Company, Report No. GLP (where relevant) / (Un)Published Claimed (Yes/No) A2.10/03 Percentage distribution of Pelargonic Acid between the different environmental compartments estimated from the MACKAY MODEL TB-Agrartechnik Service, A-2540 Bad Vöslau, Austria Report-No. 0601NEU-03 Unpublished Y W. Neudorff GmbH KG A2.10/06 2008 Exposure assessment for health for the active substance Pelargonic Acid and the biocidal product NEU 1170 H FOR PT10 TB-Agrartechnik Service, A-2540 Bad Vöslau, Austria Report-No. 0806NEU-01 Unpublished Y W. Neudorff GmbH KG A2.10/05 Environmental Exposure assessment for the active substance Pelargonic Acid and the biocidal product NEU 1170 H TB-Agrartechnik Service, A-2540 Bad Vöslau, Austria Report-No. 0706NEU-01 Unpublished Y W. Neudorff GmbH KG A2.10/07 2008b Environmental Exposure assessment for the active substance Pelargonic Acid and the biocidal product NEU 1170 H for PT10 TB-Agrartechnik Service, A-2540 Bad Vöslau, Austria Report-No. 0806NEU-02 Unpublished Y W. Neudorff GmbH KG A3.1.1/01 2000a Melting temperature of nonanoic acid ArGe GAB Biotech/IFU, D-75223 Report-No. 20001414/01-PCMP GLP, Unpublished Y W. Neudorff GmbH KG A3.1.2/01 2000b BOILING TEMPERATURE OF NONANOIC ACID ArGe GAB Biotech/IFU, D-75223 Report-No. 20001414/01-PCBP GLP, Unpublished Y W. Neudorff GmbH KG A3.1.3/01 2000c REALATIVE DENSITY OF EMERY 1202/PELARGONSÄURE ArGe GAB Biotech/IFU, D-75223 Report-No. 20001276/01-PCRD Y W. Neudorff GmbH KG
Report-No. 321558 GLP, Unpublished A6.1.3/01 1998 The BioPesticide Manual British Crop Protection Council, 1st edition, p. 25 Report-No. not applicable Not GLP, Published N Not applicable as no data protection claimed -- A6.1.3/02 -- Toxicological Similarity of Straight Chain Saturated Fatty Acids of Greater Than 8 Carbon Chain Length by Various Routes of Exposure Safer Inc, Eden Prairie MN 55334-3585, USA Report-No. not applicable Not GLP, Published N Not applicable as no data protection claimed -- A6.1.3/03 2004 Ammonium Nonanoate; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food. Federal Register: March 17, 2004, Volume 69, Number 52 Y -- A6.1.3/04 2006 BIOPESTICIDES REGISTRATION ACTION DOCUMENT AMMONIUM NONANOATE (PC code 031802) tech_docs/brad_031802.pdf Y -- A6.1.3/05 1982 Aliphatic carboxylic acids in Patty´s Industrial Hygiene and Toxicology, Clayton GD and Clayton FE (eds), 3rd Ed. Vol 2C: Toxicology, New York: John Wiley & Sons, Inc., pp. published N Not applicable as no data protection claimed - A6.1.3/06 2002 Human and environmental risk assessment on ingredients of European household cleaning products: Fatty acid salts, human health risk assessment: Draft for public comment, June 2002. published. N Not applicable as no data protection claimed - A6.1.4s/01 Primary Skin Irritation/Corrosion Study with Pelargonsäure in the Rabbit (4-Hour Application) Notox B.V, ‘s-Hertogenbosch, The Netherlands Report-no. 321604 GLP, Unpublished Y NEU
A6.1.5/01 Assessment of Contact Hypersensitivity to Pelargonsäure in the Albino Guinea Pig (Maximisation-Test) Notox B.V, ‘s-Hertogenbosch, The Netherlands Report-no. 321615 GLP, Unpublished Y NEU A6.2. 2000 THE NATURE OF DIETARY FATTY ACIDS AND THEIR NUTRIENT ROLE Source: Report-no. not applicable Not GLP; Published N Not applicable as no data protection claimed -- A6.2/01 non-sub 2003 The absorption, distribution, metabolism and excretion of fatty acids including Pelargonic Acid in mammals - extract from literature GAB Consulting GmbH, Lamstedt, Germany Report-no. not stated Not GLP, Unpublished N Not applicable as no data protection claimed NEU A6.2/02 non-sub 1972 Textbook of Physiology and Biochemistry Source: Textbook of Physiology and Biochemistry, Churchill Livingstone, Edingburgh and London Report-no. not applicable Not GLP; Published N Not applicable as no data protection claimed -- A6.2/03 non-sub 1975 Fats or Lipids Source: Introductory Nutrition, 3rd edition, pp. 37-51, C.V. Mosby Co., St. Louis, USA Report-no. not applicable Not GLP; Published N Not applicable as no data protection claimed -- A6.2/04 non-sub 1971 Biological Chemistry Source: Biological Chemistry, Harper & Row, New York, USA, 2nd edition, pp. 583-604, Report-no. not applicable Not GLP; Published N Not applicable as no data protection claimed -- A6.2/05 non-sub 1975 Human biochemistry Source: Human Biochemistry, C.V. Mosby Company, St. Louis, USA, 9th edition, pp. Report-no. not applicable Not GLP; Published N Not applicable as no data protection claimed -- A6.2/06 non-sub 2001 Biochemistry for Clinical Medicine Source: Greenwich Medical Media LTD, London, UK, pp. 85 - 109 Report-no. not applicable Not GLP; Published N Not applicable as no data protection claimed --
