Improving structure and transparency in reliability evaluations of data under REACH: suggestions for a systematic method

References

• ACC (American Chemistry Council). 2017. Personal Communication. February 2, 2017
   Google Scholar
• Ågerstrand M, Breitholtz M, and Rudén C. 2011. Comparison of four different methods for reliability evaluation of ecotoxicity data: a case study of non-standard test data used in environmental risk assessments of pharmaceutical substances. Environ Sci Europe 23:17
   Google Scholar
• Ballantyne B, Snellings WM, and Norris JC. 2006. Respiratory peripheral chemosensory irritation, acute and repeated exposure toxicity studies with aerosols of triethylene glycol. J Appl Toxicol 26:387–96
   PubMed Web of Science ®Google Scholar
• Barnes JM and Stoner HB. 1958. Toxic properties of some dialkyl and trialkyl tin salts. Brit J Industr Med 15:15–22
   PubMedGoogle Scholar
• Beronius A and Ågerstrand M. 2017. Making the most of expert judgment in hazard and risk assessment of chemicals. Toxicol Res 6:571–7
   Google Scholar
• Beronius A, Ågerstrand M, Ruden C, et al. 2017. SciRAP workshop report: Bridging the gap between academic research and chemicals regulation – the SciRAP tool for evaluating toxicity and ecotoxicity data for risk assessment of chemicals. Nordic Working Papers. Nordic Council of Ministers
   Google Scholar
• Beronius A, Molander L, Zilliacus J, et al. 2018. Testing and refining the Science in Risk Assessment and Policy (SciRAP) web‐based platform for evaluating the reliability and relevance of in vivo toxicity studies. J Appl Toxicol. DOI: 10.1002/jat.3648
   Google Scholar
• BfR (Bundesinstitut für Risikobewertung). 2015. REACH Compliance: data availability of REACH registrations. Part 1: Screening of chemicals >1000 tpa. Texte 43/2015. Environmental Research of the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety.
   Google Scholar
• Colerangle JB and Roy D. 1996. Exposure of environmental estrogenic compound nonlyphenol to noble rats alters cell-cycle kinetics in the mammary gland. Endocrine 4:115–22
   PubMed Web of Science ®Google Scholar
• Condie LW, Hill JR, and Borzelleca JF. 1988. Oral toxicology studies with xylene isomers and mixed xylenes Drug Chem Toxicol 11:329–54
   PubMed Web of Science ®Google Scholar
• Cranch AG, Smyth HF, and Carpenter CP. 1942. External contact with monoethyl ether of diethylene glycol (carbitol solvent). Arch Dermatol Syph 45:553–9
   Google Scholar
• Crocker JFS, Safe SH, and Acott P. 1988. Effects of chronic phthalate exposure on the kidney. J Toxicol Environ Health 23:433–44
   PubMed Web of Science ®Google Scholar
• Detwiler-Okabayashi KA and Schaper MM. 1996. Respiratory effects of a synthetic metalworking fluid and its components. Arch Toxicol 70:195–201
   PubMed Web of Science ®Google Scholar
• EC (European Commission). 2018. European Commission > EU Science Hub > EURL ECVAM > About EURL ECVAM > Archive of Publications > ToxRTool: ToxRTool – Toxicological data Reliability Assessment Tool. https://eurl-ecvam.jrc.ec.europa.eu/about-ecvam/archive-publications/toxrtool. February 13, 2018
   Google Scholar
• ECHA (European Chemicals Agency). 2011. Guidance on Information Requirements and Chemical Safety Assessment. Chapter R.4: Evaluation of Available Information. Version 1.1. https://echa.europa.eu/guidance-documents/guidance-on-reach
   Google Scholar
• ECHA (European Chemicals Agency). 2012a. Guidance on Registration. Guidance for the Implementation of REACH. Version 2.0. https://echa.europa.eu/guidance-documents/guidance-on-reach
   Google Scholar
• ECHA (European Chemicals Agency). 2012b. Practical Guide 3: How to Report Robust Study Summaries. Version 2.0. https://echa.europa.eu/practical-guides
   Google Scholar
