Registration Dossier

Administrative data

acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in International Research and Development Corporation

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
no guideline available
Principles of method if other than guideline:
Male and female rats were housed individually in a wire mesh cages and kept through out the experiment in controlled temperature and humidity.
Food and water was supplied ad libitum except when rats were in the control chamber.
During exposure rats were caged individually in a exposure cages, with a constant chamber airflow.
the dust athmosphere of the compound is generated by dispersing the powder at a calculated rate with a specially constructed dust generator.
Observations for pharmacotoxic signs and mortality are being conduced.
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:

Test material

Constituent 1
Reference substance name:
CH-100-993, 975-64
CH-100-993, 975-64
Constituent 2
Reference substance name:
BP4A Bis(2,3-dibromopropyl)ether
BP4A Bis(2,3-dibromopropyl)ether
Test material form:
solid: particulate/powder
migrated information: powder
Details on test material:
The compound was received from the Velsicol Chemical Corporation, Chicago, illinois

Test animals

other: Charles river CD
Details on test animals or test system and environmental conditions:
5 males and 5 females
Weight: 286-300 gr (males); 229-240 gr (females)
Rats were housed individually in wire-mesh cages and kept throughout the pre- and post- exposure periods in a temperature and humidity controlled room.
Purina laboratory Chow and water were supplied ad libitum except when rats where in the exposure chamber.
During exposure the rats were caged individualy in compartmented wire-mesh exposure cages.
The cages were placed in a 160 liter cubical stainless steel glass chamber. A constant chamber airflow was maintained by means of a rotary centrifugal air pump located at the exhaust side of the chamber. The chamber exhaust was filtered with an activated charcoal filter and a cambridge Absolute filter before being discharged outside of the laboratory.

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Details on inhalation exposure:
Dust Atmosphere: The dust atmosphere of the compound was generated by dispersing the powder at a calculated rate, with a specially constructed dust generator located near the chamber air inlet at the top of the exposure chamber. This dust generator consisted of a revolving plate with calibrated "cups" for transporting a known quantity of powder per unit time from a reservoir to a "blowhole". At the "blowhole" the powders in a "cup" were dispered into the chamber by a jet of air blowing at the rate of 10 L/min. The dusts emerging from the dust generator were diluted by the incoming chamber air at the rate of 5 L/min.
The actual quantity of powder disseminated (21.97 g/hr) was determined by weighing the quantity of powder in the reservoir before and after the experiment. The concentration of the dusts (24.4 mg/l) in the chamber atmosphere was calculated from the ration of the rates of powder dissimination (366.2 mg/min) to the total chamber airflow (15 L/min, the volume of air ejected from the dust generator plus the volume of make-up air).
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
1 h
24.4 mg/l (nominal concentration)
No. of animals per sex per dose:
5 males and 5 females
Control animals:
Details on study design:
Observations for pharmacotoxic signs and mortality were made durnig and immediately following the 1 hr exposure period and daily thereafter for 14 days. Individual body weights were recorded prior to the 1 hr exposure and periodically thereafter in order to detect any transient effects following the exposure. All surviving rats were sacrificed and discarded at the end of the 14 day observation period.

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 24.4 mg/L air (nominal)
None of the animals died during the experiment.
Clinical signs:
other: All rats appeared normal throughout the 14 day observation period.
Body weight:
Body weight gain of all rats appreared unaffected throughout the 14 days observation period.
Other findings:
increase inrespiratory rate during the exposure

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Migrated information Criteria used for interpretation of results: EU
The test substance was found to be non toxic by inhalation.
Executive summary:

Inhalation exposure of rats for 1 hr to a dust atmosphere of CH-100 -993, 975 -64 at a nominal concentration of 24.4 mg/l resulted in an increae in respiratory rate during the exposure. No other adverse effects were observed postexposure. No deaths occured during the experimental period and the body weight gain of all the rats appeared unaffected.