scholarly journals Final Report on the Safety Assessment of PEG-2, -3, -4, -6, -8, -9, -12, -20, -32, -50, -75, -120, -150, and -175 Distearate’

1999 ◽  
Vol 18 (1_suppl) ◽  
pp. 51-59
Keyword(s):  
Polyethylene Glycol ◽  
Ethylene Oxide ◽  
Stearic Acid ◽  
Developmental Toxicity ◽  
Final Report ◽  
Ocular Irritation ◽  
Cosmetic Formulations ◽  
Mild Irritant ◽  
Chain Lengths ◽  
Related Compounds

PEG Distearate compounds are the polyethylene glycol (PEG) diesters of Stearic Acid. They are manufactured by the esterification of Stearic Acid with a the number of moles of ethylene oxide corresponding to the average polyethylene glycol chain length desired. PEGs Distearate are used as emulsifying, cleansing, and solubilizing agents in a wide variety of cosmetic formulations. Not all of the polymer chain lengths covered in this assessment are currently reported to be used, but all are listed as cosmetic ingredients and may have been used in the past and could be used in the future. Very little toxicity data are available for the PEGs Distearate. Related compounds including PEGs, PEGs Stearate, Steareths, and Stearic Acid, have previously been reviewed. In general, PEGs have a low level of toxicity whether the exposure is oral or dermal. Minimal ocular irritation is seen with PEGs, PEGs Stearate, Steareths, and Stearic Acid. No evidence of mutagenicity, carcinogenicity, or reproductive and developmental toxicity of these related compounds was found. Based on clinical data in bum patients, PEGs were mild irritant/sensitizers and there was evidence of nephrotoxicity. Cosmetic manufacturers should continue to adjust product formulations to minimize any untoward effects when products are used on damaged skin. PEGs Stearate, Steareths, and Stearic Acid were not irritants, sensitizers, or phototoxins. Because of the possibility of residual ethylene oxide and/or 1,4-dioxane impurities in PEGs Distearate, cosmetic formulators are urged to continue efforts to remove these impurities before blending PEGs Distearate into cosmetic formulations. Although metabolites of ethylene glycol monoalkyl ethers are reproductive and developmental toxins, it was considered unlikely that the relevant metabolites would be found in or produced from the use of PEGs Distearate in cosmetic formulations. Based on the available data on related compounds, and current industry practices in the use and manufacture of PEGs Distearate, it was concluded that PEG-2, -3, -4, -6, -8, -9, -12, -20, -32, -50, -75, -120, -150, and -175 Distearate are safe for use in cosmetic formulations under the present practices of use.

Final Report on the Safety Assessment of Oleth-2, -3, -4, -5, -6, -7, -8, -9, -10, -11, -12, -15, -16, -20, -23, -25, -30, -40, -44, and -501

1999 ◽  
Vol 18 (2_suppl) ◽  
pp. 17-24 ◽  
Author(s):  
F. Alan Andersen
Keyword(s):  
Polyethylene Glycol ◽  
Ethylene Oxide ◽  
Animal Studies ◽  
Oleyl Alcohol ◽  
Body Weight Gain ◽  
Developmental Toxicity ◽  
Final Report ◽  
Exposure Group ◽  
Cosmetic Formulations ◽  
Mild Irritant

