PMID- 12866706 OWN - NLM STAT- MEDLINE DCOM- 20031212 LR - 20121115 IS - 1542-9733 (Print) IS - 1542-9733 (Linking) VI - 68 IP - 2 DP - 2003 Apr TI - Developmental toxicity evaluation of sodium thioglycolate administered topically to Sprague-Dawley (CD) rats and New Zealand White rabbits. PG - 144-61 AB - BACKGROUND: Sodium thioglycolate, which has widespread occupational and consumer exposure to women from cosmetics and hair-care products, was evaluated for developmental toxicity by topical exposure during the embryonic and fetal periods of pregnancy METHODS: Timed-mated Sprague-Dawley rats (25/group) and New Zealand White (NZW) rabbits (24/group) were exposed to sodium thioglycolate in vehicle (95% ethanol:distilled water, 1:1) by unoccluded topical application on gestational days (GD) 6-19 (rats) or 6-29 (rabbits) for 6 hr/day, at 0, 50, 100, or 200 mg/kg body weight/day (rats) and 0, 10, 15, 25, or 65 mg/kg/day (rabbits). At termination (GD 20 rats; GD 30 rabbits), fetuses were examined for external, visceral, and skeletal malformations and variations. RESULTS: In rats, maternal topical exposure to sodium thioglycolate, at 200 mg/kg/day (the highest dose tested) on GD 6-19, resulted in maternal toxicity, including reduced body weights and weight gain, increased relative water consumption and one death. Treatment-related increases in feed consumption and changes at the applicationsite occurred at all doses, in the absence of increased body weights or body weight change. Fetal body weights/litter were decreased at 200 mg/kg/day, with no other embryo/fetal toxicity and no treatment-related teratogenicity in any group. In rabbits, maternal topical exposure to sodium thioglycolate on GD 6-29 resulted in maternal dose-related toxicity at the dosing site in all groups; no maternal systemic toxicity, embryo/fetal toxicity, or treatment-related teratogenicity were observed in any group. CONCLUSIONS: A no observed adverse effect level (NOAEL) was not identified for maternal toxicity in either species with the dosages tested. The developmental toxicity NOAEL was 100 mg/kg/day (rats) and > or = 65 mg/kg/day (rabbits; the highest dose tested). The clinical relevance of theses study results is uncertain because no data were available for levels, frequency, or duration of exposures in female workers or end users. FAU - Tyl, R W AU - Tyl RW AD - RTI International, Center for Life Sciences and Toxicology, Research Triangle Park, North Carolina 27709-2194, USA. rwt@rti.org FAU - Price, C J AU - Price CJ FAU - Marr, M C AU - Marr MC FAU - Myers, C B AU - Myers CB FAU - van Birgelen, A P J M AU - van Birgelen AP FAU - Jahnke, G D AU - Jahnke GD LA - eng GR - N01-ES-65405/ES/NIEHS NIH HHS/United States PT - Journal Article PT - Research Support, U.S. Gov't, P.H.S. PL - United States TA - Birth Defects Res B Dev Reprod Toxicol JT - Birth defects research. Part B, Developmental and reproductive toxicology JID - 101155115 RN - 0 (Thioglycolates) RN - 7857H94KHM (2-mercaptoacetate) SB - IM MH - *Abnormalities, Drug-Induced MH - Administration, Topical MH - Animals MH - Dose-Response Relationship, Drug MH - Embryonic and Fetal Development/*drug effects MH - Female MH - Gestational Age MH - *Maternal Exposure MH - No-Observed-Adverse-Effect Level MH - Rabbits MH - Rats MH - Rats, Sprague-Dawley MH - Thioglycolates/administration & dosage/*toxicity MH - Time Factors EDAT- 2003/07/18 05:00 MHDA- 2003/12/13 05:00 CRDT- 2003/07/18 05:00 PHST- 2003/07/18 05:00 [pubmed] PHST- 2003/12/13 05:00 [medline] PHST- 2003/07/18 05:00 [entrez] AID - 10.1002/bdrb.10001 [doi] PST - ppublish SO - Birth Defects Res B Dev Reprod Toxicol. 2003 Apr;68(2):144-61. doi: 10.1002/bdrb.10001.