Publikation: Use of product databases for risk assessment purposes

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Review

Use of product databases for risk assessment purposes

Gerhard Heinemeyer*, Axel Hahn

Federal Institute for Risk Assessment (BfR), Thielallee 88-92, D-14195 Berlin, Germany Received 15 July 2004; revised 1 February 2005; accepted 15 February 2005

Available online 24 June 2005

Abstract

Product information databases are important prerequisites for providing data to poison centers (PC) to give adequate advice in cases of poisonings and for preparation of statistics as annual reports. For risk assessment measures, they can help for exposure assessments and for priority setting. A product database is a set of information of product and substance names, compositions, and uses of products. Data are provided due to national regulations as well as to national and international agreements between industry, international associations, e.g. the European Association of Poison Centres and Clinical Toxicologists (EAPCCT), and clinical toxicology institutions. They have different contents, i.e. complete formulations, frame formulations, and material safety data sheets. For definite identification of products, the product name should be readily taken from the labels and must be similar to the names provided by electronic media as databases. Products should be classified according to their use. The first system that has been prepared for that purpose is the ATC classification for pharmaceuticals. For chemicals, several systems e.g. the WHO-IPCS classification code, exist; the EU technical guidance document for risk assessment of chemicals is mentioning use categories, and they are used on national levels as well. For risk assessment purposes, statistics of poisonings and other health hazards are important as well as information about exposure. Linking cases of poisonings with product data enables risk assessors to perform statistical evaluations about health effects due to product use categories which can be compared to product compositions. If products are categorized by their use, information about use characteristics, such as frequencies and durations, can be derived. Hence, product categories can be taken to characterize scenarios and thus help for model estimations of exposure and respective doses.

Keywords:Product database; Poison centers; Clinical toxicology; Risk assessment; Exposure estimation

Contents

Introduction . . . S637 Essentials of product databases . . . S637 Name of product . . . S637 Categories . . . S638 Composition . . . S639 List of ingredients . . . S639 Structure of a product database . . . S639 Types of product data . . . S639 Household chemicals . . . S641 Pesticides . . . S641 Cosmetic products . . . S641 Pharmaceuticals . . . S642 Practical uses of product database (use of product data to estimate doses) . . . S642 Use of database to answer questions in poison centers. . . S642

doi:10.1016/j.taap.2005.02.026

* Corresponding author. Fax: +49 30 8412 3929.

E-mail address:g.heinemeyer@bfr.bund.de (G. Heinemeyer).

www.elsevier.com/locate/ytaap

YTAAP-10290; No. of pages: 9; 4C: 7

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Prospective estimation of doses in the context of risk assessment approaches . . . S642 Use of product database for statistic purposes (preparation of annual reports) . . . S643 Existing databases . . . S643 Approaches for companies to report product data to poison centers and other agencies . . . S644 Conclusions . . . S644 References . . . S644

Introduction

Poisonings and other substance-related health hazards are resulting from the acute and chronic contact of humans to a chemical, either as a pure substance, or as an ingredient in a product. Treatment of these illnesses is only possible if the entire list of ingredients in the products is known. Poison centers (PC) therefore need this information to give adequate advice, as well as information about releases of chemicals from articles of daily life such as textiles, building materials, toys, and others. Product information is also needed to prepare statistical evaluations, e.g. annual reports referring case data to exposures with critical substances. For these purposes, case data and product data have to be linked adequately in a database, and products should be categorized for their use by a structured thesaurus. This enables the assessor to refer critical cases of poisonings to dangerous uses by ranking them due to the severity of illness.

Additionally, product registers may be evaluated prospectively in risk assessment approaches for two purposes.

Regulation of chemicals frequently requires priority setting procedures. Product registers can support this approach effectively by analyzing the appearance of substances as ingredients (Heinemeyer et al., 2004). For exposure assessment, it is anticipated that substances showing high numbers of hits and having high amounts are of primary interest for consumer’s concern. Furthermore, the same data can be used to define exposure scenarios and respective models for estimations of exposure.

