Summary of Regulations & Health Risks

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Summary of Regulation/Standards and Health Risks for Ethylene Oxide, Hydrogen Peroxide and Ozone

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1.   Summary   of   Regulations   /   Standards   and   Health   Hazards          U.S.   Dept   of   Labor   Occupational   Safety   &   Health   Administration         IDLH   (Immediately Dangerous   to   Life   &   Health)       Sterilant   Gas   8   Hr   TWA   PEL   (Permissible   Exposure   Limit)   15   Min   TWA   EL (Excursion   Limit)   Ethylene   Oxide   (EtO)   1.0   ppm   (a)   5   ppm   (a)   800   ppm   (a)    Known   human   carcinogen   (a)   • A   powerful   mutagen   and   clastogen   at   all   phylogenetic   levels   (b)   • Associated   with   malignancies   of   lymphatic   and   haematopoietic   cancer   with   leukemia   risk   (b)   (c)   • increased   risks   of   lymphosarcoma/   reticulosarcoma   and   breast   cancer   (c)   (d)   • Increased   frequency   of   spontaneous   abortion   (d)   with   adverse   reproductive   effects   (e)   • Chromosomal   aberrations   in   bone   marrow   cells   (b)   (d)   • CNS   depression,   pulmonary   edema,   and   in   extreme   cases,   respiratory   distress   &   coma   may   result   from   long   term   exposure   (f)   • Skin   sensitization,   respiratory   irritation   and   nervous   system   effects   (e)       a) http://www.cdc.gov/niosh/npg/npgd0275.html   b) http://monographs.iarc.fr/ENG/Monographs/vol60/volume60.pdf   c) http://www.ccohs.ca/oshanswers/ch emicals/chem_profiles/ethylene_ oxide/health_eth.html   d) http://www.hc ‐ sc.gc.ca/ewh ‐ semt/pubs/contaminants/psl2 ‐ lsp2/ethylene_oxide/ethylene_oxide_2 ‐ eng.php#a24412   e) http://www.cdc.gov/niosh/81130_35.html   f) http://www.atsdr.cdc.gov/MHMI/mmg137.html     Hydrogen   Peroxide   (H 2 O 2 )   1.0   ppm   (g)   n/a   75   ppm   (h)   Known   Animal   carcinogen   (g)   • Concentrations   >5%   can   cause   injury   to   eye   surface/ulcerations   (j)   • Inhalation   >   10%   vapor   solution   may   result   in   severe   pulmonary   irritation   (i)   • Repeated   exposure   may   cause   chronic   irritation   of   the   respiratory   tract   and   partial   or   complete   lung   collapse   (j)   • Inhalation   of   high   concentrations   may   result   in   seizures,   cerebral   infarction   or   cerebral   embolism;   ensuing   damage   to   the   CNS   may   cause   permanent   neurological   deficits   or   death   (j)      g) http://www.osha.gov/dts/chemi calsampling/data/CH_246600.html   h) http://www.cdc.gov/niosh/npg/npgd0335.html   i) http://www.atsdr.cdc.gov/tfacts174.pdf   j) http://www.atsdr.cdc.gov/MHMI/mmg174.html       Ozone   (O 3 )   0.1   ppm    (k)   n/a   5   ppm   (k)   Primary   Irritant   • Severe   and   permanent   lung   injury   or   death   could   result   from   even   a   very   short ‐ term   exposure   to   relatively   low   concentrations   (l)   • Symptoms   following   acute   exposures   (0.25 ‐ 0.75   ppm)   include   cough,   shortness   of   breath,   tightness   of   the   chest,   a   feeling   of   an   inability   to   breathe   (dyspnea),   dry   throat,   wheezing,   headache   and   nausea   (l)   • Animal   studies   indicate   that   ozone   can   cause   a   potentially   fatal   accumulation   of   fluid   in   the   lungs   (pulmonary   edema)   (l)   • Long ‐ term   exposures   to   ozone   may   result   in   impaired   lung   function   (l)       k) http://www.cdc.gov/niosh/npg/npgd0476.html   l) http://www.ccohs.ca/oshanswers/ch emicals/chem_profiles/ozone/he alth_ozo.html            

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