Myo-inositol

Toxicity to reproduction

Administrative data

Endpoint:

one-generation reproductive toxicity

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:

Effects of Massive Doses of P-Aminobenzoic Acid and Inositol on Reproduction in the Rat.

Author:

Ershoff BH

Year:

1946

Bibliographic source:

Proc. Soc. Exptl. Biol. Med., 63:479-480

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The test substance was administered to rats via the diet in a 1-generation reproduction study.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Myo-inositol

EC Number:

201-781-2

EC Name:

Myo-inositol

Cas Number:

87-89-8

Molecular formula:

C6H12O6

IUPAC Name:

cyclohexane-1,2,3,4,5,6-hexol

Test material form:

solid

Details on test material:

- Purity: not reported

Test animals

Species:

rat

Strain:

Long-Evans

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not reported
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: 23 days
- Weight at study initiation: 41.8 g
- Fasting period before study: no
- Housing: Metal cages with raised screen bottoms to prevent access to feces
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): not reported
- Acclimation period:not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C):not reported
- Humidity (%):not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light):not reported

Administration / exposure

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Details on exposure:

Not reported

Details on mating procedure:

After the 60th day fed the diet, the animals were bred to males of proven fertility.

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

37 days prior to mating through weaning

Frequency of treatment:

Daily

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

1 other: %

Doses / concentrations 2

Dose / conc.:

1 other: %

Remarks:

1% para-Aminobenzoic acid was also added to the diet

No. of animals per sex per dose:

6

Control animals:

yes, plain diet

Positive control:

No

Examinations

Parental animals: Observations and examinations:

Animals were weighed weekly and vaginal smears were taken daily from the 48th day.

Litter observations:

At birth, litter were reduced to 6 each. The young were nursed and weaned on all diets except diet supplemented with test substance plus p-aminobenzoic acid.

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:

not specified

Mortality:

no mortality observed

Description (incidence):

No mortality was reported

Body weight and weight changes:

no effects observed

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:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Immunological findings:

not specified

Organ weight findings including organ / body weight ratios:

not specified

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:

not specified

Reproductive function: sperm measures:

not specified

Reproductive performance:

no effects observed

Details on results (P0)

No significant difference in rate of growth or gross appearance was observed.

Effect levels (P0)

Key result

Dose descriptor:

NOAEL

Effect level:

1 other: % in diet

Sex:

female

Basis for effect level:

other: no mortality or adverse effects reported

Target system / organ toxicity (P0)

Key result

Critical effects observed:

no

Results: F1 generation

General toxicity (F1)

Clinical signs:

not specified

Mortality / viability:

no mortality observed

Description (incidence and severity):

No mortality was reported.

Body weight and weight changes:

no effects observed

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:

not specified

Urinalysis findings:

not specified

Sexual maturation:

not specified

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

not specified

Histopathological findings:

not specified

Other effects:

not specified

Developmental immunotoxicity (F1)

Developmental immunotoxicity:

not specified

Effect levels (F1)

Key result

Dose descriptor:

NOAEL

Generation:

F1

Effect level:

1 other: % in diet

Sex:

male/female

Remarks on result:

other: no adverse effects reported

Overall reproductive toxicity

Reproductive effects observed:

no

Applicant's summary and conclusion

Conclusions:

No significant difference in reproductive performance was observed.

Executive summary:

Groups of 6 female rats were fed diets containing 0 or 1% inositol for 37 days and then mated with untreated male rats. An additional group was administered 1% inositol and 1% para-amino-benzoic acid. No significant difference in reproductive performance was observed in any group.No significant difference in rate of growth or gross appearance was observed in any group. Pup weights averaged 5 to 5.5 g and all pups appeared grossly to be normal in all respects.