MATERIAL SAFETY DATA SHEET COMPUDOSE 100, 200 AND 400
Revision No: 4.0, 20 March 2012 STATEMENT OF HAZARDOUS NATURE: The intact Compudose implant is not considered hazardous under normal handling procedures. The following Statement of Hazardous Nature refers to the contents of the implant which contain oestradiol: Hazardous according to the criteria of Worksafe Australia: Toxic; Reproductive Category 1. R60 May impair fertility. R61 May cause harm to the unborn child. Toxic; Carcinogen Category 1. R45 May cause cancer. Company Name and Address: Elanco Animal Health A Division of Eli Lilly Australia Pty Ltd A.B.N. 39 000 233 992 112 Wharf Road, West Ryde, N.S.W. 2114, Australia Contact Numbers: Tel:
Fax: (02) 9878 7720 Emergency Telephone Numbers: Elanco Animal Health: 1800 226 324 (Toll free) OR Poisons Information Centre: 131126 (Australia-wide) CHEMWATCH: 1800 039 008: 24 hour emergency contact number (spills and accidents) Section 1 - Identification
Other Names: Oestradiol 17β, Estradiol 17β Manufacturer’s Product Code: AH0351 (Compudose 100)
Page 1 of 8 UN Number: None Allocated Dangerous Goods Class/Subsidiary Risk: None Allocated Hazchem Code: None Allocated Poisons Schedule Number: S5 Pack Size and Container Type: Box of 10 cartridges each containing 10 implants. Use:
Major Recommended Uses: Growth promotant implants for steers, spayed heifers and vealer heifers. For increased rate of weight gain in pastured steers including suckling steers and in spayed heifers and vealer heifers. For improved feed efficiency and increased rate of weight gain in lot fed steers and spayed heifers. Major Recommended Method(s) of Application: Subcutaneous ear implantation Section 2 - Composition / Information on Ingredients
Contains no hazardous components (one percent or greater) or carcinogens (one-tenth percent or greater) not listed above. Exposure Guidelines: Oestradiol - LEG 0.01 micrograms/m3 TWA for 12 hours. Appearance: White cylindrical silicone rubber implant Physical State: Solid Odour: Odourless Emergency Overview: Primary Physical and Health Hazards: Not hazardous if intact. Skin Permeable. Carcinogen. Highly Potent. Reproductive and Hormonal Effects. Caution Statement: The intact silicon rubber implant is not considered to be a health hazard. Compudose contains oestradiol which may enter the body through the skin, causes cancer, and is highly potent. Effects of exposure to
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the contents of Compudose may include foetal changes, decreased fertility, reproductive tissue changes, menstrual disorders, and changes in hormone levels. Routes of Entry: Inhalation and skin absorption. Potential Signs and Symptoms of Occupational Exposure: The physical nature and packaging of Compudose implants make exposure to significant quantities of the active ingredient, oestradiol, highly unlikely. There have been no reports of ill effects from handling of this device. Although no significant Elanco occupational exposures to oestradiol have been reported, increased breast size and other feminizing effects have been produced in males occupationally exposed to oestrogens. Breast enlargement and menstrual disorders have been reported in oestrogen-exposed women. Even intermittent absorption of small amounts of oestrogen through the skin may result in accumulation of relatively high systemic levels. Increased breast size in boys and pseudoprecocious puberty in girls have been observed in children born to occupationally exposed women. An accelerated skeletal maturation, strong pigmentation of the sexual organs and a feminizing syndrome in boys has also been noted in children whose parents work in oestrogen production. Other effects of exposure may include headache, nausea, vomiting, abnormal blood clotting, and increased incidence of cancer. Oestradiol is highly potent based on hormonal effects. Medical Conditions Aggravated by Exposure: Oestradiol may aggravate pre-existing oestrogen-dependent neoplasias including malignancies of the female reproductive organs and breast, thromboembolic diseases, impaired liver or kidney function, and pregnancy. Carcinogenicity: Oestradiol - IARC Group 1 (sufficient evidence of carcinogenicity in humans). NTP - Reasonably Anticipated Human Carcinogen. Not listed by ACGIH or OSHA. Remaining ingredients - No carcinogenicity data found. Not listed by IARC, NTP, ACGIH, or OSHA.
