them contain sodium borate, its toxicity is probably unimportant here because these formulations, like the conventional phosphate detergents, induce prompt vomiting in dogs and presumably in man whenever they are ingested. Vomiting, however, does not protect against an alkali injury. In fact it is potentially dangerous because it insures that one of the most vulnerable organs, namely the esophagus, has a second contact with the ingested material during the act of emesis Before examining numerical data, it is important to recognize that there are two, essentially independent measures of alkalinity and that both are important for assessing the potential of any chemical solution to induce an alkali injury. These two measures can be stated in various ways: one useful way is to define the PH and the titratable alkalinity. Because the concepts involved are not widely employed outside of chemistry and the biomedical sciences, an analogy may be helpful. It is widely understood that electric currents can be injurious and that the higher the voltage, the greater the risk. However, voltage alone is not an adequate measure of the hazard. For example, in a warm house during a New England winter, when the humidity is very low, one can accumulate in his body several thousand volts by shuffling across a nylon rug, as evidence by the spark which is generated just before a radiator, stove or some other grounded object is touched. Static electricity accumulated in this way is seldom if ever dangerous, because the voltage is not sustained when attempts are made to discharge it by allowing a current to flow. Thus the capacity of the voltage source to deliver current is an important consideration, in addition to the voltage itself. While denying that alkali injury is in any way equivalent to electrical injury, we can recognize that the concept of voltage is in many ways analogous to the concept of pH. Thus the pH is a measure of the intensity of the alkalinity and of the potential for inducing tissue injury, provided that the material can sustain its pH reasonably well when tissue constituents attempt to neutralize it. The titratable alkalinity is a measure of this sustaining power. It is of concern only if the pH is high enough to be in the toxic range. With the mucosal exposures that are usually involved in internal alkali burns, this toxic range is probably always above 10 and usually above 11 pH units. Because each unit represents a 10-fold increase in the hydroxyl ion concentration, small differences in pH within the critical range may mean large differences in toxicity. Table 1 summarizes measures of the alkalinity of 41 granular commercial detergents. The data were sent to me by scientists of The Proctor and Gamble Company. Because my purpose here is to evolve some useful generalizations, code numbers instead of commercial names are used to designate the products. They are arranged into four categories. Category A includes all of the phosphate-free or low-phosphate laundry detergents that are marketed in granular form, for which both measures of alkalinity were specified. In caterogy B are two highly alkaline detergents marketed for use in automatic dishwashers. (Less alkaline automatic dishwasher preparations are also available, but have not been included here). In category C are various representatives phosphate laundry and allpurpose detergent products. Category D lists typical values for fatty acid soaps. Within each category the products have been arranged according to the pH of 1% aqueous solutions. The concentration is an arbitary one but provides a useful way to compare these materials. Similarly, the titratable alkalinity is expressed here in an arbitarary way, namely the grams of Na2O that are equivalent to the measured titratable alkalinity per 100 grams of product. The conclusions we will draw are in no way comprised by the particular set of units that were selected ot express these measures of alkalinity. It is worth noting, however, that more concentrated solutions yield higher numbers for both measures. According to Kenneth Harbison this is particularly true of some of the phosphate-free products in category A. Products in category A show wide ranges of pH and of tritratable alkalinity, but the pH's are generally above 10.5 and usually above 11. With one exception titrate alkalinities are above 20 units. In category B we see that some automatic dishwasher detergents have levels of alkalinity essentially as high as several of the non-phosphate laundry detergents in category A. It is noteworthy that product #28 is the material responsible for the severe poisoning of Mr. Snodgrass' young son. Several months after barely surviving the acute phase of his illness, this child experienced increasing difficulties in swallowing and breathing. Surgery proved that he had extensive scar tissue closing the opening into his esophagus. Strictures are widely recognized to be a late complication of corrosive alkali injury to this organ. Based on the evidence that the alkalinity of product #28 is similar to several products listed in category A, we can be reasonably certain that the latter are capable of producing the same kind of severe tissue injury as suffered by the Snodgrass baby. This prediction is supported by the experiments of Dr. James E. Weaver of the Proctor and Gamble Company and of Karl S. Grady Jr., D.V.M., of the Grady Veterinary Clinic. When 40% (w/w) aqueous slurries of product #27 were administered by stomach tube to dogs, vomiting began in less than one minute and lasted for approximately one minute. This brief exposure resulted in severe gastritis with gastric bleeding. (Hemorrhagic gastritis without gross injury to the esophagus is a characteristic response of the dog to lye, whereas the esophagus is well established to be the principal site of injury in humans). Intravenous fluid therapy over a four day period helped one of Dr. Grady's dogs to survive, but the other died in spite of treatment. Two dogs treated with product #12 managed to survive but only