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Australian Drinking Water Guidelines
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  • Australian Drinking Water Guidelines
  • Copyright
  • Table of updates
  • Contents
  • Figures
  • Tables
  • Boxes
  • Introduction
    • Chapter 1: Introduction
      • 1.1 Guiding principles
      • 1.2 About the Guidelines
        • 1.2.1 Scope of the Guidelines
        • 1.2.2 Purpose of the Guidelines
        • 1.2.3 Structure of the Guidelines
      • 1.3 Water quality characteristics
        • 1.3.1 Introduction
        • 1.3.2 Health-based targets
        • 1.3.3 Microbial health-based targets
        • 1.3.4 Physical and chemical guideline values
        • 1.3.5 Radiological screening and reference values
      • 1.4 Community consultation
      • 1.5 Development of the Guidelines
        • 1.5.1 Acknowledgments
      • 1.6 Future revisions of the Guidelines
      • 1.7 References
  • Part 1: Management of Drinking Water Quality
    • Chapter 2: Framework for Management of Drinking Water Quality: overview
      • 2.1 A preventive strategy from catchment to consumer
      • 2.2 Structure of the Framework
      • 2.3 Benefits of the Framework
      • 2.4 The need for multi-agency involvement
      • 2.5 Applying the Framework
      • 2.6 Correlations of the Framework with other systems
    • Chapter 3: Framework for Management of Drinking Water Quality: the twelve elements
      • 3.1 Commitment to drinking water quality management (element 1)
        • 3.1.1 Drinking water quality policy
        • 3.1.2 Regulatory and formal requirements
        • 3.1.3 Engaging stakeholders
      • 3.2 Assessment of the drinking water supply system (element 2)
        • 3.2.1 Water supply system analysis
        • 3.2.2 Assessment of water quality data
        • 3.2.3 Hazard identification and risk assessment
      • 3.3 Preventive measures for drinking water quality management (element 3)
        • 3.3.1 Preventive measures and multiple barriers
        • 3.3.2 Critical control points
      • 3.4 Operational procedures and process control (element 4)
        • 3.4.1 Operational procedures
        • 3.4.2 Operational monitoring
        • 3.4.3 Corrective action
        • 3.4.4 Equipment capability and maintenance
        • 3.4.5 Materials and chemicals
      • 3.5 Verification of drinking water quality (element 5)
        • 3.5.1 Drinking water quality monitoring
        • 3.5.2 Consumer satisfaction
        • 3.5.3 Short-term evaluation of results
        • 3.5.4 Corrective action
      • 3.6 Management of incidents and emergencies (element 6)
        • 3.6.1 Communication
        • 3.6.2 Incident and emergency response protocols
      • 3.7 Employee awareness and training (element 7)
        • 3.7.1 Employee awareness and involvement
        • 3.7.2 Employee training
      • 3.8 Community involvement and awareness (element 8)
        • 3.8.1 Community consultation
        • 3.8.2 Communication
      • 3.9 Research and development (element 9)
        • 3.9.1 Investigative studies and research monitoring
        • 3.9.2 Validation of processes
        • 3.9.3 Design of equipment
      • 3.10 Documentation and reporting (element 10)
        • 3.10.1 Management of documentation and records
        • 3.10.2 Reporting
      • 3.11 Evaluation and audit (element 11)
        • 3.11.1 Long-term evaluation of results
        • 3.11.2 Audit of drinking water quality management
      • 3.12 Review and continual improvement (element 12)
        • 3.12.1 Review by senior executive
        • 3.12.2 Drinking water quality management improvement plan
      • 3.13 References
    • Chapter 4: Framework for the Management of Drinking Water Quality: application to small water supplies
      • 4.1 Introduction
      • 4.2 Applying the Framework
        • 4.2.1 Assessment of the drinking water supply
        • 4.2.2 Preventive measures for drinking water quality management
        • 4.2.3 Implementation of operational procedures and process control
        • 4.2.4 Verification of drinking water quality
