- Email: [email protected]
Peer-reviewing of herbal medicine toxicity test reports under the Korean National Toxicology Program
S104
Abstracts / Toxicology Letters 196S (2010) S37–S351
tisation testing of ingredients where dermal exposure is sufficiently low. Further work has now been conducted to refine the DST process such that it can be used confidently as a risk assessment tool. The additional work described in this presentation consists of the following steps: 1. Expanding the dataset used in the original published DST analysis to investigate whether the distribution of potencies of sensitisers would hold true when additional chemicals are added. 2. Investigation of whether the use of mechanistic chemistry domains could improve the robustness of the DST methodology. Based on this work it is concluded that classification of mechanistic chemistry domains based on structure provides a useful mechanism of refining the DST and, for chemicals that are predicted to be non-reactive to proteins, a DST can be established below which there is a very small chance of an untested material posing a skin sensitisation risk. This DST value for non-reactive chemicals is higher than the DST originally determined, and at the same time provides a higher level of comfort. Chemicals which are predicted to have a protein binding potential would need to be risk assessed on a case-by-case basis. Reference Safford, R.J., 2008. Regul. Toxicol. Pharmacol. 51, 195–200.
doi:10.1016/j.toxlet.2010.03.370
P106-034 Peer-reviewing of herbal medicine toxicity test reports under the Korean National Toxicology Program I.J. Yu 1 , M.S. Dong 2 , J.Y. Lee 1 , J.H. Lee 1 , M.C. Moon 1 , C.S. Kang 1 , B.S. Han 1 , M.H. Kang 1 1
Hoseo University, South Korea, 2 Korea University, South Korea
The Korean National Toxicology Program (KNTP) was established in 2001 as a multi-disciplinary program supported by the Korean Food and Drug Administration (KFDA). The objectives of KNTP are to prevent human health from toxic chemical exposure, and to provide science based toxicity information to citizens to keep any social disturbance from the invalid toxic information. The activities of the KNTP include: sponsoring chemical toxicity testing, establishing toxicity evaluation infra-structure, developing alternative testing methods, building toxicity database with integrated toxic chemical management program, organizing inter-ministerial cooperative program, and initiating toxicology research centers to evaluate toxic chemicals in depth and systemic. The toxic substances and herbal medicines will be selected, tested, and monitored through the KNTP and finally utilized for assessing the risk of the substances. The typical KNTP toxicity battery was consisted of 14–90 days repeated dose toxicity tests, genotoxic tests including Ames test, chromosomal aberration, and in vivo micronucleus test. Especially toxicity test reports for herbal medicines that were suspected for their toxicity were peer-reviewed annually by the expert panel consisting of specialists in exposure, animal experiment, epidemiology, and mechanism. After peer-reviewing, the review panel submits technical reports both in Korean and English. These activities eventually will be helpful in improving public health and regulatory policy. The KNTP is also interesting in establishing international cooperation program to share the toxicology program experiences
with other countries and to collaborate toxicity assessment activities. doi:10.1016/j.toxlet.2010.03.371
P106-035 Ethical considerations of acceptability of biological sampling by participants in a research study N. Noisel, C. Caux, G. Carrier, M. Bouchard University of Montreal, Canada Acceptability of biological sampling is always a consideration when establishing a research protocol. In a controlled research study looking at the time course of selenium in biological matrices following a 1-month therapeutic shampoo treatment, ten healthy university volunteers were asked to provide repeated blood, urine and hair samples. Blood samples were collected by a nurse over a 3-month period, once a week during treatment and once every two weeks over two months post-treatment. With a similar sequence, volunteers were asked to provide ∼12 h urine collections. During the 3-month study period, two hair samples were also taken from the root. At the end of the study, volunteers were invited to fill a self-administered questionnaire to document their perception and acceptability of sampling methods. Most volunteers reported that repeated blood sampling was the less annoying and that repeated 12 h urine collections were more inconvenient. In fact, 12 h urine collections were reported to be constraining (necessity to stay at home, leave the bottle in the fridge) and not well perceived by other people around. Transport is also delicate (public areas, risk of spills). On the contrary, volunteers reported that blood sampling took little time, was facilitated by the fact that the appointment with the nurse was set in advance and it was not necessary to remember any procedure key points. As for hair sampling, most volunteers were more reluctant for aesthetic reasons. This exploratory survey initiates a reflection concerning the acceptability of biological sampling. Factors such as age, educational level, research protocol and other context elements can influence sampling acceptability in volunteers. Acceptability and risk perception by volunteers should also be considered by ethics boards, to define what is ethically acceptable or induces a risk of prejudice. These aspects should be further investigated in future biomonitoring studies, especially those implying multiple samplings. doi:10.1016/j.toxlet.2010.03.372
P106-036 REACH regulation (EC) 1907/2006: A survey of companies situation in view of the first registration deadline R. Butera 1 , A. Caldiroli 1 , C. Osnaghi 2 , A. Sacchi 3 , L. Manzo 1 1
IRCCS Maugeri Foundation and University of Pavia, Italy, InterConsortia, Milan and Bruxelles, Italy, 3 Sacchi Consulting, Milan and Bruxelles, Italy
2
In view of the first deadline for registration of phase-in chemicals according to REACH Regulation (EC) 1907/2006, a questionnaire was sent in January 2010 to the Italian members of InterConsortia, a transversal consortium mainly addressed to distributors and importers. The questionnaire was developed in order to determine if and to what extent companies had already undertaken actions to
Abstracts / Toxicology Letters 196S (2010) S37–S351
tisation testing of ingredients where dermal exposure is sufficiently low. Further work has now been conducted to refine the DST process such that it can be used confidently as a risk assessment tool. The additional work described in this presentation consists of the following steps: 1. Expanding the dataset used in the original published DST analysis to investigate whether the distribution of potencies of sensitisers would hold true when additional chemicals are added. 2. Investigation of whether the use of mechanistic chemistry domains could improve the robustness of the DST methodology. Based on this work it is concluded that classification of mechanistic chemistry domains based on structure provides a useful mechanism of refining the DST and, for chemicals that are predicted to be non-reactive to proteins, a DST can be established below which there is a very small chance of an untested material posing a skin sensitisation risk. This DST value for non-reactive chemicals is higher than the DST originally determined, and at the same time provides a higher level of comfort. Chemicals which are predicted to have a protein binding potential would need to be risk assessed on a case-by-case basis. Reference Safford, R.J., 2008. Regul. Toxicol. Pharmacol. 51, 195–200.
