Bumetrizole

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Remarks:

Unreliable testing facility. IBT was convicted for having falsified study reports.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

Animals were exposed (whole body exposure) to the maximum attainable dust concentration for 4 hours and then observed for 14 days.

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

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

Specific details on test material used for the study:

- Name of test material (as cited in study report): TU 1104

Test animals

Species:

rat

Strain:

other: Albino Charles River

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: young adult
- Weight at study initiation: average of 286 g
- Fasting period before study: none
- Housing: individually in stock cages
- Diet: Purina Rat Chow; ad libitum (except during the exposure period)
- Water: ad libitum except during the exposure period
- Acclimation period: at least 5 days

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Plexiglass inhalation chamber
- Exposure chamber volume: 70 L
- Method of holding animals in test chamber: caged
- Source and rate of air: 4.9 L/min
- Method of conditioning air: not stated, but dry (-40 °C dewpoint)
- System of generating particulates/aerosols: Dust suspended in feeder and passed through a high-velocity stream.
- Method of particle size determination: Counting sample using a light microscope (< 5 µm, 6 - 25 µm and > 25 µm)
- Treatment of exhaust air: exhausted at bottom of chamber, no further details
- Temperature, humidity, pressure in air chamber: 25 °C, 30.36 inches Hg

TEST ATMOSPHERE
- Brief description of analytical method used: Test atmosphere samples were obtained by drawing air through a glass fibre filter (Gelman Instrument Co., Type E filter 99.7% efficient, 0.3 µm DOP across test). The total weight of dust collected was divided by the total volume of air drawn through the filter during the sampling period. Air flow rate for sampling was regulated by a calibrated limiting orifice.
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: Data not available in existing copy of report (although it was measured)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): no data

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

0.27 mg/L air (maximum attainable concentration)

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily (body weight measured at the end of the study)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 0.27 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: No animal died.

Mortality:

There were no deaths during the exposure period or the 14-day observation period.

Clinical signs:

other: There were no clinical signs during the exposure period or the 14-day observation period.

Body weight:

No adverse effects on body weight were noted among any of the test animals. The average 14-day body weight gain was 33 g, which is within the normal range.

Gross pathology:

Necropsy of all animals showed a slight amount of lung hyperemia. No other gross pathological alterations were observed in the tissues or organs examined.