STEP 3: Safety Testing
In the course of its history, P&G has collected a large historical database of information about the effects of its products. New products (also formulations) are systematically compared with this database (see Step 1: Review of Available Data). In July 1999, this investment paid off by enabling P&G to subscribe to the elimination of animal testing for all of its non-drug, non-food products. (P&G is a strong supporter of the development of alternative, in vitro test methodologies.)
Once the potential hazards and exposures have been characterized, our scientists determine whether any testing will be required to substantiate safety. Safety testing programs are designed to address the most relevant potential hazards and conditions of exposure.
Skin contact is the most common type of exposure for laundry and cleaning products. For this reason, P&G places much emphasis on the evaluation of skin mildness of its products. Skin irritation tests are designed to assess the potential irritancy to human skin after repeated contact with diluted or undiluted products. In order to ensure an adequate margin of safety, testing may be conducted under conditions that exaggerate potential exposure. In vitro test methods are used to assess skin irritation potential. In the final stage of the program, clinical testing with human subjects can be conducted, to confirm that the product's mildness to skin is indeed what researchers had predicted it would be, based on the risk assessment.
An important part of the
To assess the potential for this type of effect, P&G conducts specially designed sensitisation tests. The animal model is the mouse. Clinical models, such as the Repeat Insult Patch Test, are also widely used. Because light is known to exacerbate allergic responses in some instances, photosensitisation test protocols combine exposure to an ingredient or product with exposure to light under controlled conditions.
The potential for short-term or long-term effects caused by dermal exposure is assessed by means of either single dose (acute dermal) or repeat dose studies in which the test substance is administered dermally, or through application onto the skin. During such studies, we are less concerned about local skin effects; rather, we are looking for systemic effects that result from the entry of the substance into the body. These studies can only be conducted with animals, typically rats. If oral exposure is relevant, toxicity studies may be performed by this route as well.
Where historical data do not suffice, eye irritation testing may be necessary to assess the effects associated with an accidental eye splash with a diluted or undiluted laundry or cleaning product. Detergent products may potentially irritate the eye to some extent. However, a long history of experience indicates that effects should be reversible within a reasonably short period of time. Therefore the test protocol prescribes that, in addition to an assessment of the seriousness of the effect, the duration for recovery is also measured. When testing is needed, we rely mostly on in vitro methods.
Acute oral toxicity testing is conducted because of the possibility of accidental ingestion by a child or deliberate ingestion by adults (this is extremely rare). Interpretation of the test results requires knowledge of the amounts that are typically ingested accidentally by children. P&G has collected this information in the course of many years, with the help of Poison Control Centers and physicians. The test protocol consists of a single administered dose, after which the effects are monitored. If the test results indicate that a child may accidentally swallow a harmful amount of the product, precautions are taken, such as adding a child-resistant closure.
A number of potential long-term effects may be considered during the risk assessment process. Some of these include immune effects, effects on the nervous system, reproductive toxicity (the ability to negatively affect the number of offspring), embryotoxicity (the ability to negatively impact the embryonic stage of development), teratogenicity
(the ability to cause malformations in offspring) and carcinogenicity (the ability to increase the incidence of malignant tumors). When evaluating a product that may be used by many people for long periods of time, our toxicologists and risk assessment scientists must determine the need to evaluate a new substance for its potential to elicit various long-term effects. The development of a comprehensive safety program is a matter of corporate responsibility and good corporate citizenship.
Once the potential hazards and exposures have been characterized, our scientists determine whether any testing will be required to substantiate safety. Safety testing programs are designed to address the most relevant potential hazards and conditions of exposure.
Skin contact is the most common type of exposure for laundry and cleaning products. For this reason, P&G places much emphasis on the evaluation of skin mildness of its products. Skin irritation tests are designed to assess the potential irritancy to human skin after repeated contact with diluted or undiluted products. In order to ensure an adequate margin of safety, testing may be conducted under conditions that exaggerate potential exposure. In vitro test methods are used to assess skin irritation potential. In the final stage of the program, clinical testing with human subjects can be conducted, to confirm that the product's mildness to skin is indeed what researchers had predicted it would be, based on the risk assessment.
An important part of the
To assess the potential for this type of effect, P&G conducts specially designed sensitisation tests. The animal model is the mouse. Clinical models, such as the Repeat Insult Patch Test, are also widely used. Because light is known to exacerbate allergic responses in some instances, photosensitisation test protocols combine exposure to an ingredient or product with exposure to light under controlled conditions.
The potential for short-term or long-term effects caused by dermal exposure is assessed by means of either single dose (acute dermal) or repeat dose studies in which the test substance is administered dermally, or through application onto the skin. During such studies, we are less concerned about local skin effects; rather, we are looking for systemic effects that result from the entry of the substance into the body. These studies can only be conducted with animals, typically rats. If oral exposure is relevant, toxicity studies may be performed by this route as well.
Where historical data do not suffice, eye irritation testing may be necessary to assess the effects associated with an accidental eye splash with a diluted or undiluted laundry or cleaning product. Detergent products may potentially irritate the eye to some extent. However, a long history of experience indicates that effects should be reversible within a reasonably short period of time. Therefore the test protocol prescribes that, in addition to an assessment of the seriousness of the effect, the duration for recovery is also measured. When testing is needed, we rely mostly on in vitro methods.
Acute oral toxicity testing is conducted because of the possibility of accidental ingestion by a child or deliberate ingestion by adults (this is extremely rare). Interpretation of the test results requires knowledge of the amounts that are typically ingested accidentally by children. P&G has collected this information in the course of many years, with the help of Poison Control Centers and physicians. The test protocol consists of a single administered dose, after which the effects are monitored. If the test results indicate that a child may accidentally swallow a harmful amount of the product, precautions are taken, such as adding a child-resistant closure.
A number of potential long-term effects may be considered during the risk assessment process. Some of these include immune effects, effects on the nervous system, reproductive toxicity (the ability to negatively affect the number of offspring), embryotoxicity (the ability to negatively impact the embryonic stage of development), teratogenicity
(the ability to cause malformations in offspring) and carcinogenicity (the ability to increase the incidence of malignant tumors). When evaluating a product that may be used by many people for long periods of time, our toxicologists and risk assessment scientists must determine the need to evaluate a new substance for its potential to elicit various long-term effects. The development of a comprehensive safety program is a matter of corporate responsibility and good corporate citizenship. Read about the next step: 
Risk Assessment
Risk Assessment