      • 4.3 Individual household supplies
      • 4.4 Reference
  • Part 2: Description of Water Quality
    • Chapter 5: Microbial Quality of Drinking Water (Updated 2022)
      • 5.1 Introduction
      • 5.2 Microorganisms in drinking water
      • 5.3 Assessing microbial risk
      • 5.4 Enteric pathogens
        • 5.4.1 Enteric pathogens of concern in drinking water
        • 5.4.2 Contamination of source waters with enteric pathogens
        • 5.4.3 Management of risk from enteric pathogens
      • 5.5 Opportunistic pathogens
      • 5.6 Cyanobacteria
      • 5.7 Nuisance organisms
        • 5.7.1 Organisms causing taste and odour problems
        • 5.7.2 Organisms causing colour problems
        • 5.7.3 Deposits due to iron and manganese bacteria
        • 5.7.4 Corrosion problems due to iron and sulphur bacteria
        • 5.7.5 Problems caused by large numbers of microorganisms
      • 5.8 References
    • Chapter 6: Physical and Chemical Quality of Drinking Water
      • 6.1 Introduction
      • 6.2 Physical quality of drinking water
        • 6.2.1 An overview of physical characteristics
        • 6.2.2 Approach used in derivation of guidelines values for physical characteristics
      • 6.3 Chemical quality of drinking water
        • 6.3.1 Inorganic chemicals
        • 6.3.2 Organic compounds (Revised 2011)
        • 6.3.3 Approach used in derivation of guideline values for chemicals
      • 6.4 Differences between Australian and WHO guideline values
      • 6.5 National and international guideline values (2016)
      • 6.6 References
    • Chapter 7: Radiological Quality of Drinking Water (Updated 2022)
      • 7.1 Introduction
      • 7.2 Sources of radiation in the environment and in drinking water
      • 7.3 Health effects of radiation
      • 7.4 Exposure to radiation
      • 7.5 Units of radioactivity and radiation dose measurement
        • 7.5.1 Units of radioactivity and radiation dose
        • 7.5.2 Converting intake to radiation dose
        • 7.5.3 Average dose of radiation
      • 7.6 Approach for derivation of reference levels and screening values for radionuclides
        • 7.6.1 System for radiation protection
        • 7.6.2 Estimation of the dose from radionuclides in water
        • 7.6.3 Estimation of risk from low-level radiation
        • 7.6.4 Reference levels and screening values for drinking water
        • 7.6.5 Application of reference levels
        • 7.6.6 Remedial measures
      • 7.7 References
    • Chapter 8: Drinking Water Treatment Chemicals (Revised 2006)
      • 8.1 Introduction
      • 8.2 Scope and limit of application of this chapter
      • 8.3 Overview of chemical treatment processes
        • 8.3.1 Control of algae
        • 8.3.2 Coagulation and flocculation
        • 8.3.3 Adsorption
        • 8.3.4 Softening
        • 8.3.5 Oxidation
        • 8.3.6 Disinfection
        • 8.3.7 Adjustment of pH
        • 8.3.8 Addition of buffering capacity
        • 8.3.9 Corrosion inhibition
      • 8.4 Public health measures
        • 8.4.1 Fluoridation
      • 8.5 Assessment of Chemicals acceptable for use in drinking water treatment (revised 2016)
        • 8.5.1 Chemicals assessed prior to 2004
        • 8.5.2 New water treatment chemicals
      • 8.6 Quality assurance for drinking water treatment chemicals
        • 8.6.1 Risks associated with drinking water chemicals
        • 8.6.2 Managing risks
        • 8.6.3 Specifications for the supply of drinking water treatment chemicals
      • 8.7 Monitoring and analytical requirements
      • 8.8 Contaminants in drinking water treatment chemicals
      • 8.9 Useful contacts
      • 8.10 References
  • Part 3: Monitoring
    • Chapter 9: Overview of monitoring (Revised 2021)
      • 9.1 Introduction
      • 9.2 Monitoring overview
        • 9.2.1 Monitoring priorities
        • 9.2.2 Principles of monitoring frequency
        • 9.2.3 Catchment-to-consumer monitoring
      • 9.3 Developing a monitoring program
      • 9.4 Operational monitoring
        • 9.4.1 Operational characteristics
