Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Triphenyl phosphite
- Commercial purity: > 97% (Phosphorus content = 10.0 %)
- Lot/batch No.: TPPx-Z18-04080A
- Supplier: Borg Warner Company, Parkersburg, WV

Test animals

Species:
rat
Strain:
other: Sherman-Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Housing: 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:
not specified
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: plexiglass
- Exposure chamber volume: 260 L
- Source and rate of air: 20 L/min
- System of generating particulates/aerosols: six-jet Collision nebulizer (BGI Incorporated, Waltham, MA). The air was passed through a desicant prior to being passed through the test material.
- Method of particle size determination: 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 ft3/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.
- Temperature, humidity, pressure in air chamber: 72 degree F
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.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
1 h
Concentrations:
Data needed for CSR report.
The sample was dosed as supplied (described as a colorless to straw-colored liquid).
No. of animals per sex per dose:
5
Control animals:
other: Data used for CSR
Details on study design:
- Duration of observation period following administration: 21 days
- Frequency of observations and weighing: observed daily for a 21-day period for signs of toxicity and mortality.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 6.7 mg/L air
Mortality:
No animals died during the experiment.
Clinical signs:
No adverse effects were observed during the one-hour exposure period. No untoward signs and symptoms were observed during the 21-day post exposure observation period.
Gross pathology:
Gross pathological examination revealed no remarkable findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LC50 (aerosol) was >6.7 mg/L. TPP is not acutely toxic via the inhalation route and not classifiable.
Executive summary:

LC50 (aerosol) was >6.7 mg/L. TPP is not acutely toxic via the inhalation route and not classifiable.