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Developmental toxicity evaluation of sodium thioglycolate administered topically to Sprague-Dawley (CD) rats and New Zealand White rabbits.
Birth Defects Res B Dev Reprod Toxicol. 2003 Apr; 68(2):144-61.BD

Abstract

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.

Authors+Show Affiliations

RTI International, Center for Life Sciences and Toxicology, Research Triangle Park, North Carolina 27709-2194, USA. rwt@rti.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

12866706

Citation

Tyl, R W., et al. "Developmental Toxicity Evaluation of Sodium Thioglycolate Administered Topically to Sprague-Dawley (CD) Rats and New Zealand White Rabbits." Birth Defects Research. Part B, Developmental and Reproductive Toxicology, vol. 68, no. 2, 2003, pp. 144-61.
Tyl RW, Price CJ, Marr MC, et al. Developmental toxicity evaluation of sodium thioglycolate administered topically to Sprague-Dawley (CD) rats and New Zealand White rabbits. Birth Defects Res B Dev Reprod Toxicol. 2003;68(2):144-61.
Tyl, R. W., Price, C. J., Marr, M. C., Myers, C. B., van Birgelen, A. P., & Jahnke, G. D. (2003). Developmental toxicity evaluation of sodium thioglycolate administered topically to Sprague-Dawley (CD) rats and New Zealand White rabbits. Birth Defects Research. Part B, Developmental and Reproductive Toxicology, 68(2), 144-61.
Tyl RW, et al. Developmental Toxicity Evaluation of Sodium Thioglycolate Administered Topically to Sprague-Dawley (CD) Rats and New Zealand White Rabbits. Birth Defects Res B Dev Reprod Toxicol. 2003;68(2):144-61. PubMed PMID: 12866706.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Developmental toxicity evaluation of sodium thioglycolate administered topically to Sprague-Dawley (CD) rats and New Zealand White rabbits. AU - Tyl,R W, AU - Price,C J, AU - Marr,M C, AU - Myers,C B, AU - van Birgelen,A P J M, AU - Jahnke,G D, PY - 2003/7/18/pubmed PY - 2003/12/13/medline PY - 2003/7/18/entrez SP - 144 EP - 61 JF - Birth defects research. Part B, Developmental and reproductive toxicology JO - Birth Defects Res. B Dev. Reprod. Toxicol. VL - 68 IS - 2 N2 - 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. SN - 1542-9733 UR - https://www.unboundmedicine.com/medline/citation/12866706/Developmental_toxicity_evaluation_of_sodium_thioglycolate_administered_topically_to_Sprague_Dawley__CD__rats_and_New_Zealand_White_rabbits_ L2 - https://doi.org/10.1002/bdrb.10001 DB - PRIME DP - Unbound Medicine ER -