Section 4 - First Aid Measures
SPECIFIC FIRST AID INSTRUCTIONS AS PER AUSTRALIAN REQUIREMENTS: If poisoning occurs, contact a doctor or Poisons Information Centre. Phone 13 1126.
1 1Handbook of First Aid Instructions and Safety Directions for Agricultural and Veterinary Chemicals (including Pesticides). Therapeutic Goods Administration
Page 3 of 8 ADDITIONAL INFORMATION PROVIDED BY MANUFACTURER: Eyes: The physical nature of Compudose implants and their packaging make injury to the eye, except by accidental mechanical means, extremely unlikely. If by remote circumstances the eyes are exposed and irritation develops, flush eyes with water and contact a physician. Skin: Oestradiol, the active ingredient in Compudose implants, is well absorbed through the skin. The physical nature of Compudose implants and their packaging eliminate exposure if proper handling instructions are followed. Remove contaminated clothing and clean before reuse. Wash all exposed areas of skin with plenty of soap and water. Get medical attention if irritation develops. Inhalation: Compudose implants present negligible human hazard through inhalation because of their physical nature and packaging. Because of the size of the implant it may cause mechanical obstruction of the airway if accidentally inhaled by a small child. If this should occur, immediately contact a physician. Ingestion: Because of the physical nature of Compudose implants, it is difficult to conceive of their presenting an acute oral hazard. If a dose is accidentally swallowed, it is estimated that 2 mg of oestradiol may be absorbed before excretion. If an adverse reaction should occur, contact a physician. Section 5 - Fire Fighting Measures
Flash Point: No applicable information found. UEL: No applicable information found. LEL: No applicable information found. Extinguishing Media: Use water, carbon dioxide, dry chemical, foam, or Halon. Unusual Fire and Explosion Hazards: None known. Hazardous Combustion Products: May emit toxic fumes when exposed to heat or fire.
Section 6 - Accidental Release Measures
Spills: If the silicon rubber implant remains intact, scoop or scrape up material into containers for disposal. If the silicon rubber implant is broken and the contents are released, contain dry material by lightly misting with water, followed by sweeping up or vacuuming. Vacuuming may disperse dust if appropriate dust collection filter is not part of the vacuum. Be aware of potential for dust explosion when using electrical equipment. Large spills due to traffic accidents, etc., should be reported immediately to Elanco Animal Health for assistance. Prevent spilled material from flowing onto adjacent
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land or into streams, ponds, or lakes. Wear protective equipment, including eye protection, to avoid exposure (see Section 8 for specific handling precautions).
Section 7 - Handling and Storage
Storage: Store below 30°C (Room Temperature).
Section 8 - Exposure Controls / Personal Protection
SPECIFIC FIRST AID INSTRUCTIONS AS PER AUSTRALIAN REQUIREMENTS: If poisoning occurs, contact a doctor or Poisons Information Centre. Phone 13 1126. ADDITIONAL INFORMATION PROVIDED BY MANUFACTURER: See Section 2 for Exposure Guideline information. Under normal use and handling conditions, no protective equipment is required. The following is recommended for a production setting: Respiratory Protection: Use an approved HEPA-filtered or supplied-air respirator. Eye Protection: Chemical goggles and/or face shield. Ventilation: Extensive local exhaust or enclosed process equipment. Other Protective Equipment: In a manufacturing setting, wear chemical- resistant gloves and body covering to minimize skin contact. If handled in a ventilated enclosure, as in a laboratory setting, respirator and goggles or face shield may not be required. Safety glasses are always required. Other Handling Precautions: CAUTION! Oestradiol is a potent drug. Avoid skin contact and inhalation. Overexposure can cause tender enlargement of the breasts and breast nodule formation in both males and females, loss of sex drive in males, and menstrual disorders in females. It has been identified as a confirmed animal carcinogen and a suspect reproductive hazard. Under normal use and handling conditions, wear goggles to protect eyes and wear impermeable gloves and protective equipment to avoid direct contact with skin. Wash thoroughly with soap and water after handling.
2 Handbook of First Aid Instructions and Safety Directions for Agricultural and Veterinary Chemicals (including Pesticides). Therapeutic Goods Administration
Page 5 of 8 Section 9 - Physical and Chemical Properties
Boiling Point: Not applicable. Melting Point: Not applicable. Specific Gravity: Not applicable. pH: Not applicable. Evaporation Rate: No applicable information found. Water Solubility: Insoluble. Vapor Density: No applicable information found. Vapor Pressure: No applicable information found.
