Document XOXQB33LeGN5ddjBMN6xGM88G

November 7, 1989 fl/J ^ Peter Lloyd CL-OTM-3 SUBJECT: LINDANE - WIRE & CABLE JACKETING This is in response to our conversation and your note to Bob Hinderer regarding the use of Lindane in wire and cable jacketing. If the use is only to protect the jacketing or coating itself against termites, the end product would not be considered a pesticide. If, however, any claims are made that the end product has pesticidal uses, then it would be subject to the Federal Insecticide, Fungicides and Rodenticide Act and all of the ramifications thereof. Consequently, one must be very careful about the claims made for such a product (see enclosed copy of 40CFR 162.4). I talked to EPA about registered termite control products. Lindane is not being used because its registration for use against termites was cancelled by default. That is, apparently the producers were not willing to develop and submit data that EPA required for this use. The product most used now is chlorpyorifos and synthetic pyrethins. I am enclosing a copy of the documentation for the TLV-TWA's for these three substances. Please note. Lindane and chlorpyrifos have a skin notation indicating that they can be absorbed through the skin. Other than complying with the exposure level limitations and OSHA Hazardous Substance Communication Regulations, I know of no other regulatory requirements. I am sorry I have no expert's names to supply you, otherwise, you may wish to consult with suppliers of the above pesticides for their recommendations. Bachtefcj, 91107-2/jp Attachments cc: R. Hinderer (w/o attachments) BGH19033 22139001 162.4 Title 40--Protection of Environment (mm) The term "teratogenic" means (2) Crop or animals treated; the property of a substance or mixture of substances to produce or induce functional deviations or developmen tal anomalies, not heritable, in or on an animal embryo or fetus. (nn) The term "toxicity" means the property of a substance or mixture of substances to cause any adverse ef (3) Application site; and (4) Application technique, rate and frequency. (rr) The term "volatility" means the property of a substance or substances to convert into vapor or gas without chemical change. fects. (1) The term "acute toxicity" means the property of a substance or mixture of substances to cause adverse effects in an organism through a single short term exposure. (2) The term "subacute toxicity" means the property of a substance or mixture of substances to cause adverse effects in an organism upon repeated or continuous exposure within less than Vi the lifetime of that organism. (3) The term "chronic toxicity" means the property of a substance or mixture of substances to cause adverse effects in an organism upon repeated or continuous exposure over a period 9162.4 Status of products as pesticides. (a) Determination of intent of use. A substance or mixture ot substances is a pesticide under the Act if it is intend ed for preventing, destroying, repel ling or mitigating any pest. (See sec tion 2(u) of the Act and f l2.3(ff).) Such intent may be either expressed or implied. If a product Is represented In any manner that results in its being used as a pesticide, it shall be deemed to be a pesticide for the purposes of the Act and these regulations. (b) Product* contidered to be pesti cide*. A product will be considered to be a pesticide if: of at least Vi the lifetime of that orga (1) Claims or recommendations for nism. use as a pesticide are made on the (00) The term "use" means any act label or labeling of the product includ of handling or rlease of a pesticide, or ing. but not limited to, collateral ad exposure of man or the environment vertising, such as publications, adver to a pesticide through acts. Including tising literature which does not accom but not limited to: pany the product, or advertisements (1) Application of a pesticide, includ by radio or television; ing mixing and loading and any re <2) Claims or recommendations for quired supervisory action in or near use as a pesticide are made verbally or the area of application; In writing by representatives of the (2) Storage actions for pesticides and manufacturer, shipper, or distributor pesticide containers; and