Determination of Safety-Relevant Data of Niobium

Transcription

1 A company of Bayer and LANXESS STUDY TITLE Determination of Safety-Relevant Data of Niobium SPONSOR CBMM Europe BV WTC H-tower Zuidplein XV Amsterdam The Netherlands DATA REQUIREMENT EC-Regulations A 16 (Relative Self-Ignition Temperature) STUDY DIRECTOR H. - P. Keldenich STUDY COMPLETION DATE TEST FACILITY Currenta GmbH & Co. OHG Safety / Process and Plant Safety Safety Laboratory D Leverkusen Federal Republic of Germany LABORATORY PROJECT ID Study No. 2009/01121 Page 1 of 12

2 This page is intentionally left blank for the purpose of submitting administrative information that is required by regulations promulgated by various countries. Page 2 of 12

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4 GLP-CERTIFICATE The test facility 'Bayer Industry Services GmbH & Co OHG' trades since 1st January 2008 under the name 'Currenta GmbH & CO OHG'. Page 4 of 12

5 VALIDITY OF THE GLP-CERTIFICATE AFTER RENAMING (PART 1 OF 2) Page 5 of 12

6 VALIDITY OF THE GLP-CERTIFICATE AFTER RENAMING (PART 2 OF 2) Page 6 of 12

7 This page is intentionally left blank for the purpose of submitting administrative information that is required by regulations promulgated by various countries. Page 7 of 12

8 Table of Contents Page Study Title... 1 Sponsor... 1 Data Requirement... 1 Study Director... 1 Study Completion Date... 1 Test Facility... 1 Laboratory Project ID... 1 GLP Compliance Statement... 3 Certification of Authenticity... 3 Study Director... 3 Archiving... 3 Quality Assurance Statement... 3 Quality Assurance Unit... 3 GLP-Certificate... 4 Validity of the GLP-Certificate after renaming (Part 1 of 2)... 5 Validity of the GLP-Certificate after renaming (Part 2 of 2)... 6 Summary of Results... 9 Test Substance Reference Substance General Study Information Sponsor Monitor Sponsors Contact Test Facility Experimental Relative Self-Ignition Temperature for Solids Enclosure 1...Graph of the Relative Spontaneous Ignition Enclosure 2... Validity of the GLP-Certificate after renaming (english translation) Page 8 of 12

9 SUMMARY OF RESULTS Determination of Safety-Relevant Data of Niobium Used test guideline: Guideline 92/69/EWG (German) 'Methods for Determination of Physicochemical Property' Official gazette No L 383 A of December 1992 Point Study-point Method Result 1 Relative Self-Ignition Temperature for Solids EC-A 16 does not undergo spontaneous combustion Page 9 of 12

10 TEST SUBSTANCE Test item: Niobium Purity: > 99.8 % CAS number: AD number: 4202 Expiry date: CUR internal sample number: Physical condition: silver-grey metal boned Storage: room temperature A copy of 'Certificate of Analysis' (Companhia Brasileira de Metalurgia e Mineracao, ) is present in CUR-SIC-VA-VSC and was archived. No repeat identity test was performed in the VA-VSC Laboratory. REFERENCE SUBSTANCE No reference substances were employed for the tests. GENERAL STUDY INFORMATION Sample arrival date: Date of study plan: Experimental start: Experimental finish: Report finalization: Author of final GLP report: H.- P. Keldenich SPONSOR Name / Address: CBMM Europe BV WTC H-tower Zuidplein XV Amsterdam The Netherlands Page 10 of 12

11 MONITOR Name / Address: CBMM Companhia Brasileira de Metalurgia e Mineracao Mr Jorge Davo Còrrego da Mata s/n Araxà MG Brasil SPONSORS CONTACT Name / Address: BSL BIOSERVICE Scientific Laboratories GmbH Behringstr. 6/ Planegg/Munich Germany TEST FACILITY Name / Address: Currenta GmbH & Co. OHG Safety / Process and Plant Safety Safety Laboratory Building B 407 D Leverkusen Federal Republic of Germany Telephone: Telefax: Address: safety-lab@currenta.de Page 11 of 12