Section 10 - Stability and Reactivity
Stability: Stable at normal temperatures and pressures. Incompatibility: May react with strong oxidizing agents (e.g., peroxides, permanganates, nitric acid, etc.). Hazardous Decomposition: May emit toxic fumes when heated to decomposition. Hazardous Polymerization: Will not occur.
Section 11 - Toxicological Information
Animal Toxicity Data Single Exposure Toxicity data for Compudose 400 and oestradiol, the active ingredient, are reported as indicated. Oral: Oestradiol - Rat, 500 mg/kg, no deaths. Skin: Compudose 400 - Rabbit, 5 implants taped to skin, no deaths or toxicity. Oestradiol - Rabbit, 100 mg/kg, no deaths or toxicity. Inhalation: No applicable information found. Skin Contact: Oestradiol - Rabbit, nonirritant. Eye Contact: Oestradiol - Rabbit, slight irritant. Animal Toxicity Data Repeat Exposure No data available for mixture or formulation. Data for ingredient(s) or related material(s) are presented. Target Organ Effects: Oestradiol – Mammary, pituitary, uterine, cervical, vaginal, testicular, and lymphoid tissue changes reported in a number of
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chronic and subchronic subcutaneous injection studies. Effects reported with doses as low as 2.5 micrograms. Reproduction: Oestradiol - Reproductive tissue changes, decreased fertility, menstrual irregularities, foetal changes and developmental changes in offspring. Sensitization: No applicable information found. Mutagenicity: Oestradiol – Negative in bacterial cells. Induced micronuclei but not chromosomal aberrations, aneuploidy, or sister chromatid exchanges in in-vitro human cell assays. It induced aneuploidy and unscheduled DNA synthesis but did not induce DNA strand breaks or sister chromatid exchanges in in-vitro rodent cell assays. Did not induce chromosomal aberrations in bone marrow cells of mice treated in-vivo.
Section 12 - Ecological Information
No environmental data for the mixture or formulation. The environmental data for ingredient(s) or related material(s) are presented. Ecotoxicity data: No applicable information found. Environmental fate: Oestradiol 10-day abiotic degradation in drinking water (measured): 39% Environmental Summary: Oestradiol - Material is almost insoluble in water and is not expected to leach significantly from soil into groundwater.
Oestrogens, as a class of compounds, are relatively persistent in the environment. However, they are naturally occuring organic molecules and so some degradation is expected.
Section 13 - Disposal Considerations
Disposal: Unused implants may not be disposed of in any way but are to be retained by the purchaser/user. Dispose of discarded needles and empty cartridges by wrapping with paper and putting in garbage.
Section 14 - Transport Information
No special transport requirements necessary.
Section 15 - Regulatory Information
As of the date of issuance, we are providing available information relevant to the handling of this material in the workplace. All information contained herein is offered with the good faith belief that it is accurate. THIS MATERIAL SAFETY DATA SHEET SHALL NOT BE DEEMED TO CREATE ANY
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WARRANTY OF ANY KIND (INCLUDING WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE). In the event of an adverse incident associated with this material, this safety data sheet is not intended to be a substitute for consultation with appropriately trained personnel. Nor is this safety data sheet intended to be a substitute for product literature which may accompany the finished product.
Section 16 - Other Information
Sections revised: Entire MSDS reviewed and template updated. No changes to content of document.