        • 9.4.2 Target criteria
        • 9.4.3 Critical limits at critical control points
        • 9.4.4 Corrective action
        • 9.4.5 Operational monitoring frequency
        • 9.4.6 Chlorination as a critical control point: an example
      • 9.5 Verification of drinking water quality
        • 9.5.1 Monitoring consumer satisfaction
        • 9.5.2 Drinking water quality monitoring
      • 9.6 Water quality issues beyond the point of supply
      • 9.7 Investigative studies and research monitoring
      • 9.8 Validation of barrier performance
      • 9.9 Incident and emergency response monitoring
      • 9.10 Reliability of monitoring data
        • 9.10.1 Sample integrity
        • 9.10.2 Methods
        • 9.10.3 Detection limits
        • 9.10.4 Measurement uncertainty
        • 9.10.5 Field testing
      • 9.11 Monitoring advice for small, remote or community-managed water supplies
      • 9.12 Assessing the significance of short-term exceedances of health-based guideline values
      • 9.13 References
    • Chapter 10: Monitoring for specific characteristics in drinking water (Updated 2022)
      • 10.1 Introduction
      • 10.2 Assessing safety: short-term evaluation of monitoring
        • 10.2.1 Short-term evaluation of operational monitoring
        • 10.2.2 Short-term evaluation of drinking water quality monitoring
      • 10.3 Assessing performance: long-term evaluation of monitoring
        • 10.3.1 Long-term evaluation of microbial performance
        • 10.3.2 Long-term evaluation of health-based chemical performance
        • 10.3.3 Long-term evaluation of aesthetic performance
        • 10.3.4 Long-term evaluation of consumer satisfaction
        • 10.3.5 Improvement plan
        • 10.3.6 Performance reporting
        • 10.3.7 Summary of guideline values for microbial, chemical and physical characteristics
        • 10.3.8 Summary of reference levels and screening values for radiological characteristics
      • 10.4 Reference
  • Part 4: Information sheets
    • 1. Disinfection
      • 1.1: Introduction to water treatment
      • 1.2: Overview of disinfection
      • 1.3: Disinfection with chlorine
      • 1.4: Chloramines
      • 1.5: Disinfection with chlorine dioxide
      • 1.6: Disinfection with ozone
      • 1.7: Disinfection with ultraviolet light
      • 1.8: Other disinfectants
    • 2. Sampling
      • 2.1: Sampling Information – handling requirements and preservation
      • 2.2: Radiological monitoring and assessment of performance (updated 2022)
    • 3. Statistics
      • 3.1: Statistics – Visualising data
      • 3.2: Statistics – Assessing data
      • 3.3: Statistics – Statistical principles
      • 3.4: Statistics – Control charts and trends
      • 3.5: Number of samples required
      • 3.6: Guidance for issuing and lifting boil water advisories
      • Attachments
  • Part 5: Fact sheets
    • Microorganisms
      • Microbial indicators
        • Bacteroides
        • Coliphages
        • Clostridium perfringens
        • Escherichia coli
        • Heterotrophic plate counts
        • Intestinal enterococci
        • Thermotolerant coliforms
        • Total coliforms
      • Bacteria
        • Aeromonas
        • Burkholderia pseudomallei
        • Campylobacter
        • Escherichia coli (E. coli) (pathogenic)
        • Helicobacter pylori
        • Klebsiella
        • Legionella
        • Mycobacterium
        • Pseudomonas aeruginosa
        • Salmonella
        • Shigella
        • Vibrio
        • Yersinia
      • Protozoa
        • Acanthamoeba
        • Blastocystis
        • Cryptosporidium
        • Cyclospora
        • Giardia
        • Naegleria fowleri
      • Cyanobacteria and their toxins
        • Cyanobacteria and their toxins
        • Cylindrospermopsin
        • Microcystins
        • Nodularin
        • Saxitoxins
      • Viruses
        • Adenovirus
        • Enterovirus
        • Hepatitis viruses
        • Norovirus
        • Rotavirus
    • Physical and chemical characteristics
      • Acephate
      • Acrylamide
