Prior Informed Consent Decision Guidance Document
Lindane

1 Identification

1.1 Common Name Lindane

Other names/synonyms gamma-HCH, gamma-BHC (refers to more than 99% gamma isomer), gamma-HKhTsH, ENT 7796, OMS17

1.2 Chemical Type

Chlorinated hydrocarbon

1.3 Use

Insecticide, Acaracide

1.4 Chemical Name

Gamma isomer of 1,2,3,4,5,6-hexachlorocyclohexane, 1-alpha, 2-alpha, 3-beta, 4-alpha, 5-alpha, 6-beta hexachlorocyclohexane

1.5 CAS No. 58-89-9
1.6 Trade Names

666; Aalindan; Africide; Agrocide; Agrocide III; Agrocide WP; Ameisenmittel Merck; Ameisentod; Aparasin; Aphtiria; Aplidal; Arbitex; BBH; Ben-Hex; Bentox; Bexol; Celanex; Chloresene; Codechine; DBH; Detmol-Extrakt; Devoran; Dol; Drill Tox-Spezial Aglukon; ENT 7796; Entomoxan; Exagamma; Forlin; Gallogama; Gamaphex; Gammalin; Gammalin 20; Gammex; Gammexane; Gammaterr; Gexane; Grammapox; Hecltox; Hexa; Hexachloran; y-Hexachloran; Hexachlorane; Hexaverm; Hexicide; Hexyclan; HGI; Hortex; Inexit; Isotox; Jacutin; Kokotine; Kwell; Lacca Hi Lin, Lacca Lin-O-Mulsion; Lendine; Lentox; Linafor; Lindafor; Lindagam; Lindagrain; Lindagam; Lindagram; Lindatox; Lindasep; Lin-O-Sol; Lindagranox; Lindalo; Lindamul; Lindapoudre; Lindaterra, Lindex; Lindust; Lintox; Lorexane; Milbol 49; Msycol; Neo-Scabicidol; Nexen FB; Nexit; Nexit-Stark; Nexol-E; Nicochloran; Novigam; Omnitox; Ovadziak;Owadizak; Pedraczak; Pflanzol; Quellada; Sang-gamma; Silvanol; Spritz-Rapidin; Spruehpflanzol; Streunex; TAP 85; Tri-6; Vitron

1.7 Mode of action

as Pesticide Insecticide with contact, stomach and respiratory action. Acts as stimulant to the nervous system causing epileptiform convulsions and death.

1.8 Formulation Types

Emulsifiable concentrates (0.45% to 40% with 11% or 12% & 20% common); flowable concentrates (0.5%, 1.0%, 30%, & 40%) wettable powders (3%, 6%, 9%, 10%, 25%, 75%); pressurized liquids (0.25%, 0.75%, 3%); dusts (0.5% to 75% with 1% common); smoke generators (10.2, 11.2, 20.0%); liquid ready-to-use (0.5% to 25% with 0.1% & 0.5% common); tech. grade (99%, 99.5%, 100%)

1.9 Basic Manufacturers

Agrolinz (Austria); All India Medical Corp. (India); Celamerck GmbH KG Ingelheim, (Fed. Rep. Germany); Drexel Chemical Co. (USA); Inquinosa (Spain); Mitsui, Inc. (Fukuoka, Japan); Rhône-Poulenc; Phytosanitaire (Lyons, France); Tianjin International Trust & Investment Corp. (Tianjin, China).

2 Summary of Control Actions

2.1 General

Actions to ban or severely restrict lindane have been taken by 11 countries. Seven countries have banned lindane.The actions reported by governments to IRPTC/UNEP are listed in Annex I.

2.2 Reasons for the Control Actions

Control actions are reported by eleven countries. Eight (Australia, Austria, Cyprus, Finland, Indonesia, the Netherlands, New Zealand and Saint Lucia) indicated that lindane was being restricted or banned because of persistency in the environment, bioaccumulation in the food chain and toxicity to humans, aquatic and terrestrial species. One country (the Netherlands) indicated the impurities of lindane (other HCH isomers) as the environmental problem. Four countries (Austria, Republic of Korea, Sri Lanka and Sweden) referred to their concern over toxicity specifically to humans. Lindane has been associated with various human health concerns for several years.

