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Evaluation of the developmental toxicity of dihydromyrcenol in rats.
Int J Toxicol. 2009 Mar-Apr; 28(2):80-7.IJ

Abstract

Dihydromyrcenol, a widely used fragrance ingredient, was evaluated for developmental toxicity in pregnant Sprague-Dawley rats (25/group). Oral dosages of 0, 250, 500, or 1000 mg/kg/d in corn oil were administered on gestational days 7 to 17. Rats were observed for viability, clinical signs, body weights, and feed consumption. Caesarean sectioning and necropsy occurred on gestational day 21. Fetuses were weighed and examined for sex, gross external changes, and soft tissue or skeletal alterations. All rats survived until scheduled termination. No clinical signs were attributed to dihydromyrcenol. There were no gross tissue changes at necropsy. The 1000-mg/kg/d dosage group had reduced mean maternal body weight gains of 5% compared with controls, whereas absolute and relative feed consumption were significantly reduced during the dosage period. This threshold systemic maternal toxicity was associated with threshold developmental toxicity in the 1000-mg/kg/d dosage group. Fetal effects included a minimal approximately 3% reduction in fetal body weight; reversible variations in ossification, including retarded ossification of the metatarsal bones in the hindpaws; and an increase in supernumerary thoracic ribs with associated increases or decreases in thoracic and lumbar vertebrae, respectively. Based on these data, maternal and developmental no observable effect levels of 500 mg/kg/d and maternal and developmental no observable adverse effect levels of 1000 mg/kg/d were established for dihydromyrcenol. It was concluded that dihydromyrcenol is not a selective developmental toxicant in rats under the conditions of this study and that a margin of safety of 25 000 exists between reversible developmental delays in rats and the estimated daily human exposure level of 0.02 mg/kg/d.

Authors+Show Affiliations

Research Institute for Fragrance Materials, Inc, 50 Tice Boulevard, Woodcliff Lake, NJ 07677, USA. vpolitano@rifm.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19482832

Citation

Politano, Valerie T., et al. "Evaluation of the Developmental Toxicity of Dihydromyrcenol in Rats." International Journal of Toxicology, vol. 28, no. 2, 2009, pp. 80-7.
Politano VT, Lewis EM, Hoberman AM, et al. Evaluation of the developmental toxicity of dihydromyrcenol in rats. Int J Toxicol. 2009;28(2):80-7.
Politano, V. T., Lewis, E. M., Hoberman, A. M., Christian, M. S., Diener, R. M., & Api, A. M. (2009). Evaluation of the developmental toxicity of dihydromyrcenol in rats. International Journal of Toxicology, 28(2), 80-7. https://doi.org/10.1177/1091581809333892
Politano VT, et al. Evaluation of the Developmental Toxicity of Dihydromyrcenol in Rats. Int J Toxicol. 2009 Mar-Apr;28(2):80-7. PubMed PMID: 19482832.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of the developmental toxicity of dihydromyrcenol in rats. AU - Politano,Valerie T, AU - Lewis,Elise M, AU - Hoberman,Alan M, AU - Christian,Mildred S, AU - Diener,Robert M, AU - Api,Anne Marie, PY - 2009/6/2/entrez PY - 2009/6/2/pubmed PY - 2009/8/19/medline SP - 80 EP - 7 JF - International journal of toxicology JO - Int J Toxicol VL - 28 IS - 2 N2 - Dihydromyrcenol, a widely used fragrance ingredient, was evaluated for developmental toxicity in pregnant Sprague-Dawley rats (25/group). Oral dosages of 0, 250, 500, or 1000 mg/kg/d in corn oil were administered on gestational days 7 to 17. Rats were observed for viability, clinical signs, body weights, and feed consumption. Caesarean sectioning and necropsy occurred on gestational day 21. Fetuses were weighed and examined for sex, gross external changes, and soft tissue or skeletal alterations. All rats survived until scheduled termination. No clinical signs were attributed to dihydromyrcenol. There were no gross tissue changes at necropsy. The 1000-mg/kg/d dosage group had reduced mean maternal body weight gains of 5% compared with controls, whereas absolute and relative feed consumption were significantly reduced during the dosage period. This threshold systemic maternal toxicity was associated with threshold developmental toxicity in the 1000-mg/kg/d dosage group. Fetal effects included a minimal approximately 3% reduction in fetal body weight; reversible variations in ossification, including retarded ossification of the metatarsal bones in the hindpaws; and an increase in supernumerary thoracic ribs with associated increases or decreases in thoracic and lumbar vertebrae, respectively. Based on these data, maternal and developmental no observable effect levels of 500 mg/kg/d and maternal and developmental no observable adverse effect levels of 1000 mg/kg/d were established for dihydromyrcenol. It was concluded that dihydromyrcenol is not a selective developmental toxicant in rats under the conditions of this study and that a margin of safety of 25 000 exists between reversible developmental delays in rats and the estimated daily human exposure level of 0.02 mg/kg/d. SN - 1092-874X UR - https://www.unboundmedicine.com/medline/citation/19482832/Evaluation_of_the_developmental_toxicity_of_dihydromyrcenol_in_rats_ DB - PRIME DP - Unbound Medicine ER -