of the product; (3) Disposal actions for pesticides (3) The product is intended for use and pesticide containers. as a pesticide after reformulation or [Use as defined here incorporates applica tion. However, the certification requirement repackaging; or (4) The product is intended for use for certain restricted use pesticides only ap both as a pesticide and for other pur plies with respect to applications of such poses. pesticides. Many aspects of use do not in clude application (e.g. storage, transporta tion), and hence are outside the require ment for certification.] (c) Products not considered pesti cide*. The following are examples of the types of products which are not considered pesticides: (pp) The tern "use-dilution" means (1) Deodorizers, bleaching agents, a dilution specified on the label or la and cleaning agents for which no pes- beling which produces the concentra ticldal claims are made in connection tion of the pesticide for a particular with manufacture, sale, or distribu purpose or effect. tion: (qq) The term "use pattern" means the manner in which a pesticide is ap plied and Includes the following pa rameters of pesticide application: (1) Target pest; (2) Paints and other formulated coatings which are treated with fungi cides to protect the coating itself and for which no pesticidal claims are made in the manufacture, sale, or die- 14 Chapter I--Environmental Protection Ag tribution of the product as to protec tion of other surfaces or objects; (3) Building material products per se, such as lumber, fiber boards, adhe sives, and caulking material, which have been treated to protect the mate rial Itself against any pest and for which no pesticidal claims are made as to protection of other surfaces or ob jects in the manufacture, sale, or dis tribution of the product; (4) Fabric products per se which have been treated to protect the fabric product itself from insects, fungi, or any other pest and for which no pesti cidal claims are made as to protection of other surfaces or objects in the manufacture, sale, or distribution of the product; (5) Fertilizers and other plant nutri ents per se; and (6) Intermediate substances intend ed for the production of a pesticide product by chemical reaction with other substances. IUU Pesticides required to be regis tered. (a) Registration Requirement No person in any state may distribute, sell, offer for sale, hold for sale, ship, deliver for shipment, or receive and (having so received) deliver or offer to deliver to any person any pesticide which is not registered with the Ad ministrator, except as provided by paragraph (b) of this section. (b) Exemption from Registration Re quirement The following pesticides are exempt from the registration re quirements of the Act and this part: (1) Pesticides transferred between es tablishments. A pesticide which is transferred from one registered estab lishment to another registered estab lishment, operated by the same pro ducer, solely for packaging at the second establishment or for use as a constituent part of another pesticide Produced at the second establishment. However, pesticides transferred in ac cordance with this subsection shall be subject to the following misbranding Provisions under section 2(q) of the Act' 2(qXl) (A), (B), (D), (E), (O), (F) *h accordance with * 162.10UXlXiil)(C), 2(qX2)(A), (C) (i) Snd (Ui)). <D): 22139002 *n*nt rfgwviromwcniol I Agency 12J fMiOeii of the product a* to protec- (2) ]Pesticides transferred under ex- gjjjj a tllto of other surfaces or objects; perimkntifl use permits. A pesticide (IVBulldin* material products per k, belnrwwnsferred for use pursuant to 3 the I h * lumber, fiber boards, adhe- and in accordance with the require Ijices I dvw. i*1 caulking material, which ments of an experimental use permit bout base been treated to protect the mate as provided by sections 5 and 12(bX5> rial ttaelf against any pest and for of the Act and Part 172 of these regu shfcb no pestiddal claims are made as lations; to proteeUon of other surfaces or ob- (3) Pesticides transferred for pur jeetrln the manufacture, sale, or dis poses of disposal A pesticide shipped tribution of the product; solely for purposes of disposal, in ac (4J Fabric products