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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
health surveillance data
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
no data available
Reliability:
other: high
Rationale for reliability incl. deficiencies:
other: Well documented publication.

Data source

Reference
Reference Type:
publication
Title:
Human pulmonary responses to experimental inhalation of high concentration fine and ultrafine magnesium oxide particles
Author:
Kuschner, W.G.; et al.
Year:
1997
Bibliographic source:
Environ. Health Perspectives, Vol. 105, No. 11: 1234-1237.

Materials and methods

Study type:
medical monitoring
Endpoint addressed:
acute toxicity: inhalation
respiratory irritation
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Characterisation of human pulmonary responses to controlled experimental high-dose exposure to fine and ultrafine magnesium oxide particles.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Magnesium oxide
EC Number:
215-171-9
EC Name:
Magnesium oxide
IUPAC Name:
215-171-9
Constituent 2
Reference substance name:
1309-48-4
Cas Number:
1309-48-4
IUPAC Name:
1309-48-4
Constituent 3
Reference substance name:
magnesium oxide
IUPAC Name:
magnesium oxide
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Magnesium oxide dust
No further details are given.

Method

Type of population:
general
Ethical approval:
not specified
Details on study design:
Subjects: 6 healthy volunteers, 4 male and 2 female subjects, 3 smokers and 3 non-smokers, aged between 21 and 43.
Treatment: Inhalation of fine and ultrafine magnesium oxide particles produced from a furnace system model. Individual exposure concentrations were (duration in parentheses) 5.8 (45 min), 230 (15 min), 210 (20 min), 123 (45 min), 110 (45 min), and 143 (45 min) mg/m³, given as MgO. By weight, 28 % of the fume particles were ultrafine (<0.1 µm in diameter) and over 98 % of fume particles were fine (<2.5 µm in diameter).
Subjects inhaled magnesium oxide fume with medical-grade air through a mouth-breathing face mask.
Observations: 18 to 20 hours after inhalation, bronchoalveolar lavage (BAL) cell and cytokine concentrations, pulmonary function and peripheral blood neutrophil concentrations were quantified. Post-exposure studies were compared with control studies from the same 6 subjects.

Results and discussion

Results:
Over 98% of fume particles were fine or ultrafine and 98.6 % were less than 1.8 µm in diameter.
There were no significant differences in BAL inflammatory cell concentrations, BAL interleukin (IL)-1, IL-6, IL-8, tumour necrosis factor, pulmonary function or peripheral blood neutrophil concentrations compared with controls.
The high-dose fine and ultrafine magnesium oxide particle exposure did not produce a measurable pulmonary inflammatory response.
None of the test persons reported any exposure-related symptoms.

Applicant's summary and conclusion

Conclusions:
It was concluded that fine and ultrafine particle inhalation (MgO) do not result in toxicity in a generic manner independent of particle composition. The findings support the concept that particle chemical composition, in addition to particle size, is an important determinant of respiratory effects.