      • Aldicarb
      • Aldrin and Dieldrin
      • Aluminium
      • Ametryn
      • Amitraz
      • Amitrole
      • Ammonia
      • Antimony
      • Arsenic
      • Asbestos
      • Asulam
      • Atrazine
      • Azinphos-methyl
      • Barium
      • Benomyl
      • Bentazone
      • Benzene
      • Beryllium
      • Bioresmethrin
      • Boron
      • Bromacil
      • Bromate
      • Bromoxynil
      • Cadmium
      • Captan
      • Carbaryl
      • Carbendazim/Thiophanate-methyl
      • Carbofuran
      • Carbon tetrachloride
      • Carboxin
      • Carfentrazone-ethyl
      • Chloral hydrate (Trichloroacetaldehyde)
      • Chlorantraniliprole
      • Chlordane
      • Chlorfenvinphos
      • Chloride
      • Chlorinated furanones
      • Chlorine
      • Chlorine dioxide, Chlorite, Chlorate
      • Chloroacetic acids: chloroacetic acid, dichloroacetic acid (DCA), trichloroacetic acid (TCA)
      • Chlorobenzene
      • Chloroketones
      • Chlorophenols
      • Chloropicrin
      • Chlorothalonil
      • Chlorpyrifos
      • Chlorsulfuron
      • Chromium
      • Clopyralid
      • Colour (True)
      • Copper
      • Cyanide
      • Cyanogen chloride
      • Cyfluthrin, Beta-cyfluthrin
      • Cypermethrin isomers
      • Cyprodinil
      • 2,4-D [(2,4-Dichlorophenoxy) acetic acid]
      • DDT (1,1,1-trichloro-di-(4-chlorophenyl) ethane)
      • Deltamethrin
      • Diazinon
      • Dicamba
      • Dichlorobenzenes
      • Dichloroethanes: 1,1-dichloroethane, 1,2-dichloroethane
      • Dichloroethenes: 1,1-dichloroethene (1,1-DCE), 1,2-dichloroethene (1,2-DCE)
      • Dichloromethane (methylene chloride)
      • 1,3-Dichloropropene
      • Dichlorprop/Dichlorprop-P
      • Dichlorvos
      • Diclofop-methyl
      • Dicofol
      • Diflubenzuron
      • Dimethoate
      • Diquat (ion), Diquat dibromide
      • Dissolved oxygen
      • Disulfoton
      • Diuron
      • 2,2-DPA
      • Endosulfan
      • Endothal
      • Epichlorohydrin
      • EPTC
      • Esfenvalerate
      • Ethion
      • Ethoprophos
      • Ethylbenzene
      • Ethylenediamine tetraacetic acid (EDTA)
      • Etridiazole
      • Fenamiphos
      • Fenarimol
      • Fenchlorphos
      • Fenitrothion
      • Fenthion
      • Fenvalerate
      • Fipronil
      • Flamprop-methyl
      • Fluometuron
      • Fluoride
      • Flupropanate
      • Formaldehyde
      • Glyphosate
      • Haloacetonitriles
      • Haloxyfop
      • Hardness (as calcium carbonate)
      • Heptachlor and heptachlor epoxide
      • Hexachlorobutadiene
      • Hexazinone
      • Hydrogen sulfide, Sulfide
      • Imazapyr
      • Iodine, Iodide
      • Iprodione
      • Iron
      • Lanthanum
      • Lead
      • Lindane
      • Maldison (Malathion)
      • Mancozeb
      • Manganese
      • MCPA
      • Mercury
      • Metaldehyde
      • Metham
      • Methidathion
      • Methiocarb
      • Methomyl
      • Methyl bromide
      • Metiram
      • Metolachlor/s-Metolachlor
      • Metribuzin
      • Metsulfuron-methyl
      • Mevinphos
      • Molinate
      • Molybdenum
      • Monochloramine
      • Naphthalophos
      • Napropamide
      • Nicarbazin
      • Nickel
      • Nitrate and nitrite
      • Nitrilotriacetic acid (NTA)
      • N-Nitrosodimethylamine (NDMA)
      • Norflurazon
      • Omethoate
      • Organotins: dialkyltins, tributyltin oxide
      • Oryzalin
      • Oxamyl
      • Paraquat
      • Parathion
      • Parathion-methyl
      • Pebulate
      • Pendimethalin
      • Pentachlorophenol
      • Per-fluoroalkyl and poly-fluoroalkyl substances (PFAS)
      • Permethrin
      • pH
      • Picloram
      • Piperonyl butoxide
      • Pirimicarb
      • Pirimiphos methyl
      • Plasticisers
      • Polihexanide
      • Polycyclic aromatic hydrocarbons (PAHs)
      • Profenofos
      • Promecarb
      • Propachlor
      • Propanil
      • Propargite
      • Propazine
      • Propiconazole
      • Propyzamide
      • Pyrasulfotole
      • Pyrazophos
      • Pyroxsulam
      • Quintozene
      • Radionuclides, Specific Alpha and Beta Emitting
