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Search results for m root_names_stdName in Standardized Name (approximate match)
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(18)(ii) skin protectant:astringent para-tertiary-Butyl-m-cresol
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
This chemical compound was studied the Japan. According this investigation, there is no available information on toxicokinetics and metabolism of 6-tert-Butyl-m-cresol. The LD50 values for acute toxicity of this substance were between 320 and 800 mg/kg in males and between 130 and 320 mg/kg in females for rats, and 580 mg/kg in males and 740 mg/kg in females for mice. This substance is corrosive to skin and eyes in rabbits. However, no irritation problem has been reported at any production site where workers wear proper clothing and equipment. A reproductive toxicity study in rats revealed that this substance was toxic to the dams at 60 mg/kg, causing depression of body weight gain and a slight decrease in the number of corpora lutea and implantations. This effect in the dams influenced the outcome of pregnancy, seen as a decrease in the number of live births and depression of weight gain in the offspring. These effects were not seen at 12.5 mg/kg/day. No evidence of gross malformations was observed at any dose. Based on these findings, the NOAEL for reproductive toxicity is considered to be 12.5 mg/kg/day for both female parents and pups. Evidence of malformations was not observed at any dose.
Status:
Possibly Marketed Outside US
Source:
M020
(2022)
Source URL:
First approved in 2022
Source:
M020
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
FERRICLATE CALCIUM SODIUM is a hematinic agent.
Status:
Possibly Marketed Outside US
Source:
M020
(2021)
Source URL:
First approved in 2021
Source:
M020
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2020)
Source URL:
First approved in 2020
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2020)
Source URL:
First approved in 2020
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Safrole is a natural product obtained from essential oil of the root bark of Sassafras tree. Safrole has been used as a flavoring agent in drugs and in the manufacture of heliotropin, perfumes, soaps, and piperonyl butoxide. Oil of sassafras, which contains safrole, was formerly used to flavor some soft drinks, such as root beer. However, this use or any other addition of safrole or oil of sassafras to food was banned in the United States in 1960 due to evidence of carcinogenicity. Numerous studies have shown that safrole from betel quid-containing safrole might be involved in the pathogenesis of hepatocellular carcinoma in human due to the formation of DNA adducts. Safrole has also been used in the illicit production of the drug 3,4-methylenedioxymethamphetamine (MDMA, or ecstasy), and the U.S. Drug Enforcement Administration has designated safrole a List I Chemical. Anticancer and anti-diabetic properties of safrole were investigated in vitro and in vivo.
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2020)
Source URL:
First approved in 2020
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 333E
(2020)
Source URL:
First approved in 2020
Source:
21 CFR 333E
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2020)
Source URL:
First approved in 2020
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 333E
(2020)
Source URL:
First approved in 2020
Source:
21 CFR 333E
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 333E
(2020)
Source URL:
First approved in 2020
Source:
21 CFR 333E
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)