Safety evaluation of certain food additives - ipcs inchem

POLYDIMETHYLSILOXANE (addendum)
First draft prepared by
Dr H.M. Lee, 1 Dr J. Baines, 2 Professor R. Walker 3 and
Dr P.M. Kuznesof 4
1 National Institute of Toxicological Research, Korea Food and Drug
Administration, Seoul, Republic of Korea
2 Food Standards Australia New Zealand, Canberra, ACT, Australia
3 School of Biomedical and Health Sciences, University of Surrey, Guildford,
Surrey, England
4 Consultant, Silver Spring, MD, United States of America (USA)
Explanation ................................................................................
Biological data ...........................................................................
Biochemical aspects ...........................................................
Absorption, distribution and excretion ...........................
Toxicological studies ...........................................................
Acute toxicity .................................................................
Short-term studies of toxicity ........................................
Long-term studies of toxicity and carcinogenicity .........
Observations in humans .....................................................
Dietary exposure .......................................................................
Screening by the budget method ........................................
Dietary exposure based on individual dietary records ........
Evaluation of dietary exposure ............................................
Comments .................................................................................
Toxicological data ...............................................................
Assessment of dietary exposure .........................................
Evaluation ..................................................................................
References ................................................................................
1. EXPLANATION
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Polydimethylsiloxane (PDMS) (synonyms: dimethylpolysiloxane,
dimethicone) is widely used in foods as an antifoaming and anticaking agent.
PDMS was placed on the agenda by the Secretariat of the Joint FAO/WHO Expert
Committee on Food Additives for consideration of the applicability of the current
acceptable daily intake (ADI) of 0–1.5 mg/kg body weight (bw) to the material
currently in commerce. This ADI was established at the eighteenth meeting
(Annex 1, reference 35). When the Committee reviewed the ADI at its twenty-third
meeting (Annex 1, reference 50), it stated that this ADI applied to PDMS with
200–300 repeat subunits of [(CH3)2SiO] (weight-average molecular weight range,
15 000–22 000) because of concern that the material of lower molecular weight
might be more readily absorbed.
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