scholarly journals Are Cosmetics Used in Developing Countries Safe? Use and Dermal Irritation of Body Care Products in Jimma Town, Southwestern Ethiopia

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Wayessa Amasa ◽  
Dante Santiago ◽  
Seblework Mekonen ◽  
Argaw Ambelu
Keyword(s):  
Skin Irritation ◽  
Sun Exposure ◽  
Rabbit Skin ◽  
Adverse Health Effects ◽  
Southwestern Ethiopia ◽  
Dermal Irritation ◽  
Cosmetic Ingredients ◽  
Body Care ◽  
Primary Irritation ◽  
Jimma Town

Background. Rabbit skin model was used to test skin irritation of the most commonly used cosmetic products in Jimma town, southwestern Ethiopia. The most commonly used cosmetics were Dove, Glysolid, College, Top Society, Fair and Lovely, Nivea, Lux, Magic fruit world, Solea, Body talk, Kris, Holly, Victoria, and Sweet Heart.Methods. Intact and abraded rabbit skins were tested for erythema and edema under shade and under sun exposure. Draize Primary Irritation Index (PII) was used to calculate skin irritation of each cosmetic. Cosmetic ingredients were analyzed from the labels.Results and Discussion. Only Dove cream caused no skin irritation except for an abraded skin under sun exposure for five consecutive days. It has been identified that application of cosmetics on abraded skin under sunny condition worsens the irritation. Cosmetic labels revealed that most ingredients used in all products were those restricted chemicals due to their adverse health effects.Conclusion. This study has concluded that use of cosmetics under sunshine and also on abraded skin increases skin irritation. Hence, those users who have abraded skin are advised not to apply those cosmetics on continuous basis specifically under sun exposure.

1 Final Report on the Safety Assessment of Laureths 4 and 23

1983 ◽  
Vol 2 (7) ◽  
pp. 1-15 ◽  
Keyword(s):  
Clinical Studies ◽  
Skin Irritation ◽  
Lauryl Alcohol ◽  
Male Rats ◽  
Final Report ◽  
Rabbit Skin ◽  
Safety Test ◽  
Cosmetic Ingredients ◽  
Rats And Mice ◽  
Primary Irritation

The Laureths, polyethoxyethers of lauryt alcohol, are used in a wide variety of cosmetic products. Laureth-4 was “practically nontoxic” when administered orally to rats and mice. Acute, subchronic, and chronic dermal tests with diluted formulations on rabbits were negative for systemic toxicity. In eye irritation studies in rabbits, undiluted Laureth-4 was moderately and minimally irritating in the unrinsed and rinsed eye, respectively; 10 and 20% dilutions were both classified as minimally and nonirritating. The acute oral LD50s for Laureth-23 were 8.6 and 3.5 g/kg for fasted male rats and mice, respectively. Undiluted Laureth-23 caused no primary irritation when applied to the rabbit skin. Undiluted Laureth-23 caused a slight conjunctival reaction in rabbits. Review of safety test data on closely-related Laureths and other lauryl alcohol ethoxylated compounds indicated no teratological, multiple generation and fertility, and mutagenicity effects for these compounds. No skin irritation or sensitization was reported in clinical studies with undiluted Laureth-4. A 6% Laureth-4 product produced no evidence of phototoxicity. No primary cutaneous irritation was observed in clinical studies using 60% Laureth-23. No evidence of sensitization was reported when a 25% solution of Laureth-23 was used in a repeated insult patch test on 168 subjects, nor was there evidence of phototoxicity when tested on a subset of this population. It is concluded that Laureth-4 and Laureth-23 are safe as cosmetic ingredients in the present practices of use and concentration.

A Statistical Basis for Using Fewer Rabbits in Dermal Irritation Testing

1990 ◽  
Vol 9 (1) ◽  
pp. 49-60 ◽  
Author(s):  
Nabil S. Hatoum ◽  
Chester L. Leach ◽  
Daniel M. Talsma ◽  
Robert D. Gibbons ◽  
Paul J. Garvin
Keyword(s):  
Statistical Study ◽  
Skin Irritation ◽  
Correlation Coefficients ◽  
Test Group ◽  
In Vivo Studies ◽  
Rabbit Skin ◽  
In Vitro Method ◽  
Dermal Irritation