Although information about ingredients in preparations¹is available for a number of products, the occurrence of substances in articles²is rather unknown. This is due to the incomplete knowledge how substances are used during manufacture of articles and thus of incomplete knowledge of downstream use. For poison centers, information about ingredients in preparations is of primary interest, but those working in the field of diseases related to chronic exposures are also very interested in data of substances in articles and its migration and release data from those articles.

Any use of product data in toxicology implies a risk assessment process, either retrospectively to explain acute effects or prospectively to characterize general risks of substances.

In clinical toxicology, risk assessment means that a potential dose a person has taken or can take is compared to known doses that can cause toxic effects in humans. For regulatory risk assessment approaches, the potential dose (exposure) of a substance of concern is compared to the highest dose which does not cause hazardous effects (no observed adverse effect level, NOAEL) in animals. This comparison is known as the approach of ‘‘margin of safety’’

evaluation. Therefore, both approaches need the knowledge of the amount of the chemical in the formulation, as a primary source of information.

This paper outlines how product databases are structured and how they are used in clinical toxicology and risk assessment.

Essentials of product databases

A ‘‘Google’’ search in the Internet taking the item ‘‘product database’’ revealed some hundred hits. The result shows that registers/databases containing product information are quite different and cover a broad range of purposes. Therefore, product databases needed for toxicological assessments must be specified, according to the structure, the information provided, and the links to other toxicological data. The European detergents industry and the European Association of Poison Centres and Clinical Toxicologists (EAPCCT) agreed upon a standard format to provide information on products to poison centers. An example is published, e.g. on the website of the Swedish³poison information center.

For toxicological purposes, the following major items are important

Name of product

This information is particularly essential for poison centers. There are products on the market having similar names but different compositions. Adequate advice is only possible if the ingredients of a particular product can be identified undoubtedly. Manufacturers sometimes change the compositions but do not change the names. A search in the BfR (Bundesinstitut fuˆr Risikobewertung) product database showed that up to 8 similar names occurred as product names which could be referred to differing formulations. Because a company can produce different products, the database may

1 Preparations are products that can be characterized by their composition, e.g. household cleaners, paints, pesticides etc.

2 Articles are products that can be characterized by their size, e.g. textiles,

furniture, floor coverings, cars, toys, etc. ³http://www.giftinformation.apoteket.se/infomanu.htm.

G. Heinemeyer, A. Hahn / Toxicology and Applied Pharmacology 207 (2005) S636 – S644 S637

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contain a non-limited number of products having identical names. In the later 1980s, in middle and northern Europe, sodium hypochlorite was removed from sanitary cleaners due to incidents by inhalation of chlorine with subsequent severe lung edema, and hypochlorite has been exchanged by hydrogen peroxide. Although the formulations changed, the names did not change.

Codes which are used by the companies to manage the products (e.g. barcode) can also be helpful for identification.

In 2000, the BfR started a campaign to prepare proposals to label products within the context of the Deutsche Industrie Norm (DIN) and the European Articles Number (EAN) standardization processes. At the end, a fixed position for the name of the product label was agreed (Hahn et al., 2000). This agreement includes a special symbol on the label together with the official name of the product, also occurring in the database. It was proposed to reserve a particular area on the label to write the official name of the product. This initiative was first followed on a national German level and then brought to the European level, together with consumer and industrial associations. The result of this initiative is shown in Fig. 1. The product name will be written on this label under the bar (or EAN) code and beneath the symbol (i). This system requires both an appropriate product register and atten- tion of the labeling rules but guarantees a high level of quality.

Categories

In a product register, each product should be categorized according to its use. For most purposes, the categories consist of a main group, with lower levels for a detailed characterization as described below inTable 1.

The following aims are followed by categorization of products: first of all, it enables the preparation of statistics.

