Registration Dossier

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Triphenyl Phosphite
- Lot/batch No.: TPPX-Z18-04080A (Borg Warner)

Test animals

Species:
rat
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 200-210 average weights
- Housing: 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
- Exposure chamber volume: 260 l
- Method of holding animals in test chamber:
- Source and rate of air: 20 liters per minute
- System of generating particulates/aerosols: six jet Collision nebulizer (BGI Incorporated, Waltham, Mass.). The air was passed through a desleant prior to being passed through the test material
- Method of particle size determination: Andersen Sampler cascade impactor. From these values the mass median diameter of the aerosol was calculated to be 0.73 microns and the concentration was calculated to be 0.10 mg/L.
- Temperature, humidity, pressure in air chamber: 70°F
Duration of exposure:
1 h
Concentrations:
6.7 mg/liter
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 21
- Frequency of weighing: day 0 and day 21
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 6.7 mg/L air (nominal)
Exp. duration:
1 h
Mortality:
No mortalities occurred.
Clinical signs:
other: No adverse effects were observed during the one hour exposure period. No untoward symptoms were observed during the three week post exposure observation period.
Body weight:
The animals gained weight during the course of the study.
Gross pathology:
Gross pathologic examination revealed nothing remarkable.

Any other information on results incl. tables

Andersen Sampler:

Concentration = 0.24 mg/liter

Particle size = 0.73µ MMD (mass median diameter)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met