Texas Specification No. 435-24-04
Effective Date: February 12, 1992
Reformatted Date: June 28, 1996
DISINFECTANT DETERGENT, PHENOLIC TYPE
1 SCOPE: This specification establishes the minimum requirements for nonselective phenolic type germicides in concentrated liquid form, for use as disinfectant and/or deodorizer and/or cleaners to control pathogenic organisms on surfaces in a health care environment.
2. APPLICABLE SPECIFICATIONS AND STANDARDS: Reference to specifications, standards, test methods, and other documents shall be to the issues in effect on the date of the Invitation for Bids. Copies of the referenced documents may be obtained from the issuing organizations at the addresses shown. The following publications form a part of this specification to the extent specified herein:
2.1. ASSOCIATION OF OFFICIAL ANALYTICAL CHEMISTS (AOAC), 2200 Wilson Boulevard, Arlington, VA 22201:
2.1.1. Official Methods of Analysis -- Fifteenth Edition 1990.
2.2. FEDERAL DOCUMENTS, Superintendent of Documents, U.S.Government Printing Office, Washington, DC 20402:
2.2.1. A-A-1439 -- Disinfectant Detergent, General Purpose (Phenolic Type).
2.2.2. Code of Federal Regulations -- 16 CFR 1500: Hazardous Substances and Articles.
2.2.3. Code of Federal Regulations -- 29 CFR 1910: Occupational Safety and Health Standards.
2.2.4. Code of Federal Regulations -- 40 CFR Chapter 1: Environmental Protection Agency (EPA).
2.2.5. Code of Federal Regulations -- 40 CFR 164: Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).
2.3. NATIONAL FIRE PROTECTION ASSOCIATION (NFPA), One Batterymarch Park, Quincy, MA 02269:
2.3.1. NFPA 99 -- Health Care Facilities.
2.4. OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA), Publications, 200 Constitution Avenue Northwest, Washington, DC 20210:
2.4.1. Compliance Assistance Guideline CPL 2-2.44B -- Enforcement Procedures of Occupational Exposure to HBV and HIV.
2.5. U.S. ENVIRONMENTAL PROTECTION AGENCY (EPA), Washington, DC 20460:
2.5.1. DIS/TSS-7 -- Vircuides, February 6, 1979.
2.6. UNDERWRITERS LABORATORIES, INC. (UL), 333 Pfingston Road, Northbrook, IL 60062:
2.6.1. Hazardous Location Equipment.
3. CLASSIFICATION: The disinfectant concentrate shall be classified by acidity and alkalinity as follows:
3.1. Acid: pH range of 1.5 -- 2.5.
3.2. Alkaline: pH range of 10.0 -- 13.0.
4. DEFINITIONS: Terminology used in this specification is intended to be generic in nature and consistent with meanings that have been defined through general use and/or accepted trade practices. Where variant meanings may exist, the applicable interpretation shall be determined by the Texas Procurement and Support Services.
4.1. Commission: Texas Procurement and Support Services.
4.2. LD50: The probable lethal dose of undiluted product to fifty percent (50%) of the test animals, when determined from Ingestion Studies.
4.3. Use Dilution: the amount added to water, as recommended on the product label, which provides effective germicidal phenolics, in a 1:256 dilution (1/2 oz/gal). Note: An equivalent dilution may be substituted. See Paragraph 13. for cost determination.
5. REQUIREMENTS: Products furnished under this specification shall meet or exceed the following requirements:
5.1. General Requirement: The product shall be a clear, stable, homogeneous liquid, suitable as a cleaner and disinfectant. It shall provide non-selective action against all major classes of microorganisms, including bacteria, fungi, viruses, and not be inactivated by blood, pus, or serum. The use dilution shall provide germicidal action when used in hard water. There shall be no phosphates. It shall have a stable shelf life.
5.2. Chemical Composition and Properties: The product shall contain effective amounts of at least one (1) ingredient from each of the following classes:
5.2.1. Non-selective Phenolic Compounds: Ortho-phenyl and/ro ortho-benzyl phenolic derivatives or equivalent phenolics.
5.2.2. Synthetic Detergents (Surfactants): A biodegradable detergent system in an aqueous medium.
5.3. Registration: The disinfectant detergent shall be registered with the Environmental Protection Agency (EPA) under the provisions of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Environmental Pesticide Control Act.
