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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
2008
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

Constituent 1
Chemical structure
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.

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.