SKIN COMPATIBILITY OF LENOR FABRIC SOFTENER

A widely-held misperception is that fabric softeners can cause skin problems (irritation, rashes, sensitization, allergies…). P&G scientists have tested Lenor Fabric Softener comprehensively on human volunteers to check its skin compatibility.
Allergic contact sensitization testing on different versions of Lenor and Lenor-treated fabrics, as well as all the perfume variants has been performed on over 5000 volunteers with results demonstrating that:
  • Lenor is compatible with skin.
  • Contact irritation testing has shown no irritation or rashes from Lenor.
  • Clinical tests on critical subgroups (including infants, atopics and those with sensitive skin) revealed that there are no adverse effects from using Lenor.
Under highly exaggerated conditions, not only was Lenor compatible with all types of skin sensitivities, it was even found to be beneficial for certain skin types (reduced friction on skin from softened fabrics).
The safety testing programme on Lenor has been reviewed with independent scientists and dermatologists who agree with our conclusions about the safety and skin compatibility of Lenor.
  • Lenor Studies on irritation, skin sensitization and allergies

    A variety of studies have been conducted that exaggerate the exposures that consumers would expect to have through normal use of fabric softeners, including the Single Application Patch, the 3-Patch Application (3-PAT) and the 21-Day Cumulative Irritation tests. P&G scientists have also performed Human Repeat Insult Patch Tests (HRIPTs) on over 5000 volunteers. The volunteer panellists included people with normal healthy skin, as well as individuals with sensitive skin. The results demonstrated that Lenor and fabrics treated with Lenor do not cause allergies and are not irritating, even to sensitive skin.
    • Single Application Patch Test

      A short-term test was conducted on 26 volunteer panellists to confirm that Lenor was not a skin irritant prior to any longer-term testing. In the single application patch test, the undiluted test material is applied to the upper arm using a small patch (smaller than the pad of a standard plaster). The patch stays in place for 4 hours, then, the test site is observed for signs of irritation over the next 3 days. If the test material is irritating, the patch site will appear red, and may appear to be dry or rough.

      Result: There was no indication that Lenor produced irritation in this test, confirming that the product is non-irritating, even when applied in concentrated form.

    • 3-Patch Application Test (3-PAT)

      Once a product or material has been shown to be non-irritating in a single application patch test, the next step is to confirm that the product will not be irritating with exposures of longer duration. The 3-Patch Application Test (3-PAT) is commonly used for this purpose. The exposure conditions of the 3-PAT are highly exaggerated over any exposures that would be encountered in real-life circumstances. Therefore, it is considered a very rigorous test of the potential to cause irritation.

      In the 3-PAT, a dilution of the test material is applied to the upper arm using a small patch, and left in place for 24 hours. After that time, it is removed and replaced with a fresh patch. This is repeated for a total of 3 applications (72 hours of patching).

      In our tests with Lenor, we chose to use only those volunteer panellists who reported that they had "sensitive skin". We pre-screened the panellists using a "sting" test: a commonly used method to identify individuals with sensitive skin for testing cosmetics and other topically-applied products. We confirmed sensitive skin in 111 volunteer panellists. These sensitive skin volunteer panellists were patched with a 0.2% solution of two different Lenor formulations.

      Result: The 3-PAT confirmed that Lenor was mild to the skin, even for individuals with sensitive skin, under conditions where the exposure was highly exaggerated over those that would be encountered in real-life circumstances.
    • 21-Day Cumulative Irritation Test

      This test was developed as a means of evaluating any irritant effects that may be cumulative with repeated exposure to a product. In this test, swatches of cotton and polyester fabrics are repeatedly laundered using high concentrations of Lenor in the rinse. These are applied to the upper arms of 50 panellists five times a week for three weeks. Each application stays in place for 24 hours. For comparison, untreated fabrics are also applied. The sites are observed for signs of irritation throughout the test. If the test material is irritating, the patch site will appear red, and may appear to be dry or rough.

      Result: The fabric treated with Lenor was no different than the untreated fabric. Therefore, Lenor did not produce any cumulative skin irritation.

      References:
      • Frosch, P. J. and A. M. Kligman. 1977. Method for appraising the stinging capacity of topically applied substances, Journal of the Society of Cosmetic Chemists, 28:197-209.
    • Human Repeat Insult Patch Tests (HRIPTs)

      Many Human Repeat Insult Patch Tests (HRIPTs) have been conducted with several Lenor variants. There were more than 5,000 volunteer panellists involved in these studies.

      Result: There was no indication that the basic formulation or any of the fragrance variations caused contact allergies. This was the expected result for the finished product formulation since none of the individual ingredients have been shown to cause skin allergies at the levels used in Lenor.

      References:

      • Stotts J., "Planning, conduct and interpretation: Human predictive sensitization patch tests," in Current Concepts in Cutaneous Toxicity, V. A. Drill and P. Lazar, Eds. (Academic Press, New York, 1980), pp. 41-53.

