Magnesium

Health surveillance data

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

Test material information

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.