Document 50JDxz0r7dEMnNJX6jwvKXzqR

Huntingdon Life Sciences NEW OECD GUIDELINE 407: IMPLICATIONS FOR NOTIFIERS OF NEW SUBSTANCES The OECD Guideline number 407 for the Repeated Dose 28-day Oral Toxicity Study in Rodents has been revised and was adopted on 27 July 1995. The main changes in the revised guideline are: addition of neurobehavioural screening an increased list of tissues for histopathological examination in the study protocol The European Commission has recently incorporated the revised OECD Guideline number 407 into its legislation as test B7 in Directive 96/54/EC which adapts to technical progress for the 22nd time Directive 67/548/EEC. For all Notification of New Substances (NONS) submissions made after 31 May 1998, the use of the new study design will be mandatory. At Huntingdon Life Sciences, we strongly recommend that the new protocol is followed for all NONS programmes started after 1 June 1997 to ensure compliance with the legislation. We believe we can provide you with invaluable assistance in this for the following reasons: we are considered to be one of the world's leading laboratories in conducting neurotoxicity studies we have been conducting 28-day studies to the revised protocol since its adoption in 1995 we have considerable experience in neurobehavioural screening and neuropathology and have validated and published methods for the Functional Observational Battery and motor activity tests 3 we have been conducting neurotoxicity studies of this type, to EPA guidelines, since 1992 r? we have a background database on over 35 chemicals comprising both validation data and commercially performed studies For studies performed at Huntingdon Life Sciences, there will be no impact on time taken to perform and report the new study design and the price of the additional investigations is competitive. + x-**^*. ~ -* ------------- - For further information, please fill in the details below and fax us in UK +44 (0)1480 892205 or USA (908) 873 3992 or Japan (03) 3238 6388 Please send me a copy of the new Neurotoxicology brochure Please call me to discuss my specific requirements Company Transverse section of peripheral nerve (I) Control (II) Acrylamide, 50mg/kg/day Alternatively, please call us: In the UK: + 44 (0)1480 892034 In the USA: + 1 (908) 873 2550 ext. 7000 In Japan: + 81 (0) 3 3238 6381 SL 109908 Huntingdon NEW CHEMICAL NOTIFICATION NEWS FIXED PRICE EU SERVICE NEW KOREAN SUPPORT NEW JAPANESE SUPPORT Huntingdon Life Sciences is a world leader in the safety testing of new compounds, with unrivalled experience in the Notification of New Substances to all the world's major regulators. These are the latest refinemerjisrto-eur service: Fixed Pfice EU Service x. Our standard service, meeting defined regulatory requirements, is offered at a fixed price depending on the nature of the-material and the tests required. All studies are carried out to GLP under the direction of an experienced project manager who will provide regular progress reports. < ' New Japanese Support ) With thirty years experience in the chemical industry behind him, Mr Nobuo ShimizuTias joined our Tokyo office to control all translation and registration work and liaise with MITI and MOHW on behalf of our Sponsors. New Korean Support Mr Jong-Soo Kang, president of Shin Won Scientific Company, operates as our in-house expert for Korean notifications under the Toxic Chemicals Control Act. He leads a team which translates reports, prepares dossiers and conducts any negotiations with the Ministry of the Environment. FAX BACK For further information please fill in the details below and fax us in UK +44 (0)1480 892205 or USA (908) 873 3992 or japan (03) 3238 6388 Please call me to discuss my requirements.......................... Please send me a copy of your Chemical Notification brochure Name: Company: Address: Position: ______________________________________________________ _______________________________________________________ Tel: E-mail: _________________________________________ Alternatively, please call us: I n the U K +44 (0)1480 892034 In the USA: +1 (908)873 2550 ext. 7000 In Japan: +81(0)3 3238 6381 Fax: SL 109909