Amended Final Report on the Safety Assessment of Cocamide DEA

1996 ◽  
Vol 15 (6) ◽  
pp. 527-542 ◽  
Keyword(s):  
Expert Panel ◽  
Present Report ◽  
Skin Irritation ◽  
Surfactant Solution ◽  
Nitroso Compounds ◽  
Final Report ◽  
Test Substance ◽  
Cosmetic Products ◽  
Patch Tests ◽  
Skin Irritation Test

Cocamide DEA is a mixture of ethanolamides of Coconut Acid that is used as a surfactant-foam booster and viscosity-increasing agent-aqueous in cosmetic products. Production formulation data submitted to the Food and Drug Administration in 1994 indicated that this ingredient was used in 745 products. The Cosmetic Ingredient Review (CIR) Expert Panel had previously evaluated the safety of Cocamide DEA, Lauramide DEA, Linoleamide DEA, and Oleamide DEA in cosmetics and concluded that they were safe as cosmetic ingredients at the concentrations that were currently being used (50%). CIR's decision to reevaluate the safety of Cocamide DEA in cosmetics is based on occupational studies indicating that this ingredient may have sensitization potential; however, the Expert Panel has determined that these studies are not relevant to cosmetic use. Furthermore, the Panel agreed that its original conclusion on Cocamide DEA should be clarified relative to use of this ingredient in rinse-off and leave-on products. Clarification of the original conclusion is based on the results of a skin irritation test in which 15 volunteers were tested with a surfactant solution containing 10% Cocamide DEA, the highest concentration tested in predictive patch tests. Additional comments that were made during the Panel's review of other data in the present report include that the severe ocular irritation reactions induced by a chemical (p H 9–10.5) containing >64% Cocamide DEA were likely a result of p H; that the renal effects noted in Fischer 344 rats in the National Toxicology Program (NTP) subchronic dermal toxicity study may be species-related and not test substance-related; and with reference to an ongoing NTP two-year chronic study that was initiated in 1993, that the results will be reviewed when the study is available. On the basis of the animal and clinical data presented in the present report, the Expert Panel concluded that Cocamide DEA is safe as used in rinse-off products and safe at concentrations 10% in leave-on cosmetic products. It was also concluded that Cocamide DEA should not be used as an ingredient in cosmetic products in which N-nitroso compounds are formed.

6: Final Report on the Safety Assessment of Panthenol and Pantothenic Acid

1987 ◽  
Vol 6 (1) ◽  
pp. 139-162 ◽  
Keyword(s):  
Safety Assessment ◽  
Skin Irritation ◽  
Allergic Sensitization ◽  
Pantothenic Acid ◽  
Final Report ◽  
Test Substance ◽  
Cosmetic Products ◽  
Toxicological Effects ◽  
Ocular Irritation ◽  
Low Concentrations

Panthenol is the alcohol analogue of Pantothenic Acid (vitamin B3). The LD50for D-Panthenol administered orally to mice was 15 g/kg. No toxicological effects were associated with the subchronic and/or chronic oral administration of Panthenol to rats. Minimal cutaneous hyperkeratosis was noted in rats in a subchronic dermal study of creams containing 0.2% Panthenol. In ocular irritation studies involving rabbits, concentrations up to 2% produced, at most, slight conjunctival redness and chemosis. Panthenol (100%) and products containing Panthenol (0.5% and 2%) administered to rabbits during skin irritation studies caused reactions ranging from no skin irritation to moderate-to-severe erythema and well-defined edema. Neither teratogenic nor fetotoxic effects were noted in the offspring when rats were fed calcium pantothenate prior to mating and throughout gestation. Skin irritation and sensitization studies of cosmetic products at concentrations up to 0.5% indicated that they were, at most, mild irritants but did not induce allergic sensitization. No test substance-related observations of eye irritation were reported for 23 subjects receiving instillations of products containing 0.1% Panthenol. Mutagenicity and carcinogenicity data were not available for the safety assessment of Panthenol. It is noted that the level of this ingredient required by humans exceeds the amount that could be absorbed from the low concentrations used in cosmetic products. The human metabolic requirement would preclude the likelihood of genotoxicity. It is concluded that Panthenol and Pantothenic Acid are safe as presently used in cosmetics.

