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CISDOC database

Document ID (ISN)108385
CIS number 08-905
ISBN(s) 978-3-86509-617-3
Year 2006
Convention or series no. Fb 1085
Author(s) Oltmanns J., Schneider K.
Bundesanstalt für Arbeitsschutz und Arbeitsmedizin
Title Examination of the limit dose for the classification of substances as toxic for reproduction
Original title Überprüfung der Grenzdosis zur Einstufung reproduktionstoxischer Stoffe [in German]
Bibliographic information Wirtschaftsverlag NW, Postfach 10 11 10, 27511 Bremerhaven, Germany, 2006. 65p. Illus. 70 ref. Price: EUR 10.50.
Abstract A dose of 1000mg/kg body weight/day is generally cited in EU directives and OECD guidelines as a maximum dose for studies on reproductive toxicity. This project investigated whether this limit remained valid in cases of high levels of workplace exposure. To this end, published exposure data together with data from the MEGA database of the German Mutual Occupational Accident Insurance Association were evaluated. It was noted that exposures to ambient concentrations of volatile substances were in the 500 to 2000mg/m3 range (time weighted averages), while the inhalation exposures to aerosols and skin exposures were low. By using the appropriate extrapolation factors, the corresponding doses were calculated for animal experiments. For volatile substances, these doses were found to be considerably higher than 1000mg/kg/day. The analysis of the results together with other findings shows that the general concept of a limit dose of 1000mg/kg/day for the classification of substances that are toxic for reproduction is not suited to all chemicals.
Descriptors (primary) threshold limit values; toxic substances; Germany; antifertility effects
Descriptors (secondary) report; inhalation; skin absorption; classification; reliability; toxicity evaluation; extrapolation animal man; volatile substances
Document type E - Books, reports, proceedings
Country / State or ProvinceGermany
Subject(s) Toxic and dangerous substances
Broad subject area(s) Chemical safety
Browse category(ies) Antifertility and prenatal effects
Genetic factors in reaction to exposures
Occupational exposure limits