SDS

SAFETY DATA SHEET
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11. TOXICOLOGICAL INFORMATION
Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s))
Genetic Toxicity: (Study Type, Cell Type/Organism, Result)
Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s))
Carcinogen Status:
See below
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PZ01360
Version: 2.2
Chromosome Aberration Chinese Hamster Ovary (CHO) cells Negative
Phenylephrine hydrochloride
Mammalian Cell Mutagenicity Mouse Lymphoma Equivocal
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Bacterial Mutagenicity (Ames) Salmonella Negative
Prenatal & Postnatal Development Rabbit Subcutaneous 15 mg/kg/day LOAEL Maternal toxicity, Fetotoxicity
Ibuprofen
Stearic acid
Phenylephrine hydrochloride
26 Week(s) Rat Subcutaneous 0.5 mg/kg/week NOAEL Not carcinogenic
Stearic acid
52 Week(s) Mouse Subcutaneous 0.05 mg/kg/week LOAEL Tumors
Fertility and Embryonic Development Rat rectal 100 mg/kg/day Fertility
Phenylephrine hydrochloride
In Vitro Bacterial Mutagenicity (Ames) Salmonella Negative
2 Year(s) Rat Oral 50 mg/kg/day Not carcinogenic
Unscheduled DNA Synthesis E. coli Negative
Fertility and Embryonic Development
Rat rectal 200 mg/kg/day Fetotoxicity
Sodium lauryl sulfate
Colloidal silicon dioxide
12 Week(s) Rat Oral10,000 ppm Death
IARC:
Group 3 (Not Classifiable)
Bacterial Mutagenicity (Ames) Salmonella Negative
Polyvinyl alcohol
Embryo / Fetal Development Rabbit Oral 60 mg/kg/day Not Teratogenic
IARC:
Group 3 (Not Classifiable)
Ibuprofen
Titanium dioxide
Revision date: 17-Sep-2015
IARC:
Group 2B (Possibly Carcinogenic to Humans)
Material Name: Advil Congestion Relief Tablets
Bacterial Mutagenicity (Ames) Salmonella Negative
Embryo / Fetal Development Rat Oral 180 mg/kg/day Not Teratogenic
Phenylephrine hydrochloride