per se which cordance with section 10, Part 16S of base been treated to protect the fabric these regulations, or applicable Ad product itself from insects, fungi, or ministrator's Orders. However, pesti amt other pest and for which no pesti- cides transferred in accordance with, cUU claims are made as to protection this subsection shall be subject to the of other surfaces or objects in the following misbranding' provisions aaiwiftrtnre, sale, or distribution of under section 2(q)- of the Act* the product; 2(qXlXA), (B). (D), (E), (F), (O) in (I) FertOters and other plant nutri- that all containers must be clearly tnts perwand merited that the product is for dispos <8) Intermediate substances intend- al only; 2(qX2XA), (0(1) and <iif>;(D): ed for the production of a pesticide (4) Pesticides intendedfor export A ' product by chemical reaction with pesticide intended solely for export to other substances. any foreign Country, when prepared or packed according to the specifications MU PestieMcs required to be regts- or directions of the foreign, purchaser, : toed. ' (6) Pesticides granted an emergence ft) Registration Requirement No exemption. A pesticide being trans Penan in any state may distribute, ferred for use by a Federal or State 4offor for sale, hold for sale, ship, agency under the provisions of ah- *ner tor shipment, or receive and emergency -exemption, as provided by (haring so received) deliver or offer to section 18 of the Act and Part 188 of jfeltar to any person any pesticide these regulations; and "fcfch is not registered with the ( X61. A pesticide product that is of ffihdstrator, except as provided by fered solely for human use and is alsos buograpb (b) of this section. (1) a new drug within the meaning of (b) Exemption from Registration Re- section 201(p) of the Federal Pood, Mrement The following peeUdded Drug, and Cosmetic Act, or (11) an arti ** exempt from the registration re cle that baa been determined by the quirements of the Act and this part: Secretary of Health, Education, and tl) Pesticides transferred between Welfare not to be a new drug by a reg tablishment*. A pesticide which is ulation establishing conditions of use wansferred from one registered estab- for the article, is exempt from the re . ushment to another .registered estab quirements of the P1FRA. Such prod lishment, operated by the same pro- ucts are subject solely to regulation by Jpeer, solely for packaging at the the Food and Drug Administration in - roeond establishment or for use as a accordance with the Federal Food, , Constituent part of another pesticide Drug, and Cosmetic Act and imple Modueed at the second establishment. menting regulations set forth in Title However, pesticides transferred in ac 21 of the Code of Federal Regulations. cordance with this subsection shall be (7) Other exemptions. The Adminis Object to the following misbranding trator may by regulation exempt from ^provisions under section 2(q) of the the requirements of the Act any pesti ^Atte XqXl) (A), (B). (D), (K). (O). (7) cide which he determines either (i) to fin accordance * with toe adequately regulated by another f 182.10(1X1X111X0, XqX2XA), (C) (i) Federal agency, or (tl) to be of a char lad (UU). (OX acter which is unnecessary to be sub- 15 BFG19035 CHLORPYRIFOS CAS: 2921-88-2 0,0-Diethyl 0-(3,5,6-trkM)ro-2-pyTkfinyl)phosphorothioate; Dursbart* QH.ANO.PS - Skin TLV-TWA, 0.2 mg/m1* CIs/Xv-CI (QHsO),-p-o'\N^va Pure chlorpyrifos is a white crystalline solid. Its physiochemical properties include: Molecular weight: 350.57 Melting point: 42.5 to 43C Vapor pressure:"1 1.87 x 10- ' torr at 25C It is soluble in most organic solvents."11 Chlorpyrifos is an organophosphorus insecticide which was in troduced for use in agriculture in 1965.'4' The acute oral LDS0 in adult female and male rats is reported at 135 and 163 mg/kg, respectively."41 Caines reported the acute oral L0;o as 82 mg/kg.51 The acute dermal LD;o in solvent solutions for rabbits is about 2000 mg/kg."41 Short-term inhalation studies have been carried out by the manufacturer and others. Chlorpyrifos is an active inhibitor of plasma cholinesterase. However, it has only moderate capacity to reduce red blood cell cholinesterase or cause