Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
publication
Title:
OECD HPV Chemical Programme, SIDS Dossier, approved at SIAM 28, 14-17 April 2009
Author:
OECD
Year:
2009
Bibliographic source:
https://hpvchemicals.oecd.org/UI/SIDS_Details.aspx?id=56B1CBB4-88AD-496E-87DD-C40C05BC9E9B

Materials and methods

Type of study / information:
Occupational exposure to test material measured at production site in Japan
Endpoint addressed:
not applicable
Principles of method if other than guideline:
Sampling of the test substance was performed during working hours, indoors and outdoors when the possibility of exposure to humans is high. Sampling was done by collecting air from near the mouth of workers. To complete this, workers were asked to repeat the operations for 2 to 6 times before sampling the air. Where possible, air was also sampled from besides the waist.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Bumetrizole
EC Number:
223-445-4
EC Name:
Bumetrizole
Cas Number:
3896-11-5
Molecular formula:
C17 H18 Cl N3 O
IUPAC Name:
2-tert-butyl-6-(5-chloro-2H-benzotriazol-2-yl)-4-methylphenol
Test material form:
solid

Method

Ethical approval:
not applicable
Details on study design:
Sampling and analytical method: The sample was collected via a glass fiber filter (Toyo Roshi Inc. / GB100R, diameter 37 mm) and filter cassette (SKC / 2-CP, diameter 37 mm) at an aspiration rate of 2.0 L/min. After collection, the glass fiber filter was extracted with 5 mL of dichloromethane by sonication for 30 min. The extracted solution was centrifuged at 3000 rpm for 10 minutes to remove any fibers and the supernatant liquid was analysed by liquid chromatography using a UV detector. LOQ = 0.0058 mg/m³ in air.

Exposure assessment:
measured
Details on exposure:
TYPE OF EXPOSURE: inhalation exposure

TYPE OF EXPOSURE MEASUREMENT: Area air sampling (near the mouth) and where possible, near the waist

Results and discussion

Results:
See table 1.
Occupational exposure to the substance can occur mainly by inhalation and dermal routes at the production and user sites during operations. The atmospheric concentration was measured at one production site in Japan. The monitored data are shown in table 1. It should be noted that operators wear overalls, gloves, helmets, protective eye goggles and a respirator during all operations, minimizing their exposure to the substance.

The air concentration of bumetrizole was in the range < 0.0058 mg/m³ - 0.21 mg/m³. The highest concentration was associated with removal of the product from the centrifuge, with the concentration around the workers mouth reaching 0.21 mg/m³.

Any other information on results incl. tables

Table 1 Measurement results of in-air concentration of bumetrizole during operation

Operation

Frequency of operation

Duration of operation

Sampling time

n

Range

Arithmetic average

Geometric average

Minimum (mg/m3)

Maximum (mg/m3)

Average (mg/m3)

S.D. (mg/m3)

Average (mg/m3)

S.D.

Diazotization and coupling reaction

1/day

120 min

30 min

2

<0.0058*

<0.0058*

<0.0058*

<0.0058*

Reductive reaction/ end check

1/day

20 min

17 min

6

<0.010*

<0.010*

<0.010*

<0.010*

Reductive reaction/ separation

1/day

30 min

30 min

6

0.0085

0.043

0.020

0.017

0.015

2.2

Automatic centrifuge of product

6/day

60 min

30 min

2

<0.0058*

0.0068

0.0063

0.0007

0.0062

1.1

Product scraping of centrifuge

1/day

10 min

10 min

6

<0.018*

0.021

0.018

0.001

0.018

1.1

Product removal from centrifuge

6/day

10 min

10 min

6

<0.018*

0.21

0.080

0.097

0.040

3.5

Carry in to drying process

6/day

10 min

10 min

6

<0.018*

0.098

0.032

0.032

0.025

2.0

Product packaging

Filling operation

6/day

30 min

26 min

6

0.0083

0.052

0.030

0.016

0.026

1.9

*Limit of determination of the analytical method for the sampling time

Applicant's summary and conclusion