<b>Bijsluiter</b>. De hyperlink naar het originele document werkt niet meer. Daarom laat Woogle de tekst zien die in dat document stond. Deze tekst kan vreemde foutieve woorden of zinnen bevatten en de opmaak kan verdwenen of veranderd zijn. Dit komt door het zwartlakken van vertrouwelijke informatie of doordat de tekst niet digitaal beschikbaar was en dus ingescand en vervolgens via OCR weer ingelezen is. Voor het originele document, neem contact op met de Woo-contactpersoon van het bestuursorgaan.<br><br>====================================================================== Pagina 1 ======================================================================

<pre>Liquefied petroleum gas (LPG)
(CAS No: 68476-85-7)
Propane
(CAS No: 74-98-6)
Butane
(CAS No: 106-97-8)
Health-based Reassessment of Administrative Occupational Exposure Limits
Committee on Updating of Occupational Exposure Limits,
a committee of the Health Council of the Netherlands
No. 2000/15OSH/134 The Hague, November 9, 2004
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<pre>Preferred citation:
Health Council of the Netherlands: Committee on Updating of Occupational
Exposure Limits. Liquefied petroleum gas (LPG), Propane, Butane; Health-
based Reassessment of Administrative Occupational Exposure Limits. The
Hague: Health Council of the Netherlands, 2004; 2000/15OSH/134.
all rights reserved
</pre>

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<pre>1     Introduction
      The present document contains the assessment of the health hazard of liquefied
      petroleum gas (LPG) and its components butane and propane by the Committee
      on Updating of Occupational Exposure Limits, a committee of the Health
      Council of the Netherlands. First drafts of separate documents on LPG and
      butane were prepared by MA Maclaine Pont, M.Sc. (Wageningen University and
      Research Centre, Wageningen, the Netherlands) and AAE Wibowo, Ph.D.
      (Coronel Institute, Academic Medical Centre, Amsterdam, the Netherlands),
      respectively.
           The evaluation of the toxicity of butane and propane has been based on the
      reviews by Berzins (Ber95a, Ber95b) and Low et al. (Low87a, Low87b). Where
      relevant, the original publications were reviewed and evaluated as will be
      indicated in the text. In addition, in February 1998, literature was searched on the
      databases Medline, Toxline, and Chemical Abstracts, starting from 1966, 1981,
      and 1937, respectively, and using the following key words: liquefied petroleum
      gas, LPG, propane, butane, butylhydride, 68476-85-7, 74-98-6, and 106-97-8.
      Data on intoxication from combustion products were excluded from the
      document.
           In March 2000, the President of the Health Council released separate drafts
      of documents on butane and LPG for public review. Comments were received
      from the following individuals and organisations: A Aalto (Ministry of Social
      Affairs and Health, Tampere, Finland), JH Urbanus (CONCAWE, Brussels,
      Belgium), P Wardenbach, Ph.D. (Bundesanstalt für Arbeitsschutz and
      Arbeitsmedizin, Dortmund, FRG), and L Whitford (Health and Safety Executive,
      London, England). These comments were taken into account when deciding on
      the final version of the document*.
           An additional search in Toxline and Medline in April 2004 did not result in
      information changing the committee’s conclusions.
*     In the finalising phase, it was decided to combine the documents on LPG (including propane) and butane into one
      document.
134-3 Liquefied petroleum gas (LPG), Propane, Butane
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<pre>2                 Identity
name                             :    liquefied petroleum gas propane                              butane
synonyms                         :    LPG; petroleum gas;      n-propane; dimethylmethane;         n-butane; butylhydride;
                                      bottled gas              propyl hydride; propyl dihydride    methylethylmethane; diethyl
molecular formula                :                             C3H8                                C4H10
structural formula               :                             CH3-CH2-CH3                         CH3-CH2-CH2-CH3
CAS number                       :    68476-85-7a              74-98-6                             106-97-8
a
     CAS does not treat this substance as a unique chemical entity in its regular CA index processing.
3                 Physical and chemical properties
                                     LPG                      propane                              n-butane
molecular weight                     42-58                    44.09                                58.12
boiling point                        >-44oC                   -42.1oC                              -0.5oC
melting point                        not available            -189.7oC                             -138.2oC
flash point                          not found                -104oC (closed cup)                  -60oC (closed cup)
vapour pressure                      >100 kPa                 at 21oC: 853 kPa                     at 25oC: 243 kPa
solubility in water                  insoluble                insoluble                            insoluble
log Poctanol/water                   not available            2.36 (experimental)                  2.89 (experimental)
                                                              1.81 (calculated)                    2.31 (calculated)
conversion factors                                            at 20oC, 101.3 kPa:                  at 20oC, 101.3 kPa:
                                                              1 mg/m3 = 0.54 ppm                   1 mg/m3 = 0.41 ppm
                                                              1 ppm = 1.84 mg/m3                   1 ppm = 2.42 mg/m3
Data from ACG02a, ACG02b, ACG02c, Ber95a, Ber95b, CON92, NLM04a, NLM04b, http://www.syrres.com/esc/
est_kowdemo.htm.
