The reproductive and developmental toxicity of chromium(VI) compounds has been evaluated with a view to establishing derived-no-effect levels (DNELs) based on these endpoints (carcinogenicity having already been assessed in a previous report). The Committee for Risk Assessment (RAC) concluded that for lead chromates, the developmental neurotoxicity of lead should be addressed. For other compounds, a range of reproductive/developmental DNELs were calculated for different population groups and exposure routes, although it was noted that the carcinogenic effects of chromium(VI) and its compounds are much more potent.
European Chemicals Agency (2016). Amendment of the RAC note “Application for Authorisation: Establishing a reference dose-response relationship for carcinogenicity of hexavalent chromium” to include the intrinsic property “Toxic to reproduction” of the Cr(VI) compounds (RAC/27/2013/06 Rev.1) agreed on 4 December 2013 at RAC- 27). Helsinki, 4 December 2015. RAC/35/2015/09. https://echa.europa.eu/documents/10162/21961120/rac_35_09_1_c_dnel_cr-vi-_en.pdf/8964d39c-d94e-4abc-8c8e-4e2866041fc6
A Swedish group has concluded that the non-reporting of confidential data, and the varied reporting of studies by registrants, makes it is difficult to follow the steps undertaken in the chemical risk assessment of substances under REACH.
Ingre-Khans E et al. (2016). Transparency of chemical risk assessment data under REACH. Environ. Sci. Process. Impacts 18, 1508-1518.
ECHA has updated its guidance document on registration, which aims to assist industry in determining their registration requirements under REACH. The revised guidance includes an updated list of information requirements and revised explanations of, for example, the ‘one substance – one registration’ principle. A corrigendum to the guidance on data sharing has also been released.
European Chemicals Agency (2016-2017).
Guidance on registration. Version 3.0. November 2016. https://echa.europa.eu/documents/10162/13632/registration_en.pdf/de54853d-e19e-4528-9b34-8680944372f2 Guidance on data sharing. Version 3.1. January 2017. https://echa.europa.eu/documents/10162/13631/guidance_on_data_sharing_en.pdf/545e4463-9e67-43f0-852f-35e70a8ead60
ECHA has updated its R.7a document on endpoint-specific guidance, which includes new information requirements for skin/eye corrosion/irritation, skin and respiratory sensitisation, and acute oral toxicity. New draft appendices relevant to nanomaterials have also been released for chapters R.7a, R.7b and R.7c on endpoint-specific guidance, and for R.6 on QSARs and the grouping of chemicals.
European Chemicals Agency (2016). Guidance on information requirements and chemical safety assessment. https://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment
ECHA’s Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) have released opinions on the authorisation of different uses of the following chromium compounds:
- acids generated from chromium trioxide and their oligomers
- chromium trioxide
- dichromium tris(chromate)
- potassium dichromate
- potassium hydroxyoctaoxodizincatedichromate
- sodium dichromate
- strontium chromate
European Chemicals Agency (2016). Annex to a news alert ECHA/NA/16/37. 13 December 2016. https://echa.europa.eu/documents/10162/22867731/annex_rac_seac_en.pdf/b18b01c2-7016-f0c8-fdf5-26584ed63f93
Following MSC agreement, four SVHC have been added to ECHA’s Candidate List for authorisation:
- bisphenol A, due to its toxicity to reproduction
- branched and linear 4-heptylphenol, due to its potential to cause endocrine disruption in the environment
- nonadecafluorodecanoic acid and its sodium and ammonium salts, due to their toxicity to reproduction, and their persistent, bioaccumulative and toxic (PBT) properties
- 4-tert-pentylphenol, for its potential to cause endocrine disruption in the environment
A decision will be made later as to whether these chemicals will be subject to authorisation. ECHA reminds companies that they may have resultant legal obligations.
The MSC has also considered 4-tert-butylphenol (due to its environmental endocrine disruption) and trimellitic anhydride (as a respiratory sensitiser), but as no unanimous agreement was made, ECHA will submit relevant opinions to the European Commission for a final decision.
European Chemicals Agency (2016). Candidate List of substances of very high concern for authorisation (together with relevant background documents and MSC opinions) available at https://echa.europa.eu/candidate-list-table
See also: ECHA/NA/16/38. https://echa.europa.eu/-/member-state-committee-issues-four-svhc-agreements-and-two-opinions
New interactive guidance on safety data sheets and exposure scenarios.
First sectoral use maps published for the adhesive and sealant industry; soap, detergents and maintenance products; and cosmetics.
Updated guidance available on the identification and naming of substances.
New version (3.1.1) of Chesar allows bulk editing of values for conditions of use, and is fully compatible with IUCLID 6.
Testing proposals involving vertebrate animals: ECHA requests information from third parties on ten chemicals, including sodium cumenesulphonate and sodium toluene-4-sulphonate (by 30 January).
The above items were taken from the January/February 2017 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here)News Home Guest Write For Us? Contact Us