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Volumn 69, Issue 3, 2014, Pages 320-332

The added value of the 90-day repeated dose oral toxicity test for industrial chemicals with a low (sub)acute toxicity profile in a high quality dataset

Author keywords

3Rs; Alternatives; Chemicals legislation; REACH; Repeated dose; Sub acute; Sub chronic

Indexed keywords

INDUSTRIAL CHEMICAL; PESTICIDE;

EID: 84904038335     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2014.04.008     Document Type: Article
Times cited : (13)

References (23)
  • 1
    • 58749111973 scopus 로고    scopus 로고
    • Estimation of acute oral toxicity using the No Observed Adverse Effect Level (NOAEL) from the 28day repeated dose toxicity studies in rats
    • Bulgheroni A., et al. Estimation of acute oral toxicity using the No Observed Adverse Effect Level (NOAEL) from the 28day repeated dose toxicity studies in rats. Regul. Toxicol. Pharmacol. 2009, 53:16-19.
    • (2009) Regul. Toxicol. Pharmacol. , vol.53 , pp. 16-19
    • Bulgheroni, A.1
  • 2
    • 79959495804 scopus 로고    scopus 로고
    • The value of acute toxicity studies to support the clinical management of overdose and poisoning: a cross-discipline consensus
    • Chapman K., et al. The value of acute toxicity studies to support the clinical management of overdose and poisoning: a cross-discipline consensus. Regul. Toxicol. Pharmacol. 2010, 58:354-359.
    • (2010) Regul. Toxicol. Pharmacol. , vol.58 , pp. 354-359
    • Chapman, K.1
  • 3
    • 73649130953 scopus 로고    scopus 로고
    • Acute toxicity testing of chemicals - opportunities to avoid redundant testing and use alternative approaches
    • Creton S., et al. Acute toxicity testing of chemicals - opportunities to avoid redundant testing and use alternative approaches. Crit. Rev. Toxicol. 2010, 40:50-83.
    • (2010) Crit. Rev. Toxicol. , vol.40 , pp. 50-83
    • Creton, S.1
  • 4
    • 84904059441 scopus 로고    scopus 로고
    • ECHA, 2011. Comments and contributions received from MSC participants following the UK proposal and analysis concerning 'Possibilities for waiving repeat dose studies for low-toxicity substances (ECHA/MSC-16/2011/002)'. ECHA/MSC-18/2011/001 (6 May 2011).
    • ECHA, 2011. Comments and contributions received from MSC participants following the UK proposal and analysis concerning 'Possibilities for waiving repeat dose studies for low-toxicity substances (ECHA/MSC-16/2011/002)'. ECHA/MSC-18/2011/001 (6 May 2011).
  • 5
    • 84904059436 scopus 로고    scopus 로고
    • ECHA, 2013. 2 923 more chemicals registered by industry under REACH. ECHA/PR/13/23, Helsinki (03 June 2013).
    • ECHA, 2013. 2 923 more chemicals registered by industry under REACH. ECHA/PR/13/23, Helsinki (03 June 2013).
  • 6
    • 66449091911 scopus 로고    scopus 로고
    • Testing costs and testing capacity according to the REACH requirements - results of a survey of independent and corporate GLP laboratories in the EU and Switzerland
    • Fleischer M. Testing costs and testing capacity according to the REACH requirements - results of a survey of independent and corporate GLP laboratories in the EU and Switzerland. J. Bus. Chem. 2007, 4:96-114.
    • (2007) J. Bus. Chem. , vol.4 , pp. 96-114
    • Fleischer, M.1
  • 7
    • 79958250200 scopus 로고    scopus 로고
    • Evaluation of carcinogenicity studies of medicinal products for human use authorised via the European centralised procedure (1995-2009)
    • Friedrich A., Olejniczak K. Evaluation of carcinogenicity studies of medicinal products for human use authorised via the European centralised procedure (1995-2009). Regul. Toxicol. Pharmacol. 2011, 60:225-248.
    • (2011) Regul. Toxicol. Pharmacol. , vol.60 , pp. 225-248
    • Friedrich, A.1    Olejniczak, K.2
  • 8
    • 84904059431 scopus 로고    scopus 로고
    • HSE, 2011. A Weight-of-Evidence Approach for Justifying the Waiving the 90-Day Repeat Dose Toxicity Test under REACH. ECHA/MSC-16/2011/002. Helsinki (19 January 2011).
    • HSE, 2011. A Weight-of-Evidence Approach for Justifying the Waiving the 90-Day Repeat Dose Toxicity Test under REACH. ECHA/MSC-16/2011/002. Helsinki (19 January 2011).
  • 9
    • 34447265983 scopus 로고    scopus 로고
    • A retrospective analysis of the two-generation study: what is the added value of the second generation?
    • Janer G., et al. A retrospective analysis of the two-generation study: what is the added value of the second generation?. Reprod. Toxicol. 2007, 24:97-102.
    • (2007) Reprod. Toxicol. , vol.24 , pp. 97-102
    • Janer, G.1
  • 10
    • 0031080387 scopus 로고    scopus 로고
    • A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data
    • Klimisch H.J., et al. A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Regul. Toxicol. Pharmacol. 1997, 25:1-5.
    • (1997) Regul. Toxicol. Pharmacol. , vol.25 , pp. 1-5
    • Klimisch, H.J.1
  • 11
    • 0033068088 scopus 로고    scopus 로고
    • Comparing and evaluating alternative (in vitro) tests on their ability to predict the Draize maximum average score
    • Lordo R.A., et al. Comparing and evaluating alternative (in vitro) tests on their ability to predict the Draize maximum average score. Toxicol. In Vitro 1999, 13:45-72.