An acceptable and validated in vitro method to evaluate the potential of a chemical to cause dermal irritation does not exist; therefore, in vivo studies remain the only alternative. Currently most laboratories utilize 6 rabbits per test, but this group size may not be necessary to derive the desired information. Data generated from 6-rabbit skin irritation tests of 105 materials were used to determine the ability of irritation scores from all possible combinations of 5-, 4-, 3-, or 2-rabbit subsets to predict the Draize score derived from 6 rabbits. There are 630, 1575, 2108, and 1575 possible combinations of 105 studies for the 5-, 4-, 3-, and 2-rabbit subseta, respectively. We classify materials using a four-level adjectival rating system based on (among other factors) the Draize score, Comparisons indicated that the 5-, 4-, 3-, and 2-rabbit scores were in 96, 94, 91, and 88% agreement, respectively, with the classification assigned on the basis of the 6-rabbit score. The correlation coefficients for randomly selected subsets of 5-, 4-, 3-, and 2-rabbit scores versus the 6-rabbit Draize score were 0.996, 0.994, 0.986, and 0.977, respectively. This study indicated that 3 rabbits per test group allow for adequate assessment of the dermal irritation potential of a chemical. These results also conformed closely to those obtainetd from a previous statistical study using eye irritancy data from 155 chemicals, where 3-rabbit subsets were 94% predictive of the 6-rabbit tests.

Final Report on the Safety Assessment of Steapyrium Chloride and Lapyrium Chloride

1991 ◽  
Vol 10 (1) ◽  
pp. 87-97 ◽  
Keyword(s):  
Test Data ◽  
Structural Characteristics ◽  
Safety Evaluation ◽  
Final Report ◽  
Rabbit Skin ◽  
Ocular Irritation ◽  
Dermal Irritation ◽  
Safety Test ◽  
Cosmetic Ingredients ◽  
Intact Rabbit

Steapyrium Chloride and Lapyrium Chloride are quaternary ammonium salts used in cosmetic products as biocides or as antistatic agents at concentrations equal to or less than 5.0%. The oral LD50 of Steapyrium Chloride was estimated to be 8.2 g/kg. Subchronic studies in rats established a no-effect dose of 100 mg/kg. Only a very slight dermal irritation was produced on abraded or intact rabbit skin by 1.0% Steapyrium Chloride. A 50% solution of Lapyrium Chloride produced slight to moderate erythema under occluded conditions. Very slight ocular irritation was produced in the eye of the rabbit by a solution containing 1.0% Steapyrium Chloride. Steapyrium Chloride was nonmutagenic when tested in a Salmonella/microsome assay, both with and without activation. Steapyrium Chloride was neither an irritant nor sensitizer when tested at 100% concentration in a repeat insult occluded patch test on 164 individuals. Steapyrium Chloride does not absorb light in the UVA or UVB range and, therefore, would not be expected to be a phototoxic agent. Only limited formulation safety test data were available for Lapyrium Chloride. However, the structural characteristics of Lapyrium Chloride and Steapyrium Chloride are very similar. Therefore, the safety test data on Steapyrium Chloride were used for the safety evaluation of both compounds. On the basis of the available data in this report, it is concluded that Steapyrium Chloride and Lapyrium Chloride are safe as cosmetic ingredients.

Final Report on the Safety Assessment of Lauramine Oxide and Stearamine Oxide

1994 ◽  
Vol 13 (3) ◽  
pp. 231-245 ◽  
Keyword(s):  
Clinical Data ◽  
Skin Irritation ◽  
Final Report ◽  
Rabbit Skin ◽  
Ocular Irritation ◽  
Amine Oxides ◽  
Animal Data ◽  
Cosmetic Ingredients ◽  
Human Volunteers ◽  
Mild Irritant

Lauramine Oxide and Stearamine Oxide are aliphatic tertiary amine oxides that are used mostly in hair care products as foam builders and stabilizers, viscosity enhancers, emollients, conditioners, emulsifiers, antistatic agents, and wetting agents. Both compounds are susceptible to nitrosation and can form nitrosamines in the presence of nitrosating agents. In rats, up to 40% of Lauramine Oxide applied to the skin was absorbed. In two human volunteers, 92% of the dose applied to the skin was recovered from the skin. The oral LD50 in rats for a formulation containing 0.3% Lauramine Oxide was estimated to be >20 g/kg. At a concentration of 30%, Lauramine Oxide produced severe dermal reactions in rabbits, but at 0.3% only slight to moderate erythema with slight edema, Assuring, and slight to moderate epithelial desquamation were found. Stearamine Oxide applied to rabbit skin at 5% did not cause irritation. Both ingredients caused mild, transient ocular irritation in rabbits. Clinical data showed dermal exposure to 3.7% Lauramine Oxide to be a mild irritant, with a slight potential for mild cumulative skin irritation at concentrations as low as 2%. At 0.3%, Lauramine Oxide was not a sensitizer in clinical studies. Lauramine Oxide was nonmutagenic in the Ames assay, but was mutagenic after nitrosation. Lauramine Oxide at 0.1% in drinking water was not carcinogenic in rats, but at 0.1% with 0.2% sodium nitrate did increase the incidence of liver neoplasms. Based on this animal data, neither ingredient should contain N-ni-troso compounds nor be used in formulations containing nitrosating agents. On the basis of the available animal and clinical data, it is concluded that Lauramine Oxide and Stearamine Oxide are safe as cosmetic ingredients for rinse-off products, but that the concentration in Lauramine Oxide leave-on products should be limited to 3.7% and that of Stearamine Oxide limited to 5%.

