Original language | English (US) |
---|---|
Article number | 112920 |
Journal | Food and Chemical Toxicology |
Volume | 161 |
DOIs | |
State | Published - Mar 2022 |
ASJC Scopus subject areas
- Food Science
- Toxicology
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In: Food and Chemical Toxicology, Vol. 161, 112920, 03.2022.
Research output: Contribution to journal › Short survey › peer-review
}
TY - JOUR
T1 - RIFM fragrance ingredient safety assessment, hexadecanolide, CAS Registry Number 109-29-5
AU - Api, A. M.
AU - Belsito, D.
AU - Botelho, D.
AU - Bruze, M.
AU - Burton, G. A.
AU - Cancellieri, M. A.
AU - Chon, H.
AU - Dagli, M. L.
AU - Date, M.
AU - Dekant, W.
AU - Deodhar, C.
AU - Fryer, A. D.
AU - Jones, L.
AU - Joshi, K.
AU - Kumar, M.
AU - Lapczynski, A.
AU - Lavelle, M.
AU - Lee, I.
AU - Liebler, D. C.
AU - Moustakas, H.
AU - Na, M.
AU - Penning, T. M.
AU - Ritacco, G.
AU - Romine, J.
AU - Sadekar, N.
AU - Schultz, T. W.
AU - Selechnik, D.
AU - Siddiqi, F.
AU - Sipes, I. G.
AU - Sullivan, G.
AU - Thakkar, Y.
AU - Tokura, Y.
N1 - Funding Information: There are no developmental toxicity data on hexadecanolide. Read-across material oxacyclohexadecen-2-one (CAS # 34902-57-3; see Section VI) has sufficient developmental toxicity data that can be used to support the developmental toxicity endpoint. An OECD 414/GLP prenatal developmental toxicity study was conducted in pregnant female Sprague Dawley CD rats. Groups of 24 rats/dose were administered oxacyclohexadecen-2-one via oral gavage at doses of 0, 50, 250, or 1000 mg/kg/day in 0.5% carboxymethyl cellulose from gestations days (GDs) 5–19. Pregnant females were euthanized on GD 20, and their uterine content was examined. No mortality was reported during the study. There were no treatment-related adverse effects observed for body weight, food consumption, clinical observations, or gravid uterus and placental weight; no significant changes were reported for the number of pregnancies, corpora lutea, implantations, or litter size. At 1000 mg/kg/day, there was a non-statistically significant and non-dose-dependent increase in pre-implantation loss when compared to controls, and without any effects on post-implantation loss or live litter size at any of the tested doses, this finding was not considered to be adverse. Fetal body weights were dose-dependently increased and reached statistical significance at 1000 mg/kg/day when compared to controls. There were no treatment-related changes in fetal viability, growth, and development, including the type of incidences of visceral or skeletal anomalies, observed. Therefore, the increased fetal body weight at the highest dose was not considered to be adverse since subsequent fetal evaluations (particularly the evaluation of skeletal development) did not indicate any significant precocious development of fetuses. The NOAEL for developmental toxicity was considered to be 1000 mg/kg/day, the highest dose tested (RIFM, 2003c).There are no fertility data on 13-methyloxacyclopentadecan-2-one. Read-across material oxacyclohexadecen-2-one (CAS # 34902-57-3; see Section VI) has sufficient fertility data that can be used to support the fertility endpoint. An OECD 415/GLP 1-generation reproduction study was conducted in Sprague Dawley Crl:CD(SD) IGS BR strain rats. Groups of 28 rats/sex/dose were administered oxacyclohexadecen-2-one via oral gavage at doses of 0, 50, 250, or 1000 mg/kg/day in 0.5% carboxymethyl cellulose. Males and females were dosed for 72 and 16 days, respectively, prior to pairing and continued throughout mating, gestation, and lactation. At weaning of pups on day 21, all parental animals and pups were euthanized and examined macroscopically, whereas reproductive organs and tissues of control and high-dose group parental animals were examined microscopically. Two mid-dose males were found dead during the mating/post-mating period. Macroscopic examination of the 2 deceased males revealed changes in the lungs that were attributed to dosing trauma. At 1000 mg/kg/day, pup body weight was statistically significantly higher than the controls at day 1 postpartum, and the group mean time to completion of incisor eruption was statistically significantly lower than the controls but were within 10% of control values. Additionally, pup body weights from the high-dose group animals were similar to controls and all treatment groups by days 7–21 postpartum. Therefore, these findings were not considered to be treatment-related. There were no treatment-related adverse effects observed in parental body weights, food consumption, mating performance, fertility, gestation, parturition, litter size at birth, viability, and subsequent growth and development of pups. The NOAEL for fertility effects and on the development of pups was considered to be 1000 mg/kg/day, the highest dose tested (RIFM, 2003b).
PY - 2022/3
Y1 - 2022/3
UR - http://www.scopus.com/inward/record.url?scp=85126358783&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85126358783&partnerID=8YFLogxK
U2 - 10.1016/j.fct.2022.112920
DO - 10.1016/j.fct.2022.112920
M3 - Short survey
C2 - 35288239
AN - SCOPUS:85126358783
SN - 0278-6915
VL - 161
JO - Food and Chemical Toxicology
JF - Food and Chemical Toxicology
M1 - 112920
ER -