Poison centers are preparing annual reports to document their

work, and most of them refer the cases of poisoning to product categories. One of the best known category thesauruses is the Anatomical Therapeutic Chemical Classification System (ATC) for classification of pharmaceuticals. The ATC code is managed by the WHO collaborating center for drug statistics methodology (WHO Collaborating Centre for Drug Statistics Method- ology, 2004). The category terms are referred to organ systems (anatomical), the therapeutic purposes, and the characterization of the active substance (chemical).

Furthermore, categorization of products enables risk assessors to characterize exposure scenarios. According to the typical uses of chemicals in products, they can be used to describe residential exposures. Because measurements of substances in private environments are very rarely performed, exposure estimations by using scenarios of exposure due to classifications

Fig. 1. Product labeling for identification of product name. Result of international cooperation of BfR, Deutsches Institut fu¨r Normung (DIN), the Verband der Chemischen Industrie (VCI, German Chemicals Association), and the CEN (Centre of European Normation).

Table 1

Thesaurus for product categories as used in the product register of the Bundersinstitut fu¨r Risikowertung, Bf R (some examples)

First level Second level Third level

Household chemical

Paint Latex paint Solvent based paint Thinner

Household cleaner

Oven cleaner Drain cleaner Carpet cleaner Cosmetic

Skin care

Soap Other Hair care

Other Pesticides

Wood protection paint

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have become a common approach in regulatory toxicology. A detailed classification of products is implemented in the American database about ‘‘Health and Safety Information on Household Products’’, published by the NIH (Table 2), and in the annual reports of the Swiss Poison Centre (Swiss Poison Information Centre, 2002). Categories for products have also been worked out in the INTOX project of the International Project on Chemical Safety (IPCS) to prepare harmonized reports of the centers around the world (IPCS-INTOX, 2004).

Use categories are also listed in the ‘‘Technical Guidance Document for Risk Assessment of New and Existing Chem- icals’’ of the European Union (European Commission, 2003), and the use of biocide categories is recommended in the European biocide regulation (European Commission, 1998).

In some cases, products can be linked to several categories due to their different uses. This applies for products which are, e.g. ruled by certain laws, but having also been characterized by specific uses. For example, a product which is used as a cleaner but has disinfectant properties may be categorized as a cleaner but also linked to a certain category of biocides due to EU regulations (European Commission, 1998).

Composition

The most appropriate information a product database can provide is given by a list of all ingredients and their amounts.

Sometimes, databases give ranges of amounts. In this case, it is important that these ranges are narrow enough to enable poison centers to give adequate advice. Some databases only provide information about those substances that are classified, e.g. in material safety data sheets (MSDS). Under consideration of these restrictions, information from MSDS is incomplete but may represent an acceptable compromise. The names of ingredients in products must unequivocally be identified.

International lists of approved names can be very helpful which exist for ingredients of cosmetic products, the International Nomenclature of Cosmetic Ingredients (INCI) (European Commission, 1996). Use of Chemical Abstracts Service (CAS) numbers also increases the certainty and quality of information.

Identification of the company producing or marketing the product of interest is essential. Sometimes, poison centers urgently need additional product information. In these cases, a direct and quick connection by phone is needed. Therefore, in the EU, the MSDS must provide phone numbers that can be called for 24 h for urgent questions.

List of ingredients

A product may have numbers of ingredients. For each substance name, the amount has to be indicated. Substance names can be expressed by lots of synonyms. The most certain way for identification of names is provided by the CAS registration code. It is therefore of great value to control the terms in the database by a list of synonyms. This list can be

linked the information of classification and labeling, as well as R- and S-phrases needed for both substances and products.

Structure of a product database

Structure and organization of product registers used in clinical toxicology depend on the questions toxicologists will ask to assess how hazardous a product is. Particular interest is focused on toxicological relevant substances occurring in products and their amounts to perform a risk assessment.

The description of a product data system should be based on the needs of poison centers, i.e. product information, company addresses, substance information, and case data. In Fig. 2, a classical relational structure of a product database is shown. It can be discussed whether for international co- operations newer approaches for exchanging information should be preferred, e.g. XML formats that allow some more flexibility. In any case, for appropriate retrievals and specific questions, a structured organization and a logical model of the database are needed and the items pointed out in the essentials

of product databases section should be standardized. An important prerequisite for structuring the product database is given by the questions the user will ask the database.