scholarly journals Final Amended Report on Safety Assessment on Aminomethyl Propanol and Aminomethyl Propanediol

2009 ◽  
Vol 28 (2_suppl) ◽  
pp. 141S-161S ◽  
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Curtis D. Klaassen ◽  
James G. Marks ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Secondary Amines ◽  
Primary Amines ◽  
Inhalation Toxicity ◽  
Toxicity Data ◽  
Oral Toxicity ◽  
Dermal Irritation ◽  
Cosmetic Ingredients ◽  
Cosmetic Formulations ◽  
Allergic Contact

Aminomethyl propanol and aminomethyl propanediol are substituted aliphatic alcohols that function as pH adjusters in cosmetic products at concentrations less than 10%; additionally, aminomethyl propanediol is a fragrance. Extensive oral toxicity data are reviewed, with fewer inhalation toxicity data. Dermal toxicity data are presented that demonstrate, for example, that a mascara with 1.92% aminomethyl propanediol does not cause dermal irritation or allergic contact sensitization, suggesting that the maximum reported use concentration of 2% in mascara would be safe. Although these ingredients are primary amines that are not substrates for N-nitrosation, they may contain secondary amines as impurities in finished products that may undergo N-nitrosation. These ingredients should not be included in cosmetic formulations containing N-nitrosating agents. The Cosmetic Ingredient Review Expert Panel concludes that aminomethyl propanol and aminomethyl propanediol are safe as cosmetic ingredients in the practices of use and concentrations as described in this safety assessment.

3 Final Report on the Safety Assessment of Nonoxynols 2, 4, 8, 9, 10, 12, 14, 15, 30, 40, and 50

1983 ◽  
Vol 2 (7) ◽  
pp. 35-60 ◽  
Keyword(s):  
Clinical Studies ◽  
Ames Test ◽  
Safety Assessment ◽  
Animal Species ◽  
Skin Irritation ◽  
Final Report ◽  
Dermal Toxicity ◽  
Rabbit Eye ◽  
Toxicity Studies ◽  
Cosmetic Ingredients

Nonoxynols are chemically stable ethoxylated alkylphenols which are chemically foaming and solubilizing agents. Estimates of the acute oral LD50s of nine of the Nonoxynols (-2 to 15) range from 0.62 to 7.4 g/kg in several animal species. Acute dermal toxicity studies in rabbits produced an LD50 range of 1.8 ml/kg to 4.4 g/kg. Skin irritation tests on rabbits indicated that Nonoxynols are nonirritating to moderately irritating. Nonoxynol compounds with short ethoxylated chains are generally severe ocular irritants, whereas long-chained Nonoxynols are only slightly irritating to the rabbit eye. No evidence of carcinogenicity was observed when Nonoxynol-4 and 9 were fed to both dogs and rats. A mutagenicity study of these two compounds by the Ames test was negative. Undiluted Nonoxynol-4 and 9 were nonirritating and nonsensitizing in clinical studies. A 50% solution of Nonoxynol-15 and/or Nonoxynol-50 produced no irritation or sensitization when tested on 168 subjects, nor was there evidence of phototoxicity when tested on a subset of this population. It is concluded that Nonoxynols 2, 4, 8, 9, 10, 12, 14, 15, 30, 40, and 50 are safe as cosmetic ingredients.