      • Radium (radium-226 and radium-228)
      • Radon-222
      • Selenium
      • Silica
      • Silver
      • Simazine
      • Sodium
      • Spirotetramat
      • Styrene (vinylbenzene)
      • Sulfate
      • Sulprofos
      • Taste and Odour
      • Temephos
      • Temperature
      • Terbacil
      • Terbufos
      • Terbuthylazine
      • Terbutryn
      • Tetrachloroethene
      • Thiobencarb
      • Thiometon
      • Thiram
      • Tin
      • Toltrazuril
      • Toluene
      • Total dissolved solids
      • Triadimefon
      • Trichlorfon
      • Trichlorobenzenes
      • 1,1,1-Trichloroethane
      • Trichloroethylene (TCE)
      • Triclopyr
      • Trifluralin
      • Trihalomethanes (THMs)
      • Turbidity
      • Uranium
      • Vernolate
      • Vinyl chloride
      • Xylenes
      • Zinc
    • Drinking water treatment chemicals
      • Aluminium chlorohydrate
      • Aluminium sulfate (alum)
      • Ammonia
      • Ammonium sulfate
      • Calcium hydroxide
      • Calcium hypochlorite
      • Calcium oxide
      • Carbon, granulated activated
      • Carbon, powdered activated
      • Chlorine
      • Copper sulfate
      • Ferric chloride
      • Ferric sulfate
      • Hydrochloric acid
      • Hydrofluorosilicic acid
      • Hydrogen peroxide
      • Hydroxylated ferric sulfate
      • Ozone
      • Polyacrylamide
      • Polyaluminium chloride
      • Polyaluminium silica sulfates
      • Polydiallyldimethylammonium chloride
      • Potassium permanganate
      • Sodium aluminate
      • Sodium bicarbonate
      • Sodium carbonate
      • Sodium fluoride
      • Sodium fluorosilicate
      • Sodium hexametaphosphate
      • Sodium hydroxide
      • Sodium hypochlorite
      • Sodium silicate
      • Sodium tripolyphosphate
      • Sulfuric acid
      • Zinc orthophosphate
  • Appendices
    • Appendix 1: Additional guidance
      • A1.1 Introduction
      • A1.2 Water supply system analysis
      • A1.3 Assessment of water quality data
      • A1.4 Hazard identification
      • A1.5 Risk assessment
      • A1.6 Preventive measures and multiple barriers
      • A1.7 Critical control points
      • A1.8 Chlorination as an example of a critical control point
      • A1.9 References
    • Appendix 2: Further sources of information on drinking water quality management
      • A2.1 Drinking water quality management - general
      • A2.2 Catchment management and source water protection
      • A2.3 Groundwater protection
      • A2.4 Risk assessment and management
      • A2.5 System analysis and management process control and optimisation
      • A2.6 Monitoring and verification
      • A2.7 Materials and chemicals
      • A2.8 Incident and emergency management
      • A2.9 Employee training and awareness
      • A2.10 Research and development
      • A2.11 Documentation and reporting
      • A2.12 Community consultation and communication
      • A2.13 Hazard analysis and critical control point (HACCP)
      • A2.14 Quality management continuous improvement
      • A2.15 Reference web sites
    • Appendix 3: Derivation of microbial treatment targets for enteric pathogens
      • A3.1 Introduction to Quantitative Microbial Risk Assessment (QMRA)
      • A3.2 Adopting the QMRA approach in the Guidelines
      • A3.3 QMRA framework for the calculation of log₁₀ reduction values (LRVs)
      • A3.4 Defining the health outcome target
      • A3.5 Selection of reference pathogens
      • A3.6 Level of reference pathogen contamination in Australian source waters
      • A3.7 Consumption volume of unheated (unboiled) water per person per day
      • A3.8 Dose response relationships
      • A3.9 Disability Adjusted Life Years (DALY) burden per case
      • A3.10 Calculation of LRVs using the QMRA framework
      • A3.11 Interpretation of calculated LRVs for practical treatment guidance
      • A3.12 Understanding log₁₀ reductions
      • A3.13 References
  • Glossary
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Australian Drinking Water Guidelines 6 2011, v3.9