Final Report on the Safety Assessment of Cetyl Lactate and Myristyl Lactate

1990 ◽  
Vol 1 (2) ◽  
pp. 97-107 ◽  
Keyword(s):  
Safety Assessment ◽  
Skin Irritation ◽  
Final Report ◽  
Cosmetic Products ◽  
Rabbit Skin ◽  
Ocular Irritation ◽  
Myristyl Alcohol ◽  
Irritation Test ◽  
Skin Irritation Test ◽  
Available Information

Cetyl Lactate and Myristyl Lactate are the esters of lactic acid and either cetyl or myristyl alcohol. They are used in a wide variety of cosmetic products up to a maximum concentration of 25%. The acute oral LD50 of Cetyl Lactate is estimated from studies with rats to be greater than 20 g/kg. Cetyl Lactate was shown to be minimally irritating to rabbit skin and nonirritating or only slightly irritating to rabbit eyes in Draize irritation tests. At 25%, Cetyl Lactate produced no signs of toxicity or irritation in a 30-day rabbit-skin irritation study. Cetyl Lactate was found to be minimally irritating and nonsensitizing to human skin at concentrations up to 5%. The acute oral LD50 of Myristyl Lactate is estimated from studies with rats to be greater than 20 g/kg. Myristyl Lactate was shown to be minimally irritating in Draize primary skin irritation tests, but one contradictory study concluded that undiluted Myristyl Lactate produced moderate irritation. It produced no signs of ocular irritation in Draize rabbit eye irritation tests. Mild irritation was elicited by a formulation in a modified Draize rabbit skin irritation test. The same formulation was found to be nonirritating and nonsensitizing in a human repeated insult patch study. Based on the available information, it is concluded that Cetyl Lactate and Myristyl Lactate are safe in the present practices of use.

Amended Safety Assessment of Fatty Acyl Sarcosines and Sarcosinate Salts as Used in Cosmetics

2021 ◽  
pp. 109158182110238
Author(s):  
Monice M. Fiume ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Fatty Acyl ◽  
Nitroso Compounds ◽  
Acyl Residue ◽  
Cosmetic Products ◽  
Panel Report ◽  
Fatty Acyl Residue

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 5 acyl sarcosines and 9 sarcosinate salts as used in cosmetics; all of these ingredients are reported to function in cosmetics as hair conditioning agents and most also can function as surfactants—cleansing agents. The ingredients reviewed in this assessment are composed of an amide comprising a fatty acyl residue and sarcosine and are either free acids or simple salts thereof. The Panel relied on relevant new data, including concentration of use, and considered data from the previous Panel report, such as the reaction of sarcosine with oxidizing materials possibly resulting in nitrosation and the formation of N-nitrososarcosine. The Panel concluded that these ingredients are safe as used in cosmetics when formulated to be non-irritating, but these ingredients should not be used in cosmetic products in which N-nitroso compounds may be formed.

Final Report of the Safety Assessment of Kojic Acid as Used in Cosmetics

2010 ◽  
Vol 29 (6_suppl) ◽  
pp. 244S-273S ◽  
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Guinea Pig ◽  
Safety Assessment ◽  
Expert Panel ◽  
Kojic Acid ◽  
Tumor Promotion ◽  
Final Report ◽  
Cosmetic Products ◽  
Pig Skin ◽  
Animal Data ◽  
Skin Lightening

Kojic acid functions as an antioxidant in cosmetic products. Kojic acid was not a toxicant in acute, chronic, reproductive, and genotoxicity studies. While some animal data suggested tumor promotion and weak carcinogenicity, kojic acid is slowly absorbed into the circulation from human skin and likely would not reach the threshold at which these effects were seen. The available human sensitization data supported the safety of kojic acid at a use concentration of 2% in leave-on cosmetics. Kojic acid depigmented black guinea pig skin at a concentration of 4%, but this effect was not seen at 1%. The Cosmetic Ingredient Review (CIR) Expert Panel concluded that the 2 end points of concern, dermal sensitization and skin lightening, would not be seen at use concentrations below 1%; therefore, this ingredient is safe for use in cosmetic products up to that level.

