Original language | English (US) |
---|---|
Article number | 113314 |
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, 113314, 09.2022.
Research output: Contribution to journal › Short survey › peer-review
}
TY - JOUR
T1 - RIFM fragrance ingredient safety assessment, 3-methoxy-5-cresol, CAS Registry Number 3209-13-0
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 limited repeated dose toxicity data on ethyl butyrate. Read-across material propyl propionate (CAS # 106-36-5; see Section VI) has sufficient data to support the repeated dose toxicity endpoint. In an OECD 422, EPA OPPTS 870.3650, and GLP-compliant study, 12 Crj:CD(SD)IGS rats/sex/dose were exposed to propyl propionate through whole-body inhalation at doses of 0, 50, 250, and 500 ppm (using the standard minute volume and body weights equivalent to 0, 61.6, 311, and 616 mg/kg/day, respectively). Treatment duration was 38 days in males and 48 days in females. No treatment-related mortality or clinical signs of toxicity were reported throughout the study. In addition, no treatment-related adverse effects were reported for organ weights, hematology, clinical chemistry, or urinalysis at any dose level. In females, body weight and food consumption were significantly lower in mid- and high-dose groups during the study. However, for both parameters, the decreases were <8% and therefore not considered to be of toxicological significance. Clinical chemistry analysis revealed a significant increase in AST levels in males of the high-dose group, but no correlated histopathological or functional changes in the liver were reported. Tension lipidosis, a pale focus in the right medial lobe of the liver, was observed in females of the high-dose group, but this was not considered to be a treatment-related adverse effect, as it is a commonly occurring lesion in rats. At all doses, several local respiratory effects were also reported. Since no systemic toxicity was reported at any dose, the NOAEL for this study was considered to be 500 ppm (616 mg/kg/day) (ECHA, 2018).There are no reproductive toxicity data on ethyl butyrate. Read-across material propyl propionate (CAS # 106-36-5; see Section VI) has sufficient reproductive toxicity data that can be used to support the reproductive toxicity endpoint. In an OECD 422/GLP study, groups of 12 Crl:CD(SD) rats/sex were administered test material n-propyl propionate via whole-body exposure at target concentrations of 0, 50, 250, and 500 ppm (equivalent to 0, 62, 308, and 616 mg/kg/day, respectively, as per standard minute volume and bodyweight parameters for Sprague Dawley rats) for 6 h per day, 7 days per week. Females were exposed for 2 weeks prior to breeding, through breeding (approximately 2 weeks), and continued through gestation day 20; the females were then subjected to gross necropsy on postpartum day 5. Males were exposed to the test material 2 weeks prior to breeding and continued through breeding (approximately 2 weeks) before being subjected to gross necropsy (day 38). In addition to systemic toxicity parameters, reproductive toxicity parameters and neurological function were also assessed. There were no treatment-related adverse effects on reproductive performance or survival and growth of pups. The NOAEL for fertility effects and the development of pups was considered to be 500 ppm or 616 mg/kg/day, the highest dose tested (ECHA, 2018). Therefore, the ethyl butyrate MOE for the reproductive toxicity endpoint can be calculated by dividing the propyl propionate NOAEL in mg/kg/day by the total systemic exposure to ethyl butyrate, 616/0.0049, or 125714.
PY - 2022/9
Y1 - 2022/9
UR - http://www.scopus.com/inward/record.url?scp=85135384929&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85135384929&partnerID=8YFLogxK
U2 - 10.1016/j.fct.2022.113314
DO - 10.1016/j.fct.2022.113314
M3 - Short survey
C2 - 35870733
AN - SCOPUS:85135384929
SN - 0278-6915
VL - 167
JO - Food and Chemical Toxicology
JF - Food and Chemical Toxicology
M1 - 113314
ER -