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Methyl Isobutyl Ketone

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Methyl Isobutyl Ketone HEAC 6/5/18 DRAFT Cal/OSHA Draft Substance Summary for the December 12, 2017 HEAC Meeting Substance name: Methyl isobutyl ketone CAS: 108-10-1 MW: 100.16 Synonyms: 4-Methylpentan-2-one, Hexone, 4-Methyl-2-pentanone Molecular formula: C6H12O Structural formula: 1 ppm to 4.1 mg/m3 conversion factors at 25 oC and 760 mm/Hg: GHS Classification GHS Hazards Flammable liquids Category 2 Acute toxicity (Inhalation) Category 4 Eye irritation Category 2A Skin irritation Category 3 Specific target organ toxicity - single exposure Category 3 (Resp. irritation) Carcinogenicity Category 2 Signal Word: Danger GHS Hazard Statements H225 Highly flammable liquid and vapor. H319 Causes serious eye irritation. H332 Harmful if inhaled. H335 May cause respiratory irritation. H351 Suspected of causing cancer. Physical characteristics at room temp: Colorless liquid with sweet odor Special physical characteristics if any: very low solubility with water but miscible with most organic solvents; can form explosive peroxides upon exposure to air. Page 1 of 14 HEAC 6/5/18 DRAFT Flammability and other hazards: flammable, Vapor pressure 20.2 hPa @ 20 °C Upper Explosive Limit: 8% Lower Explosive Limit: 1.2% Major commercial form(s): liquid Uses/applications: a solvent for nitrocellulose, lacquers, gums, paints, polymers, varnishes, resins and surface coatings. Also used as precursor to N'-phenyl-p-phenylenediamine (6PPD), an anti- oxidant used in rubber and other elastomeric compounds and in manufacturing fungicides, pharmaceuticals, germicides and electroplating solutions. Also found in adhesives, food packaging, denatured alcohol and in synthetic flavorings (it is found naturally in food.) Occupations with Potential Exposure to MIBK Occupational exposures to MIBK occur in such industries as tire manufacturing, spray painting and industrial coating applicators. Occupational Exposure Limits and Other recommendations: Title 8 PEL (?): 50 ppm STEL 75 ppm OSHA PEL (1971) 100 ppm ACGIH TLV (2010): 20 ppm STEL 75 ppm skin notation NIOSH REL (2000): 50 ppm 75 ppm STEL 500 ppm IDLH MAK (2006): 20 ppm, 83 mg/m3 Other recommendations: Source and Findings/Recomm Basis/source/ref(s) Discussion and Assessment date endations OEHHA Cancer; Cancer based on IARC Included under State of California- (2011; 2014) Developmental (2013); developmental proposition 65 list as known to the state to toxicity. toxicity based on US cause cancer and reproductive toxicity. EPA (2003a; 2003b) assessment. US EPA Developmental Developmental effects in To derive the inhalation RfC, the NOAELHEC (2003a; toxicity - fetuses (i.e. reduced fetal of 1026 mg/m3 was divided by the cumulative 2003b) Inhalation body weight, skeletal uncertainty factor (UF) of 300 (i.e. 3 for reference variations, and increased interspecies following EPA guideline, 10 for concentration fetal death in mice; and intraspecies, and 10 for database deficiency (RfC) 3.0 mg/m3. skeletal variations in rats) such as developmental neurotoxicity). after repeated inhalation Inadequate data available for cancer exposure on gestation days assessment. [NOTE: NTP 2007 chronic study 6 to 15 (Tyl et al., 1987). completed]. NTP (2007) Some evidence of Increased incidences of While generally exacerbated in all exposed carcinogenic renal tubule neoplasms in rats, the severity of nephropathy was activity in male male rats and increased increased only in the 1,800 ppm group; F344/N rats and in incidences of liver increased incidences of papillary Page 2 of 14 HEAC 6/5/18 DRAFT both male and neoplasms in both male mineralization were significant in all exposed female B6C3F1 and female mice (NTP, groups of males. Additional research is mice, and 2007). Rare renal tumors needed to characterize the binding of methyl equivocal evidence in female rats. isobutyl ketone to α2u-globulin and to clarify of carcinogenic the role of α2u-globulin in the observed activity in female tumor outcome in male rats in the current 2- F344/N rats. year study. ATSDR _ _ _ IARC (2013) Group 2B - No evidence of While tumor responses corresponded to some Possibly carcinogenicity in extent with a measure of cumulative α2µ- carcinogenic to humans and sufficient globulin nephropathy, the severity of CNP humans. evidence of generally correlated best with the pattern of carcinogenicity in tumor response. Per IARC, the strength of the experimental animals evidence that male rat kidney tumors arose (NTP, 2007). through a α2µ-globulin nephropathy mechanism is weak. Peer-reviewed journal articles used for proposed PEL Human exposure studies There are no epidemiological studies available solely of MIBK. Several volunteer studies in ranges between 2.45 and 100 ppm have found CNS and irritancy effects. One study found