2.3 Bans and restrictions

Eleven countries have partially or totally banned use on food or feed commodities. (Refer to Annex 1 for details.)

2.4 Uses Reported to be Continued in Effect

Seed treatment and soil treatment uses have been retained by several countries which have otherwise banned food/feed uses. Seven countries have retained a few remaining uses. (Refer to Annex 1 for details.)

2.5 Alternatives

Specific alternatives were suggested by some countries reporting control actions (Annex 2). It is important to remember that the effectiveness of any alternative pesticide needs to be established under conditions of use in specific crops and countries.

2.6 Contacts for Further Information

FAO/UNEP Joint Data Base, IRPTC, Geneva; Designated National Authorities (DNAs) in countries taking control actions may be a source of information on alternatives (Annex 3).

3 Summary of Further Information on Lindane

3.1 Chemical and Physical Properties

Technical lindane is a white crystalline solid with a melting point of 112.5-113.50C and boiling point of 323.40C. It is stable to light, heat, air and strong acids but decomposes to trichlorobenzenes and HCl in alkali. It is soluble in most organic solvents and is soluble in water at 10 parts per million (ppm) at 200C. Other chemical and physical properties include vapour pressure of 5.6 mPa at 200C (Pesticide Manual) and specific gravity 1.85.

3.2 Toxicological Characteristics
3.2.1 Classification

WHO a.i. Class II (moderately hazardous)
IARC Group 2B (possible carcinogen but inadequate evidence in humans)
EU Toxic, irritant

3.2.2 General

No information

3.2.3 Acute Toxicity

Oral LD50 rats 90-270 mg/kg; mice: 55-250 mg/kg; rabbit: 90-200 mg/kg (WHO, 1992)
Dermal LD50 rat: 900-1000 mg/kg, rabbit: 200-300 mg/kg (WHO ,1992)
Inhalation Rat LC50 1500 mg/m3/4 hrs (WHO, 1992)
Irritation Eye irritation depends on the inert ingredients more than the active ingredient; lindane is not a primary dermal irritant; negative in the dermal sensitization test.

3.2.4 Short-term Toxicity

Lindane was reviewed by the JMPR a number of times between 1966 and 1979. An ADI of 0.01 mg/kg bw, based on liver enlargement observed in a long-term study in rats. Long-lasting, slowly reversible kidney damage was observed. The JMPR in 1989 established the NOAEL to be 10 ppm for rat, equal to 0.75 mg/kg bw/day, and 1.6 mg/kg bw/day for dog; the ADI for humans was estimated to be 0-0.008 mg/kg bw.

Teratogenicity Foetotoxic and/or maternal toxic effects were observed after administration of lindane at 10 mg/kg bw
NOEL Rat 0.2-0.5 mg/kg bw (WHO, 1991)

3.2.5 Chronic Toxicity

Carcinogenicity There was no increase in tumours to rats fed a maximum of 100 ppm (5mg/kg/day) of lindane throughout their lifespan. A two-year mouse oncogenicity study demonstrated increased incidences of liver tumours (male and female) when dosed at 400 ppm. The IARC (1987) concluded the evidence of carcinogenicity on humans to be inadequate.

Mutagenicity The mutagenicity of lindane has been adequately studied. Overall, lindane appears not to have mutagenic potential (WHO, 1991).

3.2.6 Epidemiological Data

It can be concluded, from a few acute and short-term studies on human beings, that a dose level of approximately 1.0 mg/kg bw will not induce poisoning but that a dose level of 15-17 mg/kg bw will result in severe toxic symptoms (WHO, 1991).

3.3 Environmental Characteristics
3.3.1 Fate

Lindane is mobile in sandy soils and non-mobile in clay soils; it is also retained more strongly where humus levels are high. However, the potential for lindane contamination of surface and ground water exists based on the results of a monitoring study conducted in south-eastern USA.The half-life in soil ranges from 5 days (Kenya) to more than 400 days (temperate soils) depending on both temperature and microbiotic life of the soil (WHO, 1992).In a series of dissipation studies with lindane, it was demonstrated that persistent pesticides such as lindane dissipate much faster in the tropics than in temperate climates, probably owing to a large extent to volatilization (WHO, 1992).