                  LPG
                  LPG is a by-product of petroleum refining. It is a colourless gas with a mild
                  odour. An odour threshold ranging from 5000-20,000 ppm has been reported. A
                  foul odorant (e.g., ethanethiol) is added commercially. LPG is highly flammable
                  and is a dangerous fire and explosive hazard (ACG02a).
                      LPG is commercially available as propane (often found in colder climates),
                  butane (more widely found in the Southern States of the USA due to its higher
                  freezing and boiling points), and butane-propane mixtures (ACG02a). Others
                  state that LPG is predominantly a mixture of C3 and C4 hydrocarbons with other
                  hydrocarbons in the C1-C7 range. These are gases at normal ambient
                  temperatures and pressures (CON92). In the Netherlands, LPG is blended by the
                  Shell Company mainly from propane/propene and butane/butene refinery
                  streams, both streams consisting for >90% of C3 or C4 molecules, respectively.
134-4             Health-based Reassessment of Administrative Occupational Exposure Limits
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<pre>      The proportion of longer chain molecules (≥C5) is 2% at most; the share of the
      unsaturated molecules is approximately 30%. The boiling point ranges from -40
      to +40oC (Kat98).
      Propane
      Propane is a colourless and odourless flammable gas (Ber95a). Amoore and
      Hautala listed an odour threshold for propane of 16,000 ppm (29,440 mg/m3)
      (Amo83) while Ruth reported the odour threshold to range between 972 and
      19,440 ppm (1800 and 36,000 mg/m3) (Rut86).
      Butane
      Butane is a colourless and flammable gas with a gasoline-like or natural gas
      odour (ACG02c). Amoore and Hautala listed an odour threshold for butane of
      2700 ppm (6530 mg/m3) (Amo83) while Ruth reported the odour threshold to
      range between 1.2 and 6 ppm (2.9 and 14.6 mg/m3) (Rut86).
4     Uses
      LPG
      LPGs are widely used as fuel and as feedstock in chemical processes. In some
      countries, there is also extensive use of LPG as automotive fuel. LPGs are also
      used as propellants in pressurised aerosol containers (CON92).
      Propane
      Propane is used as fuel gas in the household, industry, and vehicles (sometimes
      mixed with butane), in organic synthesis, as an intermediate in petrochemical
      manufacture, as a refrigerant and aerosol propellant (amongst others in
      cosmetics). It occurs in natural gas (Ber95a, Moo82). In the USA, it has a GRAS
      (‘generally recognised as safe’) status for use as a food additive, i.e., to expel a
      product or to reduce the amount of oxygen in contact with the food in the
      packaging (see Code of Federal Regulations: 21CFR184.1165; revised as of
      April 1, 2003).
      Butane
      Butane is used in liquid fuels of high octane, in organic synthesis of different
      chemicals, in the production of synthetic rubbers, as a refrigerant and aerosol
      propellant (amongst others in cosmetics), and as a constituent in liquid natural
      gas (Ber95b, Moo82). In the USA, it has a GRAS (‘generally recognised as
      safe’) status for use as a food additive, i.e., to expel a product or to reduce the
134-5 Liquefied petroleum gas (LPG), Propane, Butane
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<pre>      amount of oxygen in contact with the food in the packaging (see Code of Federal
      Regulations: 21CFR184.1165; revised as of April 1, 2003).
5      Biotransformation and kinetics
      LPG
      In male ICR mice exposed to an unknown concentration of LPG (composition:
      97.4% propane, 0.3% butane, 1.2% ethane, and 1.1% 2-methylpropane) for 2
      hours, propane, butane, and 2-methylpropane and the metabolites 2-propanol,
      acetone, 2-butanol, and 2-butanone were identified in blood, brain, liver, and
      kidneys (Tsu85a).
      Propane
      One hour after inhalation of an unknown concentration of propane, unchanged
      compound was detected in blood, brain, liver, and kidneys of male ICR mice. 2-
      Propanol and acetone, metabolites of propane, were also identified. Following
      incubation of a saturated aqueous solution of propane (ca. 2.9 mM) with a mouse
      liver microsomal suspension in the presence of a NADPH-generating system,
      Tsukamoto et al. only found 2-propanol, while no ketone was detected. From
      these data, the authors presumed that propane was first metabolised into a
      secondary alcohol, 2-propanol, by the microsomal enzyme system and then into
      the corresponding ketone, acetone, by alcohol dehydrogenase (Tsu85a, Tsu85b).
      Propane has been detected in blood, brain, kidney, liver, and lungs of man
      following fatal propane exposure (Ber95a, Gra99).
      Butane
      In humans, absorption of butane was reported to be 30-45% of the dose inhaled
      (Fla90). Although the committee did not find data on absorption through the
      skin, dermal penetration of butane is expected to be low since skin contact is
      transient due to the volatility of the compound (Low87b).
          In a fatal case of butane abuse, levels of butane in liver, brain, blood, and
      kidneys amounted to 310, 282, 129, and 84 mg/kg or mg/L, respectively (Gra99).
