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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No further information available.

Data source

Reference
Reference Type:
other: Unpublished report
Title:
Unnamed
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
Other (1980).
GLP compliance:
yes
Test type:
other: Needed for data submission
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): Triisodecyl phosphite
- Commercial, purity: > 97% (Phosphorus content = 6.17 %)
- Lot/batch No.: TDPx-003-04070A
- Supplier: Borg Warner Company, Parkersburg, WV

Test animals

Species:
rat
Strain:
other: Sherman/Wistar
Sex:
male/female
Details on test animals and environmental conditions:
- 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:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION- Exposure apparatus: plexiglass exposure chamber - Exposure chamber volume: 260-L - Source and rate of air: rate of flow through the chamber was 20 L/min - System of generating particulates/aerosols: 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 desicant prior to being passed through the test material. - Method of particle size determination: - Temperature: 72o FTEST ATMOSPHERE- Brief description of analytical method used: 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 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.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
1 h
Concentrations:
No further information available.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 21 days

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 12.6 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 informationCriteria used for interpretation of results: EU
Conclusions:
There were no signs of acute inhalation toxicity based on exposure to an aerosol (above vapour saturation point).
Executive summary:

LC50 (aerosol) was >12.6 mg/L. The substance is not acutely toxic via the inhalation route and not classifiable.