Registration Dossier

Administrative data

Endpoint:
health surveillance data
Type of information:
other: occupational surveillance
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: occupational surveillance reported in brief

Data source

Reference
Reference Type:
publication
Title:
N,N-Dimethylbenzylamine: Occupational exposure, analysis and biological monitoring
Author:
Stahlbom B. et al.
Year:
1995
Bibliographic source:
Int. Arch. Occup. Environ. Health 67: 159-164 (1995)

Materials and methods

Study type:
biological exposure monitoring
Endpoint addressed:
basic toxicokinetics
Principles of method if other than guideline:
DMBA exposure in the air of an epoxy resin production plant was determined and some workers of this plant were examined for urinary DMBA after workshift of 8 hours.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
epoxy resin was mixed with hexahydrophthalic anhydride as a hardener in which DMBA was involved as accelerator (no further data)

Method

Type of population:
occupational
Ethical approval:
not specified
Details on study design:
--The study was carried out in a plant manufacturing electrical capacitors. Epoxy resin was used for electrical insulation. Hexahydrophthalic anhydride as a hardener was mixed with epoxy resin in which DMBA was involved as accelerator. During the process the temperature of the epoxy resin was increased to 90 °C.
--10 healthy male workers were studied. The workers were between 19 and 63 years old and had been employed for a mean of 10 years in the same kind of work: 7/10 were fillers, 2/10 repairers, 1/10 a foreman. There were no restrictions on their diet during the study.
--Exposure of DMBA was measured in the breathing zone to each worker during the full shift (8 h). The air samples were taken during 1 to 3-h periods with personal sampling pumps. A total of 36 breathing zone samples were collected during the shift. Urine specimens were sampled immediately after the workshift. The urine samples were acidified with concentrated hydrochloric acid. DMBA content in the urine was measured before and after reduction of the urine samples Determination of DMBA by gas chromatography.

Results and discussion

Results:
In the plant studied, the DMBA exposure ranged from 3 to 48 µg/m³ (mean 18 µg/m³) with a peak concentration
during a single sampling period of 91 µg/m³. The DMBA concentrationin the urine samples were below the detction
limit (0.02 mg/l) of the method used. After reduction of the urine samples the DMBA concentrations ranged from
0.02 mg/l to 0.22 mg/l. There was a significant correlation between the exposure to DMBA and the amount of DMBA
in the urine determined post reduction.

Applicant's summary and conclusion

Executive summary:

DMBA exposure in the air of an epoxy resin production plant was determined and some workers of this plant were

examined for urinary DMBA after workshift of 8 hours. In the plant studied, the DMBA exposure ranged from

3 to 48 µg/m³ (mean 18 µg/m³) with a peak concentration during a single sampling period of 91 µg/m³. The DMBA

concentrationin the urine samples were below the detection limit (0.02 mg/l) of the method used. After reduction of

the urine samples the DMBA concentrations ranged from 0.02 mg/l to 0.22 mg/l. There was a significant correlation

between the exposure to DMBA and the amount of DMBA in the urine determined post reduction.