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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:
key study
Study period:
1980
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
U.S. HIGH PRODUCTION VOLUME (HPV) CHEMICAL CHALLENGE PROGRAM ROBUST SUMMARY Phosphorous acid, triisodecyl ester (CAS# 25448-25-3)
Author:
General Electric Company on behalf of the Phosphite Producers HPV Consortium and Phosphite Manufacturers Consortium
Year:
2001
Bibliographic source:
US Environmental Protection Agency, HPV Information System
Reference Type:
secondary source
Title:
Unnamed
Year:
2001
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Triisodecyl phosphite (CAS# 25448-25-3, Lot #TDPx-003-04070A from
Borg Warner Company, Parkersburg, WV)
Commercial, purity: > 97% (Phosphorus content = 6.17 %)

Test animals

Species:
rat
Strain:
Sherman
Sex:
male/female
Details on test animals and environmental conditions:
The animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR, Part 3.

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
The animals were exposed to the test material inside a 260-L Plexiglas exposure chamber for one hour. The material was administered as an aerosol, which was generated by a six-jet Collision nebulizer (BGI Incorporated, Waltham, MA). The air was passed through a desiccant prior to being passed through the test material.
The rate of flow through the chamber was 20 L/min at a temperature of 72°F.
Following one hour of inhalation exposure, the animals were returned to their cages and observed daily for a 21-day period for signs of toxicity and mortality.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
1 h
Concentrations:
The average concentration of the aerosol over the one-hour exposure period was calculated to be 12.6 mg/L by differential weighing of the flask from which the aerosol was generated.
The particle size (mass median diameter) of the aerosol of the test material was determined, to assure that the animals received a respirable dose, using an Andersen Sampler cascade impactor. The sampler was run for 5 minutes midway through the exposure.
During sampling, air from the breathing zone of the animals was drawn through the cascade impactor at the rate of 1 ft 3/min. The amount of aerosol impacting on each plate of the Andersen Sampler was determined by differential weighing. From these values the mass median diameter of the aerosol was calculated to be 0.48 microns and the concentration was calculated to be 0.10 mg/L.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
1 hour exposure, whole body, then 21-day post- exposure observation period

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 12.6 mg/L air
Based on:
test mat.
Exp. duration:
1 h
Remarks on result:
other: maximum attainable concentration
Mortality:
No animals died during the experiment.
Clinical signs:
other:
Gross pathology:
gross pathological examination revealed no remarkable findings

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the LC 50 was determined > 12.6 mg/L air.
No death occured during the study and no clinical signs were observed.
Executive summary:

The study method was comparable to OECD 403 guideline. This study was quoted as reliability 1, reliable without restriction by the Phosphite Producers HPV Consortium and Phosphite Manufacturers Consortium in the US HPV dossier submitted in 2001 and EPA accepted their assessment.

Sherman Wistar rats were given Triisodecyl phosphite at the maximum attainable concentration of 12 mg/L by inhalation exposure, during 1 hour, whole body.

No death occured during the study and no clinical signs were observed. The LC 50 was determined > 12.6 mg/L air.