      In rats exposed to a butane concentration of 100 ppm (240 mg/m3) for 80
      minutes, the uptake was estimated to be 1.5-1.8 nmol/kg/min/ppm (0.09-0.1
      µg/kg/min/ppm) (Dah88). From this, a retention of ca. 10% can be calculated
      (assuming a rat body weight of 300 g and a minute volume of 125 mL/min).
134-6 Health-based Reassessment of Administrative Occupational Exposure Limits
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<pre>          Butane is distributed to various tissues. After exposing rats to lethal
      concentrations of ca. 650,000 mg/m3 (ca. 270,000 ppm) for 4 hours, Shugaev
      found the highest concentration of butane in the perirenal fat tissue, followed by
      the brain, spleen, liver, and kidney (Shu69).
          One hour after inhalation to an unknown concentration of butane, unchanged
      compound was detected in blood, brain, liver, and kidneys of male ICR mice.
      2-Butanol and 2-butanone, metabolites of butane, were also identified. As with
      propane (see above), incubation of a saturated aqueous solution of butane (ca. 6.7
      mM) with a mouse liver microsomal suspension in the presence of a NADPH-
      generating system, only 2-butanol, but no ketone was detected. Tsukamoto
      proposed a metabolism scheme similar to that described above for propane
      (Tsu85a, Tsu85b).
          Low et al. reported that in rat liver microsomes, butane was hydroxylated
      yielding 2-butanol as the major metabolite. Butane was the lowest molecular
      weight alkane demonstrated to bind as a substrate to cytochrome P450. The
      authors suggested that if 2-butanol would be the major metabolite formed in
      mammals, it could be excreted in exhaled air. Like other alcoholic metabolites
      formed from hydroxylation of normal alkanes, 2-butanol may also be conjugated
      with glucuronic acid or be oxidised into methyl ethyl ketone, which could be
      expired as well (Low87b).
          Because of its volatile nature, unchanged butane may also be exhaled, and its
      determination in exhaled air might be used for biological monitoring purposes.
6     Effects and mechanism of action
      Human data
      LPG
      A few cases on death following accidental or intentional inhalation of LPG have
      been reported (Kir92, Fuk96). Aydin and Özçakar described a case of a 28-year-
      old man complaining of nausea, malaise, and generalised weakness of the lower
      limbs. The patient was hospitalised with a diagnosis of suspected acute hepatitis
      that was attributed to have been working in an enclosed space fixing gas
      cylinders containing a propane-butane mixture (Ayd03). Abnormal liver function
      and neurological symptoms were found in a 63-year-old man after inhaling a
      mixture containing propane, butane, and 2-methylpropane (30-35%), but also
      petroleum distillates 25-35%), pentane (10-15%), and acetone (1-5%). The
      symptoms subsided after discontinuation of exposure (Pya98).
134-7 Liquefied petroleum gas (LPG), Propane, Butane
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<pre>      Propane
      At very high levels, propane has CNS depressant and asphyxiating properties.
      Several cases of fatal inhalation of propane have been described (Avi94, Gra99,
      Sie90, Tso98; see also Ber95a, Cav94). Bowen et al. reported that out of 52
      deaths associated with accidental or intentional inhalation of volatile compounds
      in Virginia (USA) in the period 1987-1996, 6 cases were due to suicide and 7 to
      accidental overexposure in, usually, the workplace, but the compounds involved
      were not specified. Of the remaining 39 cases in which death was considered to
      be a direct consequence of inhalant abuse, 5 were associated with propane
      (Bow99).
          A 17-year-old male reported feelings of euphoria, ataxia, and light-
      headedness without loss of consciousness when inhaling propane intentionally
      for 10-15 seconds and subsequently holding his breath for up to one minute.
      These sensations lasted for 1-2 minutes. This inhalation pattern would be
      repeated daily for periods up to 3 hours for 6 months. The man complained of
      severe headache and memory loss on the morning after exposure. Physical
      examination, including a neurological assessment, and laboratory tests (complete
      blood count with differential, blood urea nitrogen, serum creatinine, electrolytes,
      routine urinalysis, liver function tests) did not reveal abnormalities (Whe92).
          Several cases of cold injury from liquid propane have been published. The
      injuries were similar to frostbite but the symptoms occurred more rapidly with
      propane (Ber95a).
          No changes in EEGs, adrenocortical functions, pulmonary functions,
      neurological response, subjective response, cardiac function, cognitive response,
      or visual evoked response were seen in 8 men and women exposed to propane
      concentrations of 250 and 1000 ppm (460 and 1840 mg/m3) for 1 minute to 8
      hours or in 2 men and 2 women exposed to 1000 ppm (1840 mg/m3) propane, 8
      hours/day for 5 consecutive days at one week and 4 consecutive days the
      following week (Ber95a, Low87a, Moo82).
          Ten-minute exposures to 10,000 ppm (18,400 mg/m3) did not produce
      symptoms in 6 men and women; distinct vertigo, but no mucosal irritation of
      nose, eyes, or respiratory tract, was observed at exposures to up to 100,000 ppm
      (184,000 mg/m3) for 2 minutes (Moo82).