  • Go back to NHMRC website
On this page
  • Guideline
  • Related chemicals
  • Human risk statement
  • General description
  • Typical values in Australian drinking water
  • Treatment of drinking water
  • Measurement
  • History of the health values
  • Health considerations
  • Derivation of the health-based guideline
  • References
  1. Part 5: Fact sheets
  2. Physical and chemical characteristics

Endothal

(endorsed 2011)

Guideline

Based on human health concerns, endothal in drinking water should not exceed 0.1 mg/L.

Related chemicals

Endothal (CAS 145-73-3) belongs to the dicarboxylic-acid class of chemicals. There are currently no other pesticides in this chemical class registered for use (Tomlin 2006).

Human risk statement

With good water quality management practices, the exposure of the general population is expected to be well below levels that may cause health concerns.

If present in drinking water as a result of a spillage or through misuse, endothal would not be a health concern unless the concentration exceeded 0.1 mg/L. While the health-based guideline is based on long-term effects, there is potential for effects on the gastrointestinal tract after short-term exposure at levels 2-3 times higher than the health-based guideline. Therefore, excursions above this level even for a short period are of concern.

With good water quality management practices, pesticides should not be detected in source waters used for drinking water supplies. Persistent detection of pesticides may indicate inappropriate use or accidental spillage, and investigation is required in line with established procedures in the risk management plan for the particular water source.

General description

Uses: Endothal is a selective contact herbicide used for the control of winter grass in turf crops and lawns.

There are currently products registered in Australia that contain endothal, with both containing endothal as its di-potassium salt. Endothal products are intended for professional use on lawns. Products are liquid concentrates that are applied in diluted form using hand spray or boom spray equipment. Data on currently registered products are available from the Australian Pesticides and Veterinary Medicines Authority.

Exposure sources: The main source of public exposure to endothal and its metabolites residues in foods such as potato and cotton seed oil. Residue levels in food produced according to good agricultural practice are generally low.

Agricultural use of endothal may potentially lead to contamination of source waters through processes such as run-off, spray drift or entry into groundwater.

Typical values in Australian drinking water

There are no published reports on endothal occurrence in Australian drinking water supplies.

Treatment of drinking water

Endothal can be removed from drinking water using granular activated carbon.

Measurement

Endothal can be detected in drinking water using liquid-solid extraction followed by gas chromatography and electron capture detection, with a limit of detection (LOD) of 11.5 µg/L (EPA Method 548). Endothal has been analysed using derivatisation ion exchange extraction, acidic methanol methylation, and gas chromatography with mass spectrometry (GC/MS), with a LOD of 1.8 µg/L (EPA Method 548.1). Determination can be done using a flame ionisation detector instead of GC/MS, with a reported LOD of 0.7 µg/L (Hodgeson et al. 1992).

History of the health values

The current acceptable daily intake (ADI) for endothal is 0.03 mg per kg of bodyweight (mg/kg bw), based on a no-observed-effect level (NOEL) of 3.75 mg/kg bw/day from a long-term (1-year) study in dogs. This NOEL is based on liver necrosis and stomach hyperplasia and hyperkeratosis. The ADI incorporates a safety factor of 100 and was established in 1990.

The previous ADI for endothal was 0.1 mg/kg bw/day, established in 1977 and based on a NOEL of 10 mg/kg bw/day in a 2-year study in dogs and a 100-fold safety factor. This study was later found to be inadequate for regulatory purposes, and the ADI was amended in 1990.

The previous health value was 0.1 mg/L (NHMRC and NRMMC 2004).

Health considerations

Metabolism: Endothal is well absorbed via the gastrointestinal tract and widely distributed. Peak levels in blood are reached at 1 hour after dosing. Metabolism is limited and endothal is excreted unchanged in the urine within 48 hours (99% of total dose). A small amount of unidentified metabolites is excreted in the faeces.