cholinergic symptoms and little capacity to cause systemic injury. Chlorpyrifos is absorbed through the skin of laboratory rabbits and human volunteer subjects. The cholinesterase levels of the humans appeared to be much less affected by the same exposure than rabbits: In limited studies, four repeated doses of 10 mg/kg each, applied to the skin of humans for 12 hours each did not cause depression; but four doses of 25 mg/kg for 12 hours each produced depressed plasma cholinesterase lev els. Red blood cell cholinesterase levels wewunaffected. Chlorpyri fos does not cause demyelination. Chlorpyrifos does not have enough vapor pressure to present a vapor hazard, but inhalation of particles has been shown to depress plasma cholinesterase. Dogs and sheep were exposed for a four-hour period to a thermal fog or liquid aerosol at a concentration of 4 or 8 mg/ft* (140-280 mg/m1). The only effect observed was a mild depression of plasma cholinesterase in the dogs exposed at the higher concentration. In another study in which rabbits and humans were exposed simultaneously to an ultra low volume spray, in order to create an exaggerated exposure, rabbits showed a slight depression in plasma cholinesterase, but there was no effect on plasma cholinesterase of human subjects.1* Dogs and rats fed chlorpyrifos for two years showed no effects due to cholinesterase depression of signs of any systemic toxicity at daily dosages of 3.0 mg/kg per day.171 At daily dosages of 0.3 mg/kg per day and 0.1 mg/kg per day, there was no significant depression of cholinesterase activity in the plasma of dogs and rats, respectively. Human test subjects ingesting 0.03 mg chlorpyrifos/kg per day for three weeks did not show statistically significant plasma cholinesterase depression. Nine doses of 0.1 mg/kg per day caused reduction in plasma cholinesterase depression, but no other effect.1*1 These results were confirmed in a subsequent study of human volunteers ingesting daily for four weeks levels of 0.014, 0.03, and 0.1 mg/kg; * In 1985 the STEL appeared on the Notice of Intended Changes as a deletion with the TWA value retained. significant inhibition of plasma cholinesterase occurred only at the 0.1 mg/kg level.''" Spray workers exposed at 0.5% chlorpyrifos emulsion in field trials for malaria control on premises showed a measurable decrease in plasma and red cell cholinesterase levels."01 In this study, 5 of 7 sprayers showed more than 50 percent reduction in cholinesterase within two weeks after the spraying program began. In another study,'*1 human volunteers were exposed to thermal aerosols con taining chlorpyrifos insecticide for one period. Exposures of 3 to 8 minutes at concentrations of about 0.8 pm/m* in air produced no significant alteration of cholinesterase levels. This concentration result ed from the recommended application rate in thermal fogging. Available studies indicate that chlorpyrifos is rapidly metabolized in the animal body.'*' There was no evidence of teratologic or reproductive effects in male and female rats fed,.1,0 mg/kg per day during a three-generation reproduction and fertility study."" A time-weighted average TLV for chlorpyrifos of 0.2 mg/mJ is recommended to prevent any measurable decrease in plasma cholinesterase activities and provides a very wide margin of safety in preventing cholinergic symptoms or organic injury. The Commit tee also recommends the deletion of the STEL until additional tox icological data and industrial hygiene experience become available to provide better base for quantifying on a toxicological basis what the STEL should be. "The reader is encouraged to review the section on. Excursion Limits in the Introduction to Chemical Substances of the current TLV booklet for guidance and control of excursions above the TLV-TWA, even when the 8-hour TWA is within the recom mended limits. References 1. The Merck Index, 10th ed,, p. 309-310. Merck & Co., Inc., Rahway, New lersey U983).. 2. Martin, H.: Pesticides Manual, 2nd ed. British Crop Protection Council (3971). 3. Spencer, EYj Guide to the Chemicals Used in Crop Protection. Canada Dept, of Agriculture (1968). 4. Cray, H.E: Down to Earth 21:2b (1965). A Dow Chemical Co. Publi cation. 5. Caines, T.B.: Tox. Appl. Pharm. 