Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
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

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
Details on test animals 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

Applicant's summary and conclusion