          Assuming a correlation between the anaesthetic potency of a gas and its air/
      olive oil partition coefficient, Drummond expected that a concentration of
      propane of 47,000 ppm (86,500 mg/m3) would induce narcosis in man (Dru93).
134-8 Health-based Reassessment of Administrative Occupational Exposure Limits
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<pre>      Butane
      Several individual cases or retrospective studies (in e.g., England, Germany, and
      the USA) in which butane was identified as the toxic agent have been reported.
      They mostly concern its abuse as an inhalant, from, e.g., lighters or hair/
      deodorant sprays, by teenagers and adolescents. Butane abuse was fatal, mostly
      due to heart failure (arrhythmias, ventricular fibrillation, asystole) (Bla98,
      Bow99, Cha02, Dör02, Fie03, Gra99, Rob90, Roh97, Weh02, Wil98) and, in one
      case, due to multiple organ failure involving the central nervous system,
      cardiovascular system, pulmonary system, and the liver (Rie00). Bowen et al.
      reported that out of 52 deaths associated with accidental or intentional inhalation
      of volatile compounds in Virginia (USA) in the period 1987-1996, 6 cases were
      due to suicide and 7 to accidental overexposure in, usually, the workplace, but
      the compounds involved were not specified. Of the remaining 39 cases in which
      death was considered to be a direct consequence of inhalant abuse, 13 were
      associated with butane (Bow99). Butane induced severe acute neurological
      (seizure, somnolence, coma) or cardiovascular (ventricular fibrillation, asystole,
      collapse) complications and minor symptoms such as nausea, dizziness,
      vomiting, headache, and sore throat (Dör02, Edw00, ONe99). Döring et al.
      described a case of severe encephalopathy in a 15-year-old girl having inhaled
      butane repeatedly for 4 weeks when an acute abuse incident occurred. After
      admittance to the hospital, involving cardiopulmonary resuscitation, 6-day
      catecholamine treatment, and 11-day mechanic ventilation, severe brain damage
      with vigil coma and spastic quadriplegia became obvious during the following
      weeks. Repetitive MRI-imaging revealed disintegration of grey matter,
      increasing cerebral atrophy, and destruction of basal ganglia while EEG showed
      strongly diminished basal activity with flat amplitude (Dör02). Gray and Lazarus
      presented a case of a right-sided hemiparesis characterised by markedly reduced
      power - grade 1/5 - in the right arm and leg, flaccid tone, and absent reflexes with
      an extensor plantar reflex on this side (Gra93). Frangides et al. reported a (very
      rare) case of non-fatal acute massive rhabdomyolysis in a 27-year-old man due to
      accidental inhalation of liquid gas fumes leaking from a tank containing a
      mixture of butane (80%), propane (20%), ethanethiol, and olefines (Fra03).
      McIntyre and Long concluded that fulminant hepatic failure after taking a
      proprietary engine or carburettor cleaner, containing isopropyl alcohol, mineral
      oil, and aromatic petroleum products, was the cause of death of a 17-year-old
      male having been abusing butane aerosols for 3 years (McI92).
           Two cases of pregnant women accidentally (in pregnancy week 27) or
      intentionally (suicide attempt in week 30) were reported. The first woman gave
      birth to a child with hydranencephaly (Fer86), while the second woman gave
134-9 Liquefied petroleum gas (LPG), Propane, Butane
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<pre>       birth to a child that died after 11 hours with severe encephalomalacia and
       hypoplastic kidneys (Gos82). In both cases, these brain effects were not
       considered to be a butane-specific effect but to have been caused by intrauterine
       anoxia. In neither of these cases, estimations of the concentrations inhaled were
       made.
           Viau et al. did not find clinically significant effects on sensitive biochemical
       and immunological markers of kidney (functioning) in 53 male refinery workers
       who were occupationally exposed for an average of 11 years to a number of
       hydrocarbons, among which butane (concentration ranged from 0.4 to 17.8
       mg/m3) (Via87).
           In human subjects exposed to a butane concentration of 10,000 ppm (24,200
       mg/m3) for 10 minutes, drowsiness was reported (no more data presented)
       (Low87b, Moo82).
           Assuming a correlation between the anaesthetic potency of a gas and its air/
       olive oil partition coefficient, Drummond expected that a concentration of butane
       of 17,000 ppm (40,290 mg/m3) would induce narcosis in man (Dru93).
       Animal data
       LPG
       The committee did not find data from experimental animal studies with LPG.
       Propane
       The committee did not find data on the irritating properties of propane or of
       formulations containing propane only. Applications of several formulations
       containing 63-69% 2-methylpropane and 12-13% propane to the clipped back
       skin of rabbits resulted in primary irritation index scores of 0.38-0.73 (maximum
       possible score: 8.0) (Moo82).