14:515 (1969). 6. Ludwig, P.Ov D.j. KiRan, HJ. Dishburger and H.N. Edwards: Mosquito News 30:346 (1970). 7. FAO/WHCh Pesticide Residue Report No. FAD/RES/72.6a (November 1972). 8. The Dow Chemical Company: Personal communication to TLV Com mittee, Midland, Ml (1973). 9. Griffin, T.B. et ah Soc. Tax. Abstract No. 32. Atlanta, GA (March 1976). 10. Qiason, DA, MJ. Cranmer, D.C von Windeguth et at Mosquito News 29:591 (1969). 11. The Dow Chemical Company: Communication to the TLV Committee of unpublished data (1972). 138 BFG19036 LINDANE CAS: 58-89-9 HexacMorocyclohexane* gamma isomer cH6a6 * ' ^ " ^ Skin TLV-TWA, 0.5 mg/m3* - Lindane is a white crystalline substance with a slight musty odor. Its physiochemical properties include: Molecular weight: 290.85 Melting point: II2.5C Vapor pressure?" 9.4 x JO* torr at 20C Insoluble in water, it is soluble in chloroform, alcohol, acetone, ether, and benzene. Lindane is an insecticide. The acute oral LD.0 for male rats is 88-125 mg/kg and the acute dermal LD,0 for male rats is 500 mg/kg.*31 Male dd mice given lindane in the diet for 24 weeks at levels-of 250, 305 and 500 ppm developed liver hepatomas.13 41 Comprehensive work on the vapor toxicity of lindane has presented a basis on which to establish the threshold limit for this compound in air. Treon and co-workers`Si found minimal pathology in several species oflaboratory animals exposed seven hours a day, five days weekly for about a year at an average of 0.7 mg/m3 lindane. Spear*1 exposed rats to 0.19 mg/m3 for 24 hours daily, continuously for 655 days and found no pathology.. It would, appear from this work that the initial effect level lies somewhere-between these two values: Fitzhugh and Nelson171 and Lehman found that a dietary levefof 50 ppm (equivalent to 170 mg/man/day) for two years produced no effect in rats, whereas 100 ppm produced tissue damage. Changes of questionable significance may occasionally occur even at50ppm.'71 No change was found in rats fed 0.15 ppm,1* 10 ppm,"" or 30 ppm. "1 Kosa"31 found that patients tolerated highly purified gamma-isomer (lindane) at the rate of 40 mg/man/day.for 14 days, although the same dosage of technical BHC produced diarrhea, vertigo and headache. Lindane was well endured even at 100 mg/man;"31 however, Graeve and Hermring"3' found that, while most patients tolerated lindane at a rate of 45 mg three times a day for three days, one patient showed full epileptic convulsions'. * In 1984 the'STEL was placed on the Notice of Intended Changes as a deletion with the TWA value retained. Neurological studies on 37 workers exposed to lindane over a period of 2 years revealed three with serious EEG disturbances and with minor symptoms and signs seen in 14 of the workers. Blood lindane levels varied from 0.002 to 0.340 ppm. No changes were observed in the EEG patterns of 21 of the exposed individuals. The frequency of clinical symptoms and EEC changes was higher among individuals whose blood contained 0.02 ppm or more lindane. '41 Some authorities believe that man is more sensitive to lindane than animals. A time-weighted average TLV of 0.5 mg/m3 is believed to be sufficiently low to prevent central nervous system effects. At this time, the Committee recommends the deletion of the STEL until ad ditional toxicological data and industrial hygiene experience become available to provide a better base for quantifying on a toxicological basis what the STEL should be. The reader is encouraged to review the section on Excursion Limits in the Introduction toChemical Sub stances of excursions above the TLV-TWA. evert when the 8-hour, - TWA is within, the recommended limits." -r j. - -~ References ' -:i_~ 1. The Merck Index, 10th ed., p. 789. Merck & Gb.,lnc.,-Rahway, New. Jersey (1983). V 2. World Rev. of Pest Control 9:119 (197. - ~ 3. Treon, J.F. etals Rept. from Kettering Laboratory. Univ. of Cincinnati (July 1951). - 4. N^atald, H., S. Tomii, T. TsunueNka et afc Nippon Cangakkai kiii (Proc. lap: Cancec Assoc.) 31:33 (1972). - - 5. Spear, P.J.: Thesis. Univ. Mass. Lib.,Amherst,MA( 19521. 6. FKzhugh, O.G., AJC Nelson and f.P. Ffiwley: |. Pharm. Exptl. Ther. 100:59(1950). 