Report No. 15656-0-455CO GLP, Published Submitted as 6.6.4/01 from applicant available CAR for fatty acids prepared by RMS Ireland in the context of 91/414/EEC indicates no data protection US EPA, Anonymous 1992 The Reregistration Eligibility Document (RED) on Soap Salts. Source: US EPA Report-No.: Not applicable Not GLP, Published N Not applicable as no data protection claimed -- US EPA, Mycogen Corporation 1997 Pelargonic acid; Pesticide tolerance Petition 1/97 Source: Cornell University, 5123 Comstock Hall, Ithaca, New York Report-No.: not applicable, Not GLP, published N Not applicable as no data protection claimed -- Wester PW., Kroes R. 1988 Forestomach carcinogens: pathology and relevance to man. National Institute of Public Health and Environmental Protection, Bilthoven, The Netherlands Toxicol Pathol. 1988; 16(2): 165-71 Report-No. Not applicable Not GLP, Published N -- OF STUDIES FOR THE ACTIVE SUBSTANCE – ADDITIONAL REFERENCES INTEGRATED BY RMS Author(s) Year Title. Source (where different from company) Company, Report No. GLP (where relevant) / (Un)Published Data Protection Claimed (Yes/No) Date of 1st submission Owner Aeby P., Ashikaga T., Diembeck W.,, Eschrich D., Gerberick F.,, Kimber I, M., 2008 The COLIPA strategy for the development of in vitro alternatives: Skin sensitisation AATEX 14, Special Issue, 375-379 N Not applicable as no data protection claimed published
Maxwell G., Ovigne J.M., Tailhardat M., Teissier S. Basketter DA, Chamberlain M, Griffiths HA, Rowson M, Whittle E, York M. 1997 The classification of skin irritants by human patch test Food Chem Toxicol. 35(8):845-52. N Not applicable as no data protection claimed published Basketter DA, Griffiths HA, Wang XM, Wilhelm KP, McFadden J. 1996 Individual, ethnic and seasonal variability in irritant susceptibility of skin: the implications for a predictive human patch test. Contact Dermatitis 35(4), 208-13. N Not applicable as no data protection claimed published Basketter DA, D, Dierkes P, Jowsey IR. Does irritation potency contribute to the skin sensitization potency of contact allergens-- Cutan Ocul Toxicol. 26(4): 279-86. N Not applicable as no data protection claimed published Basketter DA, York MY, McFadden JP, Robinson MK 2004 Determinatino of skin irritation potential in the 4-h patch test Contact Dermatitis, 51:1-4 N Not applicable as no data protection claimed published Basketter DA., Gerberick GF., Kimber I. The Local Lymph Node Assay: Current Position in the Regulatory Classification of Skin Sensitizing Chemicals Cutaneous and Ocular Toxicology 26:4, 293 - 301 N Not applicable as no data protection claimed published Basketter DA., Gerberick GF., Kimber I. 1998 Strategies for Identifying False Positive Responses in Predictive Skin Sensitization Tests Food and Chemical Toxicology 36: 327-333 N Not applicable as no data protection claimed published Briggs G.B., R. L., Young J. A. 1976 Safety studies on a series of acids. American Industrial Hygiene Association Journal; April 1976 N Not applicable as no data protection claimed published ECETOC 2003 Derivation of assessment factors for human health risk assessment. Technical Report No. 86 Issn-0773-6347-86 N Not applicable as no data protection claimed published
