<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>Gezondheidsraad                               Voorzitter
Health Council of the Netherlands
Aan de Staatssecretaris van Sociale Zaken en Werkgelegenheid
Onderwerp            : Aanbieding adviezen herevaluatie bestuurlijke MAC-waarden
Uw kenmerk           : ARBO/AMIL/97/00648
Ons kenmerk          : U 2706/CB/MP/563-O3
Bijlagen             : 18
Datum                : 14 december 2000
Mijnheer de staatssecretaris,
Op verzoek van uw ambtsvoorganger bied ik u hierbij de eerste adviezen aan van een
reeks over de gezondheidskundige basis van uit het buitenland overgenomen
grenswaarden voor beroepsmatige blootstelling aan stoffen. Het verzoek om deze
adviezen is in algemene zin vervat in brief nr ARBO/AMIL/97/00648 en in latere stadia
door uw departement toegespitst op afzonderlijke stoffen. De adviezen zijn opgesteld
door een daartoe door mij geformeerde internationale commissie van de Gezondheidsraad
en beoordeeld door de Beraadsgroep Gezondheid en Omgeving.
     De beoogde reeks van in het Engels gestelde adviezen zal losbladig worden
gepubliceerd onder ons publicatienummer 2000/15OSH en, conform de aan de
Gezondheidsraad voorgelegde toespitsingen van de adviesaanvraag, betrekking hebben
op 168 stoffen. Het u thans aangeboden eerste pakket bestaat uit een Algemene Inleiding
(publicatienummer 2000/15OSH/000) en uit de adviezen genummerd 2000/15OSH/001
tot en met 2000/15OSH/017, respectievelijk betrekking hebbend op:
cesiumhydroxide, cyclopentaan, diboraan, dimethoxymethaan, dipropylketon,
fenylfosfine, germaniumtetrahydride, hexachloornaftaleen, methaanthiol,
methylcyclohexanol, methylisopropylketon, mica, natriumhydroxide,
octachloornaftaleen, silaan, tetrachloornaftaleen, en yttrium en yttriumverbindingen.
     Bij afronding van de werkzaamheden van de hierboven bedoelde commissie ontvangt
u een Nederlandstalige samenvatting van de in de gehele reeks van adviezen neergelegde
bevindingen.
Bezoekadres                                                                  Postadres
Parnassusplein 5                                                             Postbus 16052
2511 VX Den Haag                                                             2500 BB Den Haag
Telefoon (070) 340 75 20                                                     Telefax (070) 340 75 23
email: GR@gr.nl
</pre>

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<pre>Gezondheidsraad
Health Council of the Netherlands
Onderwerp            : Herevaluatie uit het buitenland overgenomen grenswaarden
Ons kenmerk          :U
Pagina               :2
Datum                : 14 december 2000
    De u thans aangeboden adviezen heb ik vandaag ter informatie doen toekomen aan
de Minister van Volksgezondheid, Welzijn en Sport en aan de Minister van
Volkshuisvesting, Ruimtelijke Ordening en Milieubeheer.
Hoogachtend,
prof. dr JJ Sixma
Bezoekadres                                                                   Postadres
Parnassusplein 5                                                              Postbus 16052
2511 VX Den Haag                                                              2500 BB Den Haag
Telefoon (070) 340 75 20                                                      Telefax (070) 340 75 23
email: GR@gr.nl
</pre>

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<pre>      Germanium tetrahydride
      (CAS reg. no: 7785-65-2)
      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/006, The Hague, 14 December 2000
006-1
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<pre>      Preferred citation:
      Health Council of the Netherlands: Committee on Updating of Occupational
      Exposure Limits. Germanium tetrahydride; Health-based Reassessment of
      Administrative Occupational Exposure Limits. The Hague: Health Council of
      the Netherlands, 2000; 2000/15OSH/006.
      all rights reserved
006-2
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<pre>1     Introduction
      The present document contains the assessment of the health hazard of
      germanium tetrahydride by the Committee on Updating of Occupational
      Exposure Limits, a committee of the Health Council of the Netherlands. The
      first draft of this document was prepared by mrs S Bosman-Hoefakker, Ph.D.
      and H Stouten, M.Sc. (TNO Nutrition and Food Research Institute, Zeist, the
      Netherlands).
