| About our activities to address antimony-related issues of the environment, health, and safety regulations |
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The Antimony Environmental Safety Committee was organized in November 1998 as a subdivision of the Japan Mining Industry Association. |
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The IAOIA was organized in October 2000 by Japanese, American and European producers of antimony oxide. |
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Still under further examination , antimony trioxide was classified, on October 25, 2000, as a substance to be included in the 4th priority list of the chemical substances for the EU Risk Assessment under EU's Existing Chemical Substances Regulations 93/793/EEC. |
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The possibility is being examined of water quality standardization on the basis of the chronic oral toxicity of antimony. |
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While there has been fear that antimony trioxide inhaled into the rungs may cause cancer, this substance is now undergoing examinations with related experiments being planned by the EU Risk Assessment or by America's Environmental Protection Agency(EPA). |
| 1. |
Setting up of "Antimony Environmental Safety Committee". |
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| With the increasing public awareness of antimony-related matters of public health
and environmental safety, Antimony Environmental Safety
Committee was organized in November 1998 as a subdivision of
Japan Mining Industry Association to collect, examine, and
study scientific facts about antimony
products for better public knowledge and education and thereby
to promote sound and steady prosperity of antimony products
producers. This committee also functions as the representative
office in Japan of the IAOIA. |
| 2. |
Setting up of "International Antimony Oxide Industry Association (IAOIA)" |
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| (1) |
Through the Flame Retardant Manufacturers' Associations in Japan and the U.S., we started in 1997 a series of meetings between Japan's and America's antimony industry businesses to exchange information on antimony-related public health and environmental safety, followed by meetings among representatives from Japan, the U.S., EU and China to compare notes and to prepare for setting up an international business association. Then, in October 2000, we had a steering committee meeting among representatives from Japan, the U.S. and EU, whereupon the International Antimony Oxide Industry Association (IAOIA) was officially started. |
| (2) |
The purpose of IAOIA as a non-profit organization is to serve the common interests of the world's antimony trioxide manufacturers in respect of the environment, health and safety regulations.
To achieve this purpose, IAOIA conducts research on the safety and usefulness of antimony trioxide, publicize relevant information, and also to present relevant scientific intelligence to governmental agencies and international organizations. |
| (3) |
In June 2004, to work more systematically on the EU Risk Assessment on antimony trioxide, we agreed with Plastics Europe (Association of Plastics Manufacturers)as EU users' association and its member industries including its major member the PET industry to commence a joint study program, whereupon we organized Antimony Trioxide Stakeholders (ATOS) to facilitate our actions. |
| (4) |
With China joining IAOIA in 2005, we have addressed the antimony-related issues of public health and environmental safety in the four-polar joint effort by Japan, the U.S., EU and China. |
| 3. |
Our responses to the designation of antimony trioxide as a priority chemical substance for the EU Risk Assessment |
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| (1) |
In October 25, 2000, antimony trioxide was designated as a substance to be included in the 4th priority list of the chemical substances for the EU Risk Assessment under EU's Existing Chemical Substances Regulations 93/793/EEC. Assessment work is being done to cover various aspects of antimony trioxide's potential ecological effects in accordance with the EU directive. |
| (2) |
Considering that it takes scientific quantitative assessment to ensure safety in the use of antimony trioxide in its entire application areas, IAOIA aggressively pursues meeting the EU Risk Assessment as a highest priority issue. |
| (3) |
IAOIA makes a point of having meetings on a regular basis with the Swedish Chemicals Inspectorate "KemI" as the one in charge of antimony trioxide, in which the results of various tests are submitted to help bridge the information gap concerning toxicological test data. |
| (4) |
In 2004, IAOIA agreed with EU user groups to organize the Antimony Trioxide Stakeholders (ATOS) to pursue a joint study program on antimony-related environmental safety.
The program's activities include subsidizing scientific research efforts by bona fide third parties and supporting the development of scientific arguments by IAOIA in the course of international technical meetings hosted by the European Chemicals Bureau (ECB) and by other organizations.
Thus, we try to ensure obtaining appropriate data on the production and use of antimony trioxide to help to have the ECB recognize the socioeconomic importance this chemical product has. |
| (5) |
In July 2004, KemI came up with the first report,(not publicized, though), whereupon the Technical Committee for New and Existing Substances (TCNES) of the European Chemicals Bureau is now examining antimony trioxide for its effects on human health and on the environment. |
| (6) |
The Environment Classification and Labeling meeting, held in Arona, Italy in April 2006, concluded that antimony trioxide "has no environmentally harmful effects on the aquatic life," and "does not need the environment safety warning labels" under the Council Directive 88/379/EEC Relating to the Classification, Packing and Labeling of Dangerous Preparation.
