Pub Date : 2018-09-03DOI: 10.1787/9789264304741-35-en
{"title":"Non-OECD mammalian screens and tests (Concptual Framework Levels 3-5)","authors":"","doi":"10.1787/9789264304741-35-en","DOIUrl":"https://doi.org/10.1787/9789264304741-35-en","url":null,"abstract":"","PeriodicalId":19458,"journal":{"name":"OECD Series on Testing and Assessment","volume":"49 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82214269","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-09-03DOI: 10.1787/9789264304741-31-en
Subchronic
902. This assay determines the subchronic inhalation toxicity of chemicals to provide robust data for quantitative inhalational hazard identification/characterisation. It is primarily used to derive regulatory concentrations for assessing worker risk in occupation settings. It is also used to assess human residential, transportation and environmental risk. Dosing duration is 90 days and the preferred species is the rat. Animals are exposed to test substance in inhalation chambers for six hours per day on a five day per week basis. The preferred mode of exposure is nose only, but whole body exposure may also be used. OECD TG 413 was first adopted in May 1981 and revised in September 2009. Although it has not been validated for the detection of endocrine active substances (EASs), this assay contains several endpoints that are suitable for the determination of endocrine effects. As all the endpoints are apical, it is difficult to discern mechanism of action from this test alone. Information on mechanism of action may need to be obtained from in vitro estrogen/androgen/thyroid/steroidogenesis (E,A,T,S) assays or in vivo lower tier tests such as the Uterotrophic Bioassay (UT – OECD TG 440) and the Hershberger Bioassay (H – OECD TG 441). Hormone measurements are not included in this assay.
{"title":"Subchronic Inhalation Toxicity: 90-Day Study (OECD TG 413)","authors":"Subchronic","doi":"10.1787/9789264304741-31-en","DOIUrl":"https://doi.org/10.1787/9789264304741-31-en","url":null,"abstract":"902. This assay determines the subchronic inhalation toxicity of chemicals to provide robust data for quantitative inhalational hazard identification/characterisation. It is primarily used to derive regulatory concentrations for assessing worker risk in occupation settings. It is also used to assess human residential, transportation and environmental risk. Dosing duration is 90 days and the preferred species is the rat. Animals are exposed to test substance in inhalation chambers for six hours per day on a five day per week basis. The preferred mode of exposure is nose only, but whole body exposure may also be used. OECD TG 413 was first adopted in May 1981 and revised in September 2009. Although it has not been validated for the detection of endocrine active substances (EASs), this assay contains several endpoints that are suitable for the determination of endocrine effects. As all the endpoints are apical, it is difficult to discern mechanism of action from this test alone. Information on mechanism of action may need to be obtained from in vitro estrogen/androgen/thyroid/steroidogenesis (E,A,T,S) assays or in vivo lower tier tests such as the Uterotrophic Bioassay (UT – OECD TG 440) and the Hershberger Bioassay (H – OECD TG 441). Hormone measurements are not included in this assay.","PeriodicalId":19458,"journal":{"name":"OECD Series on Testing and Assessment","volume":"2 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82518327","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-09-03DOI: 10.1787/9789264304741-28-en
Tg
842. This assay determines the subchronic dermal toxicity of chemicals after initial information on toxicity has been obtained by acute testing. It provides information on possible health hazards likely to arise from repeated exposure by the dermal route over a limited period of time. Dosing duration is 28 days and the preferred species are the adult rat, rabbit or guinea pig. Test substance is applied to the dorsal area of the trunk, held in place with a dressing and protected from ingestion. OECD TG 410 was adopted in May 1981. Although it has not been validated for the detection of endocrine active substances (EASs), this assay may contain endpoints that are suitable for the determination of endocrine effects. It should be noted that the only endocrine-relevant tissues that are required are testes and adrenals, therefore the information provided may be very limited. Other tissues may be taken as required and therefore the utility of this assay for detecting EASs will vary on a case-to-case basis. As all the endpoints are apical, it is difficult to discern mechanism of action from this test alone. Information on mechanism of action needs to be obtained from in vitro estrogen/androgen/thyroid/steroidogenesis (E,A,T,S) assays or in vivo lower tier tests such as the Uterotrophic Bioassay (UT – OECD TG 440) and the Hershberger Bioassay (H – OECD TG 441). Hormone measurements are not included in this assay.
