Original language | English (US) |
---|---|
Article number | 112928 |
Journal | Food and Chemical Toxicology |
Volume | 163 |
DOIs | |
State | Published - May 2022 |
ASJC Scopus subject areas
- Food Science
- Toxicology
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In: Food and Chemical Toxicology, Vol. 163, 112928, 05.2022.
Research output: Contribution to journal › Short survey › peer-review
}
TY - JOUR
T1 - RIFM fragrance ingredient safety assessment, myristo nitrile, CAS Registry Number 629-63-0
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 no repeated dose toxicity data on myristo nitrile. Read-across material dodecanenitrile (CAS # 2437-25-4; see Section VI) has sufficient data to support the repeated dose toxicity endpoint. In an OECD 422-compliant study, groups of 10 Wistar rats/sex/dose were administered dodecanenitrile via gavage (vehicle: 2% methylcellulose) at doses of 0, 50, 250, or 1000 mg/kg/day. Dodecanenitrile was administered to male rats for at least 28 days and to female rats for 14 days prior to pairing, through the pre-pairing, pairing, and gestation periods until the F1 generation reached day 4 postpartum. Mortality and alteration in clinical signs were reported among the high-dose group of females. Alterations in clinical signs were also reported among high-dose males and mid-dose females. Hematological alterations were reported among high-dose males; however, the significance remained unknown. During gross necropsy, the high-dose males were reported to have an enlarged liver and a reduction in thymus size. High-dose females were reported to have an enlarged liver, stomach with discolorations, crateriform retractions and foci, and enlarged adrenal glands. Secondary to the spontaneous deaths, the start of autolysis, ileum distended with gas, discoloration, incompletely collapsed lungs, urinary bladder distended, and discoloration of the liver were observed. High-dose males had a significant increase in the absolute and relative liver weights. Histopathological examination revealed minimal to moderate centrilobular to diffuse hepatocellular hypertrophy and atrophy/involution in the thymus among high-dose group males. Mid- and high-dose males showed ulceration, erosion, and mucosal necrosis in the forestomach and glandular stomach. The high-dose male kidneys showed an increase in tubular basophilia. High-dose females showed moderate, centrilobular to diffuse hepatocellular hypertrophy, along with incidences of moderate centrilobular necrosis and apoptosis. Increased incidence of ulceration, erosion, and mucosal necrosis in the forestomach and glandular stomach were reported among mid- and high-dose females. Ulceration was also reported to occur in the duodenum of high-dose females. Thus, the NOAEL was considered to be 50 mg/kg/day, based on histopathological alterations in the GI tract and liver, along with clinical signs among males and females of higher dose groups and mortality among high-dose group females (ECHA, 2017a).There are no reproductive toxicity data on myristo nitrile. Read-across material dodecanenitrile (CAS # 2437-25-4; see Section VI) has sufficient data to support the reproductive toxicity endpoints. In an OECD 422-compliant study, groups of 10 Wistar rats/sex/dose were administered dodecanenitrile via gavage (vehicle: 2% methylcellulose) at doses of 0, 50, 250, or 1000 mg/kg/day. Dodecanenitrile was administered to male rats for at least 28 days and to female rats for 14 days prior to mating, through the pre-mating, mating, and gestation periods until the F1 generation reached day 4 postpartum. At the high dose, 4 dams died spontaneously on day 1 postpartum, and 2 dams were euthanized in extremis on days 1 and 4 postpartum. Statistically significant decreases in birth and viability indices were observed at the high dose. At the high dose, pup body weight was slightly reduced on day 1 postpartum but distinctly reduced on day 4 postpartum; however, the results were based only on the data of 1 litter. Thus, the fertility NOAEL for this study was considered to be 250 mg/kg based on maternal death at the high dose. The developmental toxicity NOAEL for this study was considered to be 250 mg/kg/day based on decreased pup body weights and decreased birth and viability indices at the high dose (ECHA, 2017a).
PY - 2022/5
Y1 - 2022/5
UR - http://www.scopus.com/inward/record.url?scp=85127332341&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85127332341&partnerID=8YFLogxK
U2 - 10.1016/j.fct.2022.112928
DO - 10.1016/j.fct.2022.112928
M3 - Short survey
C2 - 35307454
AN - SCOPUS:85127332341
SN - 0278-6915
VL - 163
JO - Food and Chemical Toxicology
JF - Food and Chemical Toxicology
M1 - 112928
ER -