3.3.2 Effects

Fish LC50 : 0.02-0.09 mg/l (highly toxic) (WHO, 1991)
Bees Toxic to bees (Pesticide Manual, 1994)
Aquatic invertebrates Crustaceans: 0.005-0.88 µg/L (WHO 1991)
Birds LD50: 120-210 for bobwhite quail; avian dietary toxicity: 882 ppm for bobwhite quail, 561 ppm for ring-necked pheasant (both moderately toxic); >5000 ppm mallard duck (minimal toxicity)

3.4 Exposure
3.4.1 Food

In the 1970s and 1980s lindane was found in many crops throughout the world as well as in honey and fish and shellfish. Levels of lindane being consumed with food varies from year to year in nations where it has been reported. Lindane concentrates in the fat of food animals and in milk and has been reported in a number of countries in such commodities. More than 90% of human intake of lindane originates from food. Monitoring studies have shown that residues of lindane have been found in mother's milk. In several countries lindane has also been identified in blood serum, fat and adipose tissue (IARC, 1987; WHO, 1991).

3.4.2 Occupational/Use

Workers who are professionally exposed to lindane come into contact with the other HCH isomers present in lindane as impurities. A Japanese study reported levels of beta HCH in human blood plasma in 6 occupational groups who worked with lindane. The lowest mean levels were found in female farm workers (38 µg/l); the highest mean levels were found in male workers in pesticide factories (94 µg/l).

3.4.3 Environment

Monitoring outdoor air samples in the 1980s, the concentrations found in various continents ranged from 0.039 to 0.68 ng/m3. Much higher lindane concentrations (51-61 µg/m3) could be registered in houses after treatment with products containing lindane (WHO, 1991). Lindane has been detected in surface and drinking water and industrial effluent and sewage in Europe and the USA (WHO, 1991). Lindane (29-398 ng/l) has been found in rainwater in Tokyo (1975). It has also been located in soil in many parts of the world. In a Dutch study from 84 were analysed 96 samples from the upper 10 cm of soil from 38 natural reserves in the Netherlands. Fifty-nine samples contained less than 1 µg/kg, 7 contained 20-80 µg/kg. However, in the Ukraine, 36 of 136 soil samples taken at various locations contained lindane at levels of 0.1-5 mg/kg (WHO, 1991).

3.4.4 Accidental Poisoning

IARC reports that digestive tract inflammation, haemorrhaging, coma and death have been reported after lindane poisoning. Workers who were heavily exposed to lindane, DDT or both for periods ranging from 5-13 years, at time of liver biopsy showed cirrhosis and chronic hepatitis. Lindane is a central nervous system stimulant for which no specific antidote is available. A short-acting barbiturate should be used for alleviation of symptoms. Diazepam is the preferred treatment for convulsions (IARC, 1987).

3.5 Measures to Reduce Exposures

Protective clothing and gloves will reduce exposure of those handling and applying lindane. Additionally, goggles or a face shield should be worn.

3.6 Packaging and Labelling

Labels should include precautions and warnings related to applicator, handler and worker exposure, as well as hazards to aquatic organisms. Refer to the FAO Revised Guidelines on Good Labelling Practices for Pesticides (1995).

3.7 Waste Disposal Methods (WHO/IPCS, 1990)

In disposing of lindane, care should be taken to avoid contamination of natural waters and soil. Suggested methods of disposal are alkaline hydrolysis and high temperature incineration designed for organochlorine waste disposal. Detailed guidelines are under development. This section will be updated when guidelines are available.