{"title":"Repeated Dose Dermal Toxicity: 21/28-Day Study (OECD TG 410)","authors":"Tg","doi":"10.1787/9789264304741-28-en","DOIUrl":"https://doi.org/10.1787/9789264304741-28-en","url":null,"abstract":"842. This assay determines the subchronic dermal toxicity of chemicals after initial information on toxicity has been obtained by acute testing. It provides information on possible health hazards likely to arise from repeated exposure by the dermal route over a limited period of time. Dosing duration is 28 days and the preferred species are the adult rat, rabbit or guinea pig. Test substance is applied to the dorsal area of the trunk, held in place with a dressing and protected from ingestion. OECD TG 410 was adopted in May 1981. Although it has not been validated for the detection of endocrine active substances (EASs), this assay may contain endpoints that are suitable for the determination of endocrine effects. It should be noted that the only endocrine-relevant tissues that are required are testes and adrenals, therefore the information provided may be very limited. Other tissues may be taken as required and therefore the utility of this assay for detecting EASs will vary on a case-to-case basis. As all the endpoints are apical, it is difficult to discern mechanism of action from this test alone. Information on mechanism of action needs to be obtained from in vitro estrogen/androgen/thyroid/steroidogenesis (E,A,T,S) assays or in vivo lower tier tests such as the Uterotrophic Bioassay (UT – OECD TG 440) and the Hershberger Bioassay (H – OECD TG 441). Hormone measurements are not included in this assay.","PeriodicalId":19458,"journal":{"name":"OECD Series on Testing and Assessment","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83617186","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-09-03DOI: 10.1787/9789264304741-17-en
Tg
452. Modality detected/endpoints: This long-term in vivo assay with the dipteran insect Chironomus spp. is responsive to juvenile hormone (JH) (ant)agonists and ecdysteroid (Ec) (ant)agonists which can interfere with such processes as metamorphosis, moulting, growth and reproduction. It exposes the test organisms over two generations. It is important to note, however, that none of the endpoints in this apical test are specifically responsive to JHor Ec-active chemicals, and the assay will give positive results with many other substances. The lack of internationally validated mechanistic assays for endocrine activity in insects may prevent firm conclusions about whether test chemicals are endocrine dusruptors (EDs) in this taxon, although in vitro assays for JH and Ec activity are available in the literature. However, the data from the test may nevertheless be of value for classification and hazard identification/characterisation.
{"title":"Sediment-Water Chironomid Life-Cycle Toxicity Test (OECD TG 233)","authors":"Tg","doi":"10.1787/9789264304741-17-en","DOIUrl":"https://doi.org/10.1787/9789264304741-17-en","url":null,"abstract":"452. Modality detected/endpoints: This long-term in vivo assay with the dipteran insect Chironomus spp. is responsive to juvenile hormone (JH) (ant)agonists and ecdysteroid (Ec) (ant)agonists which can interfere with such processes as metamorphosis, moulting, growth and reproduction. It exposes the test organisms over two generations. It is important to note, however, that none of the endpoints in this apical test are specifically responsive to JHor Ec-active chemicals, and the assay will give positive results with many other substances. The lack of internationally validated mechanistic assays for endocrine activity in insects may prevent firm conclusions about whether test chemicals are endocrine dusruptors (EDs) in this taxon, although in vitro assays for JH and Ec activity are available in the literature. However, the data from the test may nevertheless be of value for classification and hazard identification/characterisation.","PeriodicalId":19458,"journal":{"name":"OECD Series on Testing and Assessment","volume":"87 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77569821","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-09-03DOI: 10.1787/9789264304741-32-en
Tg
922. This assay determines the general toxicity of chemicals in non-rodents after 90 days of oral dosing (by gavage, via the diet, in drinking water or in capsules). The most commonly used non-rodent species is the dog, which should be of a defined breed (beagle usually). It provides information on major toxic effects and target organ toxicity likely to arise from the post-weaning period until well into adulthood. OECD TG 409 was adopted in September 1981 and revised in September 1998.