           In guinea pigs, irregular breathing or tremors (during the first 5 minutes)
       were observed at 5-120 minute exposures to ca. 44,000-53,000 (24,000-29,000
       ppm) or 86,000-101,000 mg/m3 (47,000-55,000 ppm), respectively. Nausea,
       retching, and stupefaction were seen at longer exposure durations; narcotic
       effects not until exposure levels were ca. 92,000 mg/m3 (50,000 ppm). No
       mortality or pathological changes were observed (Low87a). The EC50 for effects
       on the central nervous system (ataxia and loss of righting reflex) in rats was ca.
       52,000 mg/m3 (28,000 ppm) (exposure time: 10 minutes) (Cla82). When propane
       was administered by tracheal cannula to anaesthetised rhesus monkeys (n=3/
       group) at concentrations of ca. 180,000 and 360,000 mg/m3 (100,000 or 200,000
       ppm), for 5 minutes followed by inhalation of room air for 10 minutes, it induced
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<pre>       increases (not statistically significant: p>0.05) in bronchoconstriction and
       respiratory depression at the high level, but no arrhythmia or myocardial
       depression (Bel74, Avi75). In anaesthetised mice and unanaesthetised dogs,
       propane did not induce arrhythmias either but (weakly) sensitised the heart to
       epinephrine-induced cardiac arrhythmias at concentrations of ca. 180,000 and
       360,000 mg/m3 (100,000 and 200,000 ppm), but in dogs not at ca. 90,000 mg/m3
       or 50,000 ppm (exposure time: mice: 6 minutes; dogs: 10 minutes) (Avi74,
       Rei71). Similar effects were observed in dogs exposed to concentrations of ca.
       280,000 to 1,656,000 mg/m3 (150,000-900,000 ppm) for 10 minutes (Low87a).
       In another study, propane was a weak cardiac sensitiser in dogs: the EC50 was ca.
       33,000 mg/m3 (18,000 ppm) (exposure time: 5 minutes) (Cla82).
            The committee did not find data from repeated-dose toxicity studies
       (including carcinogenicity and reproduction toxicity) on propane alone.
       Propane (purity: >99.9%) did not induce mutations when tested with and without
       an induced rat liver metabolic activation system in S. typhimurium strains
       TA1535, TA1537, TA1538, TA98, and TA100 at concentrations of 5-50% (v/v)
       in a desiccator (exposure time: 6 hours) (Kir80).
       Butane
       Injection of liquid butane into the anterior eye chamber of rabbits did not cause
       disturbance, and all effects disappeared in 2-4 days (Gra74).
            Kane and Alarie exposed groups of male Swiss-Webster mice to
       photochemical oxidant mixtures generated by a reaction between various
       hydrocarbons, among which butane, and nitrogen dioxide in the presence of
       ultraviolet light. Meanwhile, the respiratory rates of the mice were monitored.
       The initial hydrocarbon concentrations ranged from 0.4 to 18 ppm (0.9-42.7
       mg/m3) with the initial nitrogen dioxide concentration being one-third of the
       initial hydrocarbon concentration. Concomitant exposure to butane and nitrogen
       dioxide did not significantly affect respiratory rate, indicating no irritation of the
       upper respiratory tract. The authors also reported that butane did not cause
       irritation to the eyes of the mice (Kan78). In guinea pigs, exposure to
       concentrations of butane of 21,000-56,000 ppm (ca. 50,800-135,000 mg/m3)
       caused increased respiratory rate, sniffing, and chewing movements, animals
       recovering quickly after cessation of exposure (Low87b).
            Acute LC50 values were 658,000 and 680,000 mg/m3 (ca. 270,000 and
       279,000 ppm) in rats (exposure duration: 4 hours) and mice (2 hours),
       respectively (Shu69). In mice, 40 and 60% of the animals died at 2-hour
       exposures to ca. 653,000 and 750,000 mg/m3 (270,000 and 310,000 ppm),
134-11 Liquefied petroleum gas (LPG), Propane, Butane
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<pre>       respectively. Slight anaesthesia was observed at exposure to 130,000 or 220,000
       ppm (314,600 and 532,400 mg/m3) for 25 and 1 minute, respectively, while 15-
       minute exposure to the higher concentration induced complete anaesthesia
       (Ber95b, Low87b). In dogs, concentrations of 200,000-250,000 ppm (484,000-
       605,000 mg/m3) caused anaesthesia and mortality within a few minutes. Other
       studies showed butane to sensitise the heart to epinephrine-induced cardiac
       arrhythmias or ventricular fibrillation at levels of 150,000-900,000 (363,000-
       2,178,000 mg/m3), for 10 minutes, and of 10,000-200,000 ppm (24,200-484,000
       mg/m3), for 2 minutes to 2 hours, respectively (Ber95b, Low87b), while
       exposure to 5000 ppm (12,100 mg/m3) had caused haemodynamic changes in
       anaesthetised dogs, such as a decrease in cardiac output, left ventricular pressure,
       and stroke volume, a decrease in myocardial contractility, and aortic pressure
       (Low87b).