Page 8 of 8 MATERIAL SAFETY DATA SHEET COMPUDOSE G
Revision No: 2.0, 20 March 2012 STATEMENT OF HAZARDOUS NATURE: The intact Compudose-G implant is not considered hazardous under normal handling procedures. The following Statement of Hazardous Nature refers to the contents of the implant which contain oestradiol and trenbolone acetate: "Hazardous according to criteria of Worksafe Australia" Toxic; Reproductive Category 1. R60 May impair fertility. R61 May cause harm to the unborn child. Harmful; Carcinogen Category 3. R40 Possible risks of irreversible effects. Harmful; Mutagen Category 3. R40 Possible risks of irreversible effects. Company Name and Address: Elanco Animal Health A Division of Eli Lilly Australia Pty Ltd A.B.N. 39 000 233 992 112 Wharf Road, West Ryde, N.S.W. 2114, Australia Contact Numbers: Tel:
Fax: (02) 9878 7720 Emergency Telephone Numbers: Elanco Animal Health: 1800 226 324 (Toll free) OR Poisons Information Centre: 131126 (Australia-wide) CHEMWATCH: 1800 039 008: 24 hour emergency contact number (spills and accidents) Section 1 - Identification
Product Name: Elanco AH0359 Compudose-G Growth and Finishing Implants for Steers and Heifers Other Names: Cattle implant, implants, Compudose G, Comp G Manufacturer’s Product Code: AH0359
Page 1 of 8 UN Number: None Allocated Dangerous Goods Class/Subsidiary Risk: None Allocated Hazchem Code: [None Allocated Poisons Schedule Number: S5 Pack Size and Container Type: Box of 100 implants (5 foil pouch envelopes x 20 implants) Use:
Major Recommended Uses: For improved growth promotion in pasture fed steers and heifers. Major Recommended Method(s) of Application: Subcutaneous ear implantation. Section 2 - Composition / Information on Ingredients
Ingredient Concentration %
Contains no hazardous components (one percent or greater) or carcinogens (one-tenth percent or greater) not listed above. Exposure Guidelines: Oestradiol - PEL and TLV not established. LEG 0.01
Magnesium stearate - (Stearates) TLV 10 mg/m3 TWA.
Section 3 - Hazards Identification
Appearance: Yellow cylindrical pellets, 3 packaged as implant in a 20-dose polyethylene cartridge belt. Contains a detectable marker (stainless steel). Physical State: Solid
Page 2 of 8 Emergency Overview Primary Physical and Health Hazards: Not hazardous if intact. Skin Permeable. Carcinogen. Highly Potent. Reproductive and Hormonal Effects. Caution Statement: The intact implant is not considered to be a health hazard. Compudose-G contains trenbolone acetate and oestradiol which may enter the body through the skin, causes cancer, and is highly potent. Effects of exposure to contents of Compudose-G Implant may include foetal changes, decreased fertility, reproductive tissue changes, menstrual disorders, and changes in hormone levels.
Routes of Entry: Inhalation and skin absorption. Potential Signs and Symptoms of Occupational Exposure: Intact implants are not considered hazardous under normal handling procedures. Caution should be used to avoid contact with the contents which contain trenbolone acetate and oestradiol. Although no significant Elanco occupational exposures have been reported to oestradiol or trenbolone acetate, prominent increased breast size and other feminising effects have been produced in males occupationally exposed to oestrogens. Breast enlargement and menstrual disorders have been reported in oestrogen-exposed women. Even intermittent absorption of small amounts of oestrogen through the skin may result in accumulation of relatively high systemic levels. Increased breast size in boys and pseudoprecocious puberty in girls have been observed in children born to occupationally exposed women. Other effects of exposure to oestradiol may include headache, nausea, vomiting, abnormal blood clotting, and increased incidence of cancer. An accelerated skeletal maturation, strong pigmentation of the sexual organs and a feminizing syndrome in boys has also been noted in children whose parents work in estrogen production. Oestradiol is highly potent based on hormonal effects. Medical Conditions Aggravated by Exposure: Oestradiol may aggravate pre-existing oestrogen dependent neoplasias including malignancies of the female reproductive organs and breast, thromboembolic diseases, impaired liver or kidney function, and pregnancy. Carcinogenicity: Oestradiol - IARC Group 1 (sufficient evidence of carcinogenicity to humans). NTP – Known Human Carcinogen. Not listed by ACGIH or OSHA. Cholesterol - IARC Group 3 (inadequate evidence of human carcinogenicity). Not listed by NTP, ACGIH or OSHA. Magnesium stearate - ACGIH A4 (not classifiable as a human carcinogen). Not listed by IARC, NTP or OSHA. Polyvinylpyrrolidone - IARC Group 3 (not classifiable as to human carcinogenicity). Not listed by NTP, ACGIH or OSHA. Remaining ingredients - No carcinogenicity data found. Not listed by IARC, NTP, ACGIH or OSHA.
