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Θα πρέπει να παρέχεται αιτιολόγηση στην περίπτωση που εφαρμόζεται διάρκεια έκθεσης μικρότερη των 6 ωρών ημερησίως.
Exposure by the inhalation route is carried out for 6 hours per day, 7 days per week, but exposure for 5 days per week may also be used, if justified. The period of exposure will normally be for a period of 12 months. If rodent species other than rats are exposed nose-only, maximum exposure durations may be adjusted to minimise species-specific distress. A rationale should be provided when using an exposure duration of less than 6 hours per day.
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, Agricultural Chemical Safety Assessment:
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Θα πρέπει να χρησιμοποιούνται ζώα και των δύο φύλων.
Both sexes should be used. A sufficient number of animals should be used so that a thorough biological and statistical evaluation is possible.
Το επιλεγόμενο διάστημα μεταξύ των δόσεων εξαρτάται από τα χαρακτηριστικά της ελεγχόμενης χημικής ουσίας και δεν μπορεί να προβλεφθεί στην παρούσα μέθοδο δοκιμών, αλλά υποδιπλάσια ή υποτετραπλάσια διαστήματα εξασφαλίζουν συχνά καλές επιδόσεις στη δοκιμή για τον καθορισμό μειούμενων επιπέδων δόσης και η προσθήκη μιας τέταρτης ομάδας δοκιμής είναι συνήθως προτιμότερη της χρήσης πολύ μεγάλων διαστημάτων (π.χ. μεγαλύτερων ενός συντελεστή της τάξης του 6-10) μεταξύ των δόσεων.
However, dependent on the objectives of the study (see paragraph 6), a top dose lower than the dose providing evidence of toxicity may be chosen, e.g. if a dose elicits an adverse effect of concern that nonetheless has little impact on lifespan or body weight. 23. Dose levels and dose level spacing may be selected to establish a dose-response and, depending on the mode of action of the test chemical, a NOAEL or other intended outcome of the study, e.g. a BMD (see paragraph 25) at the lowest dose level. Factors that should be considered in the placement of lower doses include the expected slope of the dose–response curve, the doses at which important changes may occur in metabolism or mode of toxic action, where a threshold is expected, or where a point of departure for low-dose extrapolation is expected. 24. The dose level spacing selected will depend on the characteristics of the test chemical, and cannot be prescribed in this Test Method, but two to four fold intervals frequently provide good test performance for setting the descending dose levels and addition of a fourth test group is often preferable to using very large intervals (e.g. more than a factor of about 6-10) between dosages.
EPA (2005), Guidelines for Carcinogen Risk Assessment Risk Assessment Forum U.S.
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Barlow S.M., Greig J.B., Bridges J.W. et al (2002), Hazard identification by methods of animal-based toxicology, Food.
Barlow SM, Greig JB, Bridges JW et al (2002). Hazard identification by methods of animal-based toxicology. Food.
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Doe J.E., Boobis A.R., Blacker A. et al (2006), A Tiered Approach to Systemic Toxicity Testing for Agricultural Chemical Safety Assessment, Critical Reviews in Toxicology 36:
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Cooper R.L., Lamb J.S., Barlow S.M. et al (2006), A Tiered Approach to Life Stages Testing for Agricultural Chemical Safety Assessment, Critical Reviews in Toxicology 36:
Cooper RL, Lamb JS, Barlow SM et al (2006). A Tiered Approach to Life Stages Testing for Agricultural Chemical Safety Assessment.
ILSI (International Life Sciences Institute) (1997), Principles for the Selection of Doses in Chronic Rodent Bioassays, Foran JA (Ed.), ILSI Press, Washington, DC.
ILSI (International Life Sciences Institute) (1997). Principles for the Selection of Doses in Chronic Rodent Bioassays. Foran JA (Ed.). ILSI Press, Washington, DC.
Griffiths S.A., Parkinson C., McAuslane J.A.N. και Lumley C.E.
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Results and Conclusions from a Survey of Ten Years of Testing by the Agrochemical Industry, Environ Health Perspect.
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Health 206: 437-445.
Health 206: 437-445
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The Acquisition and Application of Absorption, Distribution, Metabolism, and Excretion (ADME) Data in Agricultural Chemical Safety Assessments. Crit.
, A Tiered Approach to Systemic Toxicity Testing for Agricultural Chemical Safety Assessment, Crit.
A Tiered Approach to Systemic Toxicity Testing for Agricultural Chemical Safety Assessment. Crit.
, A Tiered Approach to Life Stages Testing for Agricultural Chemical Safety Assessment, Crit.
A Tiered Approach to Life Stages Testing for Agricultural Chemical Safety Assessment. Crit.
Proceedings of the Third International Conference on Harmonisation, Queen’s University Press, Belfast, pp.
Proceedings of the Third International Conference on Harmonisation.
Carmichael N.G., Enzmann H., Pate I., Waechter F. (1997), The Significance of Mouse Liver Tumor Formation for Carcinogenic Risk Assessment:
Carmichael NG, Enzmann H, Pate I, Waechter F (1997). The Significance of Mouse Liver Tumor Formation for Carcinogenic Risk Assessment: Results and Conclusions from a Survey of 10 Years of Testing by the Agrochemical Industry.
