Sulpiride

Toxicity to reproduction

Administrative data

Endpoint:

fertility, other

Remarks:

reproductive development of female offspring

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

abstract

Data source

Reference

Reference Type:

publication

Title:

Effects of maternal exposure to the galactagogue Sulpiride on reproductive parameters in female rats.

Author:

de Azevedo Camin N

Year:

2015

Bibliographic source:

Physiol Behav. 2015; 140: 247-53.

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The aim of the study was to investigate whether maternal exposure to Sulpiride during lactation could impair reproductive development of female offspring.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sulpiride

EC Number:

239-753-7

EC Name:

Sulpiride

Cas Number:

15676-16-1

Molecular formula:

C15H23N3O4S

IUPAC Name:

sulpiride

Specific details on test material used for the study:

Sulpiride and sulpiride HCl are expected to be similar for this endpoint.

Test animals

Species:

rat

Strain:

not specified

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Duration of treatment / exposure:

The dams were treated throughout the lactation period.

Frequency of treatment:

Daily.

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

2.5 mg/kg bw/day (nominal)

Remarks:

SUL 2.5mg group

Doses / concentrations 2

Dose / conc.:

25 mg/kg bw/day (nominal)

Remarks:

SUL 25mg group

Control animals:

yes, concurrent vehicle

Examinations

Litter observations:

During early life, body weight, anogenital distance, and vaginal opening were analyzed on the female offspring. In adulthood, estrous cycle, sexual behavior, estrogen levels as well as the weight of the reproductive organs were evaluated.

Results and discussion

Results: P1 (second parental generation)

General toxicity (P1)

Details on results:

There were no differences regarding body weight, anogenital distance, puberty onset, frequency and duration of the estrous cycle and estradiol levels on female offspring. Nonetheless, there were changes in sexual behavior. There was an increase in the number of observations in reflex magnitude 0 (absence of lordosis) and reflex magnitude 2 as well as a reduction of reflex magnitude 3 in the rats of SUL 25mg group in relation to the Control group, suggesting a decrease in sexual receptivity of these animals.

Applicant's summary and conclusion

Conclusions:

Study results suggest that maternal exposure to Sulpiride can alter reproductive function in female offspring rats.

Executive summary:

The dams were treated daily by gavage with Sulpiride doses of 2.5mg/Kg (SUL 2.5mg group) and 25mg/Kg (SUL 25mg group), or distilled water (Control group) throughout the lactation period. During early life, body weight, anogenital distance, and vaginal opening were analyzed on the female offspring. In adulthood, estrous cycle, sexual behavior, estrogen levels as well as the weight of the reproductive organs were evaluated. There were no differences regarding body weight, anogenital distance, puberty onset, frequency and duration of the estrous cycle and estradiol levels on female offspring. Nonetheless, there were changes in sexual behavior. There was an increase in the number of observations in reflex magnitude 0 (absence of lordosis) and reflex magnitude 2 as well as a reduction of reflex magnitude 3 in the rats of SUL 25mg group in relation to the Control group, suggesting a decrease in sexual receptivity of these animals. These results demonstrate that maternal exposure to Sulpiride can alter reproductive function in female offspring rats.