Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed in 1978.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
See below
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test material was FM PHT-4 Diol received from Velsicol Chemical Corporation, Chicogo, IL.

Test animals

Species:
rat
Strain:
other: Charles River CD
Sex:
male/female

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
air
Remarks:
no data
Details on inhalation exposure:
Vapors were genereated by passing air (20 l/min) through a round bottom bubbler containing the compound at ambient termperature. The vapors emerging from the bubbler were introduced into the exposure chamber without dilution. The temperature in teh exposure chamber was ~23 degrees C. The atmosphere was considered saturated with the vapors of the test material. The concentration of the vapor (0.008 mg/L) in the chamber atmospehre was calculated from the ratio of the total weight loss of the material in teh bubbler after the exposure (0.01 g) to the total volume of air passing through the bubbler during the 1 hr period (1200 l).

During expousre, rats were cage individually in compartmented wire-mesh exposure cages. The cages were placed in a 160-l cubical, stainless steel and glass chamber. A constant chamber airflow was mainteained by means of a rotary centrifugal air pump located at the exhaust side of the chamber.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
ca. 1 h
Concentrations:
0.008 mg/L
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
Animal were observed for clinical signs and mortality during and following the 1 hr exposure, and twice daily thereafter for 14 d.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.008 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
1 h
Mortality:
None.
Clinical signs:
other: None.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Five male and five female Charles River CD rats were exposed for one hour to an essentially saturated atmosphere (0.008 mg/L) of TBPA Diol. Observations were made during the one-hour exposure and daily thereafter for 14 days. Body weights were recorded prior to the exposure and periodically thereafter. All rats were necropsied at the end of the 14-day observation period. No deaths occurred during the 14-day observation period. No signs of toxicity were observed. The one-hour LC50 was > 0.008 mg/L. 
Executive summary:

Five male and five female Charles River CD rats were exposed for one hour to an essentially saturated atmosphere (0.008 mg/L) of TBPA Diol. Observations were made during the one-hour exposure and daily thereafter for 14 days. Body weights were recorded prior to the exposure and periodically thereafter. All rats were necropsied at the end of the 14-day observation period. No deaths occurred during the 14-day observation period. No signs of toxicity were observed. The one-hour LC50 was > 0.008 mg/L.