Dimethyl ether

Health surveillance data

Administrative data

Endpoint:

health surveillance data

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other:

Remarks:

Rather limited reported study. Focus on absorption and contents in blood. This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Study type:

other: absorption

Endpoint addressed:

basic toxicokinetics

Principles of method if other than guideline:

The present study in humans was meant to evaluate the absorption of the test substance by measuring test substance concentrations in blood.

GLP compliance:

no

Remarks:

pre GLP

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl ether

EC Number:

204-065-8

EC Name:

Dimethyl ether

Cas Number:

115-10-6

Molecular formula:

C2H6O

IUPAC Name:

dimethyl ether

Details on test material:

- Purity: no info given except that the purity was similar to that normally required for consumer use

Method

Type of population:

not specified

Details on study design:

The present study in humans was meant to evaluate the absorption of the test substance by measuring test substance concentrations in blood.
HUMAN VOLUNTEERS
- Sex: male
- Condition: in good health
- Weight/length: 57 kg / 1.63 m; 63.5 kg / 1.76 m; 96 kg / 1.86 m; 91 kg/ 1.87 m

Results and discussion

Results:

Pharmacokinetic studies
Absorption: First 3 volunteers: Test substance was measured in blood at levels between ca. 14 and 81 ppb (µg/L blood). Volunteer no. 4 (applicator): Test subsatnce was measured in blood at levels of ca. 122-563 ppb (µg/L blood)
Excretion: First 3 volunteers: the concentrations of test subsatnce decreased slowly in blood. Volunteer no. 4 (applicator): the concentration of test substance in blood decreased rapidly in first instance (elimination constant ca. 15-20 min), followed by a slower clearance

Applicant's summary and conclusion

Conclusions:

1. Following a single short spraying application, test substance concentrations in blood are low. viz. 20-50 ppb (i.e. 20-50 µg/L blood)
2. Following a longer exposure duration (i.e. 15 min in a non-ventilated room of ca. 20 m3), in which 3 persons were sequentially sprayed (every 5 min), test substance concentrations in blood may rise up to ca. 0.5 ppm (ca. 500 µg/L blood). These test substance concentrations, however, decrease rapidly during the alpha-phase of the elimination.

The study and the conclusions fulfil the quality criteria (validity, reliability, repeatability).

Executive summary:

The study was performed to investigate the toxicokinetics of the test material following hairspray-like application to male volunteers. The study was not performed according to a guideline. Three males were exposed for 15 sec each during which period the test substance (ca. 3 g) was sprayed around their head for 7 sec in total. Blood was sampled between 2 -15, 15 -31.5 and 30 -52 min after exposure, respectively, to determine blood test substance concentrations. A 4th male volunteer, who did the spraying applications at the other volunteers in a sequence of one person every 5 min, stayed in the non-ventilated room (ca. 20 m3) for the whole 15 -min period. It was calculated that he had been exposed to ca. 450 mg/m3 (ca. 240 ppm) for 15 min assuming homogeneous distribution in the exposure room. His blood was sampled between 2 and 60 min after exposure.

Following a single short spraying application to the 3 volunteers, test substance concentrations in their blood were low. viz. 20 -50 ppb (i.e. 20 -50 µg/L blood).

Following a longer exposure duration (i.e. 15 min in a non-ventilated room of ca. 20 m3), test substance concentrations in blood may rise up to ca. 0.5 ppm (ca. 500 µg/L blood). These test substance concentrations, however, decreased rapidly during the alpha-phase of the elimination.