公益財団法人
日本食品化学研究振興財団
海外トピックス
更新日：
2006/11/21
サッカリン等の発ガン性について
−
米国立環境保健化学研究所発表
サッカリン、リストより削除
米国立環境保健化学研究所は、発ガン性物質に関する第９次報告書を発表し、人工甘味料のサッカリン、アクリル酸エチルを“発ガンの疑いのある物質”のリストから外した。
また、たばこの煙、アルコール摂取、エチレンオキサイドなどの１２項目を“発ガン性物質”として、イソプレンなど６項目を“発ガンの疑いのある物質”として新たにリストに加えた。
サッカリンについて
サッカリンは、ラットの実験で膀胱ガンができたことから、発ガンの疑いのある物質として１９８１年以来リストに掲載されてきたが、ラットにおける発ガンのメカニズムをそのまま人間に適用できないことが確認された。
Press Release
National institute of Environmental Health Sciences
FOR RELEASE at 10:30 a.m. EDT
Monday, May 15, 2000
NIEHS ADV. #00-02
NIEHS Press Contact
・
Bill Grigg
301-402-3378 or 301-496-3511
NTP Liaison Contact
Sandra Lange 919-541-0530
Fact Sheet: The Report on Carcinogens - 9th edition
Today the Department of Health and Human Services released the
Report on Carcinogens 9th edition
. Prepared by the National Toxicology Program, which is headquartered at the National Institute of Environmental Health Sciences,
the
Report
identifies substances -- such as metals, pesticides, drugs, and natural and synthetic chemicals -- and mixtures or exposure circumstances that are
"known"
or are
"reasonably anticipated"
to cause cancer, and to which a significant number of Americans are exposed. The
Report
is published every two years.
The
Report
is a scientific and public health document first ordered by Congress in 1978 to educate both the public and health professionals in the recognition that many cancers are apparently induced by chemicals in the home, workplace, general environment and from the use of certain drugs. It is important to understand that the
Report
identifies potential cancer hazards. A listing in the
Report
does not by itself establish that a substance presents a cancer risk to an individual in daily life. It is also important to note that the
Report
does not address or attempt to balance potential benefits of exposures to certain carcinogenic substances in special situations. For example, numerous drugs used to treat cancer have been shown to increase the occurrence of secondary cancers. In these instances, the benefits of exposure to the drugs for treatment or prevention of a specific disease have been determined by the FDA to outweigh the additional cancer risks associated with their use. People should not make decisi
ons concerning the use of a given drug, or any other listed agent, based solely on the information contained in the
Report
. Decisions of this type should be made only after consulting with a physician or other appropriate specialist about both risks and benefits.
An agent, substance, mixture or exposure circumstance can be listed in the
Report
either as
"known to be a human carcinogen"
or as
"reasonably anticipated to be a human carcinogen."
The
"known"
category is reserved for those substances for which there is sufficient evidence of carcinogenicity from studies in humans that indicates a cause and effect relationship between the exposure and human cancer.
The "reasonably anticipated" category includes those substances for which there is limited evidence of carcinogenicity in humans and/or sufficient evidence of carcinogenicity in experimental animals.
Conclusions regarding carcinogenicity in humans or experimental animals are based on expert, scientific judgment, with consideration given to all relevant information.
The 9th edition of the
Report
contains 218 entries. Fourteen of the listings are new. Eight of the new entries are listed as "known to be human carcinogens" and the other six entries as "reasonably anticipated to be human carcinogens." This
Report
also reclassifies six current listings from "reasonably anticipated" to "known to be human carcinogens".
2,3,7,8-Tetrachlorodibenzo-p-dioxin (TCDD) has been proposed for upgrade to the
"known to be a human carcinogen"
category. The proposed listing is currently in litigation. Depending on the outcome of the litigation, an addendum may be published following the court's ruling. Two additional substances have been removed or delisted from the
Report
: saccharin and ethyl acrylate.
The new listings in the 9th edition include some agents and substances to which large numbers of people are exposed including environmental tobacco smoke, tobacco smoking, oral use of smokeless tobacco products, alcoholic beverage consumption, diesel exhaust particulates, UV solar radiation, and use of sun lamps and sun beds. The
Report
's findings are based on three years of study that included three scientific reviews and public comment from scientists, consumers and other interested parties.
The listing of a substance in the
Report
is not a regulatory action, but listing may prompt regulatory agencies to consider limiting exposures or uses of a substance. In addition, the U.S. Congress, Federal and State Agencies, businesses, unions and the general public all use the
Report
to ensure that reasonable precautions or regulations are in place.
The following briefly describes the additions and/or changes made to the 9th edition of the
Report
:
Saccharin - Saccharin has been removed from the 9th edition. The Calorie Control Council nominated saccharin for delisting, which led to a new review of the carcinogenicity data for saccharin. Saccharin had been listed in the Report as "reasonably anticipated to be a human carcinogen" since 1981. The basis for this listing was sufficient evidence of carcinogenicity in experimental animals. Saccharin was removed from the Report after this extensive review determined that the rodent cancer data are not sufficient to meet the current criteria to list this chemical in the Report as a "reasonably anticipated human carcinogen." This is based on the determination that the observed bladder tumors in rats arose from a mechanism that is not relevant to humans.
Dr. Kenneth Olden, Director of the National Institute of Environmental Health Sciences and the National Toxicology Program, said, "Two decades ago, when saccharin was shown to produce bladder tumors in rats, it was a prudent, protective step to consider the sweetener to be a likely human carcinogen. However, our understanding of the science has advanced and allows us to make finer distinctions today. Studies now indicate that the rat bladder tumors arise from mechanisms that are not relevant to the human situation. In addition, we have decades more data from observations of humans using saccharin that adds to our confidence. In other words, with better science we can now make a better call."
Ethyl acrylate [本文省略]
The delistings of saccharin and ethyl acrylate are the first since a formal process for delisting substances from the
Report
was established in 1996.
Added as
"known human carcinogens"
or upgraded to that category in the 9th Report:
Environmental tobacco smoke [本文省略]
Tobacco smoking [本文省略]
Smokeless tobacco [本文省略]
Consumption of alcoholic beverages [本文省略]
Solar UV radiation and exposure to sunlamps and sunbeds [本文省略]
Crystalline silica (respirable size) [本文省略]
Strong inorganic acid mists containing sulfuric acid [本文省略]
Dyes metabolized to benzidine [本文省略]
1,3-Butadiene - 1,3 [本文省略]
Cadmium and cadmium compounds [本文省略]
Ethylene oxide [本文省略]
Tamoxifen [本文省略]
Added as "reasonably anticipated to be human carcinogens" in the 9th Report:
Diesel exhaust particulates [本文省略]
Isoprene [本文省略]
Chloroprene [本文省略]
Phenolphthalein [本文省略]
Tetrafluoroethylene [本文省略]
Trichloroethylene [本文省略]