Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with national standard methods (AFNOR norm).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
The temperature measured at the end of the experiment was 27°C, above the recommended limit of 25°C; only one concentration was tested; there was no monitoring of the test atmosphere: test concentration, particle size and oxygen level not measured
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): UGILEC 101
- Physical state: colourless liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: IFFA CREDO, France
- Age at study initiation: not reported
- Weight at study initiation: 188 - 200 g (mean: 193.5 g)
- Fasting period before study: not reported
- Housing: 5 per cage
- Diet (e.g. ad libitum): Sourifarrat 18%, ad libitum except during exposure
- Water (e.g. ad libitum): ad libitum except during exposure
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: not reported

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: pure air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: stainless steel cage
- Exposure chamber volume: 350 x 240 x 200 mm (100 L)
- Method of holding animals in test chamber: 5/sex/cage
- Source and rate of air: pure air passed through a debimeter; the rate was 1000 L/h
- Air changes (per hr): 10
- Method of conditioning air: not indicated
- System of generating particulates/aerosols: pure air passed through a debimeter, then in a 500-mL erlenmeyer containg 350 mL of the substance, heated at 70°C by thermo-shaking, and then delivered to the exposure chamber
- Method of particle size determination: particle size not determined
- Treatment of exhaust air: not reported
- Temperature, humidity, pressure in air chamber:
beginning: 22°C and 45% humidity
end: 27°C and 53% humidity


TEST ATMOSPHERE
- Brief description of analytical method used: Theoretical nominal concentration calculated by the ratio between the weight of substance per time unit (determined by the difference in the weight of the erlenmeyer) and air volume that passed into the exposure chamber during this time unit.
- Samples taken from breathing zone: no
- Particle size distribution: not determined
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): not determined


VEHICLE: air
- Concentration of test material in vehicle (if applicable): 1.88 mg/L
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
1.88 mg/l
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation and weighing on days 1, 2, 4, 7 and 14
- Necropsy of survivors performed: yes
Statistics:
Not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC0
Effect level:
> 1.88 mg/L air
Exp. duration:
4 h
Mortality:
No mortality was observed
Clinical signs:
Slight sialorrhea observed only during the 2 first hours of treatment.
No other clinical signs were observed during the exposure and post-exposure periods.
Body weight:
A slight decrease in the bodyweight of females was observed at day 1, then the observed bodyweight gain was normal during the study reminder.
The bodyweight of males was normal throughout the study period.
Gross pathology:
No effects were observed

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LC0 in rats by inhalation was found to be > 1.88 mg/L.
Executive summary:

The acute toxicity of benzyl toluenes vapors generated at 70°C was tested in a group of 10 Sprague-Dawley rats (5 males and 5 females). Exposure duration were 4 hours and the maximum concentration reached was 1.88 mg/l. The mortality and general behavior of the animals were observed for a period of 14 days after the administration of the test substance. Under these experimental conditions, benzyl toluenes did not induce any mortality, toxic effects and decrease of the body-weight gain.