As a consequence, the EU Risk Assessment will likely conclude that antimony trioxide is considered "environmentally harmless to the aquatic life." |
| 4. |
Our responses to the reviewing of water quality standard for antimony |
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| (1) |
In 1993, the World Health Organization (WHO) worked out the first provisional guidelines for antimony-related water quality, which drew on the lifelong animal experiments in rats, published in 1970 by the group of Schroeder and other toxicological researchers, in which rats were given level one doses of 5ppm. The EPA and Japan also use those same guidelines set by the WHO.
The animal experiments above, which did not comply with the OECD's guidelines, showed that the health of the rats had not been critically affected except that their lives were shortened insignificantly with their metabolism slightly affected
(Schroeder et. al., J.Nutr.,100.59-68,1970). |
| (2) |
The U.S. Antimony Oxide Industry Association raised objections to the EPA as follows:
| a) |
The lifelong administration animal experiments by Schroeder's group, which the WHO's 1993 guidelines for drinking water quality drew on, used antimony potassium tartrate (APT), which has a significantly higher water solubility and greater acute toxicity than antimony trioxide. |
| b) |
Chemicals to be used in toxicity assessment tests should be other representative chemicals that are highly likely to be present in industrial waste water and other ambient waters. Antimony trioxide, which is more likely to be present in the ambient waters simply because it is widespread industrial use unlike APT, should be the one to be employed rather than antimony potassium tartrate. |
| c) |
Antimony-related water quality or its environmentally tolerable levels in water should be determined by the concentration of dissolved antimony rather than by the total recoverable amount of antimony. If the concentration of dissolved antimony is not to be used, then, different levels of tolerance should be provided separately for chemicals of low water solubility as antimony trioxide.
Or, only the chemicals of high water solubility like antimony potassium tartrate should be targeted for water quality standard. |
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| (3) |
Recently, an animal experiment, sponsored by the Plastics Europe, in which rats were orally fed with 20,000 ppm of antimony trioxide for 90 days, resulting in no apparent toxic effects. This result is employed in reviewing the WHO's guidelines for drinking water quality.
(Hext et al J.Appl.Toxicol.,19,205-209,1999) |
| (4) |
The Antimony Environmental Safety Committee is sponsoring animal toxicity tests by the Medical Research School of Kyushu University, in which both antimony trioxide and antimony potassium tartrate are tested for toxicity.
With further study and analysis yet to be made for metabolism, however, so far the following results have been obtained:
| a) |
With the oral administration tests, in-organ antimony concentration as well as in-organ antimony distribution was widely different between rats and mice.
Also, with its strong affinity with red blood cells in rats, antimony is considered to be present in high concentration in rats. (the April 2000 70th presentations corpus of The Japanese Society for Hygiene) |
| b) |
As for in-organ distribution, in rats, of both antimony trioxide and antimony potassium tartrate, the greater blood flow their organs had, the higher their in-organ antimony concentration was, except for the lever, which showed low antimony concentration.
In mice, on the other hand, the whole-blood concentration of antimony is lower than in rats. It was pointed out that to make adequate toxicity assessment for antimony trioxide, animal tests need to be done in as many different animals as possible as the recent trend of animal experiment procedures goes. |
| c) |
In the tests using the same concentrations of antimony trioxide and antimony potassium tartrate, generally in-organ concentration was lower for antimony trioxide.
Also, as for antimony trioxide, let alone the dosage of antimony trioxide equivalent to 10mg of antimony per 1kg of body weight , 4-week administration at even 1,000mg per 1kg body weight, a dosage far exceeding the enough dosage at which antimony potassium tartrate would kill half the rats or mice used, showed antimony trioxide to have no apparent toxicity.
So, the conclusion was that antimony toxicity assessment should not disregard, but take into account, the distinctive differences in water solubility of each different antimony compound. (the 12th Annual Meeting in 2001 of the Japan Society for Biomedical Research on Trace Elements) |
| d) |
Since 2002, acute and chronic toxicity tests for antimony trioxide dissolved up to the saturation point, in both rats and mice, have been carried out along with tests for multi-generation toxicological effects.