The Oleth family of ingredients are the polyethylene glycol (PEG) ethers of oleyl alcohol. They are manufactured by the ethoxylation of oleyl alcohol with the number of moles of ethylene oxide corresponding to the average polyethylene glycol chain length desired. Not all of the polymer chain lengths covered in this assessment are currently reported to be used, but all are listed as cosmetic ingredients and may have been used in the past and could be used in the future. Oleths are surfactants used as emulsifying, cleansing, and solubilizing agents in cosmetic formulations. Limited safety test data are available on ingredients in the Oleth family, all consistent with surfactant properties. In feeding studies, Oleth-20 was associated with reduced body weight gain. Hepatic lesions in one exposure group were not found in any other exposure group, but were found in the controls. Oleth-20 and Oleth-10 were found to have moderate ocular irritation potential, and Oleth-10 was considered to be a cumulative skin irritant. Toxicity data, including reproductive and developmental toxicity, carcinogenesis data, and clinical testing data, available from previous safety assessments on Polyethylene Glycol and Oleyl Alcohol, were summarized. The principal finding related to PEGs, based on clinical data in burn patients, is that PEGs were mild irritant/sensitizers and there was evidence of nephrotoxicity. No such effects were seen in animal studies on intact skin. Cosmetic manufacturers should adjust product formulations containing Polyethylene Glycol to minimize any untoward effects when products are used on damaged skin. Although metabolites of ethylene glycol monoalkyl ethers are reproductive and developmental toxins, it was considered unlikely that the relevant metabolites would be found in or produced from the use of Oleths in cosmetic formulations. Of concern was the possible presence of 1,4-dioxane and ethylene oxide impurities. The importance of using the necessary purification procedures to remove these impurities was stressed. Based on particle size and cosmetic use considerations, it was not considered that these ingredients, in formulation, are respirable. Based in part on the limited data available on Oleths included in the report and on the previous reviews of Polyethylene Glycol and Oleyl Alcohol, it was concluded that Oleth-2, -3, -4, -5, -6, -7, -8, -9, -10, -11, -12, -15, -16, -20, -23, -25, -30, -40, -44, and -50 are safe in the present practices of use.

Final Report on the Safety Assessment of Ceteth-1, -2, -3, -4, -5, -6, -10, -12, -14, -15, -16, -20, -24, -25, -30, and -45

1999 ◽  
Vol 18 (2_suppl) ◽  
pp. 1-8 ◽  
Author(s):  
F. Alan Andersen
Keyword(s):  
Polyethylene Glycol ◽  
Ethylene Oxide ◽  
Animal Studies ◽  
Developmental Toxicity ◽  
Cetyl Alcohol ◽  
Skin Dose ◽  
Final Report ◽  
Intact Skin ◽  
Cosmetic Formulations ◽  
Chain Lengths

The Ceteth family of ingredients are the polyethylene glycol (PEG) ethers of cetyl alcohol. They are manufactured by the ethoxylation of cetyl alcohol with the number of moles of ethylene oxide corresponding to the average polyethylene glycol chain length desired. Not all of the polymer chain lengths covered in this assessment are currently reported to be used, but all are listed as cosmetic ingredients and may have been used in the past and could be used in the future. Ceteths are surfactants used as emulsifying, cleansing, and solubilizing agents in cosmetic formulations. Limited safety test data are available on ingredients in the Ceteth family, all consistent with surfactant properties. In separate studies, 2.5% Ceteth-2 was irritating to abraded skin, but 3.0 % was not irritating to intact skin. Dose-dependent irritation was noted for Ceteth-2 and Ceteth-10 at concentrations ranging from 5% to 100%. Ceteth-20 was found to enhance transposition of a marker from phage λ to bacterial DNA. Toxicity data, including reproductive and developmental toxicity, carcinogenesis data, and clinical testing data, available from previous safety assessments on Polyethylene Glycol and Cetyl Alcohol, were summarized. Although PEGs were mild irritants/sensitizers, there was evidence of nephrotoxicity in burn patients exposed to PEGs, and no such effects were seen in animal studies on intact skin. This led to a recommendation that PEGs not be used on damaged skin. Irritant effects of Ceteths on abraded skin not seen with intact skin likewise suggested that cosmetic manufacturers should not use Ceteths in products that may be used on damaged skin. Although metabolites of ethylene glycol monalkyl ethers are reproductive and developmental toxins, it was considered unlikely that the relevant metabolites would be found in or produced from the use of Ceteths in cosmetic formulations. Of concern was the possible presence of 1,4-dioxane and ethylene oxide impurities. The importance of using the necessary purification procedures to remove these impurities was stressed. Inhalation of Cetyl Alcohol at 26 ppm for 6 hours caused mucosal irritation, but shorter exposures at a concentration of 9.6 mg/L caused no irritation. Based on this data and with particle size and cosmetic use concentrations, Ceteths were considered to be safe for aerosolized use. Based in part on the limited data available on Ceteths included in the report and on the previous reviews of the two components found in Ceteths, it was concluded that Ceteth-1, -2, -3, -4, -5, -6, -10, -12, -14, -15, -16, -20, -24, -25, -30, and -45 are safe in the present practices of use.

