents currently the lowest OEL for general dust in Europe.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
