Registration Dossier
Registration Dossier
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EC number: 234-685-4 | CAS number: 12023-91-5
Endpoint summary
Administrative data
Description of key information
A 28 days toxicity study or a 90 days toxicity study for the oral and the dermal route are not required as the inhalation route is considered to be the most appropriate route of administration. However, no new study is required because weight of evidence evaluation covers this endpoint sufficiently.
Key value for chemical safety assessment
Additional information
Rationale: Acute toxicity via the inhalation route was not determined in an acute toxicity test with the maximum achievable test concentration which is far above the lowest maximum work place concentration (3 mg/m³ for dust*). the result of the acute toxicity study is in line with the long-term practical experience on strontium ferrite at the working place (see Annex XI 1.1.3).
*: This follows from "TRGS 559" which applies for the workers protection against such mineral dust where no specific concentration limit is fixed. This is the case for strontium ferrite. The general dust limit value for the so-called A-dust (alveolar dust fraction) applies and is 3 mg/m³. In addition, the dust limit value for the respirable dust fraction exists which is 10 mg/m³ (see "TRGS 900").
The toxicokinetic study revealed that there is no accumulation of strontium ferrite. According to Annex VIII No. 86.1, column 2 even a 90 days sub-chronic toxicity study is not required.
New tests on vertebrates shall only be conducted or proposed as a last resort when all other data sources have been exhausted (see also: ECHA: Guidance on information requirements and chemical safety assessment, Part B, chapter B.6.2). From the point of view vertebrate testing is not only undesired but also not justified.
Justification for classification or non-classification
Strontium ferrite does not show toxic effects via the oral, dermal and inhalation route. Hence, classification is not required.
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