Final Amended Report on the Safety Assessment of Octyldodecyl Stearoyl Stearate1

2005 ◽  
Vol 24 (3_suppl) ◽  
pp. 65-74
Keyword(s):  
Stearic Acid ◽  
Guinea Pigs ◽  
Ames Test ◽  
Corn Oil ◽  
Skin Permeation ◽  
Skin Irritation ◽  
Oral Toxicity ◽  
Skin Reactions ◽  
Ocular Irritation ◽  
Safety Assessments

Octyldodecyl Stearoyl stearate is an ester that functions as a skin-conditioning agent and viscosity-increasing agent. It is reported to be used in 105 cosmetic products at concentrations from 2% to 15%. In an isolated human skin permeation and penetration study, 0.005% of the applied dose permeated the skin, around 3% was found in the epidermis, around 1.5% was in tape stripped skin layers, and around 95% stayed in the material applied to the skin. A formulation having 20.6 % Octyldodecyl Stearoyl stearate was classified as minimally to mildly irritating in an in vitro ocular irritation assay. Several tests of products containing from 7.5% to 12.7% Octyldodecyl Stearoyl stearate using rabbits produced minimal to mild ocular irritation. One test of 100% Octyldodecyl Stearoyl stearate (a trade compound) and another of 10% Octyldodecyl Stearoyl stearate in corn oil using rabbits produced no ocular irritation. Tests using rabbits demonstrated that Octyldodecyl Stearoyl stearate at use concentrations was non- to mildly irritating to skin; only one study reported moderate irritation. Octyldodecyl Stearoyl stearate was not mutagenic, with or without S-9 activation, in an Ames test and did not produce a significant increase in micronucleated cells in a mouse in vivo study. In clinical single-insult patch tests at use concentrations, Octyldodecyl Stearoyl stearate was nonirritating to mildly irritating; in a cumulative irritation study, it caused mild irritation. Octyldodecyl Stearoyl stearate was nonsensitizing in clinical tests. Because few toxicity data were available on Octyldodecyl Stearoyl Stearate, summaries of data from existing safety assessments of related ingredients (Octyl Dodecanol, Stearic Acid, and Octyl Stearate) were included. Undiluted Octyl Dodecanol was nontoxic during acute oral and dermal studies using rats and guinea pigs. Stearic Acid was nontoxic to rats during acute oral studies, but caused toxicity during subchronic studies. Rabbits treated topically with the acid were not affected adversely, and mild erythema and slight induration were observed when Stearic Acid was administered intradermally to guinea pigs and rabbits. Octyl stearate had very low acute oral toxicity in rats and mice. Octyl Dodecanol produced only transient mild ocular irritation in rabbits when administered at concentrations up to 100%. Octyl Dodecanol (30% and 100%) was nonirritating to skin in one study using rabbits. In another study using multiple species, 100% Octyl Dodecanol (described as technical grade) caused severe skin irritation in rabbits, moderate irritation in guinea pigs and rats, and no irritation in swine. Stearic Acid was non- to moderately irritating in animal studies, and did not cause photosensitization. In studies using rabbits, undiluted Octyl stearate caused slight, transient ocular irritation, and minimal skin irritation. Stearic Acid did not induce mitotic crossovers and aneuploidy in Saccharomyces cerevisiae, and was nonmutagenic in the Ames test. In a feeding study using mice, Stearic Acid was noncarcinogenic at doses up to 50 g/kg/day. Mice given subcutaneous injections of the acid had low incidences of carcinomas, sarcomas, and lymphomas. In clinical studies, concentrations of up to 100% Octyl Dodecanol were non- to mildly irritating, nonsensitizing, nonphototoxic, and non-photosensitizing. Stearic Acid was nonirritating at concentrations up to 100%, and at concentrations up to 13% it was nonsensitizing and nonphotosensitizing. Octyl stearate (7.6%) in formulation was nonirritating, nonsensitizing, and nonphotosensitizing. Based on skin permeation and penetration data, the Panel does not expect any significant amount of Octyldodecyl Stearoyl stearate to be systemically available. There is no evidence of systemic toxicity associated with any of the related chemicals reviewed in previous safety assessments. None of the available toxicology or clinical data suggest a concern about adverse skin reactions to Octyldodecyl Stearoyl Stearate, or to any of the related chemicals. There is no evidence of ocular toxicity, except for a mild, transient ocular irritation associated with Octyldodecyl Stearoyl stearate and the related chemicals. Overall, Octyldodecyl Stearoyl stearate was considered safe as used in cosmetics.

