Ibuprofen

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data are given. Review-like publication presenting studies on toxicokinetics as well as on acute toxicity, repeated dose toxicity, teratogenicity, and effects on endocrine organs in different species.

Data source

Reference

Reference Type:

publication

Title:

Absorption, Distribution and Toxicity of Ibuprofen.

Author:

Adams SS et al.

Year:

1969

Bibliographic source:

Toxicol Appl Pharmacol 15: 310-330.

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

No data are given on test guidelines followed. However, the data is published in 1968; thus it can be assumed that there was no guideline available at the time period of testing.

GLP compliance:

no

Remarks:

pre-GLP study

Test type:

other: no data

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ibuprofen

EC Number:

239-784-6

EC Name:

Ibuprofen

Cas Number:

15687-27-1

Molecular formula:

C13H18O2

IUPAC Name:

2-(4-isobutylphenyl)propanoic acid

Details on test material:

- Name of test material (as cited in study report): Ibuprofen; i.e. 2-(4-isobutylphenyl)propionic acid)
- Analytical purity: no data
No further data.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
male Boots Wistar rats
- Source: Boots
- Weight at study initiation: 70-95 g
- Fasting period before study: yes, food was withdrawn at 4-6 h prior to dosing
- Diet: ad libitum
- Water: ad libitum
No further data on test animals.

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 10% acacia, 0.4% cellosize, or 0.5% methylcellulose; no further details.

Details on oral exposure:

VEHICLE
The test substance was suspended in 10% acacia, 0.4% cellosize, or 0.5% methylcellulose.

No further details.

Doses:

no data

No. of animals per sex per dose:

10 males per group

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: mortality, gross reactions
no further data

Statistics:

no data

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 1 600 mg/kg bw

Remarks on result:

other: The approximate LD50 was 1600 mg/kg bw.

Mortality:

Deaths occurred within 3 days from intestinal ulceration. No data are given on the mortality rate.
No further data.

Clinical signs:

other: Clinical signs of toxicity comprised sedation, prostration, loss of righting reflex and labored respiration. No further data.

Gross pathology:

Intestinal ulceration was reported.
No further data.

Any other information on results incl. tables

According to the authors, the results of this study indicate that ibuprofen in lethal doses depressed the central nervous system of rats and was ulcerogenic. Ulcerogenesis may have been the result of systemic and local actions.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Executive summary:

Ibuprofen induced gastrointestinal lesions in rats, the approximate lethal dose was 1600 mg/kg bw.