Results and Conclusions from a Survey of Ten Years of Testing by the Agrochemical Industry, Environ Health Perspect 105: 1196-1203.
Environ Health Perspect 105:1196-1203.
GV-SOLAS (Society for Laboratory Animal Science, Gesellschaft für Versuchstierkunde, December, 1989), Publication on the Planning and Structure of Animal Facilities for Institutes Performing Animal Experiments.
GV-SOLAS (Society for Laboratory Animal Science, Gesellschaft für Versuchstierkunde, December, 1989). Publication on the Planning and Structure of Animal Facilities for Institutes Performing Animal Experiments.
Diehl K.-H., Hull R., Morton D., Pfister R., Rabemampianina Y., Smith D., Vidal J.-M., van de Vorstenbosch C. (2001), A good practice guide to the administration of substances and removal of blood, including routes and volumes, Journal of Applied Toxicology 21:
Diehl K-H, Hull R, Morton D, Pfister R, Rabemampianina Y, Smith D, Vidal J-M, van de Vorstenbosch C. (2001). A good practice guide to the administration of substances and removal of blood, including routes and volumes.
, A Neuromuscular Screen for Use in Industrial Toxicology, J. Toxicol.
A Neuromuscular Screen for Use in Industrial Toxicology.
Environ.
J. Toxicol.Environ.
Η χρήση πιλοτικών μελετών συνιστάται και ενθαρρύνεται για την επιλογή πειραματικών παραμέτρων για τις μελέτες τοξικοκινητικής (π.χ. μεταβολισμού, ισοζυγίου μάζας, αναλυτικών διαδικασιών, εύρεσης του πεδίου τιμών δόσης, αποβολής CO2 κ.λπ. Για τον χαρακτηρισμό ορισμένων από τις παραμέτρους αυτές ενδέχεται να μην απαιτείται η χρήση ραδιοσημασμένων χημικών ουσιών.
The use of pilot studies is recommended and encouraged for the selection of experimental parameters for the toxicokinetics studies (e.g. metabolism, mass balance, analytical procedures, dose-finding, exhalation of CO2, etc.). Characterisation of some of these parameters may not necessitate the use of radiolabelled chemicals.
Stumpf W.E.
Stumpf WE (2005). Drug localization and targeting with receptor microscopic autoradiography.
, Drug localization and targeting with receptor microscopic autoradiography, J. Pharmacological and Toxicological Methods 51: 25-40.
J. Pharmacological and Toxicological Methods 51: 25-40.
, Development of good modelling practice for physiologically based pharmacokinetic models for use in risk assessment:
Development of good modelling practice for physiologically based pharmacokinetic models for use in risk assessment: The first steps.
IPCS (2010), Characterization and application of Physiologically-BasedPharmacokinetic Models in Risk Assessment.
IPCS (2010). Characterization and application of Physiologically-Based Pharmacokinetic Models in Risk Assessment.
IPCS Harmonization Project Document No 9, Geneva, World Health Organization, International Programme on Chemical Safety.
IPCS Harmonization Project Document No 9. Geneva, World Health Organization, International Programme on Chemical Safety.
Εμβαδόν κάτω από την καμπύλη σε γραφική παράσταση της συγκέντρωσης μιας ελεγχόμενης χημικής ουσίας στο πλάσμα συναρτήσει του χρόνου.
Not to be confused with “bioavailability”. Accumulation (Bioaccumulation)
Tmax:
AUC
Η ποσοτική ολόσωμη αυτοραδιογραφία, σε σύγκριση με την ανατομή των οργάνων, ενδέχεται να έχει ορισμένα πλεονεκτήματα για την αξιολόγηση της κατανομής της ελεγχόμενης χημικής ουσίας και την εκτίμηση της συνολικής ανάκτησης και του διαχωρισμού του ραδιενεργού υλικού στους ιστούς.
When autoradiography is used, experiments intended to determine mass balance of administered compound should be conducted as a separate group or in a separate study from the tissue distribution experiment, where all excreta (which may also include expired air) and whole carcasses are homogenised and assayed by liquid scintillation counting. Biliary excretion Excretion via the bile ducts. Bioaccumulation See “Accumulation”. Bioavailability
Ένα σημαντικό πλεονέκτημα, παραδείγματος χάριν, είναι ότι η τεχνική αυτή μπορεί να χρησιμοποιηθεί σε μοντέλο ζώων που φέρουν κηλίδες για την εκτίμηση της πιθανής σύνδεσης της ελεγχόμενης χημικής ουσίας με τη μελανίνη, η οποία μπορεί να δεσμεύει ορισμένα μόρια.
Fraction of an administered dose that reaches the systemic circulation or is made available at the site of physiological activity. Usually, bioavailability of a test chemical refers to the parent compound, but it could refer to its metabolite. It considers only one chemical form.
