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Toxicological information

Toxicity to reproduction

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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

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

Test animals

Species:
rat
Strain:
Long-Evans
Sex:
female
Details on test animals 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 / concentrationsopen allclose all
Dose / conc.:
1 other: %
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 animals)

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
Gross pathological findings:
not specified
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified

Reproductive function / performance (P0)

Reproductive function: estrous 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.