scholarly journals 2: Final Report on the Safety Assessment of Glyceryl Ricinoleate

1988 ◽  
Vol 7 (6) ◽  
pp. 721-739 ◽  
Keyword(s):  
Ricinoleic Acid ◽  
Castor Oil ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Ultraviolet Spectrum ◽  
Toxicity Tests ◽  
Final Report ◽  
Dermal Toxicity ◽  
Oral Toxicity ◽  
Patch Tests

Glyceryl Ricinoleate is the monoester of glycerol and ricinoleic acid. Castor oil contains 87–90% Glycerol Ricinoleate. Ricinoleic acid is metabolized by both β-oxidation and α-oxidation. Acute oral toxicity tests in mice indicated that Glyceryl Ricinoleate has an LD50 greater than 25.0 ml/kg and is, at most, mildly irritating to unrinsed rabbit eyes. This ingredient was not a primary skin irritant. Castor oil was nonmutagenic by the Ames test. Ricinoleic acid was not a carcinogen when tested in mice. In human single-insult occlusive patch tests, no indication of skin irritation potential was observed in the two products containing 5.6% Glyceryl Ricinoleate. The available data on Glyceryl Ricinoleate were insufficient to determine whether this ingredient, under each relevant condition of use, was either safe or not safe. The types of data required before a decision can be made include: (1) 28 day chronic dermal toxicity in guinea pigs, and (2) clinical sensitization and photosensitization studies (or an appropriate ultraviolet spectrum instead of the photosensitization data).

Safety Assessment of Alkyl PEG Sulfosuccinates as Used in Cosmetics

2015 ◽  
Vol 34 (2_suppl) ◽  
pp. 70S-83S
Author(s):  
Wilbur Johnson ◽  
Bart Heldreth ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Developmental Toxicity ◽  
Skin Irritation ◽  
Molecular Size ◽  
Skin Sensitization ◽  
Toxicity Data ◽  
Cosmetic Products ◽  
Dermal Penetration ◽  
Repeated Dose Toxicity

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) reviewed the safety of alkyl polyethylene glycol (PEG) sulfosuccinates, which function in cosmetics mostly as surfactants/cleansing agents. Although these ingredients may cause ocular and skin irritation, dermal penetration is unlikely because of the substantial polarity and molecular size of these ingredients. The Panel considered the negative oral carcinogenicity and reproductive and developmental toxicity data on chemically related laureths (PEG lauryl ethers) and negative repeated dose toxicity and skin sensitization data on disodium laureth sulfosuccinate supported the safety of these alkyl PEG sulfosuccinates in cosmetic products, but. The CIR Expert Panel concluded that the alkyl PEG sulfosuccinates are safe in the present practices of use and concentration when formulated to be nonirritating.

8 Final Report on the Safety Assessment of Polyquaternium-11

1983 ◽  
Vol 2 (5) ◽  
pp. 161-178 ◽  
Keyword(s):  
Molecular Weight ◽  
High Molecular Weight ◽  
Skin Irritation ◽  
Low Molecular Weight ◽  
Final Report ◽  
Dermal Toxicity ◽  
Molecular Weight Polymer ◽  
Patch Tests ◽  
Skin Patch ◽  
Available Information

Polyquaternium-11 is a quaternized copolymer of vinylpyrrolidone and di-methylamine ethylmethacrylate, and is used at concentrations up to 50% in a variety of hair care preparations. The acute oral LD50 in test animals of high molecular weight Polyqua-ternium-11 is estimated to be greater than 12.8 g/kg; the LD50 for the low molecular weight polymer is calculated to be 6.2 g/kg. At concentrations of up to 50% in water, the raw ingredient produced no signs of skin or eye irritation. There was no evidence of dermal toxicity in subchronic tests nor in a maximization test for sensitization. In clinical studies, 1 of 19 subjects showed slight skin irritation after a 24-hour single insult skin patch with 9.5% Polyquaternium-11 in water. Repeated insult patch tests at concentrations up to 50% produced no instances of skin sensitization and only isolated instances of transient skin irritation. Clinical photoreactivity studies on both low and high molecular weight polymers showed no evidence of phototoxicity or photoallergenicity. From the available information, it is concluded that Polyquaternium-11 is safe as a cosmetic ingredient in the present practices of use.