           The evaluation of the toxicity of germanium tetrahydride has been based on
      the review by the American Conference of Governmental Industrial Hygienists
      (ACG91). Where relevant, the original publications were reviewed and
      evaluated as will be indicated in the text. In addition, literature was retrieved
      from the online data bases Medline, Toxline, and Chemical Abstracts covering
      the period 1966 to 7 May 1997 (19970507/UP), 1965 to 21 March 1997
      (970321/ED), and 1967 to 13 May 1997 (970513/ED; vol 126, iss 20),
      respectively. Medline was searched with the CAS Registry Number 7782-65-2
      and the names germanium tetrahydride, germanium hydride, GeH4,
      monogermane, tetrahydrogermane, and germane AND germanium/CT,
      Toxline with the CAS Registry Number 7782-65-2, and Chemical Abstracts
      with 7782-65-2 in the Sections “Toxicology” and “Air Pollution and Industrial
      Hygiene”. HSDB (no record) and RTECS, data bases available from CD-ROM,
      were consulted as well (NIO97, NLM97). The final literature search has been
      carried out in May 1997.
           In February 1999, the President of the Health Council released a draft of the
      document for public review. Comments were received by the following
      individuals and organizations: A Aalto (Ministry of Social Affairs and Health,
      Tampere, Finland). These comments were taken into account in deciding on
      the final version of the document.
006-3 Germanium tetrahydride
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<pre>2     Identity
       name                            :    germanium tetrahydride
       synonyms                        :    germanium hydride
                                            germane
                                            monogermane
                                            tetrahydrogermane
       molecular formula               :    GeH4
       CAS reg nr                      :    7785-65-2
      Data from ACG91, Ric94.
3     Physical and chemical properties
       molecular weight                :    76.6
       boiling point                   :    -900C
       melting point                   :    -1650C
       flash point                     :    -
       vapour pressure                 :    -
       solubility                      :    insoluble in water; soluble in liquid ammonia;
                                            slightly soluble in hot hydrochloric acid;
                                            decomposes in nitric acid
       log Poct/water                  :    -
       conversion factors              :    1 ppm = 3.2 mg/m3
       (20oC, 101.3 kPa)                    1 mg/m3 = 0.31 ppm
      Data from ACG91.
      Germanium tetrahydride is a colourless gas and a catalyst.
4     Uses
      Germanium tetrahydride finds some use as a doping agent for solid-state
      electronic components, and as a catalyst (ACG91, Ric94).
006-4 Health-based Reassessment of Administrative Occupational Exposure Limits
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<pre>5     Biotransformation and kinetics
      No data on biotransformation and kinetics of germanium tetrahydride were
      found.
6     Effects and mechanism of action
      Human data
      No data on human (occupational) exposure to germanium tetrahydride were
      found.
      Animal data
      The 2 hour-LC50 in mice was 1380 mg/m3 (Fil93). In this study (reported in
      Russian), clinical signs were dyspnea, convulsion, and coma. Autopsy revealed
      congested internal organs, haemorrhages, nerve cell vacuolization, and
      degenerative changes in the cells of parenchymal organs. In guinea pigs
      exposed for 4 hours to 260-1400 mg/m3 (approximately 80-480 ppm), similar
      (histo)pathological changes were seen (Fil93).
          Exposures to 6800 mg/m3 (approx. 2130 ppm) for 1 hour, 610 mg/m3
      (approx. 190 ppm) for 30 minutes, 580 mg/m3 (approx. 180 ppm) for 1 hour, or
      480 mg/m3 (approx. 150 ppm) for 1 hour were lethal to mice (time of death:
      within 1, 8, 13 hours and 1 day, resp). Dyspnea was observed in these animals.
      Guinea pigs survived a 1-hour exposure to 480 mg/m3 (approx. 150 ppm), but
      not to 580 mg/m3 (approx. 180 ppm) (time of death: within 4 days). In both
      experiments, haemoglobinuria was seen, while from the first experiment,
      dyspnea and pneumonia were reported. Some dyspnea was observed in a rabbit
      surviving a 1-hour exposure to 310 mg/m3 (100 ppm) (all experiments were
      performed with one animal only) (Pan24).
          The oral LD50 in mice was 1280 mg/kg (Ric94).
          In a cited study, probably Russian, no visible signs of toxicity were observed
      in rats exposed to 13-170 mg/m3 (approx. 4-53 ppm), 4 hours/day, for 30 days.
      Autopsy revealed traces of occasional haemorrhages with gliotic nodules in the
      brain (Fil93).
006-5 Germanium tetrahydride
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<pre>      No data on long-term exposure, mutagenicity, genotoxicity, carcinogenicity and
      reproduction toxicity of germanium tetrahydride have been found.
7     Existing guidelines
      The current administrative occupational exposure limit (MAC) for germanium
      tetrahydride in the Netherlands is 0.6 mg/m3 (0.2 ppm), 8 h TWA.
