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EC number: 273-733-9 | CAS number: 69012-33-5 By-product of the manufacture of silicomanganese alloy containing oxides of aluminum, calcium, magnesium, 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
Endpoint summary
Administrative data
Description of key information
ORAL
LD50 > 2000 mg/kg bw, rat (male/female), EU Method B.1, Ferroatlantica (2003)
DERMAL
LD50 > 2000 mg/kg bw, rat (male/female), EU Method B.3, Ferroatlantica (2003)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-1-24 to 2003-2-7
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A non-GLP study performed to a standardised guideline with a sufficient level of detail to assess the quality of the relevant results.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- yes
- Remarks:
- no raw data
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 91.8 - 98.3 g (males); 92.5-97.7 g (females)
- Fasting period before study: yes (length not stated)
- Housing: polypropylene, with vents on top, with dimensions 445(w) x 695 (l) x 290 (h), allowing 10 animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2mL
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: body weight, organ weights, general state of animal, observable external alterations - Statistics:
- not reported
- Preliminary study:
- A study had been performed several years earlier that indicated 5000 mg/kg caused no mortalities. This was justification for starting at 2000 mg/kg in this study.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no mortalities
- Clinical signs:
- other: not reported
- Gross pathology:
- No apparent macroscopic injuries in any of the observed organs; colour and consistency were normal.
- Other findings:
- - Other observations: After administration of the substance there was slight hair erection, which disappeared in 1-2 hours.
The activity and behaviour were not affected, and at the end of the 14 days they were apparently normal. No changes were detected in the health status of the conjunctiva and mucous membranes. The appearance and colour of skin and hair was normal. - Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study the acute oral LD50 of the test substance was determined to be in excess of 2000 mg/kg bw.
- Executive summary:
The acute oral toxicity of the substance was investigated in a study which was conducted in accordance with the standardised guideline EU Method B.1.
During the study 5 male and 5 female rats received 2000 mg/kg bw test substance, at a dose volume of 2 mL, via gavage. Following dosing, the animals were observed for 14 days. No mortality occurred during the study and no adverse clinical signs were reported. Body weight gains appeared normal.
Therefore, under the conditions of the study the acute oral LD50 of the substance was determined to be in excess of 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The study was conducted to a standardised guideline with a sufficient level of detail to assess the quality of the relevant results. The study was therefore assigned a reliability score of 2 in line with the criteria of Klimisch (1997).
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-1-24 to 2003-2-7
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A non-GLP study performed to a standardised guideline with a sufficient level of detail to assess the quality of the relevant results.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- yes
- Remarks:
- no raw data for each animal
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 91.3 -99.7 g (males); 94.0 - 101.8 g (females)
- Housing: polypropylene cages with vents on top, with dimensions 445(w) x 695 (l) x 290(h) allowing 10 animals per cage.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal region
- % coverage: >10%
- Type of wrap if used: gauze pad and hypoallergenic medical tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 24 hr
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2mL of substance aqueous suspension
- For solids, paste formed: no
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: performed but no details
- Necropsy of survivors performed: yes
- Other examinations performed: body weight, organ weights, histopathology, general condition, external alterations - Statistics:
- Not reported
- Preliminary study:
- A previous study conducted several years earlier gave no mortality at 400 mg/kg and thus the use of 2000 mg/kg for this study.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality
- Clinical signs:
- other: Not reported
- Gross pathology:
- No apparent macroscopic injuries in any of the observed organs; colour and consistency were normal.
- Other findings:
- - Other observations:
General condition: After the administration of the substance there was slight hair erection, which disappeared in 1-2 hrs. The activity and behaviour were not affected, and at the end of the 14 days they were normal.
External alterations: No changes were detected in the health status of the conjunctiva and mucous membranes. Initially superficial injuries were observed in the dorsal area that was in contact with the test substance but these healed by themselves during the first week. - Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study the acute dermal LD50 of the test substance was determined to be in excess of 2000 mg/kg bw.
- Executive summary:
The acute dermal toxicity of the test substance was investigated in a study which was conducted in accordance with the standardised guideline EU Method B.3.
During the study 5 male and 5 female rats received a dermal application of 2000 mg/kg bw test substance. Twenty four hours after application the test site was washed to remove the test substance. The animals were observed for a further 13 days. No mortality occurred during the study and no adverse clinical signs were reported. Body weight gains appeared normal.
Therefore, under the conditions of the study the acute dermal LD50 of the substance was determined to be in excess of 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The study was conducted to a standardised guideline with a sufficient level of detail to assess the quality of the relevant results. The study was therefore assigned a reliability score of 2 in line with the criteria of Klimisch (1997).
Additional information
Oral
The acute oral toxicity of the substance was investigated in a study which was conducted in accordance with the standardised guideline EU Method B.1.
During the study 5 male and 5 female rats received 2000 mg/kg bw test substance, at a dose volume of 2 mL, via gavage. Following dosing, the animals were observed for 14 days. No mortality occurred during the study and no adverse clinical signs were reported. Body weight gains appeared normal.
Therefore, under the conditions of the study the acute oral LD50 of the substance was determined to be in excess of 2000 mg/kg bw.
Inhalation
In accordance with column 2 of REACH Annex VIII, testing by the inhalation route is not appropriate, taking into account the very low level of particles of an inhalable size, based on results of particle size distribution study which indicated < 3.5 % w/w of particles are less than 100 microns diameter.
Dermal
The acute dermal toxicity of the test substance was investigated in a study which was conducted in accordance with the standardised guideline EU Method B.3.
During the study 5 male and 5 female rats received a dermal application of 2000 mg/kg bw test substance. Twenty four hours after application the test site was washed to remove the test substance. The animals were observed for a total of 1 days following exposure. No mortality occurred during the study and no adverse clinical signs were reported. Body weight gains appeared normal.
Therefore, under the conditions of the study the acute dermal LD50 of the substance was determined to be in excess of 2000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
Only one study is available.
Justification for selection of acute toxicity – inhalation endpoint
In accordance with column 2 of REACH Annex VIII, testing by the inhalation route is not appropriate, taking into account the very low level of particles of an inhalable size, based on results of particle size distribution study which indicated < 3.5 % w/w of particles are less than 100 microns diameter.
Justification for selection of acute toxicity – dermal endpoint
Only one study is available.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance does not require classification with respect to acute toxicity.
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