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Diss Factsheets
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EC number: 234-858-4 | CAS number: 12037-47-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.4 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 440.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No study on long-term inhalation toxicity available.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on a oral subchronic study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route.
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 2
- Justification:
- Limited data quality (Klimisch score of 4).
- AF for remaining uncertainties:
- 2
- Justification:
- Read-across substance was taken into consideration.
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 400
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No study on long-term dermal toxicity available.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on a oral subchronic study.
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 2
- Justification:
- Limited data quality (Klimisch score of 4).
- AF for remaining uncertainties:
- 2
- Justification:
- Read-across substance was taken into consideration.
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:
- medium hazard (no threshold derived)
Additional information - workers
Systemic effects, long-term
For calculation of the DNEL for long-term inhalative systemic effects, the dose descriptor has to be converted into a corrected starting point by route-to-route extrapolation. Taking the high water solubility of silicon orthophosphate into consideration it is reasonable to assume a complete dissociation of silicon orthophosphate. Therefore, the NOAEL of 500 mg/kg bw/day from a one-generation study with the read-across substance silicon dioxide was taken into consideration for DNEL derivation. 50% absorption is assumed for oral absorption, and 100% for inhalation as recommended in ECHA-guidance Chapter R.8 and to follow a conservative approach: 500 mg/kg bw/day * (1/0.38 m³/kg bw/day) * (0.5/1) * 6.7 m³/ 10 m³) = 440.8 mg/m³.
The LOAEL of 800 mg/kg bw/day taken from the subchronic studies performed with dipotassium hydrogenorthophosphate in dogs (Schneider et al. 1980a/b) were also taken into consideration for DNEL derivation. The LOAEL was mainly based an on the changes that were observed in the kidneys at gross pathology and histopathology (nephrocalcinosis). Conversion of the oral LOAEL into a corrected inhalatory LOAEC would result in a value of 3999.99 mg/m³ (=800 mg/kg bw/day/1.4*70/10). Extrapolation of experimental data to the human situation revealed an DNEL of 13.3 mg/m³, taken the following assessment factors into consideration: dose-response relationship 3, duration of exposure 2, allometric scaling 1.4 (see correction), interspecies 2.5, intraspecies 5, quality of whole database 2, remaining 2. Hence, the worst case was taken into consideration and therefore the value of 4.4 mg/m³ based on the study on fertility was chosen as DNEL. The same is true for the dermal route. Based on the NOAEL of 500 mg/kg bw/day taken from the fertility study, a DNEL of 1.25 mg/kg bw/day was derived for systemic effects after long-term exposure. Taken the LOAEL of the study with dogs into consideration, the DNEL would be 1.9 mg/kg bw/day (=800 mg/kg bw/day / 420 (dose-response relationship 3, duration of exposure 2, allometric scaling 1.4, interspecies 2.5, intraspecies 5, quality of whole database 2, remaining 2)). Therefore, again the lower DNEL was chosen.
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
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.
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