4: Final Report on the Safety Assessment of Toluene

1987 ◽  
Vol 6 (1) ◽  
pp. 77-120 ◽  
Keyword(s):  
Human Skin ◽  
Safety Assessment ◽  
Animal Studies ◽  
Skin Irritation ◽  
Final Report ◽  
Cosmetic Products ◽  
Skin Exposure

Toluene has a wide variety of noncosmetic applications. However, the cosmetic use is limited to nail products at concentrations up to 50%. Toluene was practically nontoxic when given orally to rats; acute oral LD50 values ranged from 2.6 g/kg to 7.5 g/kg. Results of animal studies indicated that undiluted Toluene is a skin irritant. No skin irritation or sensitization was observed in subjects treated with cosmetic products containing 31-33% Toluene. No phototoxic or photoallergic reactions were noted in subjects treated with 25% or 30% Toluene. The sole cosmetic use of Toluene is in products intended to be applied directly to the nail; therefore, human skin exposure to this ingredient will be minimal under conditions of cosmetic use. On the basis of the available data and the limited user skin exposure from cosmetic products containing Toluene, it is concluded that this ingredient is safe for cosmetic use at the present practices of use and concentration.

scholarly journals Safety Assessment of Polyquaternium-22 and Polyquarternium-39 as Used in Cosmetics

2016 ◽  
Vol 35 (3_suppl) ◽  
pp. 47S-53S ◽  
Author(s):  
Wilbur Johnson ◽  
Bart Heldreth ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Developmental Toxicity ◽  
Skin Irritation ◽  
Cosmetic Products ◽  
Limited Data ◽  
Local Effects ◽  
Cosmetic Formulations ◽  
Monomer Content ◽  
Unreacted Monomer

Polyquaternium-22 and polyquaternium-39 are polymers that function as antistatic agents, film formers, and hair fixatives in cosmetic products. These ingredients are being used at concentrations up to 2% (polyquaternium-22, in a rinse-off product) and up to 3% (polyquaternium-39, in rinse-off and leave-on products). The unreacted monomer content of these ingredients was considered low and of no toxicological concern. Limited data showed no skin irritation/sensitization. Although these ingredients were nongenotoxic in bacterial assays, mammalian genotoxicity, carcinogenicity, and reproductive and developmental toxicity data were not available. These polymers, however, are large, highly polar molecules that would likely not be absorbed, and neither local effects in the respiratory tract nor systemic toxicity are expected following product application/exposure. The Expert Panel concluded that polyquaternium-22 and polyquaternium-39 are safe in the present practices of use and concentration in cosmetic formulations.

Safety Assessment of Ethanolamides as Used in Cosmetics

2015 ◽  
Vol 34 (1_suppl) ◽  
pp. 18S-34S ◽  
Author(s):  
Monice M. Fiume ◽  
Bart A. Heldreth ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
...  
Keyword(s):  
Clinical Data ◽  
Safety Assessment ◽  
Expert Panel ◽  
Nitroso Compounds ◽  
Cosmetic Products

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) rereviewed the safety of 28 ethanolamides and found them safe in the present practices of use and concentration when they are formulated to be nonirritating, and that these ingredients should not be used in cosmetic products in which N-nitroso compounds may be formed. Most of the ethanolamides are reported to function in cosmetics as hair-conditioning agents, skin-conditioning agents, and surfactant—foam boosters. The Panel reviewed available animal and clinical data, as well as information from previous CIR reports.

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