Registration Dossier
Registration Dossier
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EC number: 293-671-6 | CAS number: 91081-64-0 Slag produced during ilmenite smelting (ore or sand). Consists primarly of TiO2, FeO, Al2O3, SiO2, MgO and other metal oxides.
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF), Testing Guidelines for Toxicology Studies, 12 NohSan No. 8147 (2-1-3), 24 November 2000
- Principles of method if other than guideline:
- The attempts at generating a stable test atmosphere prior to the conduct of the study were performed on May 02, 2008. Since a stable test atmosphere could not be generated, the main study involving animal testing could not be initiated.
- GLP compliance:
- yes
- Test type:
- standard acute method
Test material
- Reference substance name:
- Slags, ilmenite electrothermal smelting
- EC Number:
- 293-671-6
- EC Name:
- Slags, ilmenite electrothermal smelting
- Cas Number:
- 91081-64-0
- Molecular formula:
- M3O5
- IUPAC Name:
- Slags, ilmenite electrothermal smelting
- Details on test material:
- - Name of test material (as cited in study report): Titanium Slag (Exxaro Sulphate Slag)
- Substance type: technical product
- Physical state: solid, black brown granular
- Composition of test material, percentage of components: 100 % UGI
- Lot/batch No.: MKT_SUL_070624_0000
- Expiration date of the lot/batch: December 2026
- Density: 3.97
- Particle size: L10 = 13.2 µm, L50 = 69.1 µm and L90 = 155.3 µm
No further details are given.
Constituent 1
Test animals
- Species:
- other: testing could not be initiated
- Strain:
- other: testing could not be initiated
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- none
Administration / exposure
- Route of administration:
- other: testing could not be initiated
- Type of inhalation exposure:
- other: testing could not be initiated
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- Atmosphere generation: Despite extensive efforts, a suitable atmosphere could not be experimentally generated from the test substance. Instead, the test substance precipitated directly behind the outlet of the rotating brush dust generator. Despite that this may have been anticipated based on the experimentally determined particle size of the test substance, experimental verification by this preliminary test was sought.
Consequently, for acute inhalation toxicity testing in rat, it is impossible to generate an aerosol with a mass median aerodynamic diameter (MMAD) of <4 µm with the supplied test item, as required by the OECD draft proposal for a new guideline: 436 - Acute Inhalation Toxicity: Acute Toxic Class (ATC) Method (08 Dec 2004). - Analytical verification of test atmosphere concentrations:
- no
- Remarks on duration:
- testing could not be initiated
- Concentrations:
- testing could not be initiated
- No. of animals per sex per dose:
- testing could not be initiated
- Control animals:
- not specified
- Details on study design:
- none
- Statistics:
- no data
Results and discussion
- Preliminary study:
- testing could not be initiated
- Mortality:
- testing could not be initiated
- Clinical signs:
- other: testing could not be initiated
- Body weight:
- testing could not be initiated
- Gross pathology:
- testing could not be initiated
- Other findings:
- testing could not be initiated
Any other information on results incl. tables
The attempts at generating a stable test atmosphere prior to the conduct of the study were performed on May 02, 2008. Since a stable test atmosphere could not be generated, the main study involving animal testing could not be initiated.
Applicant's summary and conclusion
- Conclusions:
- The performance of an acute inhalation toxicity test is neither technically feasible nor scientifically relevant for this type of compound.
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