    • (1999) Toxicol. In Vitro , vol.13 , pp. 45-72
    • Lordo, R.A.1
  • 12
    • 84904059432 scopus 로고    scopus 로고
    • OECD, 1995. Reproduction/Developmental Toxicity Screening Test, Test Guideline No. 421. OECD Guidelines for the Testing of Chemicals, OECD, Paris (adopted: 27 July 1995).
    • OECD, 1995. Reproduction/Developmental Toxicity Screening Test, Test Guideline No. 421. OECD Guidelines for the Testing of Chemicals, OECD, Paris (adopted: 27 July 1995).
  • 13
    • 84904059433 scopus 로고    scopus 로고
    • OECD, 1996. Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, Test Guideline No. 422. OECD Guidelines for the Testing of Chemicals, OECD, Paris (adopted: 22 March 1996).
    • OECD, 1996. Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, Test Guideline No. 422. OECD Guidelines for the Testing of Chemicals, OECD, Paris (adopted: 22 March 1996).
  • 14
    • 84904059434 scopus 로고    scopus 로고
    • OECD, 1998. Repeated Dose 90-Day Oral Toxicity Study in Rodents, Test Guideline No. 408. OECD Guidelines for the Testing of Chemicals, OECD, Paris (adopted: 21 September 1998).
    • OECD, 1998. Repeated Dose 90-Day Oral Toxicity Study in Rodents, Test Guideline No. 408. OECD Guidelines for the Testing of Chemicals, OECD, Paris (adopted: 21 September 1998).
  • 15
    • 84904059435 scopus 로고    scopus 로고
    • OECD, 2004. Skin Absorption. In Vitro Method, Test Guideline No. 428, OECD Guidelines for the Testing of Chemicals. OECD, Paris (adopted: 3 November 2004).
    • OECD, 2004. Skin Absorption. In Vitro Method, Test Guideline No. 428, OECD Guidelines for the Testing of Chemicals. OECD, Paris (adopted: 3 November 2004).
  • 16
    • 84904059427 scopus 로고    scopus 로고
    • OECD, 2005. Guidance Document on the Validation and International Acceptance of New or Updated Test Methods for Hazard Assessment. OECD Series on Testing and Assessment Number 34, OECD, Paris (25 August 2005).
    • OECD, 2005. Guidance Document on the Validation and International Acceptance of New or Updated Test Methods for Hazard Assessment. OECD Series on Testing and Assessment Number 34, OECD, Paris (25 August 2005).
  • 17
    • 84904059428 scopus 로고    scopus 로고
    • OECD, 2008. Repeated Dose 28-Day Oral Toxicity Study in Rodents, Test Guideline No. 407. OECD Guidelines for the Testing of Chemicals. OECD, Paris (adopted: 3 October 2008).
    • OECD, 2008. Repeated Dose 28-Day Oral Toxicity Study in Rodents, Test Guideline No. 407. OECD Guidelines for the Testing of Chemicals. OECD, Paris (adopted: 3 October 2008).
  • 18
    • 0033003549 scopus 로고    scopus 로고
    • Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. 1: overview of the validation study and Draize scores for the evaluation of the tests
    • Ohno Y., et al. Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. 1: overview of the validation study and Draize scores for the evaluation of the tests. Toxicol. In Vitro 1999, 13:73-98.
    • (1999) Toxicol. In Vitro , vol.13 , pp. 73-98
    • Ohno, Y.1
  • 19
    • 9744229430 scopus 로고    scopus 로고
    • Assessment of additional testing needs under REACH - effects of (Q)SARs, risk based testing and voluntary industry initiatives.
    • JRC Report EUR 20863.
    • Pedersen, F., et al., 2003. Assessment of additional testing needs under REACH - effects of (Q)SARs, risk based testing and voluntary industry initiatives. JRC Report EUR 20863.
    • (2003)
    • Pedersen, F.1
  • 20
    • 41949094635 scopus 로고    scopus 로고
    • A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development
    • Robinson S., et al. A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development. Regul. Toxicol. Pharmacol. 2008, 50:345-352.
    • (2008) Regul. Toxicol. Pharmacol. , vol.50 , pp. 345-352
    • Robinson, S.1
  • 21
    • 79959429790 scopus 로고    scopus 로고
    • An analysis of pharmaceutical experience with decades of rat carcinogenicity testing: support for a proposal to modify current regulatory guidelines
    • Sistare F.D., et al. An analysis of pharmaceutical experience with decades of rat carcinogenicity testing: support for a proposal to modify current regulatory guidelines. Toxicol. Pathol. 2011, 39:716-744.
    • (2011) Toxicol. Pathol. , vol.39 , pp. 716-744
    • Sistare, F.D.1
  • 22
    • 33748887871 scopus 로고    scopus 로고
    • Caco-2 cell permeability assays to measure drug absorption
    • van Breemen R.B., Li Y. Caco-2 cell permeability assays to measure drug absorption. Expert Opin. Drug Metab. Toxicol. 2005, 1:175-185.
    • (2005) Expert Opin. Drug Metab. Toxicol. , vol.1 , pp. 175-185
    • van Breemen, R.B.1    Li, Y.2
  • 23
    • 0015079408 scopus 로고
    • Study of intra- and interlaboratory variability in the results of rabbit eye and skin irritation tests
    • Weil C.S., Scala R.A. Study of intra- and interlaboratory variability in the results of rabbit eye and skin irritation tests. Toxicol. Appl. Pharmacol. 1971, 19:276-360.
    • (1971) Toxicol. Appl. Pharmacol. , vol.19 , pp. 276-360
    • Weil, C.S.1    Scala, R.A.2


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