scholarly journals Final Report on the Safety Assessment of Triacetin

2003 ◽  
Vol 22 (2_suppl) ◽  
pp. 1-10
Keyword(s):  
Acetic Acid ◽  
Cell Growth ◽  
Expert Panel ◽  
Developmental Toxicity ◽  
Final Report ◽  
Food Ingredient ◽  
Ocular Irritation ◽  
Cosmetic Formulations ◽  
Cell Growth And Proliferation ◽  
Available Information

Triacetin, also known as Glyceryl Triacetate, is reported to function as a cosmetic biocide, plasticizer, and solvent in cosmetic formulations, at concentrations ranging from 0.8% to 4.0%. It is a commonly used carrier for flavors and fragrances. Triacetin was affirmed as a generally recognized as safe (GRAS) human food ingredient by the Food and Drug Administration (FDA). Triacetin was not toxic to animals in acute oral or dermal exposures, nor was it toxic in short-term inhalation or parenteral studies, and subchronic feeding and inhalation studies. Triacetin was, at most, slightly irritating to guinea pig skin. However, in one study, it caused erythema, slight edema, alopecia, and desquamation, and did cause some irritation in rabbit eyes. Triacetin was not sensitizing in guinea pigs. Triacetin was not an irritant or a sensitizer in a clinical maximization study, and only very mild reactions were seen in a Duhring-chamber test using a 50% dilution. In humans, Triacetin reportedly has caused ocular irritation but no injury. Triacetin was not mutagenic. Although there were no available reproductive and developmental toxicity data, Triacetin was quickly metabolized to glycerol and acetic acid and these chemicals were not developmental toxins. Reports of 1,2-glyceryl diesters, which may be present in Triacetin, affecting cell growth and proliferation raised the possibility of hyperplasia and/or tumor promotion. The Cosmetic Ingredient Review (CIR) Expert Panel concluded, however, that the effects of 1,2-glyceryl diesters on cell growth and proliferation require longer ester chains on the glycerin backbone than are present when acetic acid is esterified with glycerin, as in Triacetin. On the basis of the available information, the CIR Expert Panel concluded that Triacetin is safe as used in cosmetic formulations.

scholarly journals Final Report on the Safety Assessment of PEG-2, -3, -5, -10, -15, and -20 Cocamine1

1999 ◽  
Vol 18 (1_suppl) ◽  
pp. 43-50
Keyword(s):  
Polyethylene Glycol ◽  
Clinical Data ◽  
Animal Studies ◽  
Developmental Toxicity ◽  
Chemical Properties ◽  
Coconut Oil ◽  
Final Report ◽  
Glycol Ethers ◽  
Related Data ◽  
Cosmetic Formulations

The PEGs Cocamine are the polyethylene glycol ethers of the primary aliphatic amine derived from coconut oil. These ingredients are used in cosmetic formulations as surfactants which function as emulsifying and solubilizing agents. Very little data were available on metabolism and toxicity, and no clinical data were found or provided. Toxicity data, including reproductive and developmental toxicity, carcinogenesis data, and clinical testing data available from previous safety assessments on Polyethylene Glycol and Coconut Oil were summarized. The principal finding related to PEGs was based on clinical data in burn patients; PEGs were mild irritant/sensitizers and there was evidence of nephrotoxicity. No such effects were seen in animal studies on intact skin. Cosmetic manufacturers should adjust product formulations containing Polyethylene Glycol to minimize any untoward effects when products are used on damaged skin. Various PEGs Cocamine were found to be mild to moderate skin irritants and were ocular irritants. PEG-15 Cocamine was negative in bacterial mutagenicity studies. Although metabolites of ethylene glycol monoalkyl ethers are reproductive and developmental toxins, it was considered unlikely that the relevant metabolites would be found in or produced from the use of PEGs Cocamine in cosmetic formulations. Of concern was the possible presence of 1,4-dioxane and ethylene oxide impurities. The importance of using the necessary purification procedures to remove these impurities was stressed. The limited data on PEGs Cocamine and the related data on other ingredients, however, were not sufficient to support the safety of PEGs Cocamine for use in cosmetic formulations. Additional data needs include: (1) physical and chemical properties, including impurities, and especially nitrosamines; (2) genotoxicity in a mammalian system; if the results are positive, then a dermal carcinogenesis study using National Toxicology Program (NTP) methods may be needed; (3) 28-day dermal toxicity using PEG-2 Cocamine; and (4) dermal sensitization data on PEG-2 Cocamine.