• ECHA (European Chemicals Agency). 2013. IUCLID 5. End-user Manual. https://iuclid6.echa.europa.eu/archive-iuclid-5
   Google Scholar
• ECHA (European Chemicals Agency). 2018. REACH Registration Database. https://echa.europa.eu/sv/information-on-chemicals/registered-substances. Accessed: June 7, 2018
   Google Scholar
• Fairhurst S, Knight R, Marrs TC, et al. 1989. Percutaneous toxicity of ethylene-glycol monomethyl ether and of dipropylene glycol monomethyl ether in the rat. Toxicology 57:209–15
   PubMed Web of Science ®Google Scholar
• Gaunt IF, Colley J, Grasso P, et al. 1968. Acute and short-term toxicity studies on di-n-butyltin dichloride in rats. Food Cosmet Toxicol 6:599–608
   PubMedGoogle Scholar
• Goldberg ME, Johnson HE, Pozzani UC, et al. 1964. Effect of repeated inhalation of vapors of industrial solvents on animal behavior. I. Evaluation of nine solvent vapors on pole-climb performance in rats. Am Indust Hygiene Assoc J 25:369–75
   PubMedGoogle Scholar
• Hoffmann S, de Vries RBM, Stephens ML, et al. 2017. A primer on systematic reviews in toxicology. Arch Toxicol 91:2551–75
   PubMed Web of Science ®Google Scholar
• Ingre-Khans E, Agerstrand M, Beronius A, et al. 2016. Transparency of chemical risk assessment data under REACH. Environ Sci-Process Impacts 18:1508–18
   PubMed Web of Science ®Google Scholar
• Ingre-Khans E, Ågerstrand M, Beronius A, Rudén C. 2018. Reliability and relevance evaluations of REACH data. Unpublished manuscript.
   Google Scholar
• Innis JD and Nixon GA. 1988. No evidence of toxicity associated with subchronic dermal exposure of rabbits to butoxypropanol. Toxicologist 8:213
   Google Scholar
• Kase R, Korkaric M, Werner I, et al. 2016. Criteria for Reporting and Evaluating ecotoxicity Data (CRED): comparison and perception of the Klimisch and CRED methods for evaluating reliability and relevance of ecotoxicity studies. Environ Sci Europe 28:7
   PubMed Web of Science ®Google Scholar
• Klimisch HJ, Andreae M, and Tillmann U. 1997. A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Regul Toxicol Pharmacol 25:1–5
   PubMed Web of Science ®Google Scholar
• Lake BG, Gray TJB, Foster JR, et al. 1983. Comparative studies on di-(2-ethylhexyl) phthalate-induced hepatic peroxisome proliferation in the rat and hamster. Toxicol Appl Pharmacol 72:46–60
   Web of Science ®Google Scholar
• Leber AP, Scott RC, Hodge MCE, et al. 1990. Triethylene glycol ethers: evaluations of in vitro absorption through human epidermis, 21-day dermal toxicity in rabbits, and a developmental toxicity screen in rats. J Am College Toxicol 9:507–15
   Google Scholar
• Loeser E and Lorke D. 1976a. Semichronic oral toxicity of cadmium. I. Studies on rats. Toxicology 7:215–24
   Web of Science ®Google Scholar
• Loeser E and Lorke D. 1976b. Semichronic oral toxicity of cadmium. 2. Studies on dogs. Toxicology 7:225–32
   Web of Science ®Google Scholar
• Maltoni C, Lefermine G, and Cotti G. 1986. Experimental research on trichloroethylene carcinogenesis. In: Maltoni C and Mehlman M (eds), Archives of Research on Industrial Carcinogenesis, Vol 5, pp 1–393. Princeton Scientific, Princeton, NJ
   Google Scholar
• Moermond CTA, Kase R, Korkaric M, et al. 2016. CRED: criteria for reporting and evaluating ecotoxicity data. Environ Toxicol Chem 35:1297–309
   PubMed Web of Science ®Google Scholar
• Molander L, Ågerstrand M, Beronius A, et al. 2015. Science in Risk Assessment and Policy (SciRAP) – an online resource for evaluating and reporting in vivo (eco) toxicity studies. Hum Ecol Risk Assess 21: 753–62
   Web of Science ®Google Scholar
• OECD (Organization for Economic Co-operation and Development). 1981a. OECD Test Guideline No. 410. Repeated Dose Dermal Toxicity: 21/28-Day Study. http://www.oecd.org/chemicalsafety/testing/oecdguidelinesforthetestingofchemicals.htm
