E-Book Overview
Paris: UNEP publications, 2005. - 131 p.
SIDS Initial Assessment Report For SIAM 20:Last literature search: IUCLID Chapters 1-4: 2003-08-13, Chapter 3.2.1 2004-07-27, Chapter 5: 2003-01-22. OECD/ICCA - The BUA Peer Review Process perform a quality control on the full SIDS dossier submitted by industry. This quality control process follows internal BUA guidelines/instructions for the OECD/ICCA peer review process and includes: - a full (or update) literature search to verify completeness of data provided by industry in the IUCLID/HEDSET - Review of data and assessment of the quality of data - Review of data evaluation - Check of adequacy of selection process for key studies for OECD endpoints, and, where relevant, for non-OECD endpoints by checking original reports/publications - Review of key study description according robust summaries requirements; completeness and correctness is checked against original reports/publications (if original reports are missing: reliability (4), i.e. reliability not assignable) - Review o f validity of structure-activity relationships - Review of full SIDS dossier (including SIAR, SIAP and proposal for conclusion and recommendation for further work) - In case of data gaps, review of testing plan or rationale for not testing
E-Book Content
OECD SIDS
4,4’-METHYLENEDICYCLOHEXYL DIISOCYANATE
SIDS Initial Assessment Report For SIAM 20 Paris, France, 19-22 April 2005
1. Chemical Name:
4,4´-Methylenedicyclohexyl diisocyanate
2. CAS Number:
5124-30-1
3. Sponsor Country:
Contact Point: BMU (Bundesministerium für Umwelt, Naturschutz und Reaktorsicherheit) Contact person: Prof. Dr. Ulrich Schlottmann Postfach 12 06 29 D- 53048 Bonn -
4. Shared Partnership with: 5. Roles/Responsibilities of the Partners:
Name of industry sponsor /consortium
Process used
Bayer AG, Germany Contact person: Dr. Burkhardt Stock D-51368 Leverkusen Gebäude 9115 OECD/ICCA - The BUA Peer Review Process: see next page
6. Sponsorship History
How was the chemical or category brought into the OECD HPV Chemicals Programme ?
7. Review Process Prior to the SIAM:
8. Quality check process:
9. Date of Submission: 10. Date of last Update:
by ICCA-Initiative
last literature search (update): 4 October 2004 (Human Health): databases medline, toxline; search profile CAS-No. and special search terms 8 November 2004 (Ecotoxicology): databases CA, biosis; search profile CAS-No. and special search terms OECD/ICCA IUCLID was used as a basis for the SIDS dossier. All data were checked and validated by BUA. A final evaluation of the human health part has been performed by the Federal Institute for Risk Assessment (BfR) and of the ecotoxicological part by the Federal Environment Agency (UBA). Deadline for circulation: 21 January 2005 Last literature search: IUCLID Chapters 1-4: 2003-08-13, Chapter 3.2.1 2004-07-27, Chapter 5: 2003-01-22; 1
OECD SIDS 11. Comments:
4,4’-METHYLENEDICYCLOHEXYL DIISOCYANATE OECD/ICCA - The BUA* Peer Review Process Qualified BUA personnel (toxicologists, ecotoxicologists) perform a quality control on the full SIDS dossier submitted by industry. This quality control process follows internal BUA guidelines/instructions for the OECD/ICCA peer review process and includes:
*
a full (or update) literature search to verify completeness of data provided by industry in the IUCLID/HEDSET Review of data and assessment of the quality of data Review of data evaluation Check of adequacy of selection process for key studies for OECD endpoints, and, where relevant, for non-OECD endpoints by checking original re