Page 3 of 8 Section 4 - First Aid Measures
SPECIFIC FIRST AID INSTRUCTIONS AS PER AUSTRALIAN REQUIREMENTS: If poisoning occurs, contact a doctor or Poisons Information Centre. Phone 13 1126. ADDITIONAL INFORMATION PROVIDED BY MANUFACTURER: Eyes: Flush eyes with plenty of water. Get medical attention. Skin: Remove contaminated clothing and clean before reuse. Wash all exposed areas of skin with plenty of soap and water. Get medical attention if irritation develops. Inhalation: Move individual to fresh air. Get medical attention if breathing difficulty occurs. If not breathing, provide artificial respiration assistance (mouth-to-mouth) and call a doctor immediately. Ingestion: Do not induce vomiting. Call a physician or Poisons Information Centre (Australia 13 11 26). If available, administer activated charcoal (6-8 heaping teaspoons) with two to three glasses of water. Do not give anything by mouth to an unconscious person. Immediately transport to a medical care facility and see a doctor. Section 5 - Fire Fighting Measures
Flash Point: Not applicable. UEL: No applicable information found. LEL: No applicable information found. Extinguishing Media: Use water, carbon dioxide, dry chemical, foam, or Halon. Unusual Fire and Explosion Hazards: None known. Hazardous Combustion Products: May emit toxic fumes when exposed to heat or fire. Section 6 - Accidental Release Measures
Spills: If pellets remain intact, scoop or scrape up material into containers for disposal. If pellets are broken, contain dry material by lightly misting with water, followed by sweeping up or vacuuming. Vacuuming may disperse dust if appropriate dust collection filter is not part of the vacuum. Be aware of
1 Handbook of First Aid Instructions and Safety Directions for Agricultural and Veterinary Chemicals (including Pesticides). Therapeutic Goods Administration
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potential for dust explosion when using electrical equipment. Wear protective equipment, including eye protection, to avoid exposure (see Section 8 for specific handling precautions). Large spills due to traffic accidents, etc., should be reported immediately to Elanco Animal Health for assistance. Prevent spilled material from spreading onto adjacent land or into streams, ponds, or lakes.
Section 7 - Handling and Storage
Storage: Store between 2°C and 8°C (Refrigerate. Do not freeze). Section 8 - Exposure Controls / Personal Protection
SPECIFIC FIRST AID INSTRUCTIONS AS PER AUSTRALIAN REQUIREMENTS: If poisoning occurs, contact a doctor or Poisons Information Centre. Phone 13 1126. ADDITIONAL INFORMATION PROVIDED BY MANUFACTURER: See Section 2 for Exposure Guideline information. The intact implant is not considered hazardous under normal handling procedures. The following are recommended for a production setting: Respiratory Protection: Use an approved HEPA-filtered or supplied-air respirator. Eye Protection: Chemical goggles and/or face shield. Ventilation: Extensive local exhaust or enclosed process equipment. Other Protective Equipment: In a manufacturing setting, wear chemical- resistant gloves and body covering to minimize skin contact. If handled in a ventilated enclosure, as in a laboratory setting, respirator and goggles or face shield may not be required. Safety glasses are always required. Other Handling Precautions: Under normal use and handling conditions, wear goggles to protect eyes and wear impermeable gloves and protective equipment to avoid direct contact with skin. Wash thoroughly with soap and water after handling.
2 Handbook of First Aid Instructions and Safety Directions for Agricultural and Veterinary Chemicals (including Pesticides). Therapeutic Goods Administration
Page 5 of 8 Section 9 - Physical and Chemical Properties
Appearance: Yellow cylindrical pellets, packaged as an implant Odour: Odourless Boiling Point: Not applicable. Melting Point: No applicable information found. Specific Gravity: No applicable information found. pH: No applicable information found. Evaporation Rate: No applicable information found. Water Solubility: Insoluble. Vapor Density: No applicable information found. Vapor Pressure: No applicable information found. Solvent solubility: Alcohol, acetone. Section 10 - Stability and Reactivity
Stability: Stable at normal temperatures and pressures. Incompatibility: May react with strong oxidizing agents (e.g., peroxides, permanganates, nitric acid, etc.). Hazardous Decomposition: May emit toxic fumes when heated to decomposition. Hazardous Polymerization: Will not occur. Section 11 - Toxicological Information
Animal Toxicity Data Single Exposure No data are available for mixture or formulation. Data for ingredient(s) or related material(s) are presented. Oral: Oestradiol - Rat, 500 mg/kg, no deaths. Cholesterol – Rabbit, 6000 mg/kg, no deaths (subchronic study) Skin: Oestradiol - Rabbit, 100 mg/kg, no deaths or toxicity Inhalation: No applicable information found. Skin Contact: Oestradiol - Rabbit, nonirritant. Eye Contact: Oestradiol - Rabbit, slight irritant. Animal Toxicity Data Repeat Exposure No data available for mixture or formulation. Data for ingredient(s) or related material(s) are presented.