The interim progress report says that, with the antimony trioxide group, no toxicological effects were observed in both the rats and the mice during the phase of pregnancy & delivery and in their babies during the phase of lactation and growth, whereas, with the antimony potassium tartrate group, some adverse effects were detected in the mothers during the phase of pregnancy & delivery and in the babies during the phase of lactation and growth. [the 37th Presentation Corpus dated March 2003 of the Japan Society on Water Environment (JSWE)][the76th Presentation Corpus dated March 2006 of The Japanese Society for Hygiene] |
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| (5) |
First significant revision in ten years' time was made of WHO's water quality guidelines in the third edition. The revision added antimony to the list of the chemical substances needing re-assessment, whereupon, based on the review of scientific data involved, antimony's new criteria have been significantly moderated to 0.02mg/liter, 6-7 times the provisional level of 0.003mg/liter under the WHO's 1993 guidelines.
Moreover, as described in the revision, the new criteria are very much on the safe side with the safety factor increased to 1,000 twice as high as the previous 500.
Considering that the WHO's current guidelines for antimony are still based on the results of the tests using antimony potassium tartrate(APT), a water soluble substance with high toxicity, the Antimony Environmental Safety Committee thinks that the WHO's criteria are problematic and need to be moderated for antimony whose toxicological effects are insignificant. |
| (6) |
The water quality standard of Japan has been revised in line with the WHO's drinking water quality standard. As for antimony, no legally binding criteria are provided in Japan for drinking tap water and for the ambient water. Japan has the tentative guideline criteria of 0.015mg/liter (7.5 times higher than the previous 0.002mg/liter) set on May 30, 2003 for drinking tap water and of 0.02mg/liter (more than ten times higher than the 1993 criteria) set on April 2, 2004 for the ambient water, with the result that the new tolerance levels have significantly moderated as compared with the previous ones. |
| 5. |
Our actions to address potential carcinogenicity of inhaled antimony trioxide |
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| (1) |
"Group 2B" carcinogenicity level set by the International Agency for Research on Cancer(IARC) is the level of "being potentially carcinogenic to humans" and does not necessarily mean positive carcinogenicity, leaving the need for further study.
This carcinogenicity level are grounded on the results of the experiments in the 1980s by Watt and Groth, whereas those experiments are deemed to be suspect because subsequent analyses showed that the experiments had too much dust included in the experiment conditions and that the inhalation experiment by Groth used antimony trioxide samples whose purity was as low as 80% with a high concentration of impurities like arsenic.
(Watt. Ph D Thesis, Wayne State University,Detroit,MI,1983)
(Groth et. Al., J.Toxicol.Environ.Health 18,607-626,1986) |
| (2) |
The EPA concluded that the test results by Watt and Groth were not suitable for determining antimony's carcinogenicity since they were conducted in dubious conditions.(U.S.Federal Register 48F.R.717,1983) |
| (3) |
The Antimony Environmental Safety Committee maintains that the following conclusions and opinions by the EPA are to be adopted:
| a) |
The results of the antimony inhalation experiments that were sponsored by the U.S. Antimony Industry Association and conducted using the test procedures agreed on by the EPA showed no carcinogenicity.
[FUNDAMENTAL AND APPLIED TOXICOLOGY 22,561-576(1994)] |
| b) |
Though its opinion about antimony trioxide's potential carcinogenicity is unchanged, the EPA has dropped antimony from the priority test list of the Interagency Testing Committee (ITC), maintaining that no immediate action is necessary.
In other words, with its assessment of antimony trioxide's carcinogenicity not completed yet, the EPA does not have this chemical included in its list of carcinogenic substances.
(U.S. Federal Register 56F.R.67424, 1991) |
| c) |
The lifelong administration animal experiments done in 1993 by Schroeder and others did not detect carcinogenicity by oral dosage, whereupon the EPA assesses the carcinogenicity of antimony compounds as belonging in group D: "assessment of carcinogenicity to humans not completed on account of unavailability of sufficient evidence.
(U.S. Federal Register 57F.R.31776,1992) |
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| (4) |
The EPA is now considering a National Toxicity Program to assess a range of substances for chronic toxicity and inhalation carcinogenicity, the protocols of which are expected to be made public toward September 2006. |
| (5) |
Quantitative analyses are being done of antimony trioxide under the EU Risk Assessment. Our company is determined to continue doing everything we can do through the IAOIA. |
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