Registration Dossier

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:
1982
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

Constituent 1
Chemical structure
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

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