Original language | English (US) |
---|---|
Article number | 113319 |
Journal | Food and Chemical Toxicology |
Volume | 167 |
DOIs | |
State | Published - Sep 2022 |
ASJC Scopus subject areas
- Food Science
- Toxicology
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In: Food and Chemical Toxicology, Vol. 167, 113319, 09.2022.
Research output: Contribution to journal › Short survey › peer-review
}
TY - JOUR
T1 - RIFM fragrance ingredient safety assessment, ethyl decanoate, CAS Registry Number 110-38-3
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 insufficient repeated dose toxicity data on ethyl decanoate. Read-across material ethyl hexanoate (CAS # 123-66-0; see Section VI) has sufficient repeated dose toxicity data that can be used to support the repeated dose toxicity endpoint. An OECD 422/GLP combined repeated dose toxicity with reproduction/developmental toxicity screening test was conducted in Sprague Dawley rats. Groups of 12 rats/sex/dose were administered ethyl hexanoate (ethyl caproate) at doses of 0, 100, 300, or 1000 mg/kg/day via oral gavage. Males were dosed for at least 50 days (2 weeks prior to mating and continued through the day before euthanasia), while females were dosed for 2 weeks prior to mating and continued through lactation day (LD) 13. Additional animals (6 rats/sex/group) in the control and high-dose recovery groups received ethyl caproate but were not mated; they were assigned to a 2-week period of recovery. One female in the control group was euthanized on LD 3 because all pups were found expired. This was considered to be incidental since it was observed in the control group and there were no clinical signs of toxicity. At 1000 mg/kg/day, statistically significant increased prothrombin time in both sexes and statistically significant increased kidney weights in females were observed. Furthermore, statistically significant decreases in gamma glutamyl transpeptidase were observed in all treatment group males. A statistically significant increase in thyroid hormone (T4) was observed in adult males and pups of the highest dose group. Since there were no correlated microscopic findings associated with any of the alterations observed in the highest dose group, these findings were not considered to be toxicologically relevant. Reversibility was also observed in the high-dose animals after the recovery period. Thus, the NOAEL for systemic toxicity was considered to be 1000 mg/kg/day, the highest dose tested (RIFM, 2017b; also available in ECHA, 2017a).There are insufficient reproductive toxicity data on ethyl decanoate. Read-across material ethyl hexanoate (CAS # 123-66-0; see Section VI) has sufficient reproductive toxicity data that can be used to support the reproductive toxicity endpoint. An OECD 422/GLP combined repeated dose toxicity with reproduction/developmental toxicity screening test was conducted in Sprague Dawley rats. Groups of 12 rats/sex/dose were administered ethyl hexanoate (ethyl caproate) at doses of 0, 100, 300, or 1000 mg/kg/day via oral gavage. Males were dosed for at least 50 days (2 weeks prior to mating and continued through the day before euthanasia), while females were dosed for 2 weeks prior to mating and continued through LD 13. Additional animals (6 rats/sex/group) in the control and high-dose recovery groups received ethyl caproate but were not mated; they were assigned to a 2-week recovery period. In addition to systemic toxicity parameters, the reproductive toxicity parameters were also assessed. One female in the control group was euthanized on LD 3 because all pups were found expired. This was considered to be incidental since it was observed in the control group and there were no clinical signs of toxicity. Non-parturition was also observed in 1 female each in 100, 300, and 1000 mg/kg/day dose groups; these dams were euthanized on GD 28. This was considered incidental since there were no treatment-related macroscopic or microscopic findings. A statistically significant increase in thyroid hormone (T4) was observed in adult males (1.14-fold of control) and pups (1.20-fold of control) of the highest dose group. Since there were no correlated changes in other parameters including microscopic findings in thyroids (with parathyroids), this was not considered to be toxicologically relevant. No treatment-related adverse effects were observed in the estrous cycle, pre-coital time, fertility data, reproductive and littering findings, clinical signs, body weight, anogenital distance, nipple retention, or external examination of pups. Thus, the NOAEL for reproductive toxicity was considered to be 1000 mg/kg/day, the highest dose tested (RIFM, 2017b; ECHA, 2017a). Therefore, the ethyl decanoate MOE for the reproductive toxicity endpoint can be calculated by dividing the ethyl hexanoate NOAEL in mg/kg/day by the total systemic exposure to ethyl decanoate, 1000/0.00078, or 1282051.
PY - 2022/9
Y1 - 2022/9
UR - http://www.scopus.com/inward/record.url?scp=85135343157&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85135343157&partnerID=8YFLogxK
U2 - 10.1016/j.fct.2022.113319
DO - 10.1016/j.fct.2022.113319
M3 - Short survey
C2 - 35872255
AN - SCOPUS:85135343157
SN - 0278-6915
VL - 167
JO - Food and Chemical Toxicology
JF - Food and Chemical Toxicology
M1 - 113319
ER -