AICIS Rules proposed changes and draft exposure

[Mike Dewhirst]

Placeholder ticket for planning Chemintro changes which will probably be required. The AICIS Webinar which reviews the proposals is:

​https://health-au.webex.com/health-au/j.php?MTID=m59165f01b38a9f5a62ea1e864ad925e5

[Mike Dewhirst]

Link to proposal on esters and salts of high hazard list of chemicals

​https://www.industrialchemicals.gov.au/proposed-changes-list-chemicals-high-hazards-categorisation-information-minor-changes-guidelines/proposed-changes-list-chemcials-high-hazards-categorisation

This link also refers to changes to the high hazard list including:

• List of chemicals with high hazard for categorisation 413KB.xlsx
• Additions to the List of chemicals with high hazards.xlsx
• list1.xlsx (Endocrine disruptors classified by EU)

Changes to Guidelines including:

• Generally using 'acceptable test guideline' instead of specifying which OECD test numbers to use. These will all be listed in Appendix 8.4.2. ​https://www.industrialchemicals.gov.au/guide-categorising-your-chemical-importation-and-manufacture/appendix-acceptable-test-guidelines-categorisation
• Change to guidance 5.3 "We will delete the text in brackets, ‘(the full study report or the outcomes of the study and a written undertaking that the full study report will be provided to the Executive Director if requested)’. This text was present in error." (That text removed in Chemintro. 31 Jan 2024)
• Change to guidance 6.1 definition of suitable in silico prediction
• Changes to Part 6.9.2 "For the purposes of subparagraph 30(2)(c)(iv) of the IC General Rules there are no information requirements to demonstrate the absence of the hazard characteristic, respiratory sensitisation. If you do not have any of the information detailed in part 6.9.1* that demonstrates that the chemical has this hazard characteristic, then you can assume it does not for the purposes of categorisation. * Note: The information can include that the chemical is an enzyme or a polymer that contains one or more free isocyanate groups."
• Changes to 6.26 fourteenth dot point "if the chemical is not a biocidal active and not a persistent, highly branched organic chemical(If the chemical is a biocidal active or a persistent, highly branched organic chemical, in silico predictions cannot be used to demonstrate that the chemical does not have the toxicity aspect of the persistent, bioaccumulative and toxic hazard characteristic – only in vivo chronic aquatic toxicity studies, as described in the next dot point, are acceptable.) then information on aquatic toxicity for all three trophic levels (fish, invertebrates, and algae), from suitable in silico predictions on the chemical or in vivo studies on the chemical or from suitable read-across information conducted following acceptable test guidelines for aquatic toxicity, with at least one of the following results for all each of the three trophic levels: (A combination of the following acute and chronic aquatic toxicity endpoints can be used.)
  • acute aquatic toxicity > 1 mg/L (96 h LC50 (fish), or 48 h EC50 (invertebrates) or 72 or 96 h ErC50 (algae)), or
  • chronic aquatic toxicity NOEC or EC10 > 0.1 mg/L (for chemicals that are not readily biodegradable), or
  • chronic aquatic toxicity NOEC or EC10 > 0.01 mg/L (for chemicals that are readily biodegradable), or ......."
• New footnotes A and B for "Footnote A - This option is available for introductions in human health exposure bands 3 or 4. Footnote B - This option is only available for introductions in human health exposure band 3. These footnotes will be added to:

6.12.2 – skin corrosion
6.13.2 – eye damage – also includes a minor clarification of text (shown below)
6.14.2 – skin sensitisation
6.15.2 – acute toxicity (fatal or toxic)
6.20.2 – skin irritation
6.21.2 – eye irritation
6.22.2 – acute toxicity (harmful)"

• Changes to 8.4.1 and 8.4.2 adjust OECD tests 433, 308 and 310 which are all completed in Chemintro 31 Jan 2024)