3.8 Maximum Residue Limits (mg/kg)

Codex/JMPR ADI: 0.008 mg/kg bw (FAO, 1989)

Codex MRLs: (mg/kg) Apples, 0.5; beans (dry), 1 Po; Brussels sprouts, cabbage (head and Savoy), 0.5; cacao beans, 1.0; carrots, 0.2 E; cauliflower, 0.5; cereal grains, 0.5 Po; cherries, 0.5; cocoa (butter and mass), 1.0 cranberry, 3.0; currant (red and white), 0.5; eggs, 0.1 E; endives, 2.0; grapes, 0.5; kohlrabi, 1.0; lettuce (head), 2.0; meat of cattle, pigs and sheep 2.0 (fat) V; milks, 0.01 F V; pear, 0.5; peas, 0.1; plums (including prunes), 0.5; potato, 0.05; poultry meat, 0.7 E (fat); radish, 1.0; rape seed, 0.05; spinach, 2.0; strawberry, 3.0; sugar beet (beet, leaves or tops), 0.1; tomato, 2.0.(Codex Alimentarius Commission, 1986).
US Tolerances (ppm) Apples, apricots, asparagus, avocados, broccoli, Brussels sprouts, cabbage, cauliflower, celery, cherries, collards, 1.0; cucumbers, 3.0; eggplants, 1.0; fat of meat (cattle, horses, sheep), 7.0; fat of meat (hogs), 4.0; grapes, guavas, 1.0; kale, kohlrabi, 1.0; lettuce, 3.0; mangoes, 1.0; melons, mushrooms, 3.0; mustard (greens), nectarines, okra, onions (dry bulb only), peaches, pears, 1.0; pecans 0.01; peppers, pineapples, plums (fresh prunes), 1.0; pumpkins, 3.0; quinces, spinach, 1.0; squash, squash (summer), 3.0; strawberries, swiss chard, 1.0; tomatoes, 3.0.

4 Major References

CIRAD (1990). Agricultural Requisites Scheme for Asia and the Pacific and International Co-operation Centre of Agricultural Research for Development. The ARSAP/CIRAD regional agro-pesticide index AsiaCodex Alimentarius Commission (1986). Guide to Codex recommendations concerning pesticide residues, part 2. Maximum limits for pesticide residues, 3rd prelim. issue, Rome, FAOFarm Chemicals Handbook '90 (1990). Meister Publishing. Willoughby, OH, USA FAO (1989). Report. FAO/WHO Joint Meeting on Pesticide Residues (JMPR). FAO, RomeFAO (1995). Revised guidelines on good labelling practices for pesticides. Food and Agriculture Organization, RomeFAO (1996). Technical guidelines on disposal of bulk quantities of pesticides in developing countries. FAO, RomeHealth and Welfare Canada (1990). National pesticide residue limits in food. Ottawa, Ontario, CanadaIARC (1987). International Agency for Research on Cancer. The IARC monographs on the evaluation of the carcinogenic risk of chemicals to humans. Suppl. 7, pp. 220-221. IARC, Lyons, FranceIPCS (1991). International Programme on Chemical Safety: Lindane Health and Safety Guide (No. 124). WHO, Geneva Matsummura, Fumio (1980). Toxicology of insecticides. Plenium Press, New York, NY, USARoyal Society of Chemistry (1991). The Agrochemicals Handbook (3rd ed.). Cambridge, United Kingdom, University of California (1975). Toxicity of pesticides and other agricultural chemicals to honey bees. Univ. Calif, USAU.S. Environmental Protection Agency (1985). Guidance for the reregistration of pesticide products containing lindane as the active ingredient. EPA, Washington, DC, USAU.S. Environmental Protection Agency. Pesticide fact sheet No. 73: lindane. EPA, Washington, DC (Sept. 30, 1985)WHO (1996). The World Health Organization Recommended Classification of Pesticides by Hazard and Guidelines to Classification 1996-1997. World Health Organization, Geneva, WHO/PCS/96.3Worthing, C.R. and R.J. Hance (Eds.) (1994). The Pesticide Manual: A World Compendium (10th ed.). British Crop Council, Surrey, United Kingdom

ANNEX 1

Summary of Control Actions and Remaining Uses as Reported by Countries Actions taken and year effective