a non-permanent decrease in olfactory function after exposure to 20 ppm for 7 hours. Human volunteer studies with MIBK are summarized in Table 1. Table 1: Human exposure studies Study Experimental Details Health Measures Conclusions Dick, 68 male/75 adult female Evaluations of performance on five No effects of MIBK exposure were 1992 volunteers exposed to 100 psychomotor tests, one sensorimotor detected with respect to any of the ppm (410 mg/m3) Ages test, and mood test of before performance tests or to the percentage 18-32. exposure, immediately prior to of subjects experiencing various exposure, during each of the two neurological or irritation symptoms, consecutive 2-hour exposure sessions, but a significant increase in percentage immediately after exposure, and on of subjects detecting a strong odor day following exposure. sensation and irritant effects were Chemical measurements (blood and reported in the MIBK-treated group. breath) and reports of sensory and irritant effects were measured. (Hjelm et 8 male volunteers exposed Volunteers performed light exercise Out of a possible 48 positive responses al., 1990) on 3 occasions for 2 hrs for two hours during exposure. (6 symptoms rated yes/no by 8 under conditions of light Simple reaction time (SRT) assessed subjects), 4, 11, and 11 responses exercise to 2.5 ppm (10 by test and mood, central nervous occurred at 2.5, 25 and 50 ppm, mg/m3 ), 25 ppm (100 system (CNS) and irritation respectively. At 25 or 50 ppm, three of mg/m3), or 50 ppm (200 symptoms by 17-point questionnaire the eight subjects reported nose and mg/m3) MIBK, followed at 9 times – once before exposure, 5 throat irritation and two reported by 2-hour observation times during exposure and 3 times headache and vertigo. Local irritation periods. No controls. after exposure. effects differed between exposure groups and appeared to plateau during exposure. No exposure-related effects were observed in mood ratings or performance tests. Page 3 of 14 HEAC 6/5/18 DRAFT Iregren, 6 male and 6 female Volunteers performed light exercise There was no significant effect of 1993 volunteers exposed to during the first 90 minutes and rested exposure on HR or SRT. Sensory MIBK vapors 2.5 (control) during the final 30 minutes of irritation ratings were not significantly or 50 ppm. exposure. Performance of heart rate different between the two exposure (HR), simple reaction time (SRT) levels, plateaued over the course of assessed by test and central nervous exposure and declined after exposure. system (CNS) and irritation Neurological symptoms increased in symptoms assessed by 17-point occurance and intensity over the 7 tests questionnaire at 7 times – once before and were significantly increased in the exposure, 4 times during, and twice high dose group compared to the after exposure ended. control Gagnon, Olfactory function Olfactory perception threshold (OPT) Immediate post exposure OPT was 1994 assessed in 4 subjects in was assessed using standard olfactory significantly higher than pre-exposure two sessions. Subjects kits. An acute symptoms (t = 9.0; p < 0.0001). OPT was exposed to 20 and 40 ppm, questionnaire was used to survey significantly different between for 7 hours, separated by a signs of eye, nose and throat individuals and OPT shift was 25-day interval. irritation, acute discomfort and significant for all 4 subjects. OPT perceived odor intensity. remained significantly higher than pre- exposure levels at both 20 and 40 ppm (p < 0.01). Although OPT was similar immediately following chamber exit, it was significantly higher at 40 ppm as compared to 20 ppm at 55 and 95 minutes post exposure. Eye and throat irritation was reported once each among the other subjects. Sub-chronic/chronic studies MIBK has been evaluated in rodents in numerous sub-chronic studies and one chronic study. The observed effects in rats are almost exclusively in the kidney, liver and CNS. Effects observed in rats are kidney and liver weight gain, total weight loss, kidney hyperplasia and tumors, hyaline droplet lesions and altered serum and urinary chemistries (elevated serum cholesterol and urinary glucose). These metabolic imbalances are believed to be a secondary result associated with kidney and liver toxicity. Effects observed in mice are increased liver and kidney weights and hepatocellular hyperplasia. The CNS effects associated with MIBK were behavioral changes (e.g., hypoactivity, ataxia, and unsteady gait) that were only observed during exposure events in repeated exposure studies and which rapidly dissipated when exposure was terminated. MIBK concentrations causing CNS effects were higher than those causing organ effects. The database of sub-chronic inhalation animal studies includes no reports of MIBK-induced adverse effects in histological examinations of nervous system
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