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EC number: 273-728-1 | CAS number: 69012-28-8 By-product of the manufacture of ferromanganese alloy containing primarily oxides of aluminum, manganese and silicon.
- 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:
- 0.27 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 750
- Dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
As a point of departure for the inhalation long term DNEL, the LOAEL of 100 mg/kg bw/day from the oral prenatal developmental toxicity study in rabbits was chosen. In the absence of any experimental absorption data for both the starting route (oral) and the end route (inhalation), the worst case assumption was made, assuming a limited absorption for the oral route, leading to a low (conservative) internal NOAEL. It is proposed, in the absence of route-specific information on the starting route, to include a default factor of 2 (50% absorption is assumed for oral absorption, and 100% for inhalation) in accordance with ECHA guidance document R.8 (ECHA, 2012). Furthermore, a higher end of assessment factor of 10 is applied for dose-response relationship, since the LOAEL is used as the dose descriptor and given the sensitivity of the effects (major foetal malformations in the tested species).
- AF for dose response relationship:
- 10
- Justification:
- The starting point is a LOAEL with major foetal malformations
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- NA for inhalation
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Data available on the test substance appropriate for the tonnage band
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
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:
- 0.08 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1 800
- Dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
As a point of departure for the dermal long term DNEL, the LOAEL of 100 mg/kg bw/day from the oral prenatal developmental toxicity study in rabbits was chosen. A maximal absorption was already occurred by the oral route and no additional correction factor was introduced.
Based on the inherent properties of the registered substance, the absence of dermal absorption is likely (see section 7.1). However, in the absence of measured data on dermal absorption, ECHA guidance document R.7c (ECHA, 2017) suggests the assignment of either 10% (MW > 500 and log Pow < -1 or > 4) or 100% default dermal absorption rates (ECHA, 2017). For the purpose of risk assessment for the registered substance, a conservative dermal absorption factor of 100% is applied. However, the currently available scientific evidence on dermal absorption of some metals indicates that lower figures than the lowest proposed default value of 10% could be expected (HERAG, 2017). A default dermal absorption factor of 0.1% is proposed for metal cations from dry (dust) exposure and 1.0% from exposure to liquid/wet media based on the HERAG fact sheet (HERAG, 2017).
- AF for dose response relationship:
- 10
- Justification:
- The starting point is a LOAEL with major foetal malformations
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- Rabbit to human
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Data available on the test substance appropriate for the tonnage band
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
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
Rationale for a key study selection for DNELs for slags, ferromanganese-manufg.
The main in vivo mammalian toxicity studies for the registered substances, were all guideline compliant studies conducted in accordance with GLP, and are summarised in the below table. In the key 90-day oral (gavage) repeated dose toxicity study (Cooper, 2016; IUCLID section 7.5.1), administration of the read-across substance silico-manganese slag (SiMn slag) to Sprague-Dawley rats at doses up to 1000 mg/kg/day did not cause any systemic toxicity. The NOAEL for systemic toxicity was considered to be 1000 mg/kg bw/day.
There are two prenatal developmental toxicity studies for the registered substance slags, ferromanganese-manufg. (FeMn Slag). In the rat study (Thacker, 2016;IUCLID section 7.8.2), administration of the test material was well tolerated, with no critical effects in dams up to the limit dose. There was no adverse effect on embryo-foetal survival, development or growth. Therefore, the NOAEL for maternal and developmental toxicity was considered to be 1000 mg/kg bw/day in this study. Whereas in rabbits (Stannard, 2020; IUCLID section 7.8.2), despite no clear effects of treatment in the maternal animals up to the highest dose given, as reflected in the NOAEL for maternal toxicity at 800 mg/kg/day, there was a slightly increased incidence of post implantation loss at 800 mg/kg/day. Therefore, the dose level of 300 mg/kg bw/day was concluded to be the NOAEL for embryo-foetal survival. Confounding vehicle effects were apparent in the maternal animals at all dose levels, including controls. There was an increased overall incidence of major visceral foetal abnormalities in all treated groups, with minor skeletal ossification delays also apparent at 300 or 800 mg/kg bw/day. Therefore, a NOAEL for embryo-foetal development was not established. The aetiology of these foetal malformations was unclear.
Comparisons of the prenatal developmental toxicity studies indicates a potential inter-species difference in the sensitivity of foetal development towards oral administration of FeMn slag. However, the bioanalysis for FeMn Slag in rats showed that all plasma samples analysed for proof of absorption were found to have concentrations less than the lower limit of quantification for the elements manganese, silicon, aluminium and barium (Cooper, 2019; IUCLID section 7.1.1). There is substantial evidence to support the registered substance is poorly absorbed via the oral route (see IUCLID section 7.1). This is supported by a lack of systemic effects in in vivo studies in rats. Therefore, the mechanism(s) responsible for the overt foetal toxicity seen in the prenatal study in rabbits remains unknown.