Typical questions are:

The product, identified by its name and other criteria, e.g.

company codes, represents the ‘‘heart’’ of the database. The information about the product is then relationally linked to different subtables, e.g. addresses of manufacturers and substance information.

Types of product data

Poison centers work covers all kinds of products, chemicals, biocides, pharmaceuticals, and cosmetic products which should be searchable in the same database. From this aspect, the structure of the different formulations should be harmonized to enable a common view on the different products in one database. The above given structure for product databases should therefore be applied for each type of product.

Question Purpose

What are the ingredients of the product? Daily poison center work.

How many cases have been registered with ingestions of certain products, e.g. oven cleaners?

Poison center statistics, annual reports.

Which categories of products have a certain substance as ingredient?

Risk assessment for products, exposure analyses, and listing of products having the same ingredients.

Which products have corrosive ingredients?

Listing of products having similar toxic characteristics.

How many and which products of company A have lead to poisonings?

Preparation of reports to companies.

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Table 2

List of product databases (based on an Internet search using the ‘‘Google’’ retrieval system, as well as results from the workshop TDI 2000, Berlin)

No. Name of database Contact Remarks Access for poison centers Public access Approximate number

of records 1 Registered Product

Database

http://www.nra.gov.au/pubcris/

subpage_pubcris.shtmlAustralian Pesticides and Veterinary Medicines Authority

Details of agricultural and veterinary chemical products, which are registered for use in Australia. Use categories considered.

Yes Yes Not known

2 Environment and Scientific Coordinators Toolbox

Australian Marine Safety Authority:

http://www.amsa.gov.au

MSDS Not known Not known Not known

3 Product Register of Nordic States

www.norden.org http://www.spin2000.net Data from the Danish, Swedish, and Finnish product registers, also available on CD. Use categories considered.

See under S, DK, and F

Yes 61,000

4 Swedish Product Register Kemi (National Chemical Inspectorate) Sweden:www.kemi.se/prodreg/

Covers nearly all products on the S market due to legal requirements.

No use by S Poison center

64,000 5 Finnish Product Register National Product Control Agency:

http://www.sttv.fi/kemo/english/

chemicals_frameset.htm

Due to legal requirements.

Information from safety data sheets.

Yes Authorities,

Research Institutes

>100,000

6 The Danish Product Register National Working Environment Authority, Copenhagen:http://agency.osha.eu.int/

A national register of chemical substances and preparations.

Covers 50 – 60% of products on the Danish market.

Yes Confidential >100,000

7 Norwegian Product Register Ministry of Local Government and Regional Development:http://www.produktregisteret.no

Yes Authorities 24,000

8 Swiss Product Register Swiss Health Office, Berne:

http://www.bag.admin.ch/chemikal/registr/

publikum

Chemical formulations due to legal requirements.

Use categories considered.

Yes, poison centers have online access

Restricted 150,000

9 Bf R Product Database Federal Institute for Risk Assessment, Berlin, Germany:www.bfr.bund.de

Formulations of chemical products and cosmetics due to legal

requirements, monthly updates of the database are send to the poison centers.

Yes No 160,000

10 Italian Product Register Istituto Superiore di Sanita, Rome:www.iss.it Electronic online registration process. No No 150,000 11 Federal Register

Environmental Documents

US Environmental Agency:http://www.epa.gov/

pesticides

Factsheets about pesticides, use etc. Not known Not known

12 Californian Pesticides Register Californian Environmental Protection agency (CDPR):http://www.cdpr.ca.gov/docs/epa/

epamenu.htm

Pesticides Possibly yes Restricted

(password)

Not known

13 National Pesticides Information Centre, US

Oregon State University, Corvallis, Or:

http://npic.orst.edu/tech.htm

Pesticide products, link to CDPR and MSDS.

