Diisobutyl phthalate

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:

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

Test material information

Constituent 1

Reference substance name:

Diisobutyl phthalate

EC Number:

201-553-2

EC Name:

Diisobutyl phthalate

Cas Number:

84-69-5

Molecular formula:

C16H22O4

IUPAC Name:

diisobutyl phthalate

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