Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to internationally accepted guidelines.

Data source

Reference Type:
study report
Report Date:

Materials and methods

Test guideline
according to
EPA OPP 81-3 (Acute inhalation toxicity)
GLP compliance:
Test type:
standard acute method

Test material

Test material form:
solid: particulate/powder
migrated information: powder
Details on test material:
- Name of test materialSuttocide® A (Powder) - Analytical purity:98.45% (Certificate of Analysis included) - Storage: The test article was stored at room temperature and humidity. - Date received01/13/97 - Appearance: White powder

Test animals

Details on test animals and environmental conditions:
TEST ANIMALS- Source: Ace Animals, Boyertown, PA, USA- Quarantine period of at least one week- Age at study initiation: 8 to 12 weeks- Weight at study initiation: 240 - 259 grams for males and 234 - 258 grams for females- Housing: 1 /cage in suspended cages. Bedding was placed beneath the cages and changed at least three times/week.- Diet (e.g. ad libitum): Fresh Purina Rat Chow (Diet #5012)- Water (e.g. ad libitum): tap water

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Details on inhalation exposure:
Dosing:Five male and five female rats were exposed to Suttocide® A (Powder), 2.3 mg/I, in an inhalation chamber for four hours. Following exposure the animals were returned to individual housing and observed for 14 days. Chamber Conditions: A 57 liter dynamic glass chamber designed to insure uniform spatial distribution of aerosols and which permitted continuous observation during exposure was used. The chamber was partitioned internally with wire screening into a total of ten non-restraining cubicles. One animal was placed in each cubicle. Chamber temperature and humidity of air entering the chamber were recorded. The airflow through the chamber was calculated to yield at least 1 O to 15 air changes per hour so that adequate oxygen was supplied to the animals. The chamber was maintained at a negative pressure differential to the immediate environment in order to keep the test atmosphere contained. The temperature, humidity, airflow and negative pressure were recorded at approximately thirty minute intervals during the. exposure period. Generation:Suttocide® A (Powder) was fed into a Venturi Dust Generator (lntox) via an augmented screw feeder. During the pretest concentration calibration phase, various screw feeder rates were used until the proper flow rate for generating each concentration was determined. The air flow in the Venturi tube creates suction at the constricted area and the shear flow downstream disperses the particles into aerosol form. The Venturi was powered using pre-filtered compressed air at 20 psi. Nozzle pressure was monitored using a pressure gauge and was recorded initially. The air flow through the chamber was adjusted to insure adequate mixing and uniform concentration of the test article. The chamber atmosphere was exhausted through a tube from the bottom of the chamber, thereby insuring that the aerosol was drawn over the animals' breathing zone. The exhaust air was passed through filters before entering into a rotameter and vacuum pump.
Analytical verification of test atmosphere concentrations:
Duration of exposure:
4 h
Actual concentration was determined gravimetrically during exposure to be 2.3 mg/I. Particle size analyses revealed a mass mean aerodynamic diameter of 7.0 with a geometric standard deviation of 2.06.
No. of animals per sex per dose:
Control animals:
Details on study design:
Type and Frequency of Observations:- In Vivo - Animals were observed at hourly intervals during exposure, at one hour post exposure and once daily thereafter for 14 days for signs of toxicity and pharmacological effects. The animals were observed twice daily for mortality. Body weights were recorded pretest, weekly, at death and at termination in the survivors. - Post Mortem: All animals were examined for gross pathology.

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 2.3 mg/L air
Based on:
test mat.
Exp. duration:
4 h
All animals survived the four hour 2.3 mg/I exposure.
Clinical signs:
other: Physical signs of chromodacryorrhea, ocular abnormalities, wetness of the nose/mouth and anogenital area, red staining of the nose/mouth area, coating of fur with test article and abnormal licking were noted during the exposure period. Instances of chromo
Body weight:
Body weight changes were normal in 7/1 O animals. Three females lost weight at some time during the observation period.
Gross pathology:
Necropsy results were normal.

Applicant's summary and conclusion

Interpretation of results:
relatively harmless
Migrated informationCriteria used for interpretation of results: EU