Bans

Finland
Control Action - Total ban for use as a pesticide
Effective 1988
Uses still allowed - No remaining uses are allowed
Reasons for control action High risk to human health and the environment
Date of notification

Indonesia
Control Action Registration no longer
Effective 1985
Uses still allowed No remaining uses are allowed
Reasons for control action May induce adverse effects to environment and human health
Date of notification

Korea, Republic of
Control Action Sale and use of the substance and its preparations are prohibited within the country
Effective 1986
Uses still allowed No remaining uses are allowed
Reasons for control action Harmful to human health
Date of notification

Netherlands
Control Action It is prohibited to sell, stock or use all pesticides containing HCH (99% gamma isomer) as active ingredient
Effective 1979
Uses still allowed No remaining uses are allowed
Reasons for control action Persistence of impurities (aplha-, beta-, delta-, and epsilon-isomers of HCH which do not contribute to the activity of gamma-HCH); its high bioconcentration factor leads to biomagnification in the food chain
Date of notification

New Zealand
Control Action Ban on all remaining products and uses
Effective 1990
Uses still allowed No remaining uses allowed
Reasons for control action Environmental reasons
Date of notification

Saint Lucia
Control Action Registration refused; permitted for use as a pesticide
Effective 1987
Uses still allowed No remaining uses allowed
Reasons for control action High residual effects in soil water
Date of notification

Sweden
Control Action Banned for use as pesticide
Effective 1988
Uses still allowed
Reasons for control action Suspected carcinogenic properties and persistence

Severely Restricted

Australia
Control Action Severely restricted; importation of the chemical is prohibited unless specifically approved by the Government
Effective Varies from state to state
Uses still allowed Control of white grub in pineapple
Reasons for control action The persistence of the chemical makes it environmentally unacceptable

Austria
Control Action Severely restricted for use
Effective 1992
Uses still allowed Lindane is only authorized as seed dressing against soil pests for crop farming applications
Reasons for control action High persistence in the environment, its bio-accumulation in the food chain and in human tissues. Lindane is suspected to have carcinogenic properties. There is evidence that HCH-isomers act as a tumour promoter previously initiated by other chemicals

Cyprus
Control Action Severely restricted pesticide
Effective 1987
Uses still allowed Only formulations of lindane containing less than 20% of gamma-HCH in gasoline or paints are registered for the protection of wood (control of termites and other insects). This use constitutes about 10% of all previously allowed uses.
Reasons for control action Risk associated with human health and the contamination of the environment due to its persistence and accumulation of residues in mammalian tissues

Sri Lanka
Control Action Severely restricted
Effective 1986
Uses still allowed Only permitted for pest control in coconut nurseries and for emergency use in spotted locust control. Use in shampoos allowed if approved by the Cosmetic Devices & Drugs Committee.
Reasons for control action All regulatory decisions have been made on the basis of published toxicological and ecotoxicological data in relation both to the socio-economic conditions of the user and the benefits derived from using the pesticides.

ANNEX 2
Alternatives

The following alternatives were noted by countries reporting import decisions under the PIC procedure:

Country
Austria Many alternatives for designated purposes
Australia Azinphos ethyl, carbaryl, chlorpyrifos, endosulfan, fenitrothion, methidathion, disulfoton, methamidophos, mevinphos, vamidothion, diazinon, malathion, permethrin, deltamethrin, bioresmethrin, cyfluthrin, cypermethrin, propoxur, pirimicarb, phonate, methomyl
Indonesia Permethrin, decamethrin, phormothion
Sri Lanka Carbamate pesticides have replaced lindane in agriculture

It is essential that before a country considers substituting any of these reported alternatives, it ensures that the use is relevant to its national needs. A first step may be to contact the DNA in the country where the alternative has been reported (see address: Annex 3). It will then be necessary to determine the compatibility with national crop protection practices.