The effects on foetal development were only observed in rabbits with confounding vehicle effects (see more discussion in section 7.8), with morphological changes being disparate and without a clear dose-response. Furthermeore, there were no maternal or developmental effects of prenatal exposure to the registered substance in rats. This is considered to lower the concern for human relevance but based on the findings in the rabbit study, CLP classification as Category 2 (H361) for developmental toxicity has been assigned for FeMn slag, reflecting the uncertainty in the evidence from the rabbit prenatal developmental toxicity study. Consequently, the LOAEL from the prenatal developmental toxicity study in rabbits (i.e. 100 mg.kg bw/day) is used for DNEL derivations for the human health risk assessment. This precautionary measure will be reviewed once any new evidence becomes available.
Summary of in vivo mammalian toxicity studies
Test substance |
Study (Reference; Klimisch) |
OECD TG |
Duration of exposure |
Route of |
Species, strain |
No. of animals / group |
Dose levels [mg/kg bw/day] (vehicle) |
Critical effects |
NOAEL |
SiMn slag |
90-day repeated dose toxicity study in rats (Cooper, 2016; 2#1) |
408 (GLP) |
90 day |
Gavage |
Sprague-Dawley rats |
10/sex/dose |
10, 100, 1000 (corn oil) |
No critical systemic effects. Localised histopathological changes in the glandular and non-glandular stomach at 100 and/or 1000 mg/kg bw/day, considered to be attributed to the physical properties of the test material. |
Systemic: 1000 |
FeMn Slag |
Prenatal developmental toxicity study in rats (Thacker, 2016; 1) |
414 (GLP) |
14 days (GD 6 - 19) |
Gavage |
Sprague-Dawley rats |
20 F/dose |
100, 330, 1000 (corn oil) |
No critical effects |
Maternal: 1000 |
FeMn Slag |
Prenatal developmental toxicity study in rabbits (Stannard, 2020; 2) |
414 (GLP) |
23 days (GD 6 - 28) |
Gavage |
New Zealand White rabbits |
22 F/dose |
100, 300, 800 (corn oil) |
↑ (Slight) post-implantation loss at 800 mg/kg bw/day, ↑ incidence of major visceral abnormalities in foetuses at ≥ 100 mg/kg bw/day with minor skeletal ossification delays at ≥ 300 mg/kg bw/day |
Maternal: 800 |
#1 The Klimisch score for this study is due to read-across from an analogue substance, not due to the reliability of the study.
#2 In view of the nature and incidence of major foetal abnormalities detected in all treated groups, which exceeded the concurrent control and historical control data ranges, a NOAEL for embryo-foetal development was not established.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.05 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1 500
- Dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
As a point of departure for the inhalation long term DNEL, the LOAEL of 100 mg/kg bw/day from the oral prenatal developmental toxicity study in rabbits was chosen. In the absence of any experimental absorption data for both the starting route (oral) and the end route (inhalation), the worst case assumption was made, assuming a limited absorption for the oral route, leading to a low (conservative) internal NOAEL. It is proposed, in the absence of route-specific information on the starting route, to include a default factor of 2 (50% absorption is assumed for oral absorption, and 100% for inhalation) in accordance with ECHA guidance document R.8 (ECHA, 2012). Furthermore, a higher end of assessment factor of 10 is applied for dose-response relationship, since the LOAEL is used as the dose descriptor and given the sensitivity of the effects (major foetal malformations in the tested species).
- AF for dose response relationship:
- 10
- Justification:
- The starting point is a LOAEL with major foetal malformations
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- NA for inhalation
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Data available on the test substance appropriate for the tonnage band
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
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:
- 0.03 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 3 600
- Dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
As a point of departure for the dermal long term DNEL, the LOAEL of 100 mg/kg bw/day from the oral prenatal developmental toxicity study in rabbits was chosen. A maximal absorption was already occurred by the oral route and no additional correction factor was introduced.
- AF for dose response relationship:
- 10
- Justification:
- The starting point is a LOAEL with major foetal malformations
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- Rabbit to human
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Data available on the test substance appropriate for the tonnage band
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No acute toxicity hazard (leading to C&L) has been identified for the registered substance following the oral and dermal exposure. Therefore, according to ECHA R8 Guidance, no DNEL (acute) should be set.
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:
- 0.03 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 3 600
- Dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
As a point of departure for the dermal long term DNEL, the LOAEL of 100 mg/kg bw/day from the oral prenatal developmental toxicity study in rabbits was chosen. A maximal absorption was already occurred by the oral route and no additional correction factor was introduced.
- AF for dose response relationship:
- 10
- Justification:
- The starting point is a LOAEL with major foetal malformations
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- Rabbit to human
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Data available on the test substance appropriate for the tonnage band
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
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
As for workers.
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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