           Existing occupational exposure limits for germanium tetrahydride in some
      European countries and in the USA are summarized in the annex.
8     Assessment of health hazard
      There are no human data available.
           Experimental animal data concern acute and subacute studies only.
      However, they were described and designed too poorly to allow conclusions
      with respect to effects and dose-response relationships.
      The committee considers the toxicological data base on germanium
      tetrahydride too poor to justify recommendation of a health-based occupational
      exposure limit.
      The committee concludes that there is insufficient information to comment on
      the level of the present MAC-value.
      References
ACG91 American Conference of Governmental Industrial Hygienists (ACGIH). Documentation of the threshold
      limit values and biological exposure indices. 6th ed. Cincinnati OH, USA: ACGIH 1991; 702.
ACG00 American Conference of Governmental Industrial Hygienists (ACGIH). 2000 TLVs® and BEIs®.
      Threshold Limit Values for chemical substances and physical agents. Biological Exposure Indices.
      Cincinnati OH, USA: ACGIH, 2000.
Arb96 Arbejdstilsynet. Exposure limit values for substances and materials. Copenhagen, Denmark: The
      Working Environment Service; Instruction no. 3.1.0.2. 1996.
Bel94 Beliles RB. Germanium, Ge. In: Clayton GD, Clayton FE, eds. In: Toxicology. 4th ed. New York,
      USA: J. Wiley & Sons, 1994: 2013-20 (Patty’s industrial hygiene and toxicology; Vol II Pt C).
006-6 Health-based Reassessment of Administrative Occupational Exposure Limits
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<pre>DFG99 Deutsche Forschungsgemeinschaft (DFG): Senatskommission zur Prüfung gesundheitsschädlicher
      Arbeitsstoffe. MAK- und BAT-Werte-Liste 1999. Maximale Arbeitsplatzkonzentrationen und
      biologische Arbeitsstofftoleranzwerte. Weinheim, FRG: VCH Verlagsgesellschaft mbH, 1999;
      Mitteilung 35.
Fil93 Filov VA, Ivan BA, Bandman AL. Germanium and its compounds. In: Harmful chemical substances.
      New York, USA: E. Horwood, 1993: 531-8 (Vol 1).
HSE99 Health and Safety Executive (HSE). EH40/99. Occupational Exposure Limits 1999. Sudbury
      (Suffolk), England: HSE Books, 1999.
NBO96 National Board of Occupational Safety and Health. Occupational exposure limit values. Solna,
      Sweden: NBOSH, 1996; Ordinance AFS1996/2.
NIO97 US National Institute of Occupational Safety and Health (NIOSH). Registry of Toxic Effects of
      Chemical Substances (RTECS) [CD-ROM], issue April 1997. SilverPlatter International, 1997 (last
      update germanium tetrahydride file: January 1997).
NLM97 US National Library of Medicine (NLM). Hazardous Substances Data Bank (HSDB) [CD-ROM],
      issue April 1997. SilverPlatter International, 1997.
Ric94 Richardson ML, Gangolli S, eds. G11 Germanium tetrahydride. In: The dictionary of substances and
      their effects. Cambridge, UK: Royal Society of Chemistry, 1994: 681-2 (Vol 4).
SZW00 Ministerie van Sociale Zaken en Werkgelegenheid (SZW). De nationale MAC-lijst 2000. The Hague,
      The Netherlands: Servicecentrum Sdu Uitgevers, 2000.
TRG00 TRGS 900. [Grenzwerte in der Luft am Arbeitsplatz; Technische Regeln für Gefahrstoffe]. German. B
      Arb Bl. 2000; 2.
006-7 Germanium tetrahydride
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<pre>             Annex
Occupational exposure standards for germanium tetrahydride in various countries.
country                          occupational                       time-weighted      type of exposure notea lit refb
-organisation                    exposure limit                     average            limit
                                 ppm             mg/m3
The Netherlands
-Ministry                        0.2             0.6                8h                 administrative         SZW00
Germany
-AGS                             -                                                                            TRG00
-DFG MAK-Kom.                    -                                                                            DFG99
Great-Britain
-HSE                             0.2             0.6                8h                 OES                    HSE99
                                 0.6             1.8                15 min
Sweden                           -               -                                                            NBO96
Denmark                          0.2             0.6                8h                                        Arb96
USA
-ACGIH                           0.2             0.63               8h                 TLV                    ACG00
-OSHA                            0.2                                8h                 PEL
-NIOSH                           0.2             0.6                10 h               REL
European Union
-SCOEL
a
     S = skin notation; which mean 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
006-8        Health-based Reassessment of Administrative Occupational Exposure Limits
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