scholarly journals Addendum to the Final Report on the Safety Assessment of PEGs Lanolin to Include PEG-5, -10, -24, -25, -35, -55, -100, and -150 Lanolin; PEG-5, -10, -20, -24, -30, and -70 Hydrogenated Lanolin; PEG-75 Lanolin Oil; and PEG-75 Lanolin Wax1

1999 ◽  
Vol 18 (1_suppl) ◽  
pp. 61-68
Keyword(s):  
Safety Assessment ◽  
Animal Studies ◽  
Developmental Toxicity ◽  
Final Report ◽  
Clinical Safety ◽  
Cosmetic Ingredients ◽  
Cosmetic Formulations ◽  
Hydroxy Esters ◽  
Few Data ◽  
Related Compounds

The safety of selected polyethylene glycols (PEGS) Lanolin polymers was previously reviewed. This review completes the safety assessment of all the PEGs Lanolin polymers and related cosmetic ingredients. PEGs Lanolin are prepared by ethoxylating the hydroxy fatty acids, hydroxy esters, sterols, and alcohols present in whole lanolin. The number of moles of ethylene oxide reacted with each respective lanolin component corresponds to the average polyethylene glycol chain length. PEGs Lanolins, PEGs Hydrogenated Lanolins, PEG Lanolin Oil, and PEG Lanolin Wax are used as emulsifying, soluhilizing, and cleansing agents. PEGs Hydrogenated Lanolins are also hair-conditioning agents and skin-conditioning emollients. Few data on the PEGs Lanolin were available regarding systemic toxicity, mutagenicity, carcinogenicity, and clinical safety. Related compounds including PEGs, Lanolin, and Lanolin Oil have been previously reviewed. Based on clinical data in burn patients, PEGs were mild irritants/sensitizers and there was evidence of nephrotoxicity. No such effects were seen in animal studies on intact skin. Cosmetic manufacturers should continue to adjust product formulations to minimize any untoward effects when products are used on damaged skin. No evidence of phototoxic effects was found in clinical studies. Comedogenic effects have resulted from the use of cosmetic products containing lanolin compounds. No evidence of mutagenicity, carcinogenicity, or reproductive and developmental toxicity was found with these related compounds. Although metabolites of ethylene glycol monoalkyl ethers are reproductive and developmental toxins, it was considered unlikely that the relevant metabolites would be found in or produced from the use of PEGs Cocamine in cosmetic formulations. Based primarily on data from ingredients with related structures, it was concluded that PEG-S, -10, -24, -25, -35, -55, -100, and -150 Lanolin; PEG-S, -10, -20, -24, -30, and -70 Hydrogenated Lanolin; PEG-75 Lanolin Oil; and PEG-75 Lanolin Wax are safe for use in cosmetic formulations under the present practices of use.