Acute effects: The di-potassium salt of endothal has a moderate acute oral toxicity in rats and endothal itself has a high acute dermal toxicity in rabbits. No studies are available on the skin sensitisation potential of endothal.

Short-term effects: The main toxic effect of endothal in oral short-term toxicity studies was gastrointestinal toxicity. In dogs treated for 6 weeks there was significant gastrointestinal tract erosion at the lowest dose tested, 10 mg/kg bw/day. A NOEL was not obtained for this study. A NOEL of 50 mg/kg bw/day was obtained from a short-term (28-day) dietary study in rat. In this study, high mortality rates associated with gastrointestinal necrosis and overt signs of toxicity were seen at doses of 500 mg/kg bw/day.

Following repeated dermal application of endothal to rabbits, mortality with associated histological changes in skin, liver, and kidney resulted at the lowest dose of 50 mg/kg bw/day.

Long-term effects: In long-term toxicity studies, the main toxic effects are on the stomach and liver. Stomach hyperplasia and hyperkeratosis was seen at 7.5 mg/kg bw/day in rats and 25 mg/kg bw/day in dogs. Liver necrosis was observed at 11 mg/kg bw/day in dogs, and liver hyperplasia/adenoma and ovarian cysts at 15 mg/kg bw/day in rats. The lowest NOEL was 3.75 mg/kg bw/day in a 1-year study in dogs, and this is the basis for the current ADI.

Carcinogenicity: Based on long-term toxicity studies in rats, there is no evidence of carcinogenicity for endothal.

Genotoxicity: Endothal is not considered to be genotoxic, based on in vitro and in vivo short-term studies.

Reproductive and developmental effects: A 3-generation reproduction study in rats and developmental studies in rats and mice did not produce any evidence of reproductive effects, delayed development or teratogenicity.

Poisons Schedule: Endothal is in Schedules 6 and 7 of the Standard for the Uniform Scheduling of Medicines and Poisons No.1, 2010 (the Poisons Standard)(DoHA 2010), depending on the concentration and use pattern. Current versions of the Poisons Standard should be consulted for further information.

Derivation of the health-based guideline

The health-based guideline of 0.1 mg/L for endothal was determined as follows:

 0.1 mg/L = 3.75 mg/kg body weight/day x 70 kg x 0.1  2 L/day x 100 \text{ 0.1 mg/L } = \dfrac{\text{ 3.75 mg/kg body weight/day x 70 kg x 0.1 }}{\text{ 2 L/day x 100 }} 0.1 mg/L = 2 L/day x 100  3.75 mg/kg body weight/day x 70 kg x 0.1 ​

where:

  • 3.75 mg/kg bw/day is the NOEL based on a long-term (1-year) dietary study in dog.

  • 70 kg is taken as the average weight of an adult.

  • 0.1 is a proportionality factor based on the assumption that 10% of the ADI will arise from the consumption of drinking water.

  • 2 L/day is the estimated maximum amount of water consumed by an adult.

  • 100 is the safety factor applied to the NOEL derived from animal studies. This safety factor incorporates a factor of 10 for interspecies extrapolation and 10 for intraspecies variation.

References

NOTE: The toxicological information used in developing this fact sheet is from reports and data held by the Department of Health, Office of Chemical Safety.

DoHA (2010) The Poisons Standard; Schedule 1-Standard for the Uniform Scheduling of Medicines and Poisons, Department of Health and Ageing, Commonwealth of Australia, Canberra.

Hodgeson JW, Collins J, Bashe WJ (1992). Method 548.1 Determination of Endothall in Drinking Water by Ion-Exchange Extraction, Acidic methanol Methylation and Gas Chromatography/Mass Spectometry. Revision 1.0. Environmental Monitoring Systems Laboratory Office of Research and Development, USEPA, Cincinnati, Ohio.

NHMRC (National Health and Medical Research Council), NRMMC (Natural Resources Management Ministerial Council) (2004). Australian Drinking Water Guidelines. National Water Quality Management Strategy, Paper 6. NHMRC and NRMMC.

Tomlin CD (ed) (2006). The Pesticide Manual: a world compendium, 14th Edition, British Crop Production Council, UK.

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