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i. nezrele ženke nakon odbijanja od sise i prije puberteta;
The uterine weight response will be compared to established historical data (see reference (5)).
Reakcija mase maternice usporedit će se s utvrđenim povijesnim podacima (vidjeti referencu (5)).
If this baseline positive control study does not yield the anticipated results the experimental conditions should be examined and modified.
Ako se pomoću studije osnovne pozitivne kontrole ne dobiju očekivani rezultati, potrebno je ispitati i izmijeniti eksperimentalne uvjete.
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Statistički značajno smanjenje mase dvaju ili više ciljnih organa u skupina tretiranih ispitivanom kemikalijom i TP-om u usporedbi s kontrolnom skupinom koja je primala samo TP upućuje na to da je ispitivana kemikalija pozitivna na potencijalno antiandrogeno djelovanje (vidjeti stavak 61.).
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For reproductive endpoints, it is envisaged that, as a first step and when available, information from repeat-dose studies (including screening reproductive toxicity studies, e.g. OECD TG 422 (32)), or short term endocrine disrupter screening assays, (e.g. Uterotrophic assay — test method B.54 (36); and Hershberger assay — test method B.55 (37)) is used to detect effects on reproductive organs for males and females.
Kod reproduktivnih krajnjih točaka za otkrivanje učinaka na reproduktivne organe u mužjaka i ženki predviđa se, kao prvi korak te prema dostupnosti, upotreba informacija iz studija s ponovljenim dozama (uključujući studije probira reproduktivne toksičnosti, npr. OECD-ova Smjernica za ispitivanje 422 (32)), ili kratkoročnih testova probira endokrinih disruptora (npr. uterotropni biotest – ispitna metoda B.54. (36) te Hershbergerova testa – ispitna metoda B.55. (37)).
This might include spermatogenesis (testicular histopathology) for males and oestrous cycles, follicle counts/oocyte maturation and ovarian integrity (histopathology) for females.
To može uključivati spermatogenezu (histopatologiju testisa) u mužjaka te cikluse estrusa, broj folikula/sazrijevanje jajnih stanica i integritet jajnika (histopatologiju) u ženki.
The Extended One-Generation Reproductive Toxicity Study then serves as a test for reproductive endpoints that require the interaction of males with females, females with conceptus, and females with offspring and the F1 generation until after sexual maturity (see OECD Guidance Document 151 supporting this test method (40)).
Produljena studija reproduktivne toksičnosti na jednoj generaciji tada služi kao test za reproduktivne krajnje točke za koje je potrebna interakcija mužjaka i ženki, ženki sa zamecima te ženki s potomcima i generacije F1 do završetka spolnog sazrijevanja (vidjeti OECD-ovu Smjernicu 151 kojom se potvrđuje ova ispitna metoda (40)).
Considerations should be given to the following characteristics if a vehicle or other additive is used to facilitate dosing: effects on the absorption, distribution, metabolism, or retention of the test chemical;
Ako se za doziranje upotrebljava nosač ili drugi aditiv, treba uzeti u obzir sljedeće karakteristike:
effects on the chemical properties of the test chemical that may alter its toxic characteristics; and effects on the food or water consumption or the nutritional status of the animals.
učinke na apsorpciju, distribuciju, metabolizam ili zadržavanje ispitivane kemikalije, učinke na kemijska svojstva ispitivane kemikalije koji mogu izmijeniti njezina toksična obilježja te učinke na unos hrane i vode ili nutritivni status životinja.
The duration of the pre-mating treatment in the Extended One-Generation Reproductive Toxicity Study is therefore aimed at the detection of effects on functional changes that may interfere with mating behaviour and fertilisation.
Trajanje tretmana prije parenja u ponovljenoj studiji reproduktivne toksičnosti na jednoj generaciji zato je usmjereno na otkrivanje učinaka na funkcionalne promjene koje mogu ometati ponašanje kod parenja i fertilizacije.
Systemic effects should be monitored in P animals.
U životinja P treba pratiti sustavne učinke.
Fasted blood samples from a defined site are taken from 10 randomly-selected P males and females per dose group at termination, stored under appropriate conditions and subjected to partial or full-scale haematology, clinical biochemistry, assay of T4 and TSH or other examinations suggested by the known effect profile of the test chemical (see OECD Guidance Document 151(40)).
Po usmrćenju s utvrđenog se mjesta uzimaju uzorci krvi deset nasumično odabranih mužjaka i ženki P po skupini za doziranje koji su postili, pohranjuju u odgovarajućim uvjetima i podvrgavaju djelomičnoj ili potpunoj hematologiji, kliničkoj biokemiji, testu T4 ili TSH ili drugim pregledima u skladu s poznatim profilom učinka ispitivane kemikalije (vidjeti OECD-ovu Smjernicu 151 (40)).
Full histopathology of the organs listed in paragraphs 62 and 63 is performed for all high-dose and control P animals.