Heylings J, Jones P, Robles C, Kandárová H, Gamer A, Remmele M, Curren R, Raabe H, Cockshott A, Gerner I, Zuang V. TalviOja et al. 2006 decanoic acid: Acute dermal toxicity study in rats RcC study No A86556 Y Sopura S.A TalviOja et al. 2006 decanoic acid: Acute dermal toxicity study in rats RcC study No A86556 Y Sopura S.A TM Biocides 2010 Risk characterisation of local effects in the absence of systemic effects 2010-03-05 TM Biocides Not applicable as no data protection claimed 2010 Traul K.A., Driedger A., Ingle D.L., Nakhasi D. 1999 Review of the Toxicologic Prop erties of triglycerides Food and chemical Toxicology 38 (2000), 79-98 N Not applicable as no data protection claimed - US-EPA 2003 Pelargonic Acid (Nonanoic Acid); Exemption from the Requirement of a Pesticide Tolerance Federal Register: February 19,Volume 68, Number 33 N Not applicable as no data protection claimed published Wahlberg J, Lindberg M. 2003 Nonanoic acid – an experimental irritant Contact Dermatitis 49: 117–123 N Not applicable as no data protection claimed published Wahlberg JE 1983 Assessment of skin irritancy: measurement of skin fold thickness Contact Dermatitis 9(1):21-6 N Not applicable as no data protection claimed published Wahlberg JE, Maibach HI 1980 Nonanoic acid irritation - a positive control at routine patch testing-- Contact Dermatitis 6(2):128-30 N Not applicable as no data protection claimed published Wahlberg JE, Wrangsjö K, Hietasalo A. 1985 Skin irritancy from nonanoic acid Contact Dermatitis 13(4):266-9 N Not applicable as no data protection claimed published
Webb, D.R.; Wood, F.E.; Bertram, T.A.; Fortier, N.E. 1993 a 91-day feeding study in rats with carpenin; Fd Chem. Tox. Vol 31, No 12, page 935-946, 1993; no A6.4.1.1.a/01. N Not applicable as no data protection claimed published WHO/IPCS 2005 Guidance document for the use of data in development of chemical-specific adjustment factors (CSAFs) for interspecies differences in human variability in dose/concentration-response assessment. IPCS harmonization project document ; no. 2 Not applicable as no data protection claimed Willis CM, Stephens CJ, Wilkinson JD. Assessment of erythema in irritant contact dermatitis. Comparison between visual scoring and laser Doppler flowmetry Contact Dermatitis 18(3):138-42 N Not applicable as no data protection claimed published Willis CM, Stephens JM, Wilkinson JD Experimentally-induced irritant contact dermatitis. Determination of optimum irritant concentrations Contact Dermatitis 18(1):20-4. N Not applicable as no data protection claimed published York M, Griffiths HA, Whittle E, Basketter DA. 1996 Evaluation of a human patch test for the identification and classification of skin irritation potential. Contact Dermatitis 34(3):204-12. N Not applicable as no data protection claimed published Kegley, S, Conlisk E, Moses M 2008 Marin Municiapal Water District herbicide Risk Assessment, (Draft), Chapter 7 N Not applicable as no data protection claimed published OF STUDIES FOR THE BIOCIDAL PRODUCT – SORTED BY SECTION NUMBER Section No / Reference No Author(s) Year Title. Source (where different from company) Company, Report No. GLP (where relevant) / (Un)Published Data Protection Claimed (Yes/No) Date of 1st submission Owner B3.1.1/01 Almond D.S. 2001 Storage Stability of NEU Eco-Care Technologies Inc., Sidney, BC V8L 5L6, Canada Report No. NEU1170-990409 GLP, Unpublished Y W. Neudorff GmbH KG
ArGe GAB Biotech/IFU, Report No. 99024/01-AAAf GLP, Unpublished IV-1: Note: The technical terms “active ingredient” and “active substance” are equivalent Stand. Term / Abbreviation Explanation A ampere Ach acetylcholine AchE acetylcholinesterase ADI acceptable daily intake ADME administration distribution metabolism and excretion ADP adenosine diphosphate AE acid equivalent AEC Acceptable exposure concentration AEL Acceptable exposure level AF assessment factor AFID alkali flame-ionisation detector or detection A/G albumin/globulin ai active ingredient Ann. Annex AOEL acceptable operator exposure AP alkaline phosphatase approx approximate ARC anticipated residue contribution ARfD acute reference dose as active substance AST aspartate aminotransferase (SGOT) ASV air saturation value ATP adenosine triphosphate BAF bioaccumulation factor BCF bioconcentration factor BOD biological oxygen demand bp boiling point BP Biocidal Product BPD Biocidal Products Directive BSAF biota-sediment accumulation factor BSP bromosulfophthalein bw body weight °C degrees Celsius (centigrade) CAS Chemical Abstracts Service CEC cation exchange capacity cf confer, compare to ChE cholinesterase CI confidence interval CL confidence limits cm centimetre CNS central nervous system COD chemical oxygen demand CPK creatinine phosphatase cv coefficient of variation