Final Report On the Safety Assessment of Sodium Alpha-Olefin Sulfonates

1998 ◽  
Vol 17 (5_suppl) ◽  
pp. 39-65 ◽  
Author(s):  
Bindu Nair
Keyword(s):  
Developmental Toxicity ◽  
Normal Skin ◽  
Carbon Chain ◽  
Final Report ◽  
Ocular Irritation ◽  
Toxicity Studies ◽  
Alpha Olefin ◽  
Sulfonate Salts ◽  
Low Levels ◽  
Chain Lengths

Sodium C14-16 OlefinSulfonate, Sodium C12-14 Olefin Sulfonate, Sodium C 14-18 Olefin Sulfonate, and Sodium C16-18 Olefin Sulfonate are the Sodium α-Olefin Sulfonates used in cosmetics as surfactant-cleansing agents. The highest concentration reportedly is 16% in shampoos and bath and shower products. These ingredients are a mixture of long-chain sulfonate salts prepared by sulfonation of α-olefins of various carbon chain lengths noted as subscripts. In the manufacture of these ingredients, delta and gamma sultones may be produced. Sodium α-Olefin Sulfonates are poorly absorbed through normal skin, but are significantly absorbed through damaged skin. Acute oral LD50 values were 1.3 2.4g/kg in rats and 2.5-4.3 g/kg in mice. Short-term toxicity studies using rats showed no consistent effects, even with exposures in the 0.5-1.0 g/kg range. Concentrations above 10% produced moderate ocular irritation and a concentration of 5% produced mild ocular irritation in rabbits. In reproductive and developmental toxicity studies, fetal abnormalities were noted, but only at doses that were maternally toxic. Genotoxicity data were mostly negative and oral and dermal carcinogenicity studies were negative. Various animal and clinical studies found irritation and sensitization. Sensitization was attributed to low level gamma sultone residues. Because gamma sultones are demonstrated sensitizers at very low levels, it was concluded that any product containing Sodium α-Olefin Sulfonates should have very little gamma sultone residues. The gamma sultone levels should not exceed 10 ppm for saturated (alkane) sultones, 1 ppm for chloro-sultones, and 0.1 ppm for unsaturated sultones. Sodium α-Olefin Sulfonates are otherwise considered safe for use in rinse-off products. Based on concerns about irritation, were Sodium α-Olefin Sulfonates to be used in leave-on products, it was concluded that concentrations should not exceed 2% for such uses.

Final Report On the Safety Assessment of Polyvinylpyrrolidone (PVP)

1998 ◽  
Vol 17 (4_suppl) ◽  
pp. 95-130 ◽  
Author(s):  
Bindu Nair
Keyword(s):  
Molecular Weight ◽  
Animal Studies ◽  
Developmental Toxicity ◽  
Average Molecular Weight ◽  
Skin Irritation ◽  
Lymphoid Hyperplasia ◽  
Final Report ◽  
Ocular Irritation ◽  
Negative Findings ◽  
Gross Lesions

Polyvinylpyrrolidone (PVP) is a linear polymer of 1-vinyl-2-pyrrolidone monomers used as a binder, emulsion stabilizer, film former, hair fixative, and suspending agent-nonsurfactant. The molecular weight of the polymer ranges from 10,000 to 700,000. PVP K-30, with an average molecular weight of 40,000, is typically used in cosmetic formulations. The highest concentration reported to be used is 35%. There was no significant absorption of PVP K-30 given orally to rats, and the acute oral LD50 was >100 g/kg for rats and guinea pigs. Neither toxic effects nor gross lesions were found in rats maintained for two years on a diet containing 10% PVP K-30. Short-term PVP inhalation studies produced mild lymphoid hyperplasia and fibroplasia in rats, but no inflammatory response. In animal studies, no evidence of significant ocular irritation, skin irritation, or skin sensitization was found at PVP-iodine solution concentrations of 10%. While PVP-iodine is not a cosmetic ingredient, these negative findings were considered to support the safety of the PVP component. Undiluted PVP K-30 was not a dermal irritant or sensitizer in clinical tests. No developmental toxicity was seen in vehicle controls where PVP was used as a vehicle for another agent. In certain assay systems, PVP was genotoxic, but was negative in the majority of studies. Orally administered PVP significantly decreased the rate of bladder tumors in mice exposed to bracken fern. Several studies tested the carcinogenicity of subcutaneous implants of particulate PVP in rats, mice, and rabbits. Although the majority of these studies conducted in rats were positive, tumors (sarcomas) were localized to the site of implantation. Based on the available data, it was concluded that PVP is safe as used in cosmetics.