The Effects of Vehicles on the Human Dermal Irritation Potentials of Allyl Esters

2006 ◽  
Vol 25 (3) ◽  
pp. 183-193 ◽  
Author(s):  
Valerie T. Politano ◽  
Daniel A. Isola ◽  
Jon Lalko ◽  
Anne Marie Api
Keyword(s):  
Allyl Alcohol ◽  
Human Subjects ◽  
Skin Irritation ◽  
Diethyl Phthalate ◽  
Intended Application ◽  
Dermal Irritation ◽  
Irritation Test ◽  
Solvent Systems ◽  
Test Materials ◽  
Allyl Esters

Allyl esters, frequently used in the fragrance industry, often contain a certain percentage of free allyl alcohol. Allyl alcohol is known to have a potential for delayed skin irritation. Also present in the finished product are different solvent systems, or vehicles, which are used to deliver the fragrances based upon their intended application. This study was conducted to determine whether different vehicles affect the skin irritation potential of five different allyl esters. The allyl esters tested were allyl amyl glycolate, allyl caproate, allyl (cyclohexyloxy)acetate, allyl cyclohexylpropionate, and allyl phenoxyacetate in the vehicles diethyl phthalate, 3:1 diethyl phthalate:ethanol, and 1:3 diethyl phthalate:ethanol at concentrations of 0.1%, 0.5%, 1.0%, and 2.0% ( w/w). A modified cumulative irritation test was conducted in 129 human subjects. Test materials (0.3 ml) were applied under occlusion to skin sites on the back for 1 day (24 h) using Hill Top chambers. Irritation was assessed at 1, 2, 4, and 5 days following application of test materials. Cumulative irritation scores varied considerably among test materials. There were no delayed irritation observations. The highest irritation scores were observed at the 2.0% concentration for all test materials. The irritation scores for allyl amyl glycolate, allyl (cyclohexyloxy)acetate, and allyl phenoxyacetate were highest in 1:3 diethyl phthalate:ethanol, thus the resulting calculated no-observed-effect levels, 0.12%, 0.03%, and 0%, respectively, were much lower for this vehicle compared to the diethyl phthalate vehicle, 0.33%, 0.26%, 0.25%, respectively. These data showed a trend for lower concentration thresholds to induce irritation when higher levels of ethanol were used in the vehicle.

Skin irritation testing in man for hazard assessment — evaluation of four patch systems

1995 ◽  
Vol 14 (9) ◽  
pp. 729-734 ◽  
Author(s):  
M. York ◽  
DA Basketter ◽  
JA Cuthbert ◽  
L. Neilson
Keyword(s):  
Skin Irritation ◽  
Research Programme ◽  
Predictive Testing ◽  
Hazard Identification ◽  
Hazard Evaluation ◽  
Rabbit Skin ◽  
Range Finding ◽  
Irritation Test ◽  
Patch Removal ◽  
Skin Irritation Test

1 The limitations of the Draize rabbit skin irritation test for hazard evaluation for man are widely documented. Nevertheless it remains the prescribed method for deter mining acute skin irritation hazard. 2 While the use of human testing for risk assessment of irritants is well established, the use of predictive testing in man for hazard identification has not been explored widely, and this is the object of the research programme. 3 The experiment described in this report evaluates the sensitivity of four patch testing systems (Finn chamber, Hill Top patch, Van der Bend chamber, and Webril patch) using a total of six irritant substances. 4 Following preliminary range-finding experiments, test materials were applied to the upper outer arm for up to 4 h. Assessments were performed immediately after patch removal and at 1, 24, 48 and 72 h. 5 Webril and Hill Top patches generated the greatest lev els of response, although responses with Finn and Van der Bend were observed. Hill Top patches are recom mended for future development work. 6 The use of very small preliminary panels to predict the effects in larger panels using different volunteers was only of limited value as each volunteer was found to have different irritant thresholds.

5 Final Report on the Safety Assessment of Propylene Glycol Stearate and Propylene Glycol Stearate Self-Emulsifying

1983 ◽  
Vol 2 (5) ◽  
pp. 101-124 ◽  
Keyword(s):  
Propylene Glycol ◽  
Safety Assessment ◽  
Animal Studies ◽  
Skin Irritation ◽  
Final Report ◽  
Cosmetic Products ◽  
Dermal Toxicity ◽  
Cosmetic Ingredients ◽  
Available Information

Propylene Glycol Stearates (PGS) are a mixture of the mono- and diesters of triple-pressed stearic acid and propylene glycol and are used in a wide variety of cosmetic products. Studies with 14C-labeled PGS show that it is readily metabolized following ingestion. In rats, the acute oral LD50 has been shown to be approximately 25.8 g/kg. The raw ingredient produced no significant dermal toxicity, skin irritation, or eye irritation in acute tests with rabbits. Subchronic animal studies produced no evidence of oral or dermal toxicity. Propylene glycol monostea-rate was negative in in vitro microbial assays for mutagenicity. In clinical studies, PGS produced no significant skin irritation at concentrations up to 55% nor skin sensitization on formulations containing 2.5%. Photo-contact allergenicity tests on product formulations containing 1.5% PGS were negative. From the available information, it is concluded that Propylene Glycol Stearates are safe as cosmetic ingredients in the present practices of use.

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