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Journal of Environmental Pathology, Toxicology and Oncology
IF: 1.241 5-Year IF: 1.349 SJR: 0.356 SNIP: 0.613 CiteScore™: 1.61

ISSN Print: 0731-8898
ISSN Online: 2162-6537

Journal of Environmental Pathology, Toxicology and Oncology

DOI: 10.1615/JEnvironPatholToxicolOncol.v28.i4.100
pages 361-370

Reproductive and Developmental Toxicity Evaluation of Desoris (LLL 3348) in Wistar Rats

Upendra Bhatnagar
Lupin Limited
Sudershan Arora
Novel Drug Discovery and Development (NDDD), Lupin Ltd., Mulshi, Pune - 411042
Gururaj Vishwase
Novel Drug Discovery and Development (NDDD), Lupin Ltd., Mulshi, Pune - 411042
Salim Tamboli
Novel Drug Discovery and Development (NDDD), Lupin Ltd., Mulshi, Pune - 411042

ABSTRACT

Desoris (LLL 3348), a lyophilized aqueous extract prepared from the leaves of Argemone mexicana to treat chronic stable plaque-type psoriasis, was evaluated for reproductive (male and female fertility) and developmental toxicity in rats. Lrrp: Wistar rats were administered orally with LLL 3348 at dose levels of 0 (distilled water), 250, 500, and 1000 mg/kg b.wt, and the effects on reproductive parameters were assessed. Sperm parameters (motility, epididymal sperm concentration, testicular sperm head count, and sperm morphology), organ weight, and histology of the male reproductive system were evaluated in the male fertility study. Estrus cyclicity, corpora lutea, implantation sites, litter size at birth, fetal growth, development parameters up to weaning, and organ weight and histology of male and female reproductive systems were assessed in the female fertility study. There were no overt signs of toxicity noted in male and female reproduction parameters in rats up to 1000 mg/kg of LLL 3348 administration. There were no alterations in the male reproductive organ/system, sperm parameters, male and female fertility indices, embryonic development, and pre-wean developmental landmarks of pups. No gross and histological changes were observed in these studies. In a develop mental toxicity study, the test article was administered to pregnant females during gestation (5−19 days) and the fetuses were examined for external, visceral, and skeletal abnormalities. No toxic manifestation was revealed on caesarian section parameters, and no fetus anomalies/abnormalities were found. Therefore, it is concluded that LLL 3348 at the given dose did not produce any significant toxic effect in rats. The No Observed Adverse Effect Level (NOAEL) for male fertility, female fertility, and developmental toxicity studies was established as 1000 mg/kg in rats.


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