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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

There are three reports available to assess the reproductive potential of sulfapyridine.

Rakesh K. Sharma and N.R. Kalla, 1994 precluded the testis as a site of action of sulfapyridine and confirms earlier observations that the effect of sulfapyridine was post-testicular at the level of the epididymis. In this study, sulfapyridine at doses of 60, 120 and 250 mg kg/ body weight suspended in 0.5 mL of corn oil was administered to male rats (six animals in each group) by oral intubation daily for 60 days. Sperm motility was reduced significantly at the higher dose levels of sulfapyridine. An increased frequency of abnormal spermatozoa was seen. A significant fall (56%) occurred in the cauda sperm of animals given sulfapyridine (250 mg). Total sperm reserves also decreased (28.91% and 34.93%) at the highest dose levels of sulfapyridine. A marginal (3.88%) decrease was seen in germinal height and tubular diameter of the sulfapyridine treated group. The test substances did not affect the earlier stages of spermatogenesis that proceed to form step 19 spermatids.

In the study conducted by Jeremy V. Kredentser, et al. 1991, 20 mature Sprague-Dawley rats were assigned to a treatment (400 mg/kg test substance daily), or a control group. When killed at 10 days gestation, there was a significant reduction in the proportion of fertilized oocytes between control and treatment groups. Test substance treatment had a negative effect on fertilization rates. One resorption occurred in a treatment group rat; this was classified as an adverse (non-pregnancy) outcome. These findings suggest an adverse effect of sulphapyridine on female fertility. But differences did not reach the level of statistical significance.

Another study performed by G. Chaturapanich, et al. 1999 investigated the effects of sulphapyridine on the transport of spermatozoa through the rat epididymis and on the contractility of the epididymal duct. Sulphapyridine increased the rate of sperm transport from the caput to the distal cauda epididymis by approximately 3 days after treatment with sulphapyridine at adosage of 450 mg/kg for 38-52days. The decrease in transit time may be associated, in part, with changes in the responsiveness of the epididymis to adrenergic nerve activities and a reduction in spermatocrit.

Based on the results of the existing studies, sulfapyridine can cause the adverse treatment-related effects on male and female fertility.


Short description of key information:
sulfapyridine can cause the adverse treatment-related effects on the fertility.

Justification for selection of Effect on fertility via oral route:
This study provided the scientific details and fulfill scientific principles.

Effects on developmental toxicity

Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results of the existing studies, sulfapyridine can cause the significant adverse effects on the fertility.

Thus, sulfapyridine can beclassified as category 2 for reproductive toxicity according to CLP (Regulation EC No.1272/2008).

Additional information