           Halder et al. examined the toxicity of a hydrocarbon blend vapour consisting
       of 25% (w/w) each of butane, pentane, isobutane, and isopentane by exposing
       rats (Sprague-Dawley; n=10/sex/group) to, analytical, time-weighted average,
       total hydrocarbon concentrations of 0, 116, 1150, or 11,800 mg/m3
       (0, 44, 432, and 4437 ppm). Particular attention was paid to effects on the
       kidneys. Histological examinations were also done on the brain, heart, liver,
       spleen, adrenals, and gonads. During exposure, no clinical signs of toxicity were
       observed. Post-mortem examinations did not show macroscopic or microscopic
       changes in any of the organs examined in any of the treated groups and no
       evidence of the presence of the male-rat-specific, hydrocarbon-induced
       nephropathy (Hal86). From this study, the committee concluded that the NOAEL
       for rats is at least 11,800 mg/m3 for total hydrocarbons and at least 2950 mg/m3
       (1210 ppm) for butane.
           The same research group exposed 20 male and 10 female rats (Fischer 344)
       to analytical, time-weighted average, concentrations of a mixture of butane and
       pentane of 1017 and 4489 ppm, for 13 weeks. The relative proportions of butane
       in the mixture were 51.5 and 47.5 wt%, respectively. A control group consisting
       of 40 male and 20 female animals was included. At day 28, necropsies were
       performed for half of the male rats of each treatment group. All animals survived
       exposure. Aranyi et al. reported possible treatment-related, but not dose-related,
       signs of toxicity including transient hunched posture and/or lethargy and
       intermittent tremor and statistically significantly decreased body weights for
       both males and females by test week 3 and 4. At the end of the study, body
       weights were comparable to those of controls. At post-mortem examinations,
       liver and kidney weights were not affected and no gross, treatment-related
       lesions were observed. Only the kidneys were examined microscopically and
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<pre>       scored based on the presence of hyaline droplet accumulation in the proximal
       tubule epithelial cells, of foci of regenerative tubular epithelium in the cortical
       region of the kidney, and of dilated tubuli filled with granular material located at
       the junction between the inner and outer stripes of the medulla. These kidney
       lesions were seen in all male treated and control groups but not in the female
       groups. Compared with controls, there were dose-related, not statistically
       significant increases in scores at the 28-day interim kill, but scores did not differ
       between male groups at study termination (Ara86). From this study, the
       committee concluded that the NOAEL for rats is at least 4489 ppm for the
       butane/pentane mixture and at least 2343 ppm (5670 mg/m3; calculated based on
       relative proportion of butane in this mixture of 47.5 wt%) for butane.
           The committee did not find data from repeated-dose toxicity studies
       (including carcinogenicity and reproduction toxicity) on butane alone.
       Tested under similar conditions as propane (see above), butane (purity: 99.7%)
       was negative in S. typhimurium strains TA1535, TA1537, TA1538, TA98, and
       TA100 (Kir80). Shimizu et al. obtained negative results as well when butane
       (purity: 99%) was tested with and without metabolic activation in these 5
       Salmonella strains as well as in E. coli strain WP2 uvrA at concentrations of 250-
       10,000 ppm (Shi85).
           Butane was negative in the sex-linked recessive lethal mutation assay in D.
       melanogaster, exposed by inhalation to 350,000 ppm n-butane (Fou94).
7      Existing guidelines
       The current administrative occupational exposure limits (MAC) for LPG and
       butane in the Netherlands are 1800 and 1430 mg/m3 (1000 and 600 ppm), 8-hour
       TWA, respectively. For propane, no administrative MAC value has been
       established. Propane is considered to act as a simple asphyxiant, when present at
       high concentrations in air, by reducing the oxygen content air by dilution to such
       an extent that life cannot be supported. In order to prevent this, the content of
       oxygen in air should be at least 18% (v/v).
           Existing occupational exposure limits for LPG, propane, and butane in some
       European countries and in the USA are summarised in the annex.
134-13 Liquefied petroleum gas (LPG), Propane, Butane
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<pre>8      Assessment of health hazard
       Propane
       Data from studies using mouse liver microsomal suspensions and mice suggest
       that propane might be metabolised into 2-propanol and acetone through
       oxidation by the microsomal enzyme system and alcohol dehydrogenase,
       respectively. Propane has been detected in blood, brain, liver, and kidneys of
       mice and men and in the lungs of men.
            Human data include several cases of fatal (intentional) inhalation of propane.
       In one case of long-term propane abuse, euphoria, ataxia, light-headedness,
       severe headache, and memory loss were reported, but no abnormalities were
       found at physical examination (including a neurological assessment, and
       laboratory - blood, liver function – tests). No changes in EEGs, adrenocortical
       functions, pulmonary functions, neurological response, subjective response,
       cardiac function, cognitive response, or visual evoked response were seen in
       volunteers exposed to 1000 ppm (1840 mg/m3) propane, 8 hours/day, for 9 days.
       Ten-minute exposures to 10,000 ppm (18,400 mg/m3) did not produce
       symptoms, but 2-minute exposures up to 100,000 ppm (184,000 mg/m3) resulted
       in distinct vertigo, but no mucosal irritation of nose, eyes, or respiratory tract.
       Dermal contact with liquid propane can cause frostbite.
