Registration Dossier
Registration Dossier
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EC number: 258-469-4 | CAS number: 53306-54-0
Acute Toxicity: inhalation
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:
- publication
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- exposure time was only 1 hour
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Bis(2-propylheptyl) phthalate
- EC Number:
- 258-469-4
- EC Name:
- Bis(2-propylheptyl) phthalate
- Cas Number:
- 53306-54-0
- Molecular formula:
- C28H46O4
- IUPAC Name:
- 1,2-bis(2-propylheptyl) benzene-1,2-dicarboxylate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: albino rats
- Sex:
- male/female
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: all glass exposure chamber
- Exposure chamber volume: 70 L
- System of generating particulates/aerosols: The air was passed through a desiccant prior to being passed through the test material.
- Rate of air: 10.0 L/min
- Temperature in air chamber: 70°F
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 3 - 5 µm - Analytical verification of test atmosphere concentrations:
- no
- Remarks:
- concentration was calculated by differential weighing
- Duration of exposure:
- 1 h
- Concentrations:
- 20.5 mg/L (nominal)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing prior to and at the end of study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 20.5 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 1 h
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: calculated according to GHS
- Mortality:
- No mortality
- Clinical signs:
- other: Immediately after exposure the animals were wet, ruffled, agitated and raspy sounding. After 24 hours they appeared normal.
- Body weight:
- Prior to study: mean 205 g (males), 200 g (females)
End of study: mean 250 g (males), 235 g (females) - Gross pathology:
- Gross pathologic examination revealed nothing remarkable.
Any other information on results incl. tables
According to GHS the value for dust (aerosol) has to be divided by 4 in order to compare 1 hour exposure to a 4 h exposure as recommended in the guideline. Thus, the value would be above 5 mg/L.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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