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:
other: acceptable with certain restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1959
Report date:
1959

Materials and methods

Principles of method if other than guideline:
BASF-Test: inhalation hazard test
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Palatinol IC (di-iso-butylphthalate; test substance number: IX/418)
- Molecular weight (if other than submission substance): 278
- Physical state: clear fluid
- Analytical purity: no data
No additional data provided

Test animals

Species:
rat
Strain:
Sprague-Dawley
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
Temperature chosen for vapor generation: 20°C
Two groups of 3 rats were exposed sequentially to the vapors by bubbling 200l/h air through a substance column of about 5cm above a fritted glass disc in a glas cyclinder for 8h.

The exposure time not causing lethality was tested twice.

No analytical determination of the atmosphere conc. was performed.
Analytical verification of test atmosphere concentrations:
no
Remarks:
The nominal concentration was calculated as quotient of the amount of test substance weight loss during the exposure (given in the raw data) and the amount of air used during exposure.
Duration of exposure:
8 h
Concentrations:
0.03 mg/l (nominal concentration); It is noticed that the calculated vapour saturation at 20°C (vapour pressure ca. 0.0000176 hPa) for the test substance would be 0.0002 mg/l
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days (or other?)
- Frequency of observations and weighing: group-wise documentation of clinical signs was performed over the 7 day study period. Body weight of groups was determined before start of the study and at the end of the clinical observation period in surviving animals.
- Necropsy of survivors performed: yes
Statistics:
none necessary

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: IRT
Effect level:
> 0.03 mg/L air
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
other: No deaths occurred when test substance atmosphere was saturated with test substance vapour at this unique dose level after 8-hour exposure period
Mortality:
No mortality was observed when 6 rats were exposed for 8 hours / 20C to a saturated atmosphere with the test substance.
Clinical signs:
other: no adverse effects observed
Body weight:
see Table 1; no adverse effects observed
Gross pathology:
2/6 animals showed pneumonia.

Any other information on results incl. tables

Table 1: Mean body weight

Dose level (mg/l)

Mean body weight (g) at indicated time period

At study begin

After 3 days

After 7 days

0.03 mg/l

145.7

146.7

151.8

Applicant's summary and conclusion