  • Lenor Fabric Softener Skin Benefit Studies

    Several skin studies reveal that fabrics softened with Lenor can offer a skin benefit over unsoftened fabric. The skin benefit from Lenor is probably related to reduced mechanical friction against the skin from softener-treated fibres.
    • Forearm application (with visual and instrumental grading) (Hermanns, et al., 2001)

      This type of test involves exposure to the skin of volunteers who have sensitive skin according to the independent assessment of a dermatologist. The exposure is under conditions that are exaggerated over and above the types of exposures that would be expected to occur with normal product use.
      The delicate skin of the forearm of approximately 30 volunteer panellists is pre-treated with a dilute solution of sodium lauryl sulphate (SLS) to cause a slight amount of irritation. SLS is a surfactant known to cause irritation, and has been used for decades as an irritant control in a variety of test systems, including human test model systems. After pre-treatment with SLS, the forearm is treated repeatedly over the course of 12 days by gently rubbing with cotton fabric that had been washed in either detergent alone, or detergent and Lenor.

      Results: Neither fabric sample (i.e., fabric washed in detergent alone or detergent and Lenor) had any deleterious effect on previously irritated skin. In fact, fabric washed in detergent and Lenor had a mild beneficial effect, and, for some measurements, the skin exposed to the detergent plus Lenor-treated fabric was in better condition than skin exposed to fabric treated with detergent alone.
    • Fabric Wear Test (Infants) (Peirard, et al. 1994)

      A panel of infants "wore" small squares of Lenor-treated fabrics tucked in the waistband of their diapers. At the end of the test, the skin under the fabric square was actually in slightly better condition.

      Results: Neither fabric sample (i.e., fabric washed in detergent alone or detergent and Lenor) had any adverse effects on infant skin. A slight beneficial effect was observed on some measurements with the Lenor-treated fabrics when compared to the fabrics washed in detergent alone.

    • References

      • Hermanns, J. F., V. Goffin, J. E. Arrese, C. Rodriguez, and G. E. Peirard. 2001. Beneficial effects of softened fabrics on atopic skin. Dermatology, 202(2):167-170.
      • Pierard, G. E., J. E. Arrese, C. Rodriguez, and P. A. Deskaleros. 1994. Effects of softened and unsoftened fabrics on sensitive skin. Contact Dermatitis, 30(5):286-291.
      • Pierard, G. E., J. E. Arrese, A. Dowlati, P. A. Deskaleros, and C. Rodriguez. 1994a. Effects of softened and unsoftened fabric on infant skin. Int. J. Dermatology, 33(2):138-141.
  • Studies under real use conditions

    P&G scientists have conducted two tests to assess Lenor under real use conditions: a Home Usage Test on 128 volunteers and a Toddler Home Usage Test on 110 families with toddlers. In both real use test cases, a professional assessment of the skin condition and a diagnostic test for skin allergy showed that the use of Lenor did not cause skin irritation or skin allergy.
    • Home Usage Test (Rodriguez, et al. 1994 and Bannan, et al. 1992)

      The Home Usage Test is based on realistic exposures to Lenor Fabric Softener, and can evaluate the potential of the product to cause either irritation or sensitization (allergy). In addition, skin benefits due to using Lenor can be detected both through the objective assessment of the panellists’ skin condition and through comments from the panellists during the course of the study.

      A group of 64 volunteer panellists used laundry detergent plus Lenor for all home laundry for a period of 7 weeks. An additional group of 64 panellists used laundry detergent alone. The skin condition of the panellists was assessed before the test began, and after 1, 4 and 7 weeks of at home usage. A diagnostic test for skin allergy to Lenor was also conducted (24-hour patch test application of the material on a small area of the skin of the upper arm) at the start and completion of the test to confirm there were no allergic reactions.

      Result: Responses of the group using detergent plus Lenor were no different than the group using detergent alone. There were no significant skin reactions and no evidence of skin allergies throughout the seven week usage period. In fact, the scores for dryness were slightly lower for the Lenor group, indicating these panellists’ had skin that was in slightly better condition.
    • Toddler Home Usage Test

      This type of test is based on realistic exposures to the product, and confirms that the product will not cause irritation or any other adverse effect for a very important class of consumers: young children. The design of this test is very simple. Volunteer parents are asked to substitute the new product for their current product, and to use as normal for all of their children's laundry. Every 2 weeks, the child's skin is visually evaluated by an expert for any signs of irritation or other adverse effects.

      In our test on Lenor, 110 babies/toddlers were enrolled in the study, with the consent of their parents or guardians. The majority (61) were asked to replace their normal fabric softener with Lenor. The rest (49) were asked to stop using any fabric softener. The test continued for a total of 8 weeks.

      Result: There were no differences in the skin of the panellists in the two groups (Lenor vs. no softener), confirming that there were no adverse effects due to wearing clothes softened with Lenor.
    • References

      • Rodriguez C., G. Calvin, C. Lally, J. M. LaChapelle. 1994. Skin effects associated with wearing fabrics washed with commercial laundry detergents, Journal of Toxicology - Cutaneous and Ocular Toxicology, 13:39-45.
      • Bannan, E. A., J. F. Griffith, T. L. Nusair, L. J. Sauers. 1992. Skin testing of laundered fabrics in the dermal safety assessment of enzyme-containing detergents, Journal of Toxicology - Cutaneous and Ocular Toxicology, 11:327-339.

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