assessment of the health risks from non-compliance with bromate drinking water parametric value

1
Abstracts / Toxicology Letters 189S (2009) S57–S273 S237 dye substances was compiled. The overlap of these lists was found to be low. Databases and literature were searched for structural information, physicochemical data and experimental toxicity data. The CAS numbers could be identified for 1850 dyes. Experimen- tal toxicity data (e.g. mutagenicity, carcinogenicity, reproduction toxicity, skin irritation) was publicly available for only 16% of the compounds. For that reason, the toxicity of compounds with known chemical structures was predicted by a structure-activity relation- ship (SAR) analysis software (Derek for Windows). A prioritization model was established taking into account application amounts, toxicity and exposure. The latter factor considers the total con- tent of the dye substance in the textile, migration rate out of the textile and dermal absorption. 50% of the compounds were classi- fied in the high-priority group (potentially problematic), 42% in the medium-priority group (problematic applications cannot be ruled out a priori) and 8% in the low-priority group (probably not prob- lematic). A large number of direct dyes, disperse dyes, azo dyes and anthrachinone dyes were classified in the high-priority group. doi:10.1016/j.toxlet.2009.06.444 H03 Assessment of the health risks from non-compliance with bro- mate drinking water parametric value Thomas Cartier 1,, Michel Joyeux 2 , Alain Baert 3 , Pierre-Jean Cabillic 4 , Claude Casellas 5 , Edmond E. Creppy 6 , Antoine Montiel 2 , Brigitte Pignatelli 7 , Marie-Pierre Sauvant-Rochat 8 , René Seux 9 1 Agence Franc ¸ aise de Sécurité Sanitaire des Aliments, Direction of Risk Assessment for Nutrition and Food Safety, Maisons-Alfort, France, 2 Eaux de Paris (SAGEP), Paris, France, 3 Centre anti-poison, CHU Pontchaillou, Rennes, France, 4 Service Santé-Environnement - DDASS du Morbihan, Vannes, France, 5 Département Sciences de l’Environnement et Santé Publique - Faculté de pharmacie, Montpellier, France, 6 Laboratoire de Toxicologie et d’Hygiène appliquée - UFR des Sciences Pharmaceutiques, Bordeaux, France, 7 Hospices Civils, Lyon, France, 8 Laboratoire de Santé Publique et Environnement - Faculté de Pharmacie, Clermont-Ferrand, France, 9 Laboratoire d’Etude et de Recherche en Environnement et Santé - EHESP, Rennes, France Context: In the context of the Directive 98/83/EC on the quality of water intended for human consumption, Member States can pro- vide exemptions to cover non-compliances with the parametric values. Within this context, the French Food Safety Agency (AFSSA) was requested to assess the health risks from non-compliance with sev- eral parametric values in drinking water, including bromate. Methods: The results of the regulatory sanitary control pro- gramme of drinking water quality are registered in a database named SISE-Eaux (French Ministry of Health). At least one non- compliant result was registered for 6.2% of the distribution units (10,665,000 persons). The 50th percentile of the results of the 802 analyses higher than quality limit (10 g/L) is equal to 15 g/L. For the general population, exposure to bromate is mainly due to ingestion of ozonated drinking water. The unit risk value of 0.19 (mg/kg b.w./d) 1 retained by the WHO in 2005 for the sum of incidences of testicular mesotheliomas, renal tubular and thyroid follicular tumors (WHO, 2005) observed in the chronic toxicological study in rat of De Angelo et al. (1998) was applied in the frame of this risk assessment. Based on this unit risk value, the risk level associated with the consumption of drinking water with a bromate concentration of 10 g/L would be around 2.3 × 10 4 for lifetime exposure. Conclusion: After consulting the Water Expert Committee, AFSSA considers that the excess cancer risk associated with the quality limit of 10 g/L is significant. Consequently, ingestion of water with a concentration higher than 10 g/L does not appear to be accept- able. However, the excess cancer risk estimates are in the order of magnitude of those assessed by the other international organisms. Reference De Angelo, A.B., Georges, M.H., Kilburn, S.R., et al., 1998. Carcinogenicity of potassium bromate administered in the drinking water to male B6C3F1 mice and F344/N rats. Toxicol. Pathol. 26 (4), 587–594. World Health Organization, 2005. Bromate in drinking water—Background doc- ument for development of WHO Guidelines for Drinking-water Quality. WHO/SDE/WSH/05.08/78. doi:10.1016/j.toxlet.2009.06.445 H04 Medical gloves residual risks Andrey Eskov , Rinat Kayumov, Anatoly Sokolov Firm BMK-INVEST, ZAO, Toxicology, Moscow, Russian Federation A wide range of hazardous processing chemicals is used during the manufacture of medical latex and synthetic gloves. The final prod- uct comprises organic and inorganic compounds posing a risk of allergic contact dermatitis, irritant contact dermatitis and other complications for patients. The composition of the final product highly depends on the initial ingredients, chemical reactions and leaching that occurs during processing. Cross-reactivity of various chemicals can occur. Quantification of chemicals present in medical gloves and determination of their bioavailability are problematic. The uptake of chemicals residues by skin or tissues depends on the physicochemical properties of the substances and condition of use of the gloves. Latex and synthetic gloves have been tested for cyto- toxicity in accordance with ISO 10993.5-96 to assess the risk posed by residue. 47 of 54 brands failed. Failed brands showed cytotox- icity in delutions from 1:2 up to 1:128. The test result does not depend either on the tested surface, the purpose or material of the gloves. It means that the extracts comprise substances of clinical importance of high concentration. In conformity with the European Medical Devices Directives the presence of residue must be treated as a residual risk. Unfortunately users are not adequately informed about the nature of the residual risks and applicable risk control options. Warnings on product labeling do not convey an accurate estimate of the risk. doi:10.1016/j.toxlet.2009.06.446 H05 Relative photomutagenic potency of furocoumarins and limet- tin Nicole Raquet , Christiane Lohr, Dieter Schrenk TU Kaiserslautern, Food Chemistry and Toxicology, Kaiserslautern, Germany Furocoumarins occur in plants used as food (e.g. grapefruit, lime, parsley, parsnip), cosmetics (e.g. citrus oil in perfums and lotions) or in phytomedicines (Ammi majus, Angelica archangelica). In com-

