Ibuprofen

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Do Non-Steroidal Anti-Inflammatory Drugs Induce Sister Chromatid Exchanges in T Lymphocytes?

Author:

Ozkul, Y; Erenmemisoglu, A; Ekecik, A; Saatci, C; Ozdamar, S; Demirtas, H

Year:

1996

Bibliographic source:

The Journal of International Medical Research 1996; 24: 84-87

Materials and methods

Type of study / information:

Sister Chromatid Assay

Endpoint addressed:

genetic toxicity

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

In total, 8 humans were treated with 800 mg ibuprofen per day for a period of two weeks. Before and after treatment blood samples were taken, of which mean numbers of chromatid exchanges in the lymphocytes were counted.

GLP compliance:

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

Test material form:

solid

Specific details on test material used for the study:

Brufen®, is the registered trade name of Atabay Pharmaceuticals Inc.

Method

Ethical approval:

not specified

Details on study design:

Test subjects: 27 women and 21 men (17 - 24 years), with diagnoses of soft-tissue injury. All patients were healthy non-smokers and non-drug users. Each patient was interviewed aboul smoking habits, use of other drugs, details of work (exposure to physical or chemical agents), past illnesses, dietary habits, hereditary diseases, consumption of alcohol and coffee and other lifestyle factors that might influence the results. The patients had received no treatment for their injuries before entering this study. Written permission was obtained from each subject.

Heparinized blood samples (5 mL) were collected for peripheral lymphocyte culture before the start of treatment and after 2 weeks' treatment. Chromosome harvesting, treatment with hypotonic solution, fixation and staining were carried out according to standard methods, as previously described. The slides were finally stained with 3% Giemsa solution for 20 min. Twenty metaphase cells per patient were analysed, under a blind protocol, for the presence of sister chromatid exchanges.

The mean numbers of sister chromatid exchanges in human lymphocytes before and after treatment were compared using Student's t-test for paired observations.

Exposure assessment:

measured

Details on exposure:

TYPE OF EXPOSURE: oral

TYPE OF EXPOSURE MEASUREMENT: blood samples

EXPOSURE LEVEL: 800 mg/day

EXPOSURE PERIOD: 2 weeks

EXPOSURE GROUPS: the group contained 8 patients

Results and discussion

Results:

There were no significant differences in the average numbers of sister chromatid exchanges in the peripheral lymphocytes of patients before and after treatment. There were no significant differences in the average numbers of sister chromatid exchanges between treated and untreated male and female patients. Analysis of the data for age in relation to sister chromatid exchanges revealed no change in the rate.