            In guinea pigs exposed to ca. 44,000-53,000 (24,000-29,000 ppm) or 86,000-
       101,000 mg/m3 (47,000-55,000 ppm) for 5-120 minutes, irregular breathing,
       nausea, retching, stupefaction, tremors (at 86,000-101,000 mg/m3), and narcosis
       (at levels of ca. 92,000 mg/m3 or 50,000 ppm), but no mortality or pathological
       changes were observed. Five-minute exposure by tracheal cannula to
       concentrations of 360,000 mg/m3 (200,000 ppm) did not induce
       bronchoconstriction, respiratory depression, arrhythmia, or myocardial
       depression in rhesus monkeys. In mice and dogs, 6-10 minute exposure to
       180,000 mg/m3 (100,000 ppm) did not induced arrhythmia but (weakly)
       sensitised the heart to epinephrine-induced cardiac arrhythmias.
            The committee did not find data from experiments on the toxicity (including
       carcinogenicity and reproduction toxicity) of propane following repeated
       exposure.
            Apart from a negative result in an in vitro mutation assay in S. typhimurium,
       the committee did not find data from mutagenicity and genotoxicity studies on
       propane.
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<pre>       The committee considers the toxicological database on propane too poor to
       justify recommendation of a health-based occupational exposure limit.
       Butane
       In humans, absorption of butane was stated to be 30-45% of the dose inhaled.
       From experiments in which rats were exposed to butane concentrations of 100
       ppm (240 mg/m3) for 80 minutes, the committee calculated absorption to be ca.
       10%. Although the committee did not find data on absorption through the skin,
       dermal penetration of butane is expected to be low since skin contact is transient
       due to the volatility of the compound. Following exposure of rats to lethal
       concentrations of ca. 650,000 mg/m3 (ca. 270,000 ppm), for 4 hours, the highest
       concentrations of butane were found in the perirenal fat tissue, followed by the
       brain, spleen, liver, and kidney. In vivo and in vitro experiments suggest that
       butane might be metabolised into 2-butanol by the microsomal enzyme system
       followed by conjugation with glucuronic acid or oxidation into 2-butanone by
       alcohol dehydrogenase.
           Human data on effects of exposure to butane mostly concern its abuse as an
       inhalant, from, e.g., lighters or hair/deodorant sprays. Butane abuse was
       frequently fatal, mostly due to heart failure (arrhythmias, ventricular fibrillation,
       asystole). In non-fatal cases, butane induced severe acute neurological (seizure,
       somnolence, coma) or cardiovascular (ventricular fibrillation, asystole, collapse)
       complications and minor symptoms such as nausea, dizziness, vomiting,
       headache, and sore throat. However, no quantitative exposure data were
       available.
           Butane was not irritating to the eyes of rabbits when injected as a liquid into
       the anterior chamber or to the upper respiratory tract of mice. In guinea pigs,
       some transient irritation (increased respiratory rate, sniffing, and chewing
       movements) during exposure to concentrations of 21,000-56,000 ppm (ca.
       50,800-135,000 mg/m3) was observed. Acute LC50 values were 658,000 and
       680,000 mg/m3 (269,780 and 278,800 ppm) in rats (exposure duration: 4 hours)
       and mice (2 hours), respectively. In mice, 25-minute to 130,000 ppm (314,600
       mg/m3) or 1-minute exposure to 220,000 ppm (532,400 mg/m3) induced slight
       anaesthesia; 15-minute exposure to 222,000 ppm complete anaesthesia. In dogs,
       concentrations of 200,000-250,000 ppm (484,000-605,000 mg/m3) caused
       anaesthesia and mortality within a few minutes. Butane had a cardiac sensitising
       effect in dogs.
           The committee did not find data from experiments on the toxicity (including
       carcinogenicity and reproduction toxicity) of butane following repeated
       exposure.
134-15 Liquefied petroleum gas (LPG), Propane, Butane
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<pre>           Data on rats exposed to mixtures of aliphatic hydrocarbons showed that
       exposure to a mixture containing an estimated concentration of butane of 2950
       mg/m3 did not induce an increase in the incidence of macroscopic or microscopic
       organ lesions. Exposure to another mixture containing an estimated
       concentration of butane of 5670 mg/m3 increased the incidence of kidney lesions
       (hydrocarbon-induced nephropathy) when compared to controls. However, in
       these studies, effect levels were not identified and effects on the central nervous
       system, a potential target organ, were not addressed. Therefore, the committee is
       of the opinion that the studies cannot be used as starting points in deriving a
       health-based occupational exposure limit.
           Butane was negative in in vitro mutation assays in S. typhimurium and E. coli
       and in a sex-linked recessive lethal mutation assay in D. melanogaster.
       The committee considers the toxicological database on butane too poor to justify
       recommendation of a health-based occupational exposure limit.
       Based on the animal data from studies with butane-containing mixtures (Ara86,
       Hal86), the committee concludes that there is no reason to suspect that the
       current occupational exposure limit of 1430 mg/m3 (600 ppm), as an 8-hour
       time-weighted average, is too high.
