Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed prior to international gudielines and good laboratory practices. It used a micronized form of the commerical product. Micronization may impact (e.g. increase) the potential for toxicity.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974

Materials and methods

Principles of method if other than guideline:
Rats were exposed to a single concentration of the test material for 4 hours and observed for 14 days afterward.
GLP compliance:
no
Test type:
fixed concentration procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
A micronized form of the test material was used.

Test animals

Species:
rat
Strain:
other: Spartan
Sex:
male/female
Details on test animals and environmental conditions:
Five male and five female rats were used. The rats were housed by sex in groups of 5 in metal cages above the droppings in temperature and humnidity contolled quarters. Purina Laboratory Chow and water were available ad libitum.

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
"The group of 10 rats was placed in a sealed 59.1 liter glass chamber and exposed for 4 hours to a dynamic atmosphere containing the dust of the test material. In order to prevent "piling up" during the exposure, the rats were separated into 4 units of 2 or 3 rats each. Addition of the test compound to the test chamber atmosphere was controlled by a Wright Dust Feeder. Dried and filtered air was passed through the mechanism and directly into the exposure chamber. Airflow was regulated by means of a flowmeter (Gelman Insturment Company, Ann Arbor, Michigan, Model No. 8221). The calculated atmospheric concentration administered was approximately 10.92 mg/L* of FM PHT4 (micronized), Lot N0. 6332-B.
*The physical properties of the test compound precluded administration of the test material at a higher atmospheric concentration."
Duration of exposure:
4 h
Concentrations:
10.92 mg/L
No. of animals per sex per dose:
5M/5F
Control animals:
no
Details on study design:
The rats were observed continuously during and immediately after the 4 hr exposure. All rats which died on study were necropsied. All surviving animals were necropsied at the end of the 14 d observation period.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 10.92 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
None.
Clinical signs:
During exposure: decreased activity, eye squint, slight dyspnea, erythema.
At 24 hr: 1 rat with nasal "porphyrin" discharge.
At 10-14 days: several rats with diarrhea.
Body weight:
All rats exhibited normal body weight gain during the study.
Gross pathology:
No compound-related gross lesions were observed.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The 4 hr LC50 in rats was > 10.92 mg/L.