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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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EC number: 910-356-7 | CAS number: -
- 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:
- 160 µg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 2
- Dose descriptor starting point:
- BMCL10
- Value:
- 320 µg/m³
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 1
- Justification:
- default for chronic exposure (average exposure length in the key study (geometric mean) of 5.3 years (range: 0.2–17.7 years); the most reliable long-term study in humans and also in other studies with longer exposure no effect enhancement observed)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required as basis are human data
- AF for other interspecies differences:
- 1
- Justification:
- not required as basis are human data
- AF for intraspecies differences:
- 2
- Justification:
- reduction from default - high number of study objects revealing the effects all in the same exposure height
- AF for the quality of the whole database:
- 1
- Justification:
- quality of database is considered good
- AF for remaining uncertainties:
- 1
- Justification:
- default
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
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 2
- Dose descriptor starting point:
- BMCL10
- Value:
- 320 µg/m³
- Modified dose descriptor starting point:
- BMDL10
- Value:
- 9 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no reliable and applicable studies available using the dermal exposure route for DNEL derivation.
Route-to-route extrapolation was performed using the most adequate data obtained when workers were exposed to MnO2 dust.
For adjustment of the differences of fractions becoming bioavailable via the different routes the following assumptions are made.
Inhalation bioavailability = 100 %
Dermal Bioaccessibility = 0.5 % (assumption based on data of solubility study, see IUCLID section 4.8, dermal absorption might even be lower as not all bioaccessible Mn will be absorbed into the skin and become bioavailable)
POD = BMCL10= 320μg hopcalite/m3/ 0.005 = 64000 µg hopcalite/m³
With human body weight being assumed 70 kg and a respiratory volume of 10 m³ in one shift the adjusted POD = 9140 µg hopcalite/kg bw/day ≈ 9 mg hopcalite/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required as basis are human data
- AF for other interspecies differences:
- 1
- Justification:
- not required as basis are human data
- AF for intraspecies differences:
- 2
- Justification:
- reduction from default - high number of study objects revealing the effects all in the same exposure height
- AF for the quality of the whole database:
- 1
- Justification:
- quality of database is considered good
- AF for remaining uncertainties:
- 1
- Justification:
- default
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
There are no adequate and reliable studies available for the registration substance, hopcalite, itself. However adequate and reliable studies performed with each of the two constituents of this reaction mass are at hand. For each relevant hazard the DNELs provided are based on the more critical value obtained using the critical studies for each of the two constituents as POD, respectively. Thus the hazard assessment conclusions are thought to be a conservative approach.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20 µg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 4
- Dose descriptor starting point:
- BMCL10
- Value:
- 320 µg/m³
- Modified dose descriptor starting point:
- BMCL10
- Value:
- 76.2 µg/m³
- Explanation for the modification of the dose descriptor starting point:
PBPK modeling demonstrates that the relationship between ambient Mn exposures and dose-to-target tissue is not linear due to normal tissue background levels and homeostatic controls. This application of PBPK modeling for an essential element clearly demonstrates that the conventional application of default factors to “convert” an occupational exposure to an equivalent continuous environmental exposure, followed by the application of safety factors, would be not appropriate in the case of Mn.(Gentry et al., 2017)
However in a conservative approach and according to ECHA guidance the following adjustment of POD would have to be made for different exposure pattern of workers compared to continuous exposure of the general population.
*5 day exposure workers / 7 days exposure general population
*8 h/day exposure workers /24 h/day exposure general population
leading to an approximately 4 times lower POD (BMCL10= 76.2 μg hopcalite/m³) than the one that could be used for assessment here.
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 1
- Justification:
- default for chronic exposure (average exposure length in the key study (geometric mean) of 5.3 years (range: 0.2–17.7 years); the most reliable long-term study in humans and also in other studies with longer exposure no effect enhancement observed)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required as basis are human data
- AF for other interspecies differences:
- 1
- Justification:
- not required as basis are human data
- AF for intraspecies differences:
- 4
- Justification:
- reduction from default - high number of study objects revealing the effects all in the same exposure height
- AF for the quality of the whole database:
- 1
- Justification:
- quality of database is considered good
- AF for remaining uncertainties:
- 1
- Justification:
- default
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
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 4
- Dose descriptor starting point:
- BMCL10
- Value:
- 320 µg/m³
- Modified dose descriptor starting point:
- BMDL10
- Value:
- 9 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no reliable and applicable studies available using the dermal exposure route for DNEL derivation.
Route-to-route extrapolation was performed using the most adequate data obtained when workers were exposed to MnO2 dust.
For detailed explanation on modification of the dose descriptor starting point please see explanation provided at worker dermal DNEL systemic effects long-term exposure.
(Note - no adjustment of the worker ihalation exposure to continuous exposure of the general population was performed, as this would be overly conservative for such a strictly controled essential element - see also discussion above from Gentry et al., 2017).
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required as basis are human data
- AF for other interspecies differences:
- 1
- Justification:
- not required as basis are human data
- AF for intraspecies differences:
- 4
- Justification:
- reduction from default - high number of study objects revealing the effects all in the same exposure height
- AF for the quality of the whole database:
- 1
- Justification:
- quality of database is considered good
- AF for remaining uncertainties:
- 1
- Justification:
- default
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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.23 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 4
- Dose descriptor starting point:
- BMCL10
- Value:
- 320
- Modified dose descriptor starting point:
- BMDL10
- Value:
- 910 µg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
As there are no reliable and applicable studies available using the oral exposure route for DNEL derivation a route-to-route extrapolation was performed using the most adequate data obtained when workers were exposed to MnO2 dust (Roels et al., 1992).
For adjustment of the differences of fractions becoming bioavailable via the different routes the following assumptions are made.
Inhalation bioavailability = 100 %
Oral bioavailability = 5 % (assumption based on data of limited absorption after oral administration of manganese in various forms)
POD =BMCL10= 320 μg hopcalite/m3/ 0.05 = 6400 µg hopcalite/m³
With human body weight being assumed 70 kg and a respiratory volume of 10 m³ in one shift the adjusted POD =910 µg hopcalite/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required as basis are human data
- AF for other interspecies differences:
- 1
- Justification:
- not required as basis are human data
- AF for intraspecies differences:
- 4
- Justification:
- reduction from default - high number of study objects revealing the effects all in the same exposure
height - AF for the quality of the whole database:
- 1
- Justification:
- quality of database is considered good
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
There are no adequate and reliable studies available for the registration substance, hopcalite, itself. However adequate and reliable studies performed with each of the two constituents of this reaction mass are at hand. For each relevant hazard the DNELs provided are based on the more critical value obtained using the critical studies for each of the two constituents as POD, respectively. Thus the hazard assessment conclusions are thought to be a conservative approach.
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.