Registration Dossier
Registration Dossier
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EC number: 255-911-8 | CAS number: 42613-21-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.026 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 25
- Dose descriptor:
- NOAEC
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.55 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- Overall assessment factor (AF):
- 525
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Dermal penetration of silicic acid, titanium salt (Magnapore®) is expected to be low which is supported by the findings of the studies described in section 7.1 as well as by the result of the acute dermal toxicity study (see 7.2). Therefore, systemic effects due to prolonged dermal are unlikely.
The respirable fractions of the experimental SAS aerosols that consisted of particles with aerodynamic diameters of ≤ 5 µm represented ≥ 50 wt%, those consisting of particles with aerodynamic diameters of ≤ 10 µm represented > 80 wt%.
In commercial products, the fraction of particles in the whole-size range of air-borne particles that is potentially able to reach the thoracic and alveolar site (respirable fraction, ≤ 10 µm; according to EN/DIN 481) is below 1 vol% (= wt%).
Therefore, the material used in the animal studies to derive the NOAEL of 1 mg/m3 contained in the order of 50 times the proportion of respirable material compared to SAS humans are exposed to. This fact has to be considered when margins of exposure with regard to human health are established.
Taking into account these considerations no inhalation effects (local inflammation in the lower respiratory tract) are expected due to silicic acid, titanium salt particles smaller than 10 µm.
Repeated measurements of dust (inhalable fraction, > 10 µm) in the filling room resulted in an average value of 0.44 mg/m3 (Grace Europe Holding GmbH 2008). In comparison with the limit value of 10 mg/m3 (TWA 2008, inhalable dust) a risk potential is not to be expected via inhalation.
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.007 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Dose descriptor:
- NOAEC
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.28 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- Overall assessment factor (AF):
- 1 050
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.28 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- Overall assessment factor (AF):
- 1 050
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Since Magnapore is only used in an industrial process as a catalyst, exposure of the general population will not arise/is not expected at all.
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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