Ωστόσο, παρόλο που προσφέρει εύκολη επισκόπηση των θέσεων σύνδεσης υψηλής χωρητικότητας αλλά χαμηλής συγγένειας σε ολόκληρο το σώμα, η τεχνική αυτή ενδέχεται να υπόκειται σε περιορισμούς όσον αφορά την αναγνώριση συγκεκριμένων θέσεων στόχου, όπως οι θέσεις σύνδεσης με υποδοχείς, όταν απαιτείται σχετικά υψηλή ανάλυση και υψηλή ευαισθησία για την ανίχνευση.
Nota Bene: bioavailability and absorption are not the same. The difference between e.g. oral absorption (i.e. presence in gut wall and portal circulation) and bioavailability (i.e. presence in systemic blood and in tissues) can arise from chemical degradation due to gut wall metabolism or efflux transport back to the intestinal lumen or presystemic metabolism in the liver, among other factors (10).
Όταν χρησιμοποιείται αυτοραδιογραφία, πρέπει να εκτελούνται πειράματα με σκοπό τον προσδιορισμό του ισοζυγίου μάζας της χορηγούμενης ουσίας, ως χωριστή ομάδα ή σε μελέτη χωριστή από το πείραμα ιστικής κατανομής, όπου όλα τα απεκκρίματα (ενδεχομένως συμπεριλαμβανομένου του εκπνεόμενου αέρα) και ολόκληρα τα σφάγια ομογενοποιούνται και υποβάλλονται σε δοκιμασία με μέτρηση σπινθηρισμού υγρών.
Bioavailability of the toxic component (parent compound or a metabolite) is a critical parameter in human risk assessment (high-to-low dose extrapolation, route-to-route extrapolation) for derivation of an internal value from the external NOAEL or BMD (applied dose). For liver effects upon oral administration, it is the oral absorption that suffices.
Κλάσμα της χορηγούμενης δόσης που φθάνει στη συστημική κυκλοφορία ή είναι διαθέσιμο στην περιοχή φυσιολογικής δραστηριότητας.
Biopersistence See “Persistence”.
Συνήθως, η βιοδιαθεσιμότητα μιας ελεγχόμενης χημικής ουσίας αναφέρεται στη μητρική ένωση, αλλά μπορεί να αναφέρεται επίσης στους μεταβολίτες της.
Biotransformation (Usually enzymatic) chemical conversion of a test chemical of interest into a different chemical within the body.
Σημείωση:
Cmax
Η βιοδιαθεσιμότητα του τοξικού στοιχείου (μητρική ένωση ή μεταβολίτης) αποτελεί κρίσιμη παράμετρο κατά την εκτίμηση των κινδύνων για τον άνθρωπο (παρέκταση από την υψηλή δόση σε χαμηλή, παρέκταση από μια οδό σε άλλη) για τον προσδιορισμό εσωτερικής τιμής από την εξωτερική τιμή NOAEL ή BMD (εφαρμοζόμενη δόση).
Quantitative measure of the rate at which a test chemical is removed from the blood, plasma or a certain tissue per unit time. Compartment
Για την αξιολόγηση των επιδράσεων στο ήπαρ μετά από χορήγηση από το στόμα, αρκεί η απορρόφηση από το στόμα.
Structural or biochemical portion (or unit) of a body, tissue or cell, that is separate from the rest. Detoxification pathways
Ωστόσο, για την αξιολόγηση οποιασδήποτε άλλης επίδρασης πέραν του σημείου εισόδου, η βιοδιαθεσιμότητα και όχι η απορρόφηση αποτελεί γενικά πιο αξιόπιστη παράμετρο για περαιτέρω χρήση στην εκτίμηση των κινδύνων.
Series of steps leading to the elimination of toxic chemicals from the body, either by metabolic change or excretion. Distribution
Βιομετασχηματισμός:
Dispersal of a test chemical and its derivatives throughout an organism. Enzymes/Isozymes
(Συνήθως ενζυματική) χημική μετατροπή μιας ελεγχόμενης χημικής ουσίας που ενδιαφέρει σε διαφορετική χημική ουσία μέσα στο σώμα.
Proteins that catalyse chemical reactions. Isozymes are enzymes that catalyse similar chemical reactions but differ in their amino acid sequence.
Συνώνυμο του όρου “μεταβολισμός”.
Enzymatic Parameters Km: Michaelis constant and Vmax: maximum velocity.
Βλέπε “Συσσώρευση”.
Introduced from or produced outside the organism or system. Extrapolation
Γραμμικότητα/γραμμική κινητική:
Inference of one or more unknown values on the basis of that which is known or has been observed. Half-life (t1/2)
Μια διεργασία είναι γραμμική από πλευράς κινητικής, όταν όλα τα ποσοστά μεταφοράς μεταξύ διαμερισμάτων είναι ανάλογα με τις παρούσες ποσότητες ή συγκεντρώσεις, δηλαδή κινητική πρώτης τάξεως.
The time taken for the concentration of the test chemical to decrease by one-half in a compartment. It typically refers to plasma concentration or the amount of the test chemical in the whole body.
Επομένως, οι όγκοι κάθαρσης και κατανομής, όπως και ο χρόνος υποδιπλασιασμού, είναι σταθεροί.
Induction/Enzyme induction Enzyme synthesis in response to an environmental stimulus or inducer molecule. Linearity/linear kinetics