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Page 1: Assessment of the health risks from non-compliance with bromate drinking water parametric value

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Abstracts / Toxicology L

ye substances was compiled. The overlap of these lists was foundo be low. Databases and literature were searched for structuralnformation, physicochemical data and experimental toxicity data.he CAS numbers could be identified for 1850 dyes. Experimen-al toxicity data (e.g. mutagenicity, carcinogenicity, reproductionoxicity, skin irritation) was publicly available for only 16% of theompounds. For that reason, the toxicity of compounds with knownhemical structures was predicted by a structure-activity relation-hip (SAR) analysis software (Derek for Windows). A prioritizationodel was established taking into account application amounts,

oxicity and exposure. The latter factor considers the total con-ent of the dye substance in the textile, migration rate out of theextile and dermal absorption. 50% of the compounds were classi-ed in the high-priority group (potentially problematic), 42% in theedium-priority group (problematic applications cannot be ruled

ut a priori) and 8% in the low-priority group (probably not prob-ematic). A large number of direct dyes, disperse dyes, azo dyes andnthrachinone dyes were classified in the high-priority group.

oi:10.1016/j.toxlet.2009.06.444

03ssessment of the health risks from non-compliance with bro-ate drinking water parametric value

homas Cartier 1,∗, Michel Joyeux 2, Alain Baert 3, Pierre-Jeanabillic 4, Claude Casellas 5, Edmond E. Creppy 6, Antoineontiel 2, Brigitte Pignatelli 7, Marie-Pierre Sauvant-Rochat 8,

ené Seux 9

Agence Francaise de Sécurité Sanitaire des Aliments, Direction ofisk Assessment for Nutrition and Food Safety, Maisons-Alfort,rance, 2 Eaux de Paris (SAGEP), Paris, France, 3 Centre anti-poison,HU Pontchaillou, Rennes, France, 4 Service Santé-Environnement -DASS du Morbihan, Vannes, France, 5 Département Sciences de

’Environnement et Santé Publique - Faculté de pharmacie,ontpellier, France, 6 Laboratoire de Toxicologie et d’Hygiène

ppliquée - UFR des Sciences Pharmaceutiques, Bordeaux, France,Hospices Civils, Lyon, France, 8 Laboratoire de Santé Publique etnvironnement - Faculté de Pharmacie, Clermont-Ferrand, France,Laboratoire d’Etude et de Recherche en Environnement et Santé -HESP, Rennes, France

ontext: In the context of the Directive 98/83/EC on the quality ofater intended for human consumption, Member States can pro-

ide exemptions to cover non-compliances with the parametricalues.

