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Toxicological information

Acute Toxicity: inhalation

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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

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-1,2,3-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.

Applicant's summary and conclusion