Potpuna histopatologija organa navedenih u stavcima 62. i 63. obavlja se na svim životinjama P iz kontrolne skupine i skupine koja je primala visoku dozu.
Organs demonstrating treatment-related changes should also be examined in all animals at the lower dose groups to aid in determining a NOAEL.
Treba pregledati i organe svih životinja iz skupina koje su primale nižu dozu u kojih su uočene promjene povezane s tretmanom radi utvrđivanja vrijednosti kod kojih nisu uočeni štetni učinci.
Zoetis, T. and I. Walls (2003), Principles and Practices for Direct Dosing of Pre-Weaning Mammals in Toxicity Testing and Research, ILSI Press, Washington, DC.
Zoetis, T. and I. Walls (2003.), Principles and Practices for Direct Dosing of Pre-Weaning Mammals in Toxicity Testing and Research, ILSI Press, Washington, DC.
OECD (2013), Guidance Document supporting TG 443:
OECD (2013.), Guidance Document supporting TG 443: Extended One Generation Reproductive Toxicity Study, Series on Testing and Assessment, No.
The solubility of the test chemical, forskolin and prochloraz in the solvent; and
topljivost ispitivane kemikalije, forskolina i prokloraza u otapalu,
Unless prior information such as information on solubility limits or cytotoxicity provides a basis for selecting test concentrations, it is recommended that the test concentrations for the initial run be spaced at log10 intervals with 10–3 M being the maximum concentration.
Osim ako su ranije informacije poput informacija o graničnim vrijednostima topljivosti ili citotoksičnosti osnova za odabir ispitnih koncentracija, preporučuje se da se ispitne koncentracije za početni pokus rasporede u intervalima log10, pri čemu je 10-3 M najviša koncentracija.
If the chemical is soluble, and not cytotoxic at any of the tested concentrations, and the first run was negative for all concentrations, then it is to be confirmed in one more run using the same conditions as the first run was conducted (Table 7).
Ako je kemikalija topljiva i nije citotoskična ni kod jedne ispitne koncentracije te ako je prvi pokus bio negativan na sve koncentracije, tada to treba potvrditi u jednom pokusu ili više njih u uvjetima jednakima prvom pokusu (tablica 7.).
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Hecker, M., Hollert, H., Cooper, R., Vinggaard, A.-M., Akahori, Y., Murphy, M., Nellemann, C., Higley, E., Newsted, J., Wu, R., Lam, P., Laskey, J., Buckalew, A., Grund, S., Nakai, M., Timm, G., and Giesy, J. P. (2007.), The OECD validation program of the H295R steroidgenesis assay for the identification of in vitro inhibitors or inducers of testosterone and estradiol production, Phase 2:
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Dostupno na [http://www.oecd.org/document/30/0,3746,en_2649_34377_1916638_1_1_1_1,00.html].
Available at:
Dostupno na:
Battelle (2005), Detailed Review Paper on Steroidogenesis, Available at:
Battelle (2005.), Detailed Review Paper on Steroidogenesis, dostupno na:
Hilscherova, K., Jones, P. D., Gracia, T., Newsted, J. L., Zhang, X., Sanderson, J. T., Yu, R. M. K., Wu, R. S. S. and Giesy, J. P. (2004), Assessment of the Effects of Chemicals on the Expression of Ten Steroidogenic Genes in the H295R Cell Line Using Real-Time PCR, Toxicol.
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Sanderson, J. T., Boerma, J., Lansbergen, G. and Van den Berg, M. (2002.), Induction and inhibition of aromatase (CYP19) activity by various classes of pesticides in H295R human adrenocortical carcinoma cells, Toxicol.
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A suitable compromise for the measurement of mutant frequencies in both rapidly and slowly proliferating tissues is 28 consecutive daily treatments (as indicated in paragraph 26) and sampling three days after the final treatment; although the maximum mutant frequency may not manifest itself in slowly proliferating tissues under these conditions.
Odgovarajući kompromis za mjerenje učestalosti mutacija kod tkiva koja se razmnožavaju sporo, odnosno brzo, 28 je uzastopnih dnevnih tretmana (kako je navedeno u stavku 26.) i uzorkovanje tri dana nakon konačnog tretmana, iako se maksimalna učestalost mutacije može ne pokazati kod tkiva koja se sporo razmnožavaju u tim uvjetima.
G. Pfeifer (ed.), Technologies for Detection of DNA Damage and Mutations, Part II, Plenum Press, New York, NY, USA, pp. 391–410.
G. Pfeifer (ed.), Technologies for Detection of DNA Damage and Mutations, Part II, Plenum Press, New York, NY, USA, str. 391. – 410.
The evaluation consists of observations to detect gross neurologic and behavioural abnormalities, including the assessment of physical development, behavioural ontogeny, motor activity, motor and sensory function, and learning and memory; and the evaluation of brain weights and neuropathology during postnatal development and adulthood.
