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PARENT SESSION 18 - Endocrine Disruption 8:00 AM to 6:30 PM, Monday, 13 May 2002 Exhibition Area
(18-80) New study with mice confirms the absence of estrogenic activity of the main metabolite of parabens and alkylphenols.
Gimeno, Sylvia*,1, Webb, Simon1, 1 Procter & Gamble, Central Product Safety, Temselaan, 100, B-1853, Strombeek-Bever
ABSTRACT- Parabens are derivatives of 4-pHBA widely used as preservatives in food, cosmetic and pharmaceutical preparations. Methyl-, ethyl-, propyl- and butylparaben have all been reported as oestrogenic in the in vivo yeast screening assay (Routledge et al., 1998). Butylparaben is the only paraben that exhibits in vivo estrogenic activity in rats in the uterotrophic bioassay. Activity of which depends on the route of administration (Routledge et al 1998). Recent studies from the Danish Institute of Food Health and Toxicology (Hossaini et al. 2000) similarly confirm that butylparaben is the only paraben with estrogenic activity, when this is applied sub-cutaneously. Results with mice regarding the possible estrogenic activity of the main metabolite of the parabens (p-hydroxybenzoic acid) are contradictory (Jobling et al. 1995, Lemini et al. 1997, Pedersen et al. 1999, Hossaini et al. 2000, Madigou et al. 2001). Lemini et al. (1997) reports a positive uterotrophic response of mice to p-HBA at (range concentration). In order to verify this response, a uterotrophic assay was conducted with mice (Alpk:ApfCD-1) following a protocol recommended by the OECD and under GLP (Good Laboratory Practice). Various doses (0.5 to 100 mg/kg bw/day) of p-acid hydrobenzoic acid were administrated daily sub-cutaneoulsy, during 3 days in immature mice aged 20-21 days at the beginning of the experiment. No toxic effect was observed and no uterotrophic response was observed at the applied doses.
Key words: estrogenicity, uterotrophic assay, parabens, p-hydrobenzoic acid
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