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_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 724060 - Unbranded Gasoline Reformulated with Ethanol Page 7/10 Issue Date: 20-Jun-2016 Status: FINAL Other Comments: Most adverse health effects associated with ethanol, a component of this material, are related to the chronic ingestion of alcoholic beverages. Alcoholism has been associated with liver, stomach, heart, and nervous system damage, cancer, adverse reproductive effects, and effects on the developing fetus. Many of these effects may be related to metabolic changes that result from constantly high blood levels of alcohol. This exposure pattern is significantly different from that of persons handling industrial ethanol in the workplace or from refueling cars with gasoline containing ethanol. Gasoline engine exhaust has been classified by the International Agency for Research on Cancer (IARC) as possibly carcinogenic to human. Information on Toxicological Effects of Components Gasoline Carcinogenicity: Based on component information. Two year inhalation studies of vaporized unleaded gasoline produced an increased incidence of kidney tumors in male rats and liver tumors in female mice. Repeated skin application of various petroleum naphthas in mice for two years resulted in an increased incidence of skin tumors but only in the presence of severe skin irritation. Follow-up mechanistic studies suggest that the occurrence of these tumors may be the consequence of promotional processes and not relevant to human risk assessment. Epidemiology data collected from a study of more than 18,000 petroleum marketing and distribution workers showed no increased risk of leukemia, multiple myeloma, or kidney cancer from gasoline exposure. Unleaded gasoline has been identified as a possible carcinogen by the International Agency for Research on Cancer. Reproductive Toxicity: Based on component information. No evidence of developmental toxicity was found in pregnant laboratory animals (rats and mice) exposed to high vapor concentrations of unleaded gasoline and petroleum naphthas via inhalation. A two-generation reproductive toxicity study of vapor recovery gasoline did not adversely affect reproductive function or offspring survival and development. Target Organ(s): Two year inhalation studies of wholly vaporized unleaded gasoline, and 90 days studies of various petroleum naphthas, did not produce significant target organ toxicity in laboratory animals. Nephropathy in male rats, characterized by the accumulation of alpha-2-u- globulin in epithelial cells of the proximal tubules was observed, however follow-up studies suggest that these changes are unique to the male rat. Germ Cell Mutagenicity: Gasoline was negative in microbial mutagenicity and unscheduled DNA tests in rat hepatocytes. Gasoline did not induce chromosome aberrations in vivo in rat bone marrow cells and was negative in a mouse dominant lethal assay. Toluene Carcinogenicity: Exposure of rats and mice to toluene at concentrations ranging from 120-1200 ppm for two years did not demonstrate evidence of carcinogenicity. Toluene has not been listed as a carcinogen by IARC. Reproductive Toxicity: Exposure to toluene during pregnancy has demonstrated limited evidence of developmental toxicity in laboratory animals. Decreased fetal body weight and increased skeletal variations in both inhalation and oral studies, but only at doses that were maternally toxic. No fetal toxicity was seen at doses that were not maternally toxic. Decreased sperm counts have been observed in male rats in the absence of a reduction in fertility. Toluene has been reported to cause mental or growth retardation in the children of solvent abusers who directly inhale toluene during pregnancy. Target Organ(s): Epidemiology studies suggest that chronic occupational overexposure to toluene may damage color vision. Subchronic and chronic inhalation studies with toluene produced kidney and liver damage, hearing loss and central nervous system (brain) damage in laboratory animals. Intentional misuse by deliberate inhalation of high concentrations of toluene has been shown to cause liver, kidney, and central nervous system damage, including hearing loss and visual disturbances. Xylenes (o-, m-, p- isomers) Reproductive Toxicity: Both mixed xylenes and the individual isomers produced limited evidence of developmental toxicity in laboratory animals. Inhalation and oral administration of xylene resulted in decreased fetal weight, increased incidences of delayed ossification, skeletal variations and resorptions, but no evidence of teratogenicity. Target Organ(s): Rats exposed to xylenes at 800, 1000 or 1200 ppm 14 hours daily for 6 weeks demonstrated high frequency hearing loss. Another study in rats exposed to 1800 ppm 8 hours daily for 5 days demonstrated middle frequency hearing loss. Ethyl alcohol Carcinogenicity: Ingestion of alcoholic beverages has been classified by IARC as "carcinogenic to humans" (Group 1). Occupational exposures to ethanol and exposures other than by ingestion (i.e., dermal and inhalation) have not been associated with cancer in humans. Reproductive Toxicity: Adverse reproductive effects are not anticipated from workplace inhalation exposure. Excessive consumption of alcoholic beverages during pregnancy has been associated with effects on the developing fetus referred to collectively as the fetal alcohol syndrome. The effects most frequently manifested include psychomotor dysfunction, growth retardation and a characteristic cluster of facial anomalies. It also affects the reproductive system including reduced sperm count and motility and loss of libido in men, abnormal menstrual function, and decreased plasma estradiol and progesterone levels in women. Target Organ(s): Chronic alcoholism has been associated with damage to the liver in humans (e.g., cirrhosis of the liver). Excessive consumption of alcoholic beverages has also been associated with adverse effects on the central nervous system, digestive system and cardiovascular system. Benzene Carcinogenicity: Benzene is an animal carcinogen and is known to produce acute myelogenous leukemia (a form of cancer) in humans. Benzene has been identified as a human carcinogen by IARC, the US National Toxicology Program and the US-Occupational Safety and Health Administration. Reproductive Toxicity: Some studies in occupationally exposed women have suggested benzene exposure increased risk of