after a severe illness with gastroscopic evidence of intense hemorrhagic gastritis. In contrast, none of the conventional phosphate detergents in category C has been found to be injurious to dogs when administered by stomach tube. They do tend to induce a brief episode of vomiting, and the stomach lining is sometimes a little redder than usual for a few days, but exposed dogs are not otherwise ill. This demonstration supports the clinical experience of physicians who have examined children after they mouthed and sometimes swallowed phosphate detergent formulations. As noted above, episodes of this kind have been reported to poison centers repeatedly. I know of no permanent injury or critical illness that has resulted from the ingestion of these products, but sometimes superficial mucosal burns in the mouth are described. The so-called "neutral" soaps in category D are also generally regarded as safe materials, even when they are eaten. From these observations I conclude that significant alkali injury to the mouth, esophagus or stomach is not apt to result from the ingestion of any commercial detergent that yields a solution pH below about 10.5. In the pH range of 10.5 to 11, the evidence is equivocal. Above pH 11, any product with an appreciable titratable alkalinity must be regarded as potentially hazardous. Rather similar opinions have been expressed by W. Morton Grant, M.D., concerning the likelihood of an alkali injury to the cornea of the eye. This structure like the esophagus is particularly sensitive to such injury. Evidence is cited in "Toxicology of the Eye" (published by C. C. Thomas, Springfield, Illinois, 1962) to indicate that aqueous solutions of pH 11 cause mild and reversible lesions in the eye but that the intensity of the injury rises sharply as the pH exceeds 11.5. In both man and experimental animals (e.g., rabbits), permanent opacities of the cornea have resulted. Concentrated solutions of many products in category A lie above 11; in some cases they lie above 12.5. In contrast even saturated slurries of typical phosphate detergents have pH's that are characteristically about 10.5. SUMMARY AND CONCLUSIONS 1. The warning statement proposed for labelling and advertising phosphate detergents will serve to encourage consumers to switch to phosphate-free formulations. 2. Of the currently available phosphate-free detergents about which I have any information, some of the liquid formulations and almost all of the grandular ones are so alkaline as to constitute a toxic hazard in the home. The threat of injury is particularly serious when these materials are misused, as in the kinds of accidental exposures that have occurred repeatedly with the comparatively safe and widely used phosphate detergents. 3. I believe that the accidental ingestion of these phosphate-free formulations will produce in some children severe corrosive injuries of the esophagus and stomach, including esophageal strictures. Splashed into the eye, concentrated solutions of these detergents are expected to lead to corneal opacities that may severely compromise vision. These predictions are based on experimental studies in dogs and rabbits and on at least one clinical episode involving an automatic dishwasher preparation no more alkaline than several phosphate-free products that are now being promoted as home laundry detergents. 4. In my opinion these products should carry a warning label of the type prescribed under the Federal Hazardous Substances Act. However, I do not expect such cautionary labelling to prevent a considerable number of serious personal injuries if these products gain general consumer acceptance. 5. In my opinion the use of phosphate detergents should not be discouraged until there is available at least one alternative product that is established to be safe as well as effective. The home is still an important part of our environment, and ecological principles should apply inside as well as outside the home. Respectfully, ROBERT E. GROSSELIN, M.D., Ph. D., Profesor and Chairman of Pharmacology, Director, Hanover Poison Control Center. TABLE 1.1-THE ALKALINITY OF GRANULAR DETERGENT PRODUCTS ON THE RETAIL MARKET IN MARCH 1971 2 Based on 1 percent solutions in distilled water, measured with a glass electrode. Based on titration of 1 percent solutions to the methyl orange endpoint. Expressed as the equivalent amount of Na2O in grams per 100 grams of product. MASSACHUSETTS DepartmeNT OF PUBLIC HEALTH, Boston, Mass., April 1, 1971. Mr. W. C. KRUMREI, Director, Technical Government Relations, Procter and Gamble Co., Cincinnati, Ohio. DEAR MR. KRUMREI: Enclosed is a copy of the letter sent to Dr. Edwards, Commissioner Food and Drug Administration. You can present this statement at the FTC hearing. Sincerely, Enclosure. JOEL J. ALPERT, M.D. Dr. CHARLES C. EDWARDS, Commissioner, Food and Drug Administration, Washington, D.C. APRIL 1, 1971. DEAR DR. EDWARDS: The Federal Trade Commission is now holding hearings requiring labelling of phosphates in detergents. Already on the market are substitute, highly alkaline products that have been seized by the FDA as improperly labelled. Undoubtedly, there will be more alkaline products on the market as manufacturers use less phosphates. This would cause a serious problem of accidental ingestion. Detergents are a common source of ingestion most of which are now harmless. Labelling of more caustic products would not help since children cannot read. If these products were marketed they should be packaged as requested in the Child Safety Packaging Act. Those products that cause serious damage to a child's esophagus, (see enclosed editorial) should not be marketed. I am concerned about this potential hazard. Sincerely, Enclosure. JOEL J. ALPERT, M.D. [From the New England Journal of Medicine, Mar. 18, 1971] ACCIDENTAL POISONING AND THE LAW (Joel J. Alpert, M.D.) The accidental ingestion of lye has been recognized for years as a major cause of acquired esophageal stricture in children. One would like to believe, therefore, that manufacturers