{"title":"Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents (OECD TG 409)","authors":"Tg","doi":"10.1787/9789264304741-32-en","DOIUrl":"https://doi.org/10.1787/9789264304741-32-en","url":null,"abstract":"922. This assay determines the general toxicity of chemicals in non-rodents after 90 days of oral dosing (by gavage, via the diet, in drinking water or in capsules). The most commonly used non-rodent species is the dog, which should be of a defined breed (beagle usually). It provides information on major toxic effects and target organ toxicity likely to arise from the post-weaning period until well into adulthood. OECD TG 409 was adopted in September 1981 and revised in September 1998.","PeriodicalId":19458,"journal":{"name":"OECD Series on Testing and Assessment","volume":"161 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74198030","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-09-03DOI: 10.1787/9789264304741-3-en
{"title":"Introduction to specific guidelines","authors":"","doi":"10.1787/9789264304741-3-en","DOIUrl":"https://doi.org/10.1787/9789264304741-3-en","url":null,"abstract":"","PeriodicalId":19458,"journal":{"name":"OECD Series on Testing and Assessment","volume":"200 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76042392","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Specific guidance for the test guidelines addressed","authors":"","doi":"10.1787/g27e118db3-en","DOIUrl":"https://doi.org/10.1787/g27e118db3-en","url":null,"abstract":"","PeriodicalId":19458,"journal":{"name":"OECD Series on Testing and Assessment","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88744661","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-09-03DOI: 10.1787/9789264304741-26-en
Tg
795. The OECD Prenatal Developmental Toxicity Study is an apical assay designed to provide general information concerning the effects of prenatal exposure to a chemical on the pregnant test animal and on the developing organism. This may include assessment of maternal effects as well as death, structural abnormalities or altered growth in the foetus. The primary purpose of this study is to provide data on adverse effects related to development. The current version of the guideline was adopted in January 2001. Previous versions of this test guideline (TG) had a less extensive exposure period and fewer endpoints. The study was not designed to detect endocrine active substances (EASs), but has some endpoints relevant for the assessment of possible endocrine disruption and is currently being updated to include more. Following a feasibility study (OECD, 2015), this assay was updated in July 2018 to include some endocrine-relevant endpoints as the exposure periods cover some of the sensitive periods during development (prenatal period). It should be noted that if an assay was conducted before 2018, it is unlikely to include these extra endpoints.
{"title":"Prenatal Developmental Toxicity Study (OECD TG 414)","authors":"Tg","doi":"10.1787/9789264304741-26-en","DOIUrl":"https://doi.org/10.1787/9789264304741-26-en","url":null,"abstract":"795. The OECD Prenatal Developmental Toxicity Study is an apical assay designed to provide general information concerning the effects of prenatal exposure to a chemical on the pregnant test animal and on the developing organism. This may include assessment of maternal effects as well as death, structural abnormalities or altered growth in the foetus. The primary purpose of this study is to provide data on adverse effects related to development. The current version of the guideline was adopted in January 2001. Previous versions of this test guideline (TG) had a less extensive exposure period and fewer endpoints. The study was not designed to detect endocrine active substances (EASs), but has some endpoints relevant for the assessment of possible endocrine disruption and is currently being updated to include more. Following a feasibility study (OECD, 2015), this assay was updated in July 2018 to include some endocrine-relevant endpoints as the exposure periods cover some of the sensitive periods during development (prenatal period). It should be noted that if an assay was conducted before 2018, it is unlikely to include these extra endpoints.","PeriodicalId":19458,"journal":{"name":"OECD Series on Testing and Assessment","volume":"6 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87181009","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-09-03DOI: 10.1787/9789264304741-10-en
Tg
343. Modality detected/endpoints: This medium-term reproduction in vivo assay with the sexually reproducing pulmonate pond snail Lymnaea stagnalis is expected to be responsive to endocrine disrupters of reproduction in molluscs including inter alia to retinoid X receptor (RXR) (ant)agonists. It exposes the test organisms for less than a whole generation. It is important to note, however, that none of the endpoints in this apical test are specifically responsive to endocrine-active chemicals, and the assay will give positive results with many other substances. The lack of mechanistic assays for endocrine activity in molluscs will prevent firm conclusions about whether test chemicals are endocrine disrupters (EDs) in this taxon, but the data from the test may nevertheless be of value for classification and hazard identification/characterisation.