Final Report on the Safety Assessment of Acetamide MEA

1993 ◽  
Vol 12 (3) ◽  
pp. 225-236 ◽  
Keyword(s):  
Guinea Pigs ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Nitroso Compounds ◽  
Final Report ◽  
Skin Exposure ◽  
Ocular Irritation ◽  
Cosmetic Formulations ◽  
A Minor ◽  
Primary Irritation

Acetamide MEA is used in cosmetics as a skin conditioning agent-humectant and hair conditioning agent. Oral LD50s of 27 g/kg were reported for Acetamide MEA in rats. No rabbits died following an acute dermal exposure of 20 ml/kg Acetamide MEA. In ocular irritation studies, 70% Acetamide MEA and cosmetic formulations containing 1.3% Acetamide MEA were classified as nonocular irritants in rabbits. Only mild skin irritation occurred following a 24-h skin exposure to undiluted Acetamide MEA. In the maximization test, Acetamide MEA was classified as a nonsensitizer in guinea pigs when tested at a concentration of 5.0%. Neither primary irritation nor sensitization reactions to 7.5% Acetamide MEA were observed in a human repeated insult patch test. Acetamide MEA was not nonmutagenic in the Ames assay. In the presence of nitrosating agents, Acetamide MEA may form N-nitroso compounds; acetamide may be a minor impurity in Acetamide MEA. On the basis of the data presented in this report, it is concluded that Acetamide MEA is safe as a cosmetic ingredient at concentrations not to exceed 7.5% in leave-on products and is safe in the present practice of use in rinse-off products. Cosmetic formulations containing Acetamide MEA should not contain nitrosating agents or significant amounts of free acetamide.

scholarly journals Final Report on the Safety Assessment of Propylene Glycol (PG) Dicaprylate, PG Dicaprylate/Dicaprate, PG Dicocoate, PG Dipelargonate, PG Isostearate, PG Laurate, PG Myristate, PG Oleate, PG Oleate SE, PG Dioleate, PG Dicaprate, PG Diisostearate, and PG Dilaurate

1999 ◽  
Vol 18 (2_suppl) ◽  
pp. 35-52 ◽  
Author(s):  
Wilbur Johnson
Keyword(s):  
Polyethylene Glycol ◽  
Propylene Glycol ◽  
Skin Irritation ◽  
Skin Penetration ◽  
Final Report ◽  
Limited Data ◽  
Oral Toxicity ◽  
Cosmetic Ingredients ◽  
Cosmetic Formulations ◽  
Safety Assessments

The Propylene Glycol Dicaprylate family of ingredients includes several esters and diesters of Propylene Glycol and fatty acids. These ingredients are used in cosmetic formulations as skin conditioning agents, viscosity increasing agents, and surfactants. Two skin irritation studies (minimal to no irritation) and a comedogenicity study (insignificant comedogen) on Propylene Glycol Dicaprylate/Dicaprate and a skin irritation study (slight) and an acute oral toxicity study (nontoxic) on Propylene Glycol Laurate were available. Available data were also found indicating that Propylene Glycol Dicaprylate/Dicaprate and Propylene Glycol Dipelargonate may enhance the skin penetration of other chemicals. Because of the ability of these Polyethylene Glycol esters and diesters to enhance penetration of other agents, it was recommended that care be taken in using these and other Polyethylene Glycol esters and diesters in cosmetic products. Previous Cosmetic Ingredient Review safety assessments of related ingredients, including Polyethylene Glycol, Polyethylene Glycol Stearate, Coconut Oils and Acids, Isostearic Acid, Lauric Acid, Myristic Acid, Oleic Acid, and Caprylic/Capric Triglyceride, were summarized. Included were mutagenicity, chronic toxicity, and skin irritation and sensitization data. Based in part on the limited data available on the ingredients included in the report, but more so on the previous reviews of chemically similar moieties, it was concluded that Propylene Glycol Dicaprylate, Propylene Glycol Dicaprylate/Dicaprate, Propylene Glycol Dicocoate, Propylene Glycol Dipelargonate, Propylene Glycol Isostearate, Propylene Glycol Laurate, Propylene Glycol Myristate, Propylene Glycol Oleate, Propylene Glycol Oleate SE, Propylene Glycol Dioleate, Propylene Glycol Dicaprate, Propylene Glycol Diisostearate, and Propylene Glycol Dilaurate are safe for use as cosmetic ingredients in the present practices of use.

Toxicity Studies of Microbial Insecticide Bacillus thuringiensis var. kenyae in Rats, Rabbits, and Fish

2002 ◽  
Vol 21 (2) ◽  
pp. 99-105 ◽  
Author(s):  
S. M. Meher ◽  
S. L. Bodhankar ◽  
Arun Kumar ◽  
J. N. Dhuley ◽  
D. J. Khodape ◽  
...  
Keyword(s):  
Bacillus Thuringiensis ◽  
Skin Irritation ◽  
Fresh Water Fish ◽  
Pest Species ◽  
Oral Toxicity ◽  
Ocular Irritation ◽  
Powder Formulation ◽  
Microbial Insecticide ◽  
Wettable Powder ◽  
Lepidopteran Pest

Bacillus thuringiensis var. kenyae (B.t.k.) is a microbial insecticide effective against lepidopteran pest species. Acute oral toxicity in rats and acute dermal toxicity, ocular irritation, skin irritation in rabbits were