of lye-containing household products would have been making efforts to reduce the toxicity of such products and the likelihood of their accidental ingestion. Unbelievably, exactly the opposite appears to have taken place (see page 578). Tragic is the only way to describe the unfortunate child victimized by a liquid caustic so toxic that the apparent mere licking of a cap permanently damaged her esophagus. Although this particular household product has now been removed from the market, it is also unfortunate that this action was taken only after the agent's toxicity was demonstrated through the occurrence of serious accidental ingestions. Particularly deplorable is the fact that this household substance probably accomplishes no useful function that safer products could not serve. This experience highlights the numerous household products that are especially hazardous to children but are currently sold to an unsuspecting public. The practice continues despite educational and now legislative efforts. Public Law 91-601 provides that all household substances potentially harmful to children will be marketed in special packaging to reduce the likelihood of accidental poisoning. These substances include not only drugs, both prescription and over-the-counter, but also household products such as waxes, polishes, detergents and bleaches. They must be marketed in safety packages, but if a manufacturer offers his product in more than one form, he may offer one form or size of the product in a conventional or nonsafe container to be used by the elderly, handicapped and households without children. Thus, as the legislation is written, the decision to purchase the nonsafe container rests with the purchaser. This law is to be applauded. Generally, industry has resisted such legislation. Manufacturers of household products are loath to package popular agents in safe packages because of the implied acknowledgement that such agents might be dangerous. Unfortunately, the business ethic that has subjected children to continued abuse from such hazards as furniture polish and caustics left legislation as the only effective approach. Now that this legislation is law, manufacturers, it is hoped, will co-operate to make the law effective. The law, however, is only the first step. What is a safety package, and is it really effective? A safety package or child-resistant container for medicine has been defined as one that cannot be opened, without the child's being shown how, by at least 65 per cent of the children, and can be opened and closed by 90 per cent of adults after a demonstration. This definition leaves much to be desired, especially since physicians can expect that over 95 per cent of these child patients will be protected by already available containers such as strip (unit) packages and screw-lock enclosures for drugs. Similarly high standard and effective containers should be available for household products to satisfy the intent of the new legislation. Safety packaging, if combined with an educational program an recognition by the physician of family disorders that predispose to poisoning, should be an effective approach to the problem of accidental childhood poisoning. But there must also be an adequate federal review mechanism that prevents substances as obviously toxic as liquid lye from ever reaching the patient's home. AMERICAN ACADEMY OF PEDIATRICS, Re Rule 434.1: Labeling of Synthetic Detergent ASSISTANT DIRECTOR FOR INDUSTRY GUIDANCE, Federal Trade Commission, Washington, D.O. SIB: Concerning the proposed rule for labeling synthetic detergents as to phosphate content, the Committee on Accident Prevention of the American Academy of Pediatrics, an organization representing specialists in child health, while neither actively favoring nor opposing the intent of the rule, wishes to call the following important factors to the attention of the Commission. 1. Despite ecological considerations, phosphate "builders" have safety features far exceeding all presently available alternates. Since nitrogen-containing “builders" have recently been eliminated because of previously unsuspected dangers, elimination of phosphates will result in the production of detergents containing highly alkaline substances such as trisodium silicate; these are potentially so caustic as to have necessitated seizure recently, under the Federal Hazardous Substance Act by the Bureau of Product Safety, U.S. Food and Drug Administration. 2. Detergents probably account for about 50% of the objectionable phosphate contamination of bodies of water, the remainder coming from excreta. In particular, the effluent of sewage treatment plants is high in phosphates. It is our feeling that the eventual remedy for phosphate-induced overgrowth of aquatic plants will be in the realm of improved phosphate removal, using technology already available, at the sewage treatment level. Sincerely yours, ALLAN B. COLEMAN, M.D., Chairman, Committee on Accident Prevention. Mr. W. C. KRUMEI, UNIVERSITY OF OREGON MEDICAL SCHOOL, April 6, 1971. Director, Technical Government Relations, Procter and Gamble Co., Cincinnati, Ohio. DEAR MR. KRUMREI: I am concerned about the proposed warning label the Federal Trade Commission is suggesting for labeling and advertising of phosphate-containing detergents. I do not wish to take sides on the water pollution problem, but I am concerned about increasing accidental poisoning in children. This particular warning label seems to me to be poor on two counts: First, the warning does not pertain directly to human use. Packages with warnings against indirect hazards, I am afraid, will.detract from the efficacy of warnings against products containing truly toxic materials. Secondly, the wording is such as to encourage the industry to move toward more hazardous products. This would involve an increase in pH rendering the products more caustic. The average household will now have a more toxic laundry detergent as well as a toxic dishwasher detergent. That toddlers do not read labels is attested to |