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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
review article or handbook
Title:
Inositol Safety: Clinical Evidences
Author:
Carlomagno G and Unfer V
Year:
2011
Bibliographic source:
European Review for Medical and Pharmacological Sciences, 15:931-936

Materials and methods

Study type:
clinical case study
Endpoint addressed:
repeated dose toxicity: oral
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Clinical trials ranging from 1 to 12 months were carried out in order to evaluate the effects of the test substance in pathologic conditions, mainly neuropsychiatric disease (depression, Alzheimer disease, panic disorder) and polycystic ovary syndrome (PCOS).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Purity: not reported

Method

Type of population:
other: patients with pathologic conditions (depresskon, Alzheimer disease, panic disorder, and polycystic ovary syndrome)
Ethical approval:
not specified
Route of exposure:
oral
Reason of exposure:
intentional
Exposure assessment:
measured
Details on exposure:
Patients were orally administered the test substance for treatment of neuropsychiatric disease (depression, Alzheimer disease, panic disorder) and polycystic ovary syndrome (PCOS). Dose levels ranged from 4 to 30 g/day (equal to 67 to 500 mg/kg bw/day for a 60 kg person), and the duration of the treatments ranged from 1 to 12 months.

Results and discussion

Outcome of incidence:
No mortality was reported. The most frequently reported symptoms were flatulence, loose stool, or diarrhea. Mild gastrointestinal symptoms were experienced for the first month only. Additional symptoms included mild insomnia, nausea, increased glycemia, sleepiness, tiredness, and/or headache.

Applicant's summary and conclusion

Conclusions:
No mortality was reported in clincal trials with the test substance at doses up to 30 g/day. The test substance at doses greater than 12 g/day induced mild gastrointestinal side effects such as nausea, flatus and diarrhoea.
Executive summary:

Data from 12 controlled clinical trials in a total of 250 adults given oral doses of 4 to 30 g inositol/person per day (equal to 67 and 500 mg/kg bw per day for a 60 kg person) over 1 to 12 months were reviewed.No mortality was reported. The most frequently reported symptoms were flatulence, loose stool, or diarrhoea. Mild gastrointestinal symptoms were experienced for the first month only. Additional symptoms included mild insomnia, nausea, increased glycemia, sleepiness, tiredness, and/or headache.