Yes Yes Not known

14 Health and Safety Information on Household Products

National Institute of Health National Library of Medicine, USA:http://www.toxnet.nlm.nih.gov

MSDS, detailed information about use, toxicological info, very comfortable retrieval.

Yes Yes 4000

15 PSD Registered Products Pesticides Safety Authority United Kingdom:

www.pesticides.gov.uk,http://www.pesticides.gov.uk/

farmers_growers_home.asp#Product_Information

Product details with links to crops/situations and replacement, no concentration data.

Source in information: industry

Yes Yes ~4000

16 ACVM Database on Currently Registered Pesticides

New Zealand Food Safety authority:

http://www.nzfsa.govt.nz/acvm/

No information Yes Yes Not known

G.Heinemeyer,A.Hahn/ToxicologyandAppliedPharmacology207(2005)S636–S644

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Household chemicals

Household chemicals are most important target for poison center work! This category should list all products that can be used in the household, hobby, and craft. Lots of different uses of the products and the respective ingredients have to be considered, e.g. corrosive ingredients, as well as solvents.

Knowledge upon the whole formulation is essential.

Pesticides

Although in many countries the use of pesticides is restricted by law, these products represent the most toxic ones in households and other residential areas around the world, as shown by poison center reports. Data from poison centers in countries having less strict regulations, e.g. Brazil⁴, show that health hazards from pesticides represent the most serious in- toxications having high incidences. In some cases, the toxicity of solvents has to be accounted also due to high percentage.

Cosmetic products

For specific groups of substances, frame formulations have been prepared. In Europe, based on the cosmetics directive, EAPCCT and the Comitee de Liaison des Associations Europeennes de Industrie de la Parfumerie des Produits Cosmetique (COLIPA) have agreed upon frame formulations of cosmetic products, giving maximum levels of ingredients (Colipa and EAPCCT, 2000). It must also be mentioned that most ingredients are given by group-names, e.g. solvents, stabilizers. However, for some ingredients, e.g. ethanol and other potentially toxic ingredients, the exact names and their amounts in the product must be indicated. The official list of frames contains 109 coded formulations.

In this system, the information is forwarded by the cosmetic manufacturers to PCs on three levels:

1. the category code without any additions

2. the category code plus additional information about possible dangerous ingredients

3. the complete formulation.

4 http://www.fiocruz.br/sinitox.

Fig. 2. Possible relational organization structure of a product database for risk assessment purposes.

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In Germany, the cosmetics frame formulation approach has been taken into regulation since 1997. Furthermore, the information is circulated by an electronic procedure between industry, the BfR and the PC’s using a simple ASCII exchange format (see below).

Pharmaceuticals

Normally, toxic effects are caused by the active ingredients of the drugs, and therefore the pieces of information which can be drawn from the official lists of drugs are sufficient for poison center information, except some homeopathic products possibly containing high amounts of, e.g. alcohol.

Practical uses of product database (use of product data to estimate doses)

Principally, product data evaluations can be characterized as dose estimation by multiplication of the concentration of the substance in the incorporated medium and the amount of this medium. This is represented by the amount ingested (e.g.

number of tablets, a teaspoonful or a sip), the respiration volume per time (after evaporation of a volatile substance into air), or the amount of a layer (e.g. a cosmetic product) on skin.

Use of database to answer questions in poison centers

Poison centers have to estimate possible doses of substances in cases of poisonings to check the adequate therapeutic measures. However, an estimate of the amount ingested or inhaled is very difficult because the information due to incidental poisonings is very uncertain. Therefore, approaches trying to estimate doses that are potentially toxic have been published, which is particularly important for

children, commonly swallowing only one tablet or eat one teaspoonful (Heinemeyer and Oberdisse, 1990; Koren, 1993).

Rapid access to databases for answering questions of callers is therefore essential for poison centers to give appropriate advices. The relational structure of product database as shown above does, not only provide the access to product data, but also to case data and information about substances and to the contact data of the manufacturer.

