Registration Dossier
Registration Dossier
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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.
Acute Toxicity: oral
Administrative data
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- Slags, silicomanganese-manufg.
- EC Number:
- 273-733-9
- EC Name:
- Slags, silicomanganese-manufg.
- Cas Number:
- 69012-33-5
- Molecular formula:
- UVCB identified to contain the following formulae: Na2O, MgO, Al2O3, SiO2, P2O5, K2O, CaO, TiO2, V2O5, Cr2O3, Fe2O3,BaO, ZrO2, ZnO, SrO, SiMn
- IUPAC Name:
- Slags, silicomanganese-manufacturing
- Details on test material:
- - Name of test material (as cited in study report): Slag SiMn
- Appearance: Greenish Solid
- Lot/batch No.: 002/AN-03
Constituent 1
Test animals
- 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
Administration / exposure
- 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
Results and discussion
- 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.
Effect levels
- 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.
Applicant's summary and conclusion
- 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.
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