doi:10.1016/j.toxlet.2010.03.370
P106-034 Peer-reviewing of herbal medicine toxicity test reports under the Korean National Toxicology Program I.J. Yu 1 , M.S. Dong 2 , J.Y. Lee 1 , J.H. Lee 1 , M.C. Moon 1 , C.S. Kang 1 , B.S. Han 1 , M.H. Kang 1 1
Hoseo University, South Korea, 2 Korea University, South Korea
The Korean National Toxicology Program (KNTP) was established in 2001 as a multi-disciplinary program supported by the Korean Food and Drug Administration (KFDA). The objectives of KNTP are to prevent human health from toxic chemical exposure, and to provide science based toxicity information to citizens to keep any social disturbance from the invalid toxic information. The activities of the KNTP include: sponsoring chemical toxicity testing, establishing toxicity evaluation infra-structure, developing alternative testing methods, building toxicity database with integrated toxic chemical management program, organizing inter-ministerial cooperative program, and initiating toxicology research centers to evaluate toxic chemicals in depth and systemic. The toxic substances and herbal medicines will be selected, tested, and monitored through the KNTP and finally utilized for assessing the risk of the substances. The typical KNTP toxicity battery was consisted of 14–90 days repeated dose toxicity tests, genotoxic tests including Ames test, chromosomal aberration, and in vivo micronucleus test. Especially toxicity test reports for herbal medicines that were suspected for their toxicity were peer-reviewed annually by the expert panel consisting of specialists in exposure, animal experiment, epidemiology, and mechanism. After peer-reviewing, the review panel submits technical reports both in Korean and English. These activities eventually will be helpful in improving public health and regulatory policy. The KNTP is also interesting in establishing international cooperation program to share the toxicology program experiences
with other countries and to collaborate toxicity assessment activities. doi:10.1016/j.toxlet.2010.03.371
P106-035 Ethical considerations of acceptability of biological sampling by participants in a research study N. Noisel, C. Caux, G. Carrier, M. Bouchard University of Montreal, Canada Acceptability of biological sampling is always a consideration when establishing a research protocol. In a controlled research study looking at the time course of selenium in biological matrices following a 1-month therapeutic shampoo treatment, ten healthy university volunteers were asked to provide repeated blood, urine and hair samples. Blood samples were collected by a nurse over a 3-month period, once a week during treatment and once every two weeks over two months post-treatment. With a similar sequence, volunteers were asked to provide ∼12 h urine collections. During the 3-month study period, two hair samples were also taken from the root. At the end of the study, volunteers were invited to fill a self-administered questionnaire to document their perception and acceptability of sampling methods. Most volunteers reported that repeated blood sampling was the less annoying and that repeated 12 h urine collections were more inconvenient. In fact, 12 h urine collections were reported to be constraining (necessity to stay at home, leave the bottle in the fridge) and not well perceived by other people around. Transport is also delicate (public areas, risk of spills). On the contrary, volunteers reported that blood sampling took little time, was facilitated by the fact that the appointment with the nurse was set in advance and it was not necessary to remember any procedure key points. As for hair sampling, most volunteers were more reluctant for aesthetic reasons. This exploratory survey initiates a reflection concerning the acceptability of biological sampling. Factors such as age, educational level, research protocol and other context elements can influence sampling acceptability in volunteers. Acceptability and risk perception by volunteers should also be considered by ethics boards, to define what is ethically acceptable or induces a risk of prejudice. These aspects should be further investigated in future biomonitoring studies, especially those implying multiple samplings. doi:10.1016/j.toxlet.2010.03.372
P106-036 REACH regulation (EC) 1907/2006: A survey of companies situation in view of the first registration deadline R. Butera 1 , A. Caldiroli 1 , C. Osnaghi 2 , A. Sacchi 3 , L. Manzo 1 1
IRCCS Maugeri Foundation and University of Pavia, Italy, InterConsortia, Milan and Bruxelles, Italy, 3 Sacchi Consulting, Milan and Bruxelles, Italy
2
In view of the first deadline for registration of phase-in chemicals according to REACH Regulation (EC) 1907/2006, a questionnaire was sent in January 2010 to the Italian members of InterConsortia, a transversal consortium mainly addressed to distributors and importers. The questionnaire was developed in order to determine if and to what extent companies had already undertaken actions to