Within this context, the French Food Safety Agency (AFSSA) wasequested to assess the health risks from non-compliance with sev-ral parametric values in drinking water, including bromate.

Methods: The results of the regulatory sanitary control pro-ramme of drinking water quality are registered in a databaseamed SISE-Eaux (French Ministry of Health). At least one non-ompliant result was registered for 6.2% of the distribution units10,665,000 persons). The 50th percentile of the results of the 802nalyses higher than quality limit (10 �g/L) is equal to 15 �g/L.

For the general population, exposure to bromate is mainly dueo ingestion of ozonated drinking water.

The unit risk value of 0.19 (mg/kg b.w./d)−1 retained by the WHOn 2005 for the sum of incidences of testicular mesotheliomas, renal

ubular and thyroid follicular tumors (WHO, 2005) observed in thehronic toxicological study in rat of De Angelo et al. (1998) waspplied in the frame of this risk assessment. Based on this unit riskalue, the risk level associated with the consumption of drinking

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189S (2009) S57–S273 S237

ater with a bromate concentration of 10 �g/L would be around.3 × 10−4 for lifetime exposure.

Conclusion: After consulting the Water Expert Committee, AFSSAonsiders that the excess cancer risk associated with the qualityimit of 10 �g/L is significant. Consequently, ingestion of water withconcentration higher than 10 �g/L does not appear to be accept-ble. However, the excess cancer risk estimates are in the order ofagnitude of those assessed by the other international organisms.

eference

e Angelo, A.B., Georges, M.H., Kilburn, S.R., et al., 1998. Carcinogenicity of potassiumbromate administered in the drinking water to male B6C3F1 mice and F344/Nrats. Toxicol. Pathol. 26 (4), 587–594.

orld Health Organization, 2005. Bromate in drinking water—Background doc-ument for development of WHO Guidelines for Drinking-water Quality.WHO/SDE/WSH/05.08/78.

oi:10.1016/j.toxlet.2009.06.445

04edical gloves residual risks

ndrey Eskov ∗, Rinat Kayumov, Anatoly Sokolov

Firm BMK-INVEST, ZAO, Toxicology, Moscow, Russian Federation

wide range of hazardous processing chemicals is used during theanufacture of medical latex and synthetic gloves. The final prod-

ct comprises organic and inorganic compounds posing a risk ofllergic contact dermatitis, irritant contact dermatitis and otheromplications for patients. The composition of the final productighly depends on the initial ingredients, chemical reactions and

eaching that occurs during processing. Cross-reactivity of varioushemicals can occur. Quantification of chemicals present in medicalloves and determination of their bioavailability are problematic.he uptake of chemicals residues by skin or tissues depends on thehysicochemical properties of the substances and condition of usef the gloves. Latex and synthetic gloves have been tested for cyto-oxicity in accordance with ISO 10993.5-96 to assess the risk posedy residue. 47 of 54 brands failed. Failed brands showed cytotox-city in delutions from 1:2 up to 1:128. The test result does notepend either on the tested surface, the purpose or material of theloves. It means that the extracts comprise substances of clinicalmportance of high concentration. In conformity with the European

edical Devices Directives the presence of residue must be treateds a residual risk. Unfortunately users are not adequately informedbout the nature of the residual risks and applicable risk controlptions. Warnings on product labeling do not convey an accuratestimate of the risk.

oi:10.1016/j.toxlet.2009.06.446

05elative photomutagenic potency of furocoumarins and limet-in

icole Raquet ∗, Christiane Lohr, Dieter Schrenk

TU Kaiserslautern, Food Chemistry and Toxicology, Kaiserslautern,

ermany

urocoumarins occur in plants used as food (e.g. grapefruit, lime,arsley, parsnip), cosmetics (e.g. citrus oil in perfums and lotions)r in phytomedicines (Ammi majus, Angelica archangelica). In com-