Dodecairon strontium nonadecaoxide

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

sub-chronic toxicity: inhalation

Type of information:

not specified

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

other:

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

no information

Test material

Test material information

Constituent 1

Reference substance name:

Dodecairon strontium nonadecaoxide

EC Number:

234-685-4

EC Name:

Dodecairon strontium nonadecaoxide

Cas Number:

12023-91-5

Molecular formula:

Fe12O19.Sr

IUPAC Name:

dodecairon(3+) strontium(2+) nonadecaoxidandiide

Constituent 2

Reference substance name:

dodecairon strontium nonadeacaoxide

IUPAC Name:

dodecairon strontium nonadeacaoxide

Results and discussion

Effect levels

Remarks on result:

not measured/tested

Target system / organ toxicity

Critical effects observed:

no

Lowest effective dose / conc.:

3 mg/L air

System:

other:

Applicant's summary and conclusion

Conclusions:

No new study required because weight of evidence evaluation covers this endpoint sufficiently. 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.