12 EXPERIMENTAL 1. Relative Self-Ignition Temperature for Solids The test was performed as stipulated in EC Test Procedure A 16 'Relative Self-Ignition Temperature for Solids'. 8 ml of the substance was filled in a stainless steel wire mesh (0.045 mm openings, dimensions of 2 x 2 x 2 cm) and placed in a 2-litre-oven (self-build) at room temperature. The oven was operated with natural air circulation. For the controlling of the oven temperature an eurothermcontroller type 818 P was used and for recording of all temperatures Fe-CuNi-Thermocouples (type L) were used. The temperature/time curve relating to conditions in the centre of the sample was electronically recorded (software FIX32) while the temperature of the oven was increased to 410 C at a rate of 0.5 C/min. For this purpose, the temperature of the oven at which the sample temperature reached 400 C by self-heating is called the self-ignition temperature. Beginning at about 408 C the sample showed a weak exothermic reaction. A copy of the recorder trace is attached (see Graph of the Relative Spontaneous Ignition). Niobium' is classified as not undergoing spontaneous combustion when tested according to EC Test Procedure A 16. Page 12 of 12

13 SI Process and Plant Safety Temperature in C Sample temperature 2. Oven temperature Determination of the Relative Spontaneous Ignition Temperature (EC-A16) Report No. 2009/01121 VA-internal Sample No Test Substance Niobium Temperature Rate 0.5 K/min Test Volume 8 ml Enclosure 1 of 2 Date Tester Colianni This Diagram is not the original. The figures are based on original plotter diagram :00: :00: :00: :00: :00: :00: :00: :00: :00: :00:00 Time in hhhh:mm:ss

14 Ministry of Labor, Health and Social Affairs of North Rhine-Westphalia Enclosure 2 of 2 to report 2009/01121 Ministry of Labor, Health and Social Affairs of North Rhine-Westphalia, Düsseldorf Date: Currenta GmbH & Co. OHG Page 1 of 2 SIC-VA-VSC Prüfeinrichtung "Sicherheitstechnisches Laboratorium" Reference II A Gebäude B 407 Please indicate in any Chempark correspondence D Leverkusen Validity of the GLP certificate dated July 13, 2005 owing to your change of name Your mail dated December 17, 2007 Ladies and gentlemen, From February 22 to 23, 2005, an inspection was carried out by a team of inspectors from North Rhine-Westphalia in the above testing facility to check compliance with the principles of Good Laboratory Practice in accordance with Annex 1 of the German Chemicals Act (in the version in the notification dated June 20, 2002). As you stated in your mail dated December 17, 2007, the name of your company will change from January 1, According to your mail, the legal form (GmbH & Co. OHG), the ownership structure (Bayer/LANXESS), the areas of operation and the organizational structure will remain unchanged, this also applying to the GLP testing facility of the Sicherheitstechnisches Laboratorium (Technical Safety Laboratory). Translation for Information The new name of the testing facility will be: Currenta GmbH & Co. OHG SIC-VA-VSC Prüfeinrichtung "Sicherheitstechnisches Laboratorium" Gebäude B 407 Chempark D Leverkusen The GLP certificate dated July 13, 2005 assigned to Bayer Industry Services GmbH & Co OHG; Prüfeinrichtung SUA-VA 1; Gebäude B 407; D Leverkusen Sabine Börner Phone Fax sabine.boerner@mags.nrw.de Office building and delivery address: Fürstenwall 25, Düsseldorf Phone Fax poststelle@mags.nrw.de Public transport: Rheinbahn lines 704, 709 Stop: Stadttor Rheinbahn lines 719,725 Stop: Polizeipräsidium

15 continues to retain its validity. The new address data will be taken into account in the next regular inspection in Page 2 of 2 Yours sincerely i.a. (Dr. Dorothee Hippe) Translation for Information