Registration Dossier
Registration Dossier
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EC number: 246-998-3 | CAS number: 25448-25-3
Acute Toxicity: inhalation
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- other: Unpublished report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
- 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 substance name:
- Triisodecyl phosphite
- EC Number:
- 246-998-3
- EC Name:
- Triisodecyl phosphite
- Cas Number:
- 25448-25-3
- Molecular formula:
- C30H63O3P
- IUPAC Name:
- tris(2-methylnonyl) phosphite
- Reference substance name:
- 246-998-3.
- IUPAC Name:
- 246-998-3.
- 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
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Sherman/Wistar
- Sex:
- male/female
- Details on test animals or test system 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:
- other: 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.
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