5.4. Germicidal Effectiveness: The use dilution solution shall be microbicidal to a broad spectrum of organisms and vegetative bacterial strains when tested in accordance with Paragraph 6.1. The test organisms shall include the following bacterial species as a minimum:
Staphylococcus aureus ATCC # 6538
Salmonella choleraesuis ATCC # 10708
Pseudomonas aeruginosea ATCC # 15442
5.5. Turberculocidal Effectiveness: The use dilution solution shall be tuberculocidal for Mycobacterium tuberculosis var. Bovis (BCG) when tested in accordance with Paragraph 6.1.
5.6. Fungicidal Effectiveness: The use dilution solution shall be fungicidal for Trichophyton mentagrophytes (ATCC # 9533) as a minimum when tested in accordance with Paragraph 6.1.
5.7. Virucidal Effectiveness: The use dilution solution shall be virucidal for Herpes simplex, Vaccinia and Influenza A2 as a minimum when tested in accordance with Paragraphs 6.1. and 6.4.
5.8. Hard Water Conditions: The use dilution solutions shall be effective as a disinfectant against all organisms listed above in hard water containing 400 ppm of hardness as calcium carbonate (AOAC).
5.9. Toxicity: The concentrate shall have an Acute Oral Toxicity Value (LD50) of more than 1.2 g/kg body weight (slightly toxic) when tested in accordance with Paragraph 6.2.
5.10. Skin Irritancy: The strongest use dilution recommended on the product label shall not be a primary skin irritant or sensitizer (dermal irritation index less than five (5)) when tested in accordance with Paragraph 6.3.
5.11. Storage Stability: The product shall show no loss of anti-microbial action after one (1) year of storage at temperatures in the range 50 ° -- 86 °F. The use dilution shall show no tendency to from a precipitate or to stratify.
5.12. Odor: The recommended use dilution shall have a pleasant odor. the solution shall be an effective deodorizer.
5.13. Detergent Action: The use dilution solution shall provide sufficient detergent action without the addition of soap or other cleaners. It shall not damage any surface unharmed by water when used as recommended.
5.14. Effect on Conductive Floorings: When conductive flooring which meets the requirements of NFPA 99 is washed with the use dilution of the product and allowed to dry without rinsing, it shall still meet the conductivity requirements of NFPA 99. Alternatively, the product may be classified by Underwriters Laboratories, Inc. (UL) as a "Floor Cleaner Relating to Hazardous Locations (ILQV)".
6. TESTING: Testing shall be done by, or at the direction of, the Commission and/or the receiving State agency. Tests shall be performed on products from shipments to ordering agencies. In the event products tested fail to meet or exceed all conditions and requirements of this specification, the cost of the samples are used and the cost of testing shall be borne by the supplier.
6.1. The products furnished under this specification shall be tested by the following methods or approved equally applicable procedures:
6.1.1. Germicidal Effectiveness: Perform in-vitro testing by the use dilution method of AOAC, in the presence of 5% blood serum, as required by the EPA.
6.1.2. Toxicity: Determine LD50 with white rats by the method of 16 CFR 1500.3, issued by the Consumer Product Safety Commission.
6.1.3. Skin Irritancy: Determine compliance with 16 CFR 1500.3 by the skin patch test.
6.1.4. Virucidal Effectiveness: Test in accordance with EPA DIS/TSS-7.
6.1.5. Certification: When so specified in the Invitation for Bids, the vendor shall provide technical data sheets from the manufacturer showing material safety data (use OSHA form) and test data.
7. SAMPLES: When so specified in the Invitation for Bids, no prepurchase samples shall be required. Samples tested shall be obtained from products supplied on regular orders.
8. INSPECTION: Products furnished under this specification shall be inspected by, or at the direction of, the Commission and/or the ordering State agency either at the destination or place of manufacture.
9. WARRANTY: All disinfectant detergent shall carry the manufacturer's standard warranty and shall be guaranteed against defects for a minimum of one (1) year. The warranty shall begin on the date of acceptance of the unit by the ordering agency. During this warranty period, the vendor shall replace defective components and/or units at no cost to the State of Texas.