CSF Confidential Statement of Formula Cv ceiling value d day(s) DIS draft international standard (ISO) DNA deoxyribonucleic acid dna designated national authority DO dissolved oxygen DOC dissolved organic carbon DT50(lab) period required for 50 percent dissipation (under laboratory conditions) (define method of estimation) period required for 90 percent dissipation (under field conditions) (define method of estimation) dw dry weight DWEL Drinking Water Equivalent Level decadic molar extinction coefficient EbC50 median effective concentration, biomass ErC50 median effective concentration, growth rate EC50 median effective concentration ECD electron capture detector ED50 median effective dose EDI estimated daily intake EINECS European inventory of existing commercial substances ELINCS European list of notified chemical substances e-mail electronic mail EMDI estimated maximum daily intake EN European norm EPA U.S. Environmental Protection Agency EPMA electron probe micro-analysis EUSES European Union system for the evaluation of substances F field F0 parental generation F1 filial generation, F2 filial generation, second FBS full base set FDA Food and Drug Administration FELS fish early-life stage FID flame ionisation detector Fmol fractional equivalent of the metabolite´s molecular weight compared to the active substance FOB functional observation battery foc organic carbon factor (compartment dependent) fp freezing point FPD flame photometric detector FPLC fast protein liquid chromatography g gram(s) GAP good agricultural practice GC gas chromatography GC-EC gas chromatography with electron capture detector GC-FID gas chromatography with flame ionisation detector GC-MS gas chromatography-mass spectrometry GC-MSD gas chromatography with detection GEP good experimental practice GGT gamma glutamyl transferase GI gastro-intestinal GIT gastro-intestinal tract GL guideline level GLC gas liquid chromatography GLP good laboratory practice GM geometric mean GPC gel-permeation chromatography GSH glutathione GV granulosevirus h hour(s) H Henry’s Law constant (calculated as a unitless value) ha hectare(s)
Hb haemoglobin HC5 concentration which will be harmless to at least 95 % of the species present with a given level of confidence (usually 95 %) HDT highest dose tested hL hectolitre HEED high energy electron diffraction HID helium ionisation detector HPAEC high performance anion exchange chromatography HPLC high pressure liquid chromatography or high performance liquid chromatography HPLC-MS high pressure liquid chromatography – mass spectrometry HPPLC high pressure planar liquid chromatography HPTLC high performance thin layer chromatography HRGC high resolution gas chromatography HS Shannon-Weaver Ht haematocrit HUSS and use safety standard I indoor I50 inhibitory dose, 50% IC50 median immobilisation concentration or median inhibitory concentration 1 ID ionisation detector im intramuscular inh inhalation ip intraperitoneal IPM integrated pest management IR infrared ISBN international standard book number ISSN international standard serial number IUCLID International Uniform Chemical Information Database iv intravenous k (in combination) kilo k rate constant for biodegradation K Kelvin Ka acid dissociation constant Kb base dissociation constant Kads adsorption constant Kdes apparent desorption coefficient kg kilogram KH Henry´s Law constant (in atmosphere per cubic metre per mole) Koc organic carbon adsorption coefficient Kom organic matter adsorption coefficient Kow octanol-water partition coefficient Kp solid-water partition coefficient kPa kilopascal(s) l, L litre LAN area network light amplification by stimulated emission of radiation LBC loosely bound capacity LC liquid chromatography LC-MS liquid chromatography- mass spectrometry LC50 concentration, median LCA life cycle analysis LC-MS-MS liquid chromatography with tandem mass spectrometry LD Lethal Dose-low LD50 lethal dose, median; dosis letalis media LEL Lowest Effect Level ln natural logarithm lowest observable adverse effect concentration LOAEL lowest observable adverse effect level LOC Level of Concern LOD limit of detection LOEC lowest observable effect concentration LOEL lowest observable effect level log logarithm to the base 10 LOQ limit of quantification (determination)
