Large Scale Toxicity / Carcinogenicity and Co-Carcinogenicity Studies of GSM/DCS Wireless Communication Signals
Overview
The BioElectroMagnetic/EMC Group in close cooperation with the Foundation on Information Technologies in Society (IT'IS) is involved in large scale in vitro, in vivo, human as well as epidemiological studies. PERFORM A will be the largest toxicological study ever performed in the context of health risk assessment of mobile communications. The objectives are to address the issue of potential carcinogenic effects in humans of low-level exposure to RF from the use of cellular telephony, and adhering to the recommendations as outlined in the WHO agenda (Repacholi, 1998), The following studies will be conducted:
| Study 1: |
Two combined toxicity / carcinogenicity studies of 900 MHz GSM & 1800 MHz DCS wireless communication signals in B6C3F1 mice performed at the Fraunhofer Institute of Toxicology and Aerosol Research, Hannover; |
| Study 2: |
Two combined toxicity / carcinogenicity studies of 900 MHz GSM & 1800 MHz DCS wireless communication signals in WISTAR rats at RCC in Basel; |
| Study 3: |
Evaluation of 900 MHz GSM wireless communication signals on DMBA-induced mammary tumors in Sprague Dawley rats at Österreichisches Forschungszentrum Seibersdorf GmbH; |
| Study 4: |
Evaluation of 900 MHz GSM wireless communication signals on Lymphoma induction in Eµ-PIM 1 transgenic mice at RBM, Italy. |
Each of the four biological studies will be conducted in compliance with GLP according to the EU directives 83/571/EU Appendix 3 and 91/507/EU as well as the relevant "Carcinogenicity" as well as "Combined Chronic Toxicity / Carcinogenicity" guidelines.
The two 2-year bioassays (Study 1 & 2) will be performed as "classical" combined chronic toxicity and carcinogenicity studies at three dose levels, and will be designed like studies routinely performed for health risk evaluation for chemicals, pharmaceuticals or environmental agents. Necropsy, tissue and slide preparation, and complete histopathological evaluations will be carried out on site and follow the international organizations and programs (EU, OECD, EPA, NTP) suggested guidelines for tissue collection, sectioning, and preparation. The DMBA mammary tumor study (Study3) has been proposed because it employs a well characterized chemically initiated model for the analysis of tumor promoting effects. Further, this study will address previous studies that examined the effects of low-level RF exposure on a similar DMBA mammary tumor model and reported inconsistent results. The Eµ-Pim 1 transgenic mouse study (Study 4) more directly reevaluates and replicates a previous study by Repacholi et al reporting a 2.4 fold increased lymphoma incidence (compared to sham-exposed mice) following daily exposure to 900 MHz RF fields. In contrast to the study of Repacholi et al, however, also tumors other than lymphomas will be analyzed in the present transgenic mouse investigation in accordance with international guidelines. Further, animals that survive past the scheduled 18 month exposure period will also be subject to a pathological examination in the present transgenic mouse study (in case of high survival rates, the study and exposure schedule will be prolonged from 18 to 24 months).
Task and Objectives of IIS/IT'IS
Development, construction, installation and testing of setups for the exposures of rats and mice at 900 MHz and 1800 MHz, which satisfy the following performance requirements:
| SAR (whole-body): |
3 different dose levels 1, 1/3, 1/9; highest dose determined by pilot study on thermal stress in animals |
| SAR (organ): |
averaged SAR of each organ shall be specified during entire life |
| homogeneity: |
as good as possible |
| variability: |
<+/-2dB for whole body SAR (across animal and entire life) |
| exposure: |
blinded, self-detection of malfunctions |
Provision of technical quality control, support and maintenance during the period of experiments.
Description of Work
The provision of highly reliable, high quality setups for this experiment is a great challenge for research as well as for engineering. Well-defined exposures in animals having body sizes in the range of the wavelength are a difficult task since a large number of constrains are given by the biological experiments. The WHO review concluded that the largest problem in this research field is the poorly defined and characterized exposure conditions in the experiments. The project requires the development of new exposure concepts, performance optimization, new dosimetric tools (e.g., more powerful simulation tools, microthermal sensors, etc.) greatly improved electromagnetic as well as thermal animal models, etc...
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Several old and new concepts have been evaluated in detail by simulations using SEMCAD. Each of the approaches has been ranked according to the achievable homogeneity, technical feasibility, biological compatibility as well as cost. The most promising approach had been optimized. |
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For experimental evaluation, a prototype with a scale of 1:1 was built on which the simulated predictions are verified as well as its sensitivity to various mechanical tolerances assessed. |
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