10. PACKING and/orPACKAGING: Packaging for shipment shall be in accordance with the manufacturer's standard practice and in a manner readily accepted by common carriers engaged in interstate commerce. Within the shipping carton, units shall be packed in a manner designed to minimize damage during shipment due to rough or improper handling.
10.1. Container Size: The product shall be furnished in the following size container or as specified in the Invitation for Bids.
10.1.1. One (1) gallon containers, four (4) per case or six (6) per case.
10.2. Container Material: There shall be no reaction between the container and the product.
10.3. Dispensers: When so specified in the Invitation for Bids, 1/2 ounce or one (1) ounce dispensers for one (1) gallon containers shall be supplied.
11. MARKING and/or LABELING:
11.1. Marking: Each shipping container shall be clearly marked with:
11.1.1. Name of contents.
11.1.3. Name and address of the manufacturer.
The container or shipping documents shall include:
11.1.4. Order number or contract number
11.1.5. Name and address of ordering agency.
11.1.6. Agency requisition number.
11.2. Labeling: Each product containers shall bear a securely affixed and durable label. Each product container label shall fully conform to the requirements of the EPA and the FIFRA including the following information:
11.2.1. Name of the product, including brand name, if any.
11.2.2. Net contents, in U.S. liquid measure.
11.2.3. Active ingredients, precautionary statements, and other data as required by FIFRA.
11.2.4. EPA Registration Number.
11.2.5. Batch number.
11.2.6. The recommended use dilution (s) for the recommended disinfecting purpose (s).
11.2.7. Name and address of the manufacturer.
12. BID LITERATURE:; All bids shall be accompanied by a description of the products being offered.
12.1. Labels: The bidder shall submit one (1) product label with each item bid.
13. RELATIVE COST: the relative cost shall be determined on the basis of the use dilution. The formula for determining the relative cost (RC) per gallon is calculated as follows:
RC = C x Vc
Where: Vc = Volume in ounces of concentrate as required to produce one (1) gallon of the use dilution.
C = Cost per gallon of concentrate.
V = Volume in ounces of the container.
When so specified in the Invitation for Bids, the bidder shall submit the relative cost with the bid.
14. COMPLIANCE: In order for consideration to be given to the bid on an item under this specification, the bidder must comply with the following conditions.
14.1. Equipment Identification: The make, model number, name of the manufacturer, brand or trade name, etc., as applicable, of the item which the vendor proposes to furnish must be state as part of the bid.
14.2. Exceptions: Notwithstanding the above, any exception taken by the bidder to the requirements and conditions of this specification must be stated and described in detail as a part of the bid. If no exceptions or deviations are identified in this manner, the items must be furnished exactly as described herein.
14.3. Proof: The bidder shall bear the burden of proof of compliance with this specification.
15. PRODUCT INFORMATION: Phenolic type disinfectant detergents are intended for raid, non-selective action against pathogens to protect patients from cross-contamination.
15.1. Surfaces: the solution is effective on hard, non-porous hospital surfaces. The effectiveness is lessened by the presence of heavy soil which should first be removed. It chemically neutralizes odors. Surface should remain wet for ten (10) minutes minimum. Use primarily on non-food surfaces. Food surfaces must be rinsed thoroughly after use.
15.2. Use-Dilution: The manufacturer's use dilution and application recommendations should be followed carefully. Do not mix this type of disinfectant with any chemicals. Thoroughly rinse empty containers.
15.3. Health Hazards: The concentrated product is corrosive to eyes, tissues, skin, and mucous membranes. Protective rubber gloves and eye protection should be used. The use dilution mist may be irritating to nasal passages and lungs.
It has been reported that daily contact with the concentrate, over a period of time, without the protection of rubber gloves may cause skin irritation and/or depigmentation in a small portion of the population.
16. ORDERING DATA: When ordering products conforming to this specification, the requisitioning agency shall specify the following:
16.1. The number of this specification (435-24-04),
16.2. Type: acidic or alkaline (See Paragraph 3.).
16.3. Size container (s) desired (See Paragraph 10.1.).
16.4. Dispenser (See Paragraph 10.3.).
16.5. Quantity of each type.
17. AVAILABILITY OF SPECIFICATIONS: Copies of this specification may be obtained by writing or calling:
Texas Procurement and Support Services
P. O. Box 13186
Austin, TX 78711-3047