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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:
weight of evidence
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically acceptable study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Principles of method if other than guideline:
according to BASF-internal standard
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: MUS RATTUS, Brunnthal, Germany (SPF breeding)
- Age at study initiation: Not reported
- Weight at study initiation: 185 +/- 15 g
- Fasting period before study: Not reported
- Housing: Not reported
- Diet: Herilan MRH of H. EGGERSMANN KG, Rinteln/Weser, Germany, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: Not reported

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Whole-body inhalation system (groups of 5 animals are placed in wire cages which are located in a glass-steel inhalation chamber)
- Exposure chamber volume: V= 200 L
- Method of holding animals in test chamber: Wire cages
- Source and rate of air: Generator system: Continuous infusion pump UNITA I (BRAUN, Germany)
- Method of conditioning air: By means of a continuous infusion pump, constant amounts of the test substance were supplied to an evaporator heated to 75°C. The vapours that were formed were mixed with a flow of fresh air and passed into the inhalation chamber.
- System of generating particulates/aerosols: Glass evaporator with thermostat (BASF)
- Method of particle size determination: No further data
- Treatment of exhaust air: No further data
- Temperature, humidity, pressure in air chamber: No further data

TEST ATMOSPHERE
- Brief description of analytical method used: Gaschromatography
- Samples taken from breathing zone: yes (4 mm probe)
- Pressure ratio: By means of an exhaust air system, the pressure ratios in the inhalation system were adjusted in such a way that there was a pressure slightly below the atmospheric pressure (negative pressure). The inhalation mixture was offered to the animals for inhalation for 4 hours.

VEHICLE
- Composition of vehicle: fresh air
- Concentration of test material in vehicle: technical maximal attainable concentration
- Justification of choice of vehicle: volatility of test substance

TEST ATMOSPHERE
- Particle size distribution: No data available
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): No data available
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gaschromatography (HP5040 A)
Duration of exposure:
4 h
Concentrations:
2.35; 2.5 mg/L (analytical concentrations)
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- 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:
> 2.5 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: technical maximal attainable concentration
Mortality:
1/10 (2.5 mg/L) after 1 day
0/10 (2.35 mg/L)
Clinical signs:
other: Intermittently resp. irregular breathing, eyelid closure, clotty fur, long-legged and staggering gait, ruffled fur. After 4 resp. 5 days no findings.
Body weight:
2.5 mg/L: mean body weight before study start 177.5 g, after 14 days 223.5 g
2.35 mg/L: mean body weight before study start 177.5 g, after 14 days 233.5 g
Gross pathology:
Sacrificed animals: heart: dilatation of the atrium, acute congestive hyperemia; liver: slightly pale-grey
Animal that died: nothing abnormal detected.
Other findings:
Dosing group 1:
Nominal concentration: 9.78 mg/L, analytical conc. 2.5 mg/L

Dosing group 2:
Nominal concentration: 2.35 mg/L, analytical conc. 9.07 mg/L

Applicant's summary and conclusion

Executive summary:

In an acute inhalation study according to BASF-internal standard (BASF1980), the test substance was tested in 20 rats (10 animals per sex) at the technical maximal attainable concentration. The analytical concentrations were 2.35 and 2.5 mg/L. As clinical signs irregular breathing, eyelid closure, clotty fur, long-legged and staggering gait, and ruffled fur were observed up to max. 5 days after study beginning.One animal died after 1 day (2.5 mg/L), necropsy revealed no irregular findings. In sacrificed animals, observations were: heart: dilatation of the atrium, acute congestive hyperemia; liver: slightly pale-grey.The LC50 (4h) was deemed as > 2.5 mg/L (> 530 ppm).