Prospective estimation of doses in the context of risk assessment approaches

For prospective risk assessment purposes, e.g. for preparation of risk assessments reports within the context of regulations, exposure estimations have to be performed. In these reports, hazard levels, e.g. the NOAEL, will be compared with exposure data. Furthermore, threshold values may be estimated for certain substances, e.g. pesticides which can be controlled by checking the accepted limits, e.g. the Acceptable Daily Intake (ADI) with exposure estimations.

For this work, information about the use of the substances and concentration data are needed as well. The use product categories can characterize exposure scenarios on a standardized basis, representing the first step of exposure analysis.

Secondly, the product database can be analyzed for the concentrations of the substance of concern in products belonging to that category. To give an example and to de- monstrate the general principle of the approach, the US household products database, provided by the National Library of Medicine (NLM) and the National Institute of Health (NIH), was evaluated. A search for acetone as ingredient revealed 302 hits of household products, 129 products, mostly aerosols, were categorized by their use as

‘‘hobby/craft.’’Fig. 3shows that the range of acetone concentration is between 7.8 and 45.4%, with a double peak.

Fig. 3. Distribution of acetone concentrations in hobby and craft products. Evaluation of the ‘‘Household Products Database’’ provided by NLM/NIH. Left side:

frequencies of concentrations in all products, right side: frequencies in the subgroup ‘‘hobby, craft paints’’ of ‘‘hobby, craft general-products’’.

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Although these categories should be subcategorized due to the different uses as, e.g. glues, paints, air freshener, this example gives an impression about the properties of appropriate product concentration data in combination with use categories. In fact, it is possible to separate paints for hobby and crafts having a relative small range of acetone content between 30 and 40%. A similar approach has been used to analyze exposures to propylene glycol monomethyl ether (PGME) by using product data from the Swiss Product Re- gister (Dentan and Devanthe´ry, 2000). This approach also may help poison centers for estimating possible toxic amounts of ingredients if the product names are not known or uncertain.

Use of product database for statistic purposes (preparation of annual reports)

Statistical evaluations are needed by poison centers for the preparation of annual reports to inform the public and the sponsors about their experiences. In Germany, this work is ruled by the chemicals law. Poison centers have to exchange their experiences with the responsible Federal Institute for Risk Assessment (BfR). Many works in this field have been done also by the abovementioned WHO- IPCS/INTOX project. The impact of this work for risk assessments is also discussed in the contributions given by Onyon et al. (2003, 2004)and byTempowski (2003). The central task is to identify cases of poisonings and other health effects with certain hazardous substances and to link them to products and product groups. From the structure of the products database as characterized in Fig. 2, it can be drawn that this problem can be solved by linking cases with particular products having the substance of interest as an ingredient. If each product is linked also to a category of use, then the preparation of lists of cases referred to categories of chemical products, to pharmaceuticals, plants, or animal poisons, is very simple. This principle of evaluation is used by numbers of poison centers worldwide using, e.g. the WHO-INTOX case documentation tool or own database structures. Most poison centers provide such evaluations as annual reports on their homepages, e.g. PCs in Go¨ttingen⁵and Lille⁶.

Harmonization of databases would improve cooperation of poison centers and other institutions involved in clinical toxicology and risk assessment. The structure proposed in this paper can therefore aid to exchange data on a simple basis.

Existing databases

A number of databases providing information about products have been identified by the abovementioned ‘‘Goo- gle’’ search. For Europe, an overview about product data is given by the results of the workshop of the project Toxico- logical Documentation and Information Network (TDI), which was held 2002 in the BgVV⁷(Berlin) (TDI, 2002). A list of product databases/registers is given inTable 2. For example, the Nordic countries have combined their product information systems by sharing a common database (numbers 3, 4, 3, 6 in Table 2), providing access for poison centers. A comprehen- sive report has been published that compares the properties of the four combined databases (Kraft et al., 2001).