7. Lehman, AJa Q. Bull. Assoc. Food DrUgOfT US. 16:47 (1932)2 8. Ortega, K WJ. Haye* Jr. and WJ. DwfaM Ardfc-Rath. 64:614 (1957). 9. Klknmer, O.ILs Arch. Ixper. Rath. u^ffjarmacoL 227:183 (1955k 10. Metis, IL: Nuovi Ann. ig. MicrobioL 6:90 (1955). __ " 11. Taylor, H. and |. Frodshane Nature l58t55S{1956> - 12. Klosa, Die Phamazie 5:615 (1950). , 13. Graeve. K. and G. Herrnring: Klin.' Wochschr. 28:62^.(1950). 14. CzegfedHanko, G. and F. Avars Brit 1. fed. Med- 27:283 (1970). 22139005 -m- 348 BFG19037 PYRETHRUM CAS: 8003-34-7 1) Pyrethrin I or II; 2) Gncrin I or II; 3) Jasmolin I or II 1) C2tHM0, or CjjHj.0,; 2) QH^O, or C2,H2,05; 3) C2,HM03 or C22HmOs TLV-TWA, 5 mg/m3* A viscous brown resin or solid, pyrethrum's active principles are pyrethrins I and II, cinerins I and II, and jasmolin I and II, which are collectively known as the pyrethrins. The arrangement of these ac tive components indicates these to be esters as depicted by the struc ture above. Their physiochemical properties include: Molecular weights: 316 to 374 Vapor pressure: ~ 0 torr at 20C Open cup flash points: 180 to I90F (82 to 88C) 1) 1 II 2) 1 II 3) 1 II R -CHj-CH-CH-CH-CHj -CHj-CH-CH-CH-CH, -CHrCH-CH-CHj -CHrCH-CH-CH, -CHj-CH-CH-CHj-CHj -CHrCH-CH-CHrCH, R* -CH, -COOCH, -CH, -COOCH, -CH, -COOCH, Pyrethrum is insoluble in water, but soluble in alcohol, acetone, kero sene, carbon tetrachloride, nitromethane, and ethylene dichloride. Alkalies and acids speed up hydmlysis of the pyrethrins. Pyrethrum is a botanical insecticide and the pyrethrins may be ex tracted in kerosene, alcohol, acetone or ethylene dichloride for for mulation in dust, sprays, etc. They are stable for long periods of time in water based aerosols, but are oxidized on exposure to air and may loose 20% of their activity in a year.1" Pyrethrum has a low order of toxicity to warm blooded animals. The acute oral LDW for the rat is 1500 mg/kg, while the acute der mal LDm is greater than 1800 mg/kg."1 Carpenter and co-workers'31 found the oral LDW to be 820 mg/kg for rats. No gross effects were observable in animals fed diets containing less than 500 ppm pyrethrins. The same authors exposed rats at 6000 mg/m3 of pyrethrum in peanut oil for thirty minutes.'31 Moderate lung conges tion resulted. Rats and dogs inhaled a concentration of 16 mg/m3 for 30-minute periods during 31 days with only slight lung irritation. Lehman'31 estimated that the fatal human dose might be 100 grams (1430 mg/kg) for a 70-kg man. Ambrose and Robbins'41 reported no effect in rats fed pyrethrins at a dietary level of 1000 ppm for two years, but tissue damage and gross signs appeared in some rats given 5000 ppm. Lehman'51 con firmed these results. The no-effect level corresponds to a rate of 3600 mg/man/day. * In 1985 the STEL was placed on the Notice at Intended Change* a* a deletion with the TWA value retained. Mitchell et a/ have described a case of allergic dermatitis to pyrethrum which was confirmed by patch test.161 No exposure esti mates were made. Baer et a/ have reported that 3.1 % of 200 pa tients selected for contact dermatitis or other skin disease responded to pyrethrum.171 The TLV of 5 mg/m3, as a time-weighted average, is believed to be low enough to prevent systemic effects. At this time, the"Com mittee recommends the elimination of the STEL until additional tox icological data and industrial hygiene experience become available to provide a better base for quantifying on a toxicological basis what the STEL should be. The reader is encouraged to review the section on Excursion Limits in the Introduction to the Chemical Substances of the current TLV booklet for guidance and control of excursions above the TLV-TWA, even when the 8-hour TWA is within the recom mended limits. References 1. farm Chemicals Handbook. Meister Publishing Co., Willoughby, OH (1979). 2. Carpenter, CP., CS. Wed, U.V. Pozzani and H.F. Smyth, Jr.: Arch Ind. Hyg. Occup. Med. 2:420 (1950). 3. Lehman, AJu Q. Bull. Assoc. Food Drug Off. U.S. 13:65 (1949). 4. Ambrose, AM. and D. Robbins Fed. Proc. 10:276 (1951). 5. Lehman, A.|u Q. Bull. Assoc. Food Drug Off. U.S. T6:47 (1949). 6. MitcheB, J.C, C Dupuis and CRN. Towers Brit I. Dermatol. 86(6):568 (1972). 7. Baer, ILL., D.L Ramsey and E. Biondb Arch. Dermatol. 108:74 (1973). 22139006 506 BFG19038