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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
Myoinositol. III. Effect of an Excess Dosage of Myoinositol on the Pattern of Lipids in the Liver of Young Rats
Author:
Natsume K
Year:
1965
Bibliographic source:
Bitamin, 32(4):363-368

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Male rats were given oral doses of the test substance for 45 days.
GLP compliance:
no

Test material

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

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
45 days
Frequency of treatment:
Daily
Doses / concentrationsopen allclose all
Dose / conc.:
10 mg/kg bw/day (nominal)
Remarks:
20-day old rats for 45 days; 10.0 mg/kg/day is equivalent to 0.5 mg/animal/day
Dose / conc.:
100 mg/kg bw/day (nominal)
Remarks:
20-day old rats for 45 days; 100.0 mg/kg/day is equivalent to 5 mg/animal/day
Dose / conc.:
200 mg/kg bw/day (nominal)
Remarks:
20-day old rats for 45 days; 200.0 mg/kg/day is equivalent to 10 mg/animal/day
Dose / conc.:
1 000 mg/kg bw/day (nominal)
Remarks:
20-day old rats for 45 days; 1000.0 mg/kg/day is equivalent to 50 mg/animal/day
Dose / conc.:
5 mg/kg bw/day (nominal)
Remarks:
3-month-old rats for 1 month
Dose / conc.:
50 mg/kg bw/day (nominal)
Remarks:
3-month-old rats for 1 month
Dose / conc.:
500 mg/kg bw/day (nominal)
Remarks:
3-month-old rats for 1 month
Dose / conc.:
5 000 mg/kg bw/day (nominal)
Remarks:
3-month-old rats for 1 month
Control animals:
yes, concurrent vehicle

Examinations

Other examinations:
Growth of the animals was determined. Total lipids, total cholesterol and serum in the liver were determined, and urine was analyzed for the test substance.

Results and discussion

Results of examinations

Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Growth for the 20-day old rats administered 0.5 mg/animal/day (the 10 mg/kg/day group) was better than the control group while growth for the 50 mg/animal/day (the 1000 mg/kg/day group) was slightly retarded when compared with the control group. For the 3-month-old rats, no compound-related effects on growth were noted.
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
not specified

Effect levels

Dose descriptor:
other: adverse effects
Remarks on result:
other: Administration of the test substance exhibited a favourable effect on the growth rate of rats at doses of 0.5-5 mg/animal/day. Slight growth retardation was observed at 50 mg/animal/day evident 10-15 days after onset of administration.

Target system / organ toxicity

Critical effects observed:
no

Applicant's summary and conclusion

Executive summary:

The effects of the test substance on the weight gain and liver lipid pattern in white rats were investigated. A large dose seemed to inhibit the growth of young animals. The young animals raised on a feed containing a large dose of the test substance showed smaller weight gain than those given feeds containing the standard dosage or sub-standard dosage of the test substance. The administration of the test substance at even larger dose to mature rats produced no growth inhibition. The examination of liver lipid patterns of different groups of animals showed no significant change in the total lipid level or cholesterol level in the liver.