Public accessible information about products is provided by the US NLM/NIH (no. 14 inTable 2). The presentation of the data is well structured, and questions can easily be asked.

Unfortunately, this database contains only about 4000 records based on information from MSDS. In Switzerland, manufacturers and dealers must provide product formulations on a regulatory basis to the Federal Institute of Health which provides direct access to the Swiss Poison Centre (no. 8 in Table 2). In Italy, an electronic system for reporting the formulations has been established (Binetti et al., 2003).

Many products used as pesticides represent highly toxic substances, therefore many databases exist making information about those substances available. Mostly, MSDS information is provided by a less or more convenient retrieval procedure in the databases in UK (no. 15 inTable 2), New Zealand (no. 16), Australia (no. 1, 2), and US (no. 11, 12, 13, 14). The latter databases are linked among each other and are also providing information about the substances.

No adequate information about substances is existing occurring in articles, i.e. toys, textiles, furniture, building materials. The Joint Research Centre of the EU DG Sanco has

5 www.giz-nord.de.

6 http://www.chru-lille.fr/cap/usca4cap.htm.

7Former ‘‘Bundesinstitut fu¨r gesundheitlichen Verbraucherschutz und Veterina¨rmedizin’’ (BgVV, Federal Institut for Protection of Health of Consumers and Veterinary Medicine), now BfR.

Table 3

Tools for electronic transfer of product data from industry to poison centers

Name of tool Product type Provider Contact Country Language

Product writer General WHO-IPCS www.who.int International English

ISS formula General Istituto Superiore

di Sanita

www.iss.it Italy Italian

EMIL Household products,

biocides

TDI-Project http://www.tdi-network.org/

Network/TheNetworkIndex.html

Germany German

Sysdecos Cosmetic products German Detergents

Association

www.ikw.org Europe German

English French G. Heinemeyer, A. Hahn / Toxicology and Applied Pharmacology 207 (2005) S636 – S644 S643

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initiated a project ‘‘EIS-Chemrisks’’ with a focus to establish a database where stakeholders, agencies, and other interested people may collect data about measurements of substance in the respective media and of data characterizing their releases⁸ and subsequent exposures.

Taken all together, the information provided by product registers is very different throughout the world. This paper proposes how product registers may be built up and which information is required for poison centers as well as for other regulatory purposes.

Approaches for companies to report product data to poison centers and other agencies

Because product information is rapidly changing due to changes of formulations, systems for rapid updating the databases are essential. Electronic data exchange, representing a common approach for information exchange, is still not commonly used in poison center work. The reason may lie in the unanswered question of how the confidentiality can be kept. During the last years, electronic tools for exchange of product data have been developed which can be used by manufacturers. Some tools for electronic product information exchange are listed inTable 3. For example, the ‘‘sysdecos’’

system for reporting cosmetic formulations has been primarily developed in Germany and was translated into the English and French language to enable data exchange from companies in different European states to any European poison center (Glassl, 2002). In the framework of this system, about 150,000 cosmetic formulations have been exchanged between about 4000 cosmetic manufacturers and the BfR during the last 7 years. The BfR, the ten German Poison Centres, and the Austrian Poison Centre share a common database system.

Monthly updates are sent to each center on CD ROM.

Conclusions

Product information is one of the most important basis for poison center work and for general risk assessments. There are many various worldwide available product databases, however, with different aims. Therefore, a prototype of a database that can be used for poison center work has been designed. Quality of data in product databases differ, according to the information the industry is providing and to the regulatory background. Therefore, criteria should be established to guarantee a high degree of quality of information.

Only data that provide information of the total ingredients and their amounts allow adequate advice. On the other hand, risk assessment estimations for populations require an overview on the complete occurrence of products on the market.

Thus, well organized national product registers are a useful tool for supporting poison centers and risk assessors.

Aside from giving advice in poison centers, product databases help risk assessors to identify incidences of health hazards (acute more than chronic) from substances as ingredients in products to prepare annual reports and to support formal exposure and risk analysis approaches.

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