{"title":"Lymnaea stagnalis Reproduction Test (OECD TG 243)","authors":"Tg","doi":"10.1787/9789264304741-10-en","DOIUrl":"https://doi.org/10.1787/9789264304741-10-en","url":null,"abstract":"343. Modality detected/endpoints: This medium-term reproduction in vivo assay with the sexually reproducing pulmonate pond snail Lymnaea stagnalis is expected to be responsive to endocrine disrupters of reproduction in molluscs including inter alia to retinoid X receptor (RXR) (ant)agonists. It exposes the test organisms for less than a whole generation. It is important to note, however, that none of the endpoints in this apical test are specifically responsive to endocrine-active chemicals, and the assay will give positive results with many other substances. The lack of mechanistic assays for endocrine activity in molluscs will prevent firm conclusions about whether test chemicals are endocrine disrupters (EDs) in this taxon, but the data from the test may nevertheless be of value for classification and hazard identification/characterisation.","PeriodicalId":19458,"journal":{"name":"OECD Series on Testing and Assessment","volume":"39 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74917231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2018-09-03DOI: 10.1787/9789264304741-23-en
Tg
724. This assay determines the general toxicity of chemicals in rodents after 90 days of oral dosing (by gavage, via the diet or in drinking water). The rat is the preferred species. It provides information on major toxic effects and target organ toxicity likely to arise from the post-weaning period until well into adulthood. OECD TG 408 was adopted in September 1998 and was updated in 2017 to add endocrine disrupter relevant endpoints intended to improve the detection of endocrine activity of test chemicals and mirrors updates to OECD TG 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents). In the updated version, an emphasis was placed on including additional thyroid parameters that could inform, alone or in combination with other information, on the potential of test chemicals to perturb the thyroid pathway. The update mirrored that of OECD TG 407 and therefore a comparison can be made with validation of the OECD TG 407 (28-Day Oral Toxicity Study) for endocrine endpoints where substances that were moderate and strong endocrine disruptors (EDs) for (anti)estrogenicity and (anti)androgenicity (e.g. ethinylestradiol and flutamide) and weak and strong modulators of thyroid hormone-related effects (e.g. propylthiouracil, T4 and methyl testosterone) were detected (OECD, 2006). Steroidogenesis inhibition was also detected, although only one (potent) chemical was used in the validation study (CGS 18320B). OECD TG 408 is likely to be more sensitive than OECD TG 407 because of the extended dosing period and the larger number of animals per group (ten male and ten female per group compared with five in OECD TG 407).
{"title":"Repeated Dose 90-Day Oral Toxicity Study in Rodents (OECD TG 408)","authors":"Tg","doi":"10.1787/9789264304741-23-en","DOIUrl":"https://doi.org/10.1787/9789264304741-23-en","url":null,"abstract":"724. This assay determines the general toxicity of chemicals in rodents after 90 days of oral dosing (by gavage, via the diet or in drinking water). The rat is the preferred species. It provides information on major toxic effects and target organ toxicity likely to arise from the post-weaning period until well into adulthood. OECD TG 408 was adopted in September 1998 and was updated in 2017 to add endocrine disrupter relevant endpoints intended to improve the detection of endocrine activity of test chemicals and mirrors updates to OECD TG 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents). In the updated version, an emphasis was placed on including additional thyroid parameters that could inform, alone or in combination with other information, on the potential of test chemicals to perturb the thyroid pathway. The update mirrored that of OECD TG 407 and therefore a comparison can be made with validation of the OECD TG 407 (28-Day Oral Toxicity Study) for endocrine endpoints where substances that were moderate and strong endocrine disruptors (EDs) for (anti)estrogenicity and (anti)androgenicity (e.g. ethinylestradiol and flutamide) and weak and strong modulators of thyroid hormone-related effects (e.g. propylthiouracil, T4 and methyl testosterone) were detected (OECD, 2006). Steroidogenesis inhibition was also detected, although only one (potent) chemical was used in the validation study (CGS 18320B). OECD TG 408 is likely to be more sensitive than OECD TG 407 because of the extended dosing period and the larger number of animals per group (ten male and ten female per group compared with five in OECD TG 407).","PeriodicalId":19458,"journal":{"name":"OECD Series on Testing and Assessment","volume":"79 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73521351","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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