Diisobutyl phthalate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Scientifically acceptable well documented study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1959

Report date:

1959

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

only 7-day observation period

Principles of method if other than guideline:

BASF test was generally performed as described in OECD guideline 401

GLP compliance:

no

Test type:

standard acute method

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

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gassner
- Age at study initiation: no data
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
No additional data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10% (in the 207.8 and 1662.7 mg/kg dose groups) and 60%) (in the 1662.7, 3325.4, 6650.9, 8313.6 and 10392.0 mg/kg dose groups)
- Amount of vehicle (if gavage): 12, 16, 5.33, 10.7, 13.3 and 16.7 ml, respectively in the 207.8, 1662.7, 3325.4, 6650.9, 8313.6 and 10392.0 mg/kg dose groups

MAXIMUM DOSE VOLUME APPLIED: 16.7 ml/kg

Doses:

ca. 0, 207.8, 1662.7, 3325.4, 6650.9, 8313.6 and 10392.0 mg/kg bw (calculated from 0, 0.2, 1.6, 3.2, 6.4, 8.0 and 10.0 ml/kg bw bw considering test substance density of 1.0392g/cm3 at 20°C)

No. of animals per sex per dose:

3 (only males) in the 207.8 and 1662.7 mg/kg dose groups, 5 (only females) in the 3325.4, 6650.9 and 8313.6 mg/kg dose groups and 10 (only females) in the 10392.0 mg/kg dose group

Control animals:

yes

Details on study design:

- The test substance was administered via single dose gavage to groups of five animals per sex and dose level.
- Body weight was determined before the start of the study for determination of dose.
- Animals were observed approximately 1-3 hours after dosing and then daily over a period of 7 days.
- At necropsy, all rats were examined for gross pathological changes. No further details available.

Statistics:

none necessary

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 10 392 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 5/10 animals died at this dose level

Mortality:

see below (Table 1)

Clinical signs:

1) Clinical signs in dose groups 10392.0 - 6650.9 mg/kg bw: directly after application rats showed signs of Dyspnea, 24h later test animals were apathic and some of the animals had diarrhea. After 4-6 days animals showed no clinical signs any more - but in some cases horrent fur.

2) Clinical signs in dose groups 3200 mg/kg bw: 1 hour after application of test substance rats showed signs of Dyspnea.

Body weight:

no data

Gross pathology:

Gross pathology: 10392.0 showed signs of lobular pattern of the liver.

Other findings:

- Histopathology: 10392.0 2/2 animals showed signs of diffuse fatty degeneration of the liver.
- Potential target organs: liver

Any other information on results incl. tables

Table 1: Mortality

Dose level (mg/kg bw)	Total mortality/total animals in the group after
	1 hour	24 hours	48 hours	7 days
10392.0	0/10	2/10	4/10	5/10
8313.6	0/5	0/5	1/5	1/5
6650.9	0/5	0/5	1/5	1/5
3325.4	0/5	0/5	0/5	0/5
1662.7	0/3	0/3	0/3	0/3
207.8	0/3	0/3	0/3	0/3
0	0/10	0/10	0/10	0/10