…Practical guidance on IUCLID toxicological summaries and DNEL derivation

ECHA’s fourteenth practical guide provides advice on how to produce endpoint summaries, and summaries of toxicological information in IUCLID 5.4, and how to derive certain DNELs (derived no effect levels). Also described is the way that results of the hazard assessment impact on the scope of the exposure assessment and type of risk characterisation subsequently performed.

European Chemicals Agency. Practical guide 14: How to prepare toxicological summaries in IUCLID and how to derive DNELs. July 2012.



…Proposal for the harmonised classification and labelling of diisohexyl phthalate (DIHP)

Under EC Regulation No. 1272/2008 on Classification, Labelling and Packaging, there is a legal obligation for suppliers to evaluate the hazards of chemicals (substances and mixtures) to be placed on the market, and to classify and label them appropriately. An option also exists for Member State Competent Authorities or industry to ask for the classification and labelling of a substance to be harmonised across Europe, whereupon the European Chemicals Agency organises a public consultation period of 45 days. Under this scheme, a proposal has been recently submitted by the Swedish authorities to standardise the classification and labelling of DIHP.

European Chemicals Agency. Proposal for harmonised classification and labelling on diisohexyl phthalate (DIHP). Based on Regulation (EC) No. 1272/2008 (CLP Regulation), Annex VI, Part 2. June 2012.



…Other items of interest

Draft revised guidance on the application of the CLP criteria – part 2: physical hazards and part 3: health hazards sent to Partner Expert Group.

http://echa.europa.eu/documents/10162/13562/clp_2nd_atp_chapter_2_phys_chem_en.pdf  (part 2)

http://echa.europa.eu/documents/10162/13562/guidance_2nd_atp_update_v3_peg_draft_part_3_only_en.pdf (part 3)

Draft revision of the guidance on information requirements and chemical safety assessment, part E: risk characterisation sent to Partner Expert Group.


ECHA has identified a need to refine its methodology for calculating “total tonnage” bands.


ECHA publishes Guidance in a Nutshell on data sharing.


Prior informed consent (PIC) regulation adds to ECHA’s tasks.


5 testing proposals involving vertebrate animals: request for information from third parties (by 17 September or 1 October 2012).



The above items were taken from the September 2012 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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