       LPG
       Apart from a few fatal cases and one case of nausea, malaise, general weakness
       of the lower limbs, and acute hepatitis, the committee did not find any
       information from reports on toxic effects of LPG in men and experimental
       animals.
       The committee considers the toxicological database on LPG too poor to justify
       recommendation of a health-based occupational exposure limit.
       Based on the available human and animal data on butane, the committee has no
       reason to suspect that the current administrative MAC value for LPG of 1800
       mg/m3 (1000 ppm), as an 8-hour time-weighted average, is too high.
       References
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134-16 Health-based Reassessment of Administrative Occupational Exposure Limits
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<pre>              Annex
Occupational exposure limits for liquefied petroleum gas (LPG) in various countries.
country                           occupational exposure limit time-weighted          type of exposure notea       referenceb
- organisation                                                   average             limit
                                  ppm              mg/m3
the Netherlands
- Ministry of Social Affairs and 1000              1800          8h                  administrative               SZW04
Employment
Germany
- AGS                             -                -                                                              TRG04
- DFG MAK-Kommission              -                -                                                              DFG04
Great Britain
  - HSE                           1000             1750 2180     8h                  OES                          HSE03
                                  1250                           15 min              STEL
Sweden                            -                -                                                              Swe00
Denmark                           -                -c                                                             Arb02
USA
  - ACGIH                         1000d            -             8h                  TLV                          ACG04b
  - OSHA                          1000             1800          8h                  PEL                          ACG04a
  - NIOSH                         1000             1800          10 h                REL                          ACG04a
European Union
  - SCOEL                         -                -                                                              EC04
a
     S = skin notation; which means that skin absorption may contribute considerably to the body burden; sens = substance can
     cause sensitisation.
b
     Reference to the most recent official publication of occupational exposure limits.
c
     Reference to propane: 1000 ppm/1800 mg/m3, 8-hour TWA.
d
     Reference to ‘aliphatic hydrocarbon gases: alkane [C1-C4]’.
134-21        Liquefied petroleum gas (LPG), Propane, Butane
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<pre>Occupational exposure limits for propane in various countries.
country                           occupational exposure         time-weighted      type of exposure  notea    referenceb
- organisation                    limit                         average            limit
                                  ppm           mg/m3
the Netherlands
- Ministry of Social Affairs and -              -c                                                            SZW04
Employment
Germany
- AGS                             1000          1800            8h                                            TRG04
                                  4000          7200            15 min
- DFG MAK-Kommission              1000          1800            8h                                            DFG04
                                  2000          3960            15 mind                              e
Great-Britain
- HSE                             -             -c                                                            HSE02
Sweden                            -             -                                                             Swe00
Denmark                           1000          1800            8h                                            Arb02
USA
- ACGIH                           1000f         -               8h                 TLV                        ACG04b
- OSHA                            1000          1800            8h                 PEL                        ACG04a
- NIOSH                           1000          1800            10 h               REL                        ACG04a
European Union
- SCOEL                           -             -                                                             EC04
a
     S = skin notation; which means that skin absorption may contribute considerably to the body burden; sens = substance can
     cause sensitisation.
b
     Reference to the most recent official publication of occupational exposure limits.
c
     Asphyxiant.
d
     Maximum number per shift: 4, with a minimum interval between peaks of 1 hour.
e
     Listed among substances with MAK values but no pregnancy risk group classification.
f
     Reference to ‘aliphatic hydrocarbon gases: alkane (C1-C4)’.
134-22        Health-based Reassessment of Administrative Occupational Exposure Limits
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<pre>Occupational exposure limits for butane in various countries.
country                            occupational exposure        time-weighted      type of exposure  notea    referenceb
- organisation                     limit                        average            limit
                                   ppm          mg/m3
the Netherlands
- Ministry of Social Affairs and 600            1430            8h                 administrative             SZW04
Employment
Germany
- AGS                              1000         2350            8h                                            TRG04
                                   4000         9400            15 min
- DFG MAK-Kommission               1000         2400            8h                                            DFG04
                                   4000         9600            15 minc                              d
Great-Britain                                                                                                 HSE02
- HSE                              600          1450            8h                 OES
                                   750          1810            15 min             STEL
Sweden                            -             -                                                             Swe00
Denmark                            500          1200            8h                                            Arb02
USA
- ACGIH                            1000e        -               8h                 TLV                        ACG04b
- OSHA                             -            -                                                             ACG04a
- NIOSH                            800          1900            10 h               REL                        ACG04a
European Union
- SCOEL                            -            -                                                             EC04
a
     S = skin notation; which means that skin absorption may contribute considerably to body burden; sens = substance can
     cause sensitisation.
b
     Reference to the most recent official publication of occupational exposure limits.
c
     Maximum number per shift: 4, with a minimum interval between peaks of 1 hour.
d
     Listed among substances with MAK values but no pregnancy risk group classification.
e
     Reference to: ‘aliphatic hydrocarbon gases: alkane (C1-C4)’.
134-23        Liquefied petroleum gas (LPG), Propane, Butane
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<pre>134-24 Health-based Reassessment of Administrative Occupational Exposure Limits</pre>

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<br><br>