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Toxicological information

Health surveillance data

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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: see 'Remark'
Remarks:
No data on batch no., composition not given (only indication that DME was of a purity as normally required for consumer products). 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:
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 which are drawn from it 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.