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.
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity testing was performed with UGI Exxaro sulphate slag, since this test material was chosen as representative material based on particle size distribution (smallest particle size as reported under section particle size distribution (Weidenfeller 2007) and in vitro bioavailablity/bioaccessibility testing (highest bioelution pattern as reported under section basic toxicokinetics).
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute toxicity via inhalation: Atmosphere generation: Despite extensive efforts, a suitable atmosphere could not be 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).
Justification for classification or non-classification
Acute oral toxicity
The reference Leuschner (2008) is considered as the key study for acute oral toxicity and will be used for classification. Rats were dosed at 2,000 mg/kg orally via gavage.During the conduct of the study no mortalities occurred, no biologically important body weight loss occurred after dosing, and no gross lesions were present in the rats at necropsy.
LD50 oral, rat > 2,000 mg/kg bw
The classification criteria acc. to regulation (EC) 1272/2008 as acutely toxic are not met since the ATE is above 2,000 mg/kg body-weight, hence no classification required.
Specific target organ toxicant (STOT) – single exposure: oral
The classification criteria acc. to regulation (EC) 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value, oral for a Category 1 classification of 300 mg/kg bw and at the guidance value, oral for a Category 2 classification of 2000 mg/kg bw. No classification required.
Acute inhalation toxicity, Specific target organ toxicant (STOT) – single exposure: inhalation
see discussion above.
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