Assessment Workflows for Read Across and Substance Category Formation

Transcription

1 1 Workshop on CEFIC LRI Project EEM9.4 LRI AMBIT with IUCLID6 support and extended search capabilities Assessment Workflows for Read Across and Substance Category Formation

2 2 Overview General aspects on non-testing approaches Guidance elements of the analogue approach / category formation workflow Practical example from the past AMBIT elements of the analogue approach / category formation workflow

3 3 General aspects on non-testing approaches General aspects on non-testing approaches Guidance elements of the analogue approach / category formation workflow Practical example from the past AMBIT elements of the analogue approach / category formation workflow

4 4 General aspects on non-testing approaches REACH Article Information on intrinsic properties of substances may be generated by means other than tests, toxicity, information shall be generated whenever possible by means other than vertebrate animal tests alternative methods, for example from information from structurally related substances (grouping or readacross). Article In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort.

5 5 General aspects on non-testing approaches Options that registrants use to cover REACH information requirements for different data endpoints Extract from The use of alternatives to testing on animals for the REACH Regulation Third Report under Article 117(3) of the REACH Regulation

6 6 Guidance elements of the analogue approach / category formation workflow General aspects on non-testing approaches Guidance elements of the analogue approach / category formation workflow Practical example from the past AMBIT elements of the analogue approach / category formation workflow

7 7 Guidance elements of the analogue approach / category formation workflow analogue approach category development Extract from Guidance on information requirements and chemical safety assessment, Chapter R.6: QSARs and grouping of chemicals

8 8 Guidance elements of the analogue approach / category formation workflow analogue approach START Task Workload Ambit Support Step 1 Step 2 Step 3 Step 4 Step 5 Identify potential analogue(s) high high Data gathering for the analogues high high Evaluation if available data are adequat high low Construct a matrix of data availability high high Assess the suitability of read-across, and fill data gaps high mid Step 6 Document the read-across mid mid STOP Extract from Guidance on information requirements and chemical safety assessment, Chapter R.6: QSARs and grouping of chemicals

9 9 Practical example from the past General aspects on non-testing approaches Guidance elements of the analogue approach / category formation workflow Practical example from the past AMBIT elements of the analogue approach / category formation workflow

10 10 Practical example from the past Data matrix for mammalian toxicity Naphtol AS Pigment Category Pigment Red XY Not skin sensitising Skin sensitization

11 11 Practical example from the past Data matrix for mammalian toxicity Naphtol AS Pigment Category Number of fields to be filled for mammalian toxicity (16 category members, 17 endpoints): 272 Additional fields have to be filled for: physicochemical properties environmental fate environmental toxicity

12 12 AMBIT elements of the analogue approach workflow General aspects on non-testing approaches Guidance elements of the analogue approach / category formation workflow Practical example from the past AMBIT elements of the analogue approach / category formation workflow

13 13 AMBIT elements of the analogue approach /category formation workflow

14 14 AMBIT elements of the analogue approach workflow Step 1: Identify potential analogue(s)

15 15 AMBIT elements of the analogue approach workflow Step 1: Identify potential analogue(s)

16 16 AMBIT elements of the analogue approach workflow Step 1: Identify potential analogue(s)

17 17 AMBIT elements of the analogue approach workflow Step 1: Identify potential analogue(s)

18 18 AMBIT elements of the analogue approach workflow Step 1: Identify potential analogue(s)

19 19 AMBIT elements of the analogue approach workflow Step 1: Identify potential analogue(s)

20 20 AMBIT elements of the analogue approach workflow Step 1: Identify potential analogue(s)

21 21 AMBIT elements of the analogue approach workflow Step 2: Data gathering for analogues

22 22 AMBIT elements of the analogue approach workflow Step 2: Data gathering for analogues

23 23 AMBIT elements of the analogue approach / workflow Step 3: Evaluation of available data for adequacy

24 24 AMBIT elements of the analogue approach workflow Step 3: Evaluation of available data for adequacy Step 4: Construct a matrix of data availability

25 25 AMBIT elements of the analogue approach workflow Step 4: Construct a matrix of data availability Step 5: Assess the adequacy of read-across and fill data gap Θ

26 26 AMBIT elements of the analogue approach workflow Step 4: Construct a matrix of data availability Step 5: Assess the adequacy of read-across and fill data gap

27 27 AMBIT elements of the analogue approach workflow Step 6: Document the read-across

28 28 AMBIT elements of the analogue approach workflow Step 6: Document the read-across

29 29 AMBIT elements of the analogue approach workflow Step 6: Document the read-across

30 30 AMBIT elements of the analogue approach workflow Step 6: Document the read-across

31 31 AMBIT elements of the analogue approach workflow Step 6: Document the read-across

32 32 CONCLUSION In contrast to the traditional procedure for analogue approach and category formaion, AMBIT enables the assessor to generate more consistent, high-quality reports, involving less efforts and spending less time.

33 33

34 34 Backup

35 35 Guidance elements of the analogue approach / category formation workflow analogue approach category development Extract from Guidance on information requirements and chemical safety assessment, Chapter R.6: QSARs and grouping of chemicals

36 36 AMBIT elements of the analogue approach workflow Step 1: Identify potential analogue(s) Search structures and associated data Search IUCLID substances by identifiers Search IUCLID substances by endpoint data

37 37 AMBIT elements of the analogue approach workflow Step 1: Identify potential analogue(s)

38 38 AMBIT elements of the analogue approach workflow Step 1: Identify potential analogue(s)