scholarly journals Final Report on the Safety Assessment of Stearoxy Dimethicone, Dimethicone, Methicone, Amino Bispropyl Dimethicone, Aminopropyl Dimethicone, Amodimethicone, Amodimethicone Hydroxystearate, Behenoxy Dimethicone, C24–28 Alkyl Methicone, C30–45 Alkyl Methicone, C30–45 Alkyl Dimethicone, Cetearyl Methicone, Cetyl Dimethicone, Dimethoxysilyl Ethylenediaminopropyl Dimethicone, Hexyl Methicone, Hydroxypropyldimethicone, Stearamidopropyl Dimethicone, Stearyl Dimethicone, Stearyl Methicone, and Vinyldimethicone

2003 ◽  
Vol 22 (2_suppl) ◽  
pp. 10-35
Keyword(s):  
Adverse Effects ◽  
Expert Panel ◽  
Developmental Toxicity ◽  
Oral Exposure ◽  
Final Report ◽  
Short Term ◽  
Fluid Mixture ◽  
Inhalation Study ◽  
Cosmetic Formulations ◽  
Siloxane Polymers

Dimethicone is a fluid mixture of fully methylated linear siloxane polymers end-blocked with trimethylsiloxy units. Methicone is a linear monomethyl polysiloxane. The other dimethicones and methicones covered in this review are siloxane polymers of Dimethicone and Methicone. Most of these ingredients function as conditioning agents in cosmetic formulations at current concentrations of use of ≤ 15%. Clinical and animal absorption studies reported that Dimethicone was not absorbed following oral or dermal exposure. Dimethicone, Methicone, and Vinyldimethicone were not acutely toxic following oral exposure. No adverse reactions were found in rabbits following short-term dermal dosing with 6% to 79% Dimethicone, yet adverse effects were noted with a hand cream formulation containing 1% Dimethicone, suggesting something else in the preparation was toxic. Mice and rats were dosed for 90 days with up to 10% Dimethicone without adverse effect. Dimethicone did not produce adverse effects in acute and short-term inhalation-route studies, Methicone and Vinyldimethicone were negative in acute exposure studies using rats, but Hexyl Methicone was toxic to rats at 5 mg/L delivered in small particle (mean diameter of 0.29 μ) aerosols. Most dermal irritation studies using rabbits classified Dimethicone as a minimal irritant. Dimethicone (tested undiluted and at 79%) was not a sensitizer in four assays using mice and guinea pigs. It was not a sensitizer at 5.0% in a clinical repeated insult patch test using 83 panelists. Most ocular irritation studies using rabbits classified Dimethicone as a mild to minimal irritant. Dimethicone was tested in numerous oral-dose (using rats) and dermal-dose (using rats, rabbits, and monkeys) reproductive and developmental toxicity studies. In a few studies, treated males had significantly decreased body weight and/or decreased testes or seminal vesicles weights. No treatment-related adverse findings were noted in dosed pregnant females or fetuses. Dimethicone was negative in all genotoxicity assays. It was negative in both an oral (tested at 91%) and dermal (tested at an unknown concentration) dose carcinogenicity assay using mice. The Cosmetic Ingredient Review (CIR) Expert Panel considered it unlikely that any of these polymers would be significantly absorbed into the skin due to their large molecular weight. Although adverse effects were noted in one inhalation study with small aerosol particles, the expected particle sizes for cosmetic products would primarily be in the range of 60 to 80 μ, and less than 1% would be under 10 μ, which is an upper limit for respirable particles. Overall, the safety test data support the safety of these ingredients at the concentrations they are known to be used in cosmetic formulations. Accordingly, the CIR Expert Panel was of the opinion that Stearoxy Dimethicone, Dimethicone, Methicone, Amino Bis-propyl Dimethicone, Aminopropyl Dimethicone, Amodimethicone, Amodimethicone Hydroxystearate, Behenoxy Dimethicone, C24–28 Alkyl Methicone, C30–45 Alkyl Methicone, C30–45 Alkyl Dimethicone, Cetearyl Methicone, Cetyl Dimethicone, Dimethoxysilyl Ethylenediaminopropyl Dimethicone, Hexyl Methicone, Hydroxypropyldimethicone, Stearamidopropyl Dimethicone, Stearyl Dimethicone, Stearyl Methicone, and Vinyldimethicone are safe as used in cosmetic formulations.