Vrednovanje se sastoji od opažanja radi otkrivanja velikih neuroloških abnormalnosti i abnormalnosti u ponašanju, uključujući procjenu fizičkog razvoja, bihevioralnu ontogenezu, motoričku aktivnost, motoričke i osjetilne funkcije te učenje i pamćenje te vrednovanja težine mozga i neuropatologije tijekom postnatalnog razvoja i u odrasloj dobi.
to identify types of neuropathological alterations resulting from exposure to the test chemical; and
utvrditi vrste neuropatoloških promjena koje su posljedica izloženosti ispitivanoj kemikaliji;
Guidance Document on Mammalian Reproductive Toxicity Testing and Assessment. Environment Directorate, OECD, Paris.
Guidance Document on Mammalian Reproductive Toxicity Testing and Assessment.
Qualitative and quantitative comparability of human and animal developmental neurotoxicity.
Qualitative and quantitative comparability of human and animal developmental neurotoxicity.
Neurotoxicology:
Neurotoxicology:
Effects of neonatal naltrexone on neurological and somatic development in rats of both genders.
Effects of neonatal naltrexone on neurological and somatic development in rats of both genders.
The rationale for culling of rodent litters.
The rationale for culling of rodent litters.
Foot tattoo of neonatal mice.
Foot tattoo of neonatal mice.
Ontogeny of Learning and Memory.
Ontogeny of Learning and Memory.
Perinatal Development:
Perinatal Development:
Stimulating research to improve the scientific basis of risk assessment.
Stimulating research to improve the scientific basis of risk assessment.
Concurrent use of behavioral/functional testing in existing reproductive and developmental toxicity screens:
Concurrent use of behavioral/functional testing in existing reproductive and developmental toxicity screens:
Interpreting the toxicologic significance of alterations in anogenital distance:
Interpreting the toxicologic significance of alterations in anogenital distance:
Jr., Ostby, J., Furr, J., Price, M., Veeramachaneni, D.N., Parks, L. (2000) Perinatal exposure to the phthalates DEHP, BBP, and DINP, but not DEP, DMP, or DOTP, alters sexual differentiation of the male rat.
Jr., Ostby, J., Furr, J., Price, M., Veeramachaneni, D.N., Parks, L. (2000.) Perinatal exposure to the phthalates DEHP, BBP, and DINP, but not DEP, DMP, or DOTP, alters sexual differentiation of the male rat.
Collaborative behavioral teratology study:
Collaborative behavioral teratology study:
Preputial separation as an external sign of pubertal development in the male rat.
Preputial separation as an external sign of pubertal development in the male rat.
Neurobehavioral assessment during the early postnatal period.
Neurobehavioral assessment during the early postnatal period.
Motor activity:
Motor activity:
Developmental neurotoxicity following neonatal exposure to 3,3'-iminodipropionitrile in the rat.
Developmental neurotoxicity following neonatal exposure to 3,3'-iminodipropionitrile in the rat.
Development of locomotor activity of rat pups in figure-eight mazes.
Development of locomotor activity of rat pups in figure-eight mazes.
Interlaboratory comparison of motor activity experiments:
Interlaboratory comparison of motor activity experiments:
Reflex modification and the assessment of sensory dysfunction.
Reflex modification and the assessment of sensory dysfunction.
Evaluation of sensory system function using reflex modification of the startle response.
Evaluation of sensory system function using reflex modification of the startle response.
Solvent-induced ototoxicity in rats:
Solvent-induced ototoxicity in rats:
Reflex modification as an objective test for sensory processing following toxicant exposure.
Reflex modification as an objective test for sensory processing following toxicant exposure.
Learning and memory deficits in rats following exposure to 3,3'-iminopropionitrile.
Learning and memory deficits in rats following exposure to 3,3'-iminopropionitrile.
Effects of delay, intertrial interval, delay behavior and trimethyltin on spatial delayed response in rats.
Effects of delay, intertrial interval, delay behavior and trimethyltin on spatial delayed response in rats.
Differential ontogeny of working memory and reference memory in the rat.
Differential ontogeny of working memory and reference memory in the rat.
Maze learning in rats:
Maze learning in rats:
Methods for detecting long-term CNS dysfunction after prenatal exposure to neurotoxins.
Methods for detecting long-term CNS dysfunction after prenatal exposure to neurotoxins.
Practical aspects of neuropathology:
Practical aspects of neuropathology:
Integrated evaluation of central nervous system lesions:
Integrated evaluation of central nervous system lesions:
Fluoro-Jade B:
Fluoro-Jade B:
Regulatory developmental neurotoxicity testing:
Regulatory developmental neurotoxicity testing:
Unbiased Stereology:
Unbiased Stereology:
Stereology:
Stereology:
Stereological methods for estimating the total number of neurons and synapses:
Stereological methods for estimating the total number of neurons and synapses:
Design-based stereology in neuroscience.
Design-based stereology in neuroscience.
Brain morphogenesis and developmental neurotoxicology.
Brain morphogenesis and developmental neurotoxicology.