ANNEX 3

List of Pesticide DNAs in Countries Reporting Control Actions or Alternatives

Australia P Mr. Ian ColemanAgricultural and Veterinary Chemicals Policy SectionDept. of Primary Industries and EnergyGPO Box 858Canberra ACT 2601 Tel.: 0061 6 271 6371Fax.: 0061 6 272 5899Email:icoleman@dpie.gov.au
C Assistant Secretary Environment Standard BranchEnvironment Protection Agency (EPA)40 Blackall St.Barton ACT 2600(Attn.: Ms. Kaye Dal Bon) Fax: 616 274 1172Tel: 616 274 1757

Austria CP Ministry of the EnvironmentDepartment II/3Stubenbastei 5 A - 1010 Vienna Tel: (0043-1-51522 2701 Fax: (0043-1-51522 7744

Cyprus P The ChairmanPest Control Products Bd.Department of Agriculture,, Ministry of Agriculture & Natural ResourcesNicosia Tel: 30-2250/30-2254Tlx: 4660 Minagri CYCab: MINAGRI CYPRUSFax: 361425 Nicosia
C Director Environment ServiceMinistry of Agriculture, Natural Resources & EnvironmentNicosia Tel: 30-2883 Tlx: 4660 Minagri CYCab: MINAGRI CYPRUSFax: 363945 Nicosia
\
Finland CP Finnish Environment AgencyChemicals Division(Attn: Senior Advisor Magnus Nyström)SF - 00251 Helsinki Tel: 358-0-403 005 45 s/b 403 000)Fax: 358-0-4-3-005 91

Indonesia P ChairmanPesticides CommitteeDirektorat Bina Perlindungan TanamanJln. AUP. Pasar MingguJakarta Selatan Tel: 62 (21) 7805652/7806213Fax: 62 (21) 7805652
CP Ms. Masnellyarti HilmanBapedal OfficesArthaloka Bldg., 11th FloorJl. Jend. Sudirman No. 2Jakarta Pusat Tel: (021) 583918Tlx: 62 21 583918Fax: (021) 5703365

Korea, Republic of P DirectorSustainable Agriculture DivisionAgricultural Policy BureauMinistry of Agriculture, Forestry and FisheriesGovernment Complex IIKwacheon 427-760 Tel: 82 2 5037284Fax: 82 2 5073963
CP The DirectorBasic Chemicals Industry DivisionBasic Industry BureauMinistry of Trade, Industry and EnergyGovernment Complex IIKwacheon 427-760 Tel: 82 2 5002464Fax:: 82 2 5039471
C DirectorToxic Substances Management DivisionMinistry of EnvironmentGovernment Complex IIKwacheon 427-760 Tel: 82 2 5049288Fax: 82 2 5046068

Kuwait P The DirectorPlant Wealth DepartmentThe Public Authority for Agriculture Affairs & Fish Res.P.O. Box 21422 13075 Safat Tel: (965) 2452790, 2456835/36Tlx: 46408 EP CNCL KTFax: (965) 2421993-2456836

Netherlands CP The DirectorChemicals DivisionMinistry of Housing, Physical Planning and EnvironmentDirectorate for Chemicals, External Safety and Radiation ProtectionP.O. Box 309452500 GX The Hague(Attn: Dr. K.A. Gijsbertsen) Tel: 31 70 - 3393939Fax: 31 70 - 3391297

New Zealand CP Mr. D.W. LunnChief Scientist (Pesticides)Agricultural Compounds UnitMinistry of Agriculture & FisheriesP.O. Box 40-063Upper Hutt Tel: 064 4 528-6089Fax: 064 4 528-4675

Saint Lucia CP The ChairmanNational Pesticides Control Boardc/o Ministry of AgricultureManoel StreetCastries Tel: 809 4522526Fax: 809 4536314

Sri Lanka P Registrar of PesticidesPesticides Registration OfficeRoyal Botanical GardensP.O. Box 49 PeradeniyaGetambe Tel: 94 08 88135Fax: 94 08 88206

Sweden CP National Chemicals DirectorateAttn.: Mr. Ule JohanssonP.O. Box 1384171 27 Solna Tel: 46 (8) 730 6004Tlx: 10460 AMS SFax: 46 (8) 735 7698

C Industrial and consumer product chemicals
P Pesticides
CP Pesticides, industrial and consumer product chemicals

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