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Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifcally acceptable

Data source

Reference
Reference Type:
publication
Title:
Experimental human exposure o N,N-dimethylbenzylamine: generation of a controlled atmosphere and biological monitoring
Author:
Stahlbom B, Akesson B, Jönsson B
Year:
1997
Bibliographic source:
Int. Arch. Occup. Environ. Health (1997) 70: 393-398

Materials and methods

Type of study / information:
in vivo experiment with human volunteers
Endpoint addressed:
basic toxicokinetics
Principles of method if other than guideline:
6 healthy non-smoking male volunteers were exposed to concentrations of 20, 45, and 80 µg/m³ of DMB. for 8 hours. Concentrations of DMBA in
exspired air and urine were determined. Uptake and elimination were calculated.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no further detail given

Method

Ethical approval:
not specified
Details on study design:
6 Healthy non-smoking male volunteers aged 31-38 years participated in the study. The volunteers did not use any drug or alcohol within 24 hours of or during the experiment.The exposure chamber was a 4.7 m³- room. The volunteers were exposed against 20, 45, and 80 µg/m³, respectively, for 8 hours. The air concentration was determined in parallel with the exhaled air sampling also measuring the breathing volume. DMBA uptake was calculated as the difference between the exposure level and the concentration in exhaled air
Urine samples were collected before and 2, 4, 6 and 8 h after the onset of exposure. Urine samples were taken for up to 24 h after the end of the exposure. To determine the total urinary amount of DMBA possible metabolites (not determined) have to be reduced to DMBA
Exposure assessment:
measured
Details on exposure:
The exposure chamber was a 4.7 m³- room. The volunteers were exposed against 20, 45, and 80 µg/m³, respectively, for 8 hours

Results and discussion

Results:
DMBA uptake by inhalation was 76%.
DMBA was quickly distributed and biotransformed to nearly 100 % since no free DMBA could be detected.
DMBA was eliminated by expired air ranging from 3 % to 6 %
After chemical reduction total urinary DMBA could be detected.
The excretion of DMBA in urine increased rapidly during exposure period and decreased quickly after the end of exposure. More than 50 % was eleminated within 2 hours of exposure. DMBA was eleminated in the urine with a half time of 4.3 h (range. 4.2-4.8 h)
The total amount of DMBA excreted during the exposure and during post exposure period for up to 24 hours, expressed as a fraction of the total respiratory uptake, was 90 % (range: 63-146 %).

Applicant's summary and conclusion

Executive summary:

6 healthy volunteers in an exposure chamber were exposed against 20, 45, or 80 µm/m³ for 8 hours DMBA uptake by inhalation was 76%.DMBA was quickly distributed and biotransformed to nearly 100 %. DMBA was eliminated by expired air ranging from 3 % to 6 %. The excretion of DMBA in urine increased rapidly during exposure period and decreased quickly after the end of exposure. More than 50 % was eleminated within 2 hours of exposure. DMBA was eleminated in the urine with a half time of 4.3 h (range. 4.2-4.8 h). The total amound of DMBA excreted during the exposure and post exposure for up to 24 hours, expressed as a fraction of the total respiratory uptake, was 90 % (range: 63-146 %).