LPLC low pressure liquid chromatography LSC liquid scintillation counting or counter LSD least squared denominator multiple range test LSS liquid scintillation spectrometry LT lethal threshold m M molar µm micrometer (micron) MAC maximum allowable concentration MAK maximum allowable concentration MC moisture content MDL method detection limit µg microgram mg milligram MHC moisture holding capacity MIC minimum inhibitory concentration min minute(s) MKC minimum killing concentration mL millilitre MLD median lethal dose MLT minimum lethal time mm millimetre mo month(s) MOE margin of exposure mol mole(s) MOS margin of safety Mp melting point MRL maximum residue level or limit MS mass spectrometry MSDS material safety data MTD maximum tolerated dose MT material test MW molecular weight n.a., N/A not applicable n- normal (defining isomeric configuration) N number of observations nd not detected NEL no effect level NERL no effect residue level ng nanogram nm nanometre NMR nuclear magnetic resonance no, n° number no observed adverse effect concentration no observed adverse effect level NOEC no observed effect concentration NOErC no observed effect concentration, growth rate NOED no observed effect dose NOEL no observed effect NPD nitrogen-phosphorus detector or detection NPV nuclear polyhedrosis NR not reported OC organic carbon content OEL occupational exposure OH hydroxide OJ Official Journal OM organic matter content Pa pascal PAD pulsed amperometric detection pc paper chromatography PC personal computer PEC predicted environmental concentration PECA predicted environmental concentration in air PECS predicted environmental concentration in soil PECSW predicted environmental concentration in surface water predicted environmental concentration in ground water PED plasma-emissions-detector pH
pKa negative logarithm (to the base 10) of the acid dissociation constant pKb negative logarithm (to the base 10) of the base dissociation constant PNEC predicted no effect concentration (compartment to be added as subscript) po by mouth POP persistent organic pollutants ppb parts per billion (10 -9) PPE personal protective equipment ppm parts per million (10 -6) PPP plant protection product ppq parts per quadrillion (10 -24) ppt parts per trillion (10 -12) PRL practical residue limit PT product type PT(CEN) project team CEN PTT partial thromboplastin time Q*1 The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model (Q)SAR quantitative structure-activity relationship r correlation coefficient r2 coefficient of determination RA risk assessment RC risk characterisation Rf retardation factor RfD reference dose RH relative humidity RP reversed phase RRT relative retention time RS Registration Standard RSD relative standard deviation s second S solubility SAP serum alkaline phosphatase SAR structure/activity relationship SBLC shallow bed liquid chromatography sc subcutaneous SCAS semi-continous activated sludge SCTER smallest chronic toxicity exposure ratio (TER) SD standard deviation se standard error SEM standard error of the mean SF safety factor SIMS secondary ion mass spectroscopy SOP standard operating procedures sp species (only after a generic name) SPE solid phase extraction SPF specific pathogen free ssp subspecies STP sewage treatment plant t tonne(s) (metric ton) t½ half-life (define method of estimation) TC Toxic Concentration TD Toxic Dose TG technical guideline, technical TGD Technical guidance document TID thermionic detector, alkali flame detector TER toxicity exposure TERI toxicity exposure ratio for initial exposure toxicity exposure ratio following repeated exposure TERLT toxicity exposure ratio following chronic exposure tert tertiary (in a chemical name) TLC thin layer chromatography TMDI theoretical maximum daily intake TNsG technical notes for guidance TOC total organic carbon TTC Toxicological-Threshold-of-Concern TWA time weighted average UF uncertainty factor (safety factor) ULV ultra low volume
UR unit risk UV ultraviolet UVC unknown or variable composition, complex reaction products UVCB undefined or variable composition, complex reaction products in biological material v/v volume ratio (volume per volume) vis visible WBC white blood cell Wk week WP Wettable Powder WPS Worker Protection Standard wt weight w/v weight per volume ww wet weight w/w weight per weight Yr year < less than less than or equal to > greater than greater than or equal to