The REACH Regulation puts much emphasis on the obligations for registrants to collect all available relevant data on the intrinsic properties of a substance by performing a thorough, reliable and well-documented information gathering exercise. With more than 200 cumulative years of experience of data evaluation, bibra toxicologists have a unique understanding of the relative values of different information sources on mammalian toxicology in the public domain, and apply a variety of pragmatic yet comprehensive, search methodologies to ensure that we capture data in the most efficient way possible. Our skills in searching toxicity data sources are world-renowned and, indeed, our Director of Toxicology, Pete Watts, was heavily involved in the early stages of developing technical guidance to industry on information requirements for REACH (RIP 3.3).
REACH stresses that the information on intrinsic properties of substances may be generated by using sources of information other than in vivo testing (provided that certain conditions, set out in the Regulation, are met). The Registrant may use a variety of alternative methods such as (Q)SAR ((Quantitative) Structure Activity Relationships), in vitro tests, the grouping of substances/category approach, and read-across. All of these different sources of information can be used in an approach based on a weight-of-evidence argument. In the area of mammalian toxicology, we are confident that we can provide advice and support on an appropriate and scientifically justifiable approach to take, and can assist with the development of reasoned justification for applying adaptations (i.e. derogations/waiving) from the standard testing requirements. We can advise on the appropriate interpretation of in vitro tests. Our high level of expertise will allow sensible determination of which studies to use in the hazard assessment, whether a specific study should be used as a key study (as the most suitable to describe an endpoint) or as supporting information, and which studies can be used as a part of a weight-of-evidence approach. We can also then advise on proposals for further testing, if relevant.
All of our toxicologists are familiar with the (robust) study summaries format adopted within REACH for data input. We strongly believe we can provide efficient and cost-effective support of the highest quality on the preparation of endpoint study records (robust study summaries or study summaries) within IUCLID, and the drafting of endpoint summaries. Our team is actively familiarising themselves with the detailed technical operation of IUCLID 5.
We can help on the determination of classification and labelling for any molecule in accordance with Directive 67/548/EEC or on the establishment of Derived No Effect Levels (DNELs) or Derived Minimal Effect Levels (DMELs) for relevant routes of human exposure.
We can assist with the drafting of Chemical Safety Reports (CSRs), as outlined in Annex I of REACH, to document, in each case, the Chemical Safety Assessments (CSAs). We have considerable experience of preparing hazard reviews to any required level of detail and using any specified format. In particular, in recent years, we have been extensively involved in reviewing and providing comments on a large number of OECD HPV Chemicals Programme SIDS Initial Assessment Reports (SIARs), which have a very similar structure and format to those required for CSRs under REACH. We can, of course, also advise on the development of risk characterisations using appropriate exposure scenarios for any substances of interest and assist in the drafting of high quality Safety Data Sheets, as outlined in Annex II of REACH.
REACH places a duty on registrants to keep information up to date, and explicitly requires that the European Chemicals Agency (ECHA) be informed where any new relevant available information is identified. There is thus an obligation to regularly screen databases for new substance information that would change the results of the CSA and Safety Data Sheet. As detailed elsewhere in this website, we have considerable experience in providing on-going and regular searches (Selective Dissemination of Information – SDIs) of appropriate and relevant toxicological databases, including our own in-house database, TRACE (which is listed as a valuable data source by ECHA).
The bibra team of experienced chemical hazard and risk assessors is available to lead projects related to the REACH regulatory objectives on mammalian toxicology. Our six most senior scientists have each been evaluating mammalian toxicity and related physicochemical data for a minimum of 20 years, and the quality of their endeavours is widely recognised. The productivity of our team of 15 toxicologists is greatly assisted by their proximity to bibra's unique in-house databank of papers on applied chemical toxicology. We are confident that the application of this combination of human resource and data availability to any project requiring substantial input on mammalian toxicology will result in cost-effective and quality outputs all round.
Working side-by-side with our consortium partners we are confident that we can help you in all stages of a REACH implementation.