   Google Scholar
• OECD (Organization for Economic Co-operation and Development). 1981b. OECD Test Guideline No. 411. Subchronic Dermal Toxicity: 90-Day Study. http://www.oecd.org/chemicalsafety/testing/oecdguidelinesforthetestingofchemicals.htm
   Google Scholar
• OECD (Organization for Economic Co-operation and Development). 1998a. OECD Test Guideline No. 408. Repeated Dose 90-Day Oral Toxicity Study in Rodents. http://www.oecd.org/chemicalsafety/testing/oecdguidelinesforthetestingofchemicals.htm
   Google Scholar
• OECD (Organization for Economic Co-operation and Development). 1998b. OECD Test Guideline No. 409. Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents. http://www.oecd.org/chemicalsafety/testing/oecdguidelinesforthetestingofchemicals.htm
   Google Scholar
• OECD (Organization for Economic Co-operation and Development). 2002. OECD Series on Testing and Assessment Number 32 and OECD Series on Pesticides Number 10. Guidance Notes for Analysis and Evaluation of Repeat-Dose-Toxicity Studies. ENV/JM/MONO(2000)18. http://www.oecd.org/chemicalsafety/pesticides-biocides/pesticides-publications-chronological-order.htm
   Google Scholar
• OECD (Organization for Economic Co-operation and Development). 2008. OECD Test Guideline No. 407. Repeated Dose 28-Day Oral Toxicity Study in Rodents. http://www.oecd.org/chemicalsafety/testing/oecdguidelinesforthetestingofchemicals.htm
   Google Scholar
• OECD (Organization for Economic Co-operation and Development). 2009a. OECD Test Guideline No. 403. Acute Inhalation Toxicity. http://www.oecd.org/chemicalsafety/testing/oecdguidelinesforthetestingofchemicals.htm
   Google Scholar
• OECD (Organization for Economic Co-operation and Development). 2009b. OECD Test Guideline No. 412. Subacute Inhalation Toxicity: 28-Day Study. http://www.oecd.org/chemicalsafety/testing/oecdguidelinesforthetestingofchemicals.htm
   Google Scholar
• OECD (Organization for Economic Co-operation and Development). 2009c. OECD Test Guideline No. 452. Chronic Toxicity Studies. http://www.oecd.org/chemicalsafety/testing/oecdguidelinesforthetestingofchemicals.htm
   Google Scholar
• OECD (Organization for Economic Co-operation and Development). 2009d. Series on Testing and Assessment. Number 39. Guidance Document on Acute Inhalation Toxicity Testing. ENV/JM/MONO(2009)28. http://www.oecd.org/chemicalsafety/testing/seriesontestingandassessmenttestingforhumanhealth.htm
   Google Scholar
• OECD (Organization for Economic Co-operation and Development). 2012. OECD Test Guideline No. 211. Daphnia magna Reproduction Test. http://www.oecd.org/chemicalsafety/testing/oecdguidelinesforthetestingofchemicals.htm
   Google Scholar
• OECD (Organization for Economic Co-operation and Development). 2013. OECD Test Guideline No. 236. Fish Embryo Acute Toxicity (FET) Test. http://www.oecd.org/chemicalsafety/testing/oecdguidelinesforthetestingofchemicals.htm
   Google Scholar
• OECD (Organization for Economic Co-operation and Development). 2016. OECD Template #67: Repeated dose Toxicity: Oral (Version 5.17-April 2016). https://www.oecd.org/ehs/templates/
   Google Scholar
• OHAT (Office of Health Assessment and Translation). 2015. Handbook for Conducting a Literature-Based Health Assessment Using OHAT Approach for Systematic Review and Evidence Integration. Office of Health Assessment and Translation (OHAT). Division of the National Toxicology Program. National Institute of Environmental Health Sciences
   Google Scholar
• Penninks AH and Seinen W. 1982. Comparative toxicity of alkyltin and estertin stabilizers. Food Chem Toxicol 20:909–16
   PubMed Web of Science ®Google Scholar
• REACH. (2006). Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 Dec 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, 2006 OJ L 396/1