Final Report on the Safety Assessment of Isostearamidopropyl Morpholine Lactate

1999 ◽  
Vol 18 (3_suppl) ◽  
pp. 51-56 ◽  
Author(s):  
F. Alan Andersen
Keyword(s):  
Developmental Toxicity ◽  
Metabolic Activation ◽  
Skin Penetration ◽  
Toxicity Study ◽  
Final Report ◽  
Inhalation Toxicity ◽  
Oral Toxicity ◽  
Rabbit Skin ◽  
Cosmetic Formulations ◽  
Mammalian System

Isostearamidopropyl Morpholine Lactate is the lactic acid salt of isostearamidopropyl morpholine used as an antistatic agent in 20 cosmetic formulations, mostly hair preparations. The concentration of use in hair preparations is in the 1-5% range- Isostearamidopropyl Morpholine Lactate was nontoxic in acute oral toxicity studies in rats. Although Morpholine is considered a cutaneous, ocular, and mucous membrane irritant, and a sensitizer, Isostearamidopropyl Morpholine Lactate exhibits none of the sensitization and irritant reactions observed with Morpholine. Isostearamidopropyl Morpholine Lactate was minimally irritating to rabbit eyes, and mildly irritating to intact and abraded rabbit skin. Although sensitization was not seen in clinical tests, some irritancy was noted. Isostearamidopropyl Morpholine Lactate was not mutagenic in the Ames test, with or without metabolic activation, although cell killing was seen at most test concentrations. Although Morpholine is readily nitrosated to form carcinogenic nitrosamines, N-nitroso impurities were not detected in Isostearamidopropyl Morpholine Lactate. Mutagenicity data on Isostearamidopropyl Morpholine Lactate in a mammalian system were not available, nor were data available on skin penetration or toxicity associated with inhalation exposures. Accordingly, the safety of this ingredient in leave-on cosmetic formulations could not be determined. Based on the available data, this ingredient was considered safe for use in rinse-off cosmetic products. Additional data needed for assessing the safety of leave-on uses include: (i) skin penetration; if there is significant skin penetration, then both a 28-day dermal toxicity study to assess general skin and systemic toxicity, and a reproductive and developmental toxicity study are needed; (ii) one genotoxicity study in a mammalian system; if positive, then a 2-year dermal carcinogenesis study using National Toxicology Program (NTP) methods may be needed; and (iii) inhalation toxicity data.

Final Report on the Safety Assessment of Dimethyl Stearamine

1995 ◽  
Vol 14 (6) ◽  
pp. 428-432
Keyword(s):  
Safety Assessment ◽  
Developmental Toxicity ◽  
Final Report ◽  
Inhalation Toxicity ◽  
Dermal Toxicity ◽  
Ocular Irritation ◽  
Dermal Irritation ◽  
Safety Test ◽  
Mammalian System ◽  
Additional Safety

Dimethyl Stearamine is a tertiary aliphatic amine that is used as an antistatic agent in cosmetics at concentrations up to 5%. Bacterial studies suggest antibacterial action at concentrations as low as 3.6 moles per 106. Mutagenicity testing was negative, even though the ingredient can act as a biocide. Additional safety test data are needed, including concentration of use, impurities, inhalation toxicity (or information on particle size), ocular irritation, dermal irritation and sensitization, and a 28-day dermal toxicity study (possibly followed by absorption, distribution, and metabolism studies). Additionally, if significantly absorbed, reproduction and developmental toxicity (including teratogenicity) data and two genotoxicity assays, one using a mammalian system, are needed. If the mutagenesis data are positive, then a dermal carcinogenesis study may be needed. In the absence of this further information, the available data are insufficient to support the safety of Dimethyl Stearamine in cosmetics.

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