Page 6 of 8 Target Organ Effects: Oestradiol – Mammary, pituitary, uterine, cervical, vaginal, testicular and lymphoid tissue changes reported in a number of chronic and subchronic subcutaneous injection studies. Effects reported with doses as low as 2.5 micrograms. Reproduction: Oestradiol - Reproductive tissue changes, decreased fertility, menstrual irregularities, foetal changes, and developmental changes in offspring. Cholesterol – Decreased offspring survival, decreased foetal weight, and cleft palate observed at high oral doses or with subcutaneous injections. Sensitization: No applicable information found. Mutagenicity: Oestradiol – Negative in bacterial cells. Induced micronuclei but not chromosomal aberrations, aneuploidy, or sister chromatid exchanges in in-vitro human cell assays. It induced aneuploidy and unscheduled DNA synthesis but did not induce DNA strand breaks or sister chromatid exchanges in in-vitro rodent cell assays. Did not induce chromosomal aberrations in bone marrow cells of mice treated in-vivo. Cholesterol – negative in Ames assay. Negative in Syrian hamster embryo cell, Chinese hamster ovary cell, mouse lymphoma and unscheduled DNA synthesis assays. Section 12 - Ecological Information
No environmental data for the mixture or formulation. The environmental data for ingredient(s) or related material(s) are presented.
Environmental Summary: Oestradiol – Material is almost insoluble in water and is not expected to leach significantly from soil into groundwater. Oestrogens, as a class of compounds, are relatively persistent in the environment. However, they are naturally occurring organic molecules and so some degradation is expected. Cholesterol – Material can be considered to be bioaccumulative, but is expected to readily degrade in the environment. Cholesterol is insoluble in water and is not expected to leach from soil into groundwater. Section 13 - Disposal Considerations
Disposal: Unused implants may not be disposed of in any way but are to be retained by the purchaser/user. Dispose of empty cartridges by wrapping with paper and putting in garbage. Discarded needles should immediately be placed in a designated and appropriately labelled "sharps" container.
Page 7 of 8 Section 14 - Transport Information
No special transport requirements necessary.
Section 15 - Regulatory Information
Poisons Schedule: 5 APVMA Number: 56075
Section 16 - Other Information Sections revised: Entire MSDS reviewed and template updated. No changes to content of document. As of the date of issuance, we are providing available information relevant to the handling of this material in the workplace. All information contained herein is offered with the good faith belief that it is accurate. THIS MATERIAL SAFETY DATA SHEET SHALL NOT BE DEEMED TO CREATE ANY WARRANTY OF ANY KIND (INCLUDING WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE). In the event of an adverse incident associated with this material, this safety data sheet is not intended to be a substitute for consultation with appropriately trained personnel. Nor is this safety data sheet intended to be a substitute for product literature which may accompany the finished product.
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Printed on Uncoated Permanent Printing PaperFor sale by the U. S. Government Printing OfficeSuperintendent of Documents, Mail Stop: SSOP, Washington, DC 20402-9328 J U S T I C E S S U P R E M E C O U R T WILLIAM H. REHNQUIST, Chief Justice. JOHN PAUL STEVENS, Associate Justice. SANDRA DAY O’CONNOR, Associate Justice. ANTHONY M. KENNEDY, Associate Justice. RUTH BADER GINSBURG, Associa
Surg Endosc (2005) 19: 1082–1085DOI: 10.1007/s00464-004-2170-yÓ Springer Science+Business Media, Inc. 2005A prospective study of ambulatory laparoscopic cholecystectomyP. K. Jain, J. D. Hayden, P.C. Sedman, C. M. S. Royston, C. J. OÕBoyleDivision of Upper Gastrointestinal and Minimally Invasive Surgery, Hull Royal Infirmary, Anlaby Road, Hull HU3 2JZ, United KingdomReceived: 7 July 200