   Google Scholar
• Roth N and Ciffroy P. 2016. A critical review of frameworks used for evaluating reliability and relevance of (eco)toxicity data: perspectives for an integrated eco-human decision-making framework. Environ Int 95:16–29
   PubMed Web of Science ®Google Scholar
• Roy D. 2017. Personal communication. September 19, 2017
   Google Scholar
• Rudén C. 2002. From Data to Decision. A Case Study of Controversies in Cancer Risk Assessment. Karolinska Institute, Karolinska University Press, Stockholm, Sweden
   Google Scholar
• Rudén C, Adams J, Ågerstrand M, et al. 2017. Assessing the relevance of ecotoxicological studies for regulatory decision making. Integr Environ Assess Manag 13:652–63
   PubMed Web of Science ®Google Scholar
• Samuel GO, Hoffmann S, Wright RA, et al. 2016. Guidance on assessing the methodological and reporting quality of toxicologically relevant studies: a scoping review. Environ Int 92–93:630–46
   PubMed Web of Science ®Google Scholar
• SCENIHR (Scientific Committee on Emerging and Newly Identified Helath Risks). 2012. Memorandum on the use of the scientific literature for human health risk assessment purposes – weighing of evidence and expression of uncertainty
   Google Scholar
• Schneider K, Schwarz M, Burkholder I, et al. 2009. "ToxRTool", a new tool to assess the reliability of toxicological data. Toxicol Lett 189: 138–44
   PubMed Web of Science ®Google Scholar
• SciRAP (Science in Risk Assessment and Policy). 2017a. Evaluation of in vivo toxicity studies. http://www.scirap.org/Page/Index/a0130706-adce-45e0-83aa-64516c855fda/evaluate-reliability-relevance. October 31, 2017
   Google Scholar
• SciRAP (Science in Risk Assessment and Policy). 2017b. SciRAP criteria and guidance for assessing methodological quality of in vivo toxicity studies. http://www.scirap.org/Upload/Documents/SciRAP%20critera%20for%20methodologial%20quality%20-%20with%20guidance_ver170428.pdf. October 31, 2017
   Google Scholar
• SciRAP (Science in Risk Assessment and Policy). 2018. Development of SciRAP. http://www.scirap.org/Page/Index/ef39c65b-815d-4ba9-8e63-e85748e720ae/development-of-scirap. March 21, 2018
   Google Scholar
• van der Ven LTM, Verhoef A, van de Kuil T, et al. 2006. A 28-day oral dose toxicity study enhanced to detect endocrine effects of hexabromocyclododecane in wistar rats. Toxicol Sci 94:281–92
   PubMed Web of Science ®Google Scholar
• Vandenberg LN, Ågerstrand M, Beronius A, et al. 2016. A proposed framework for the systematic review and integrated assessment (SYRINA) of endocrine disrupting chemicals. Environ Health 15:1–19
   PubMed Web of Science ®Google Scholar
• Wandall B. 2004. Values in science and risk assessment. Toxicol Lett 152:265–72
   PubMed Web of Science ®Google Scholar
• Wandall B, Hansson SO and Rudén C 2007. Bias in toxicology. Arch Toxicol 81: 605–17
   PubMed Web of Science ®Google Scholar
• Whaley P, Halsall C, Ågerstrand M, et al. 2016. Implementing systematic review techniques in chemical risk assessment: challenges, opportunities and recommendations. Environ Int 92:556–64
   PubMed Web of Science ®Google Scholar
• Whelton BD, Peterson DP, Moretti ES, et al. 1997. Skeletal changes in multiparous, nulliparous and ovariectomized mice fed either a nutrient-sufficient or -deficient diet containing cadmium. Toxicology 119:103–21
   PubMed Web of Science ®Google Scholar
• WHO/UNEP. 2013. State of the Science of Endocrine Disrupting Chemicals – 2012. http://www.who.int/ceh/publications/endocrine/en/
   Google Scholar
• Zissu D. 1995. Histopathological changes in the respiratory tract of mice exposed to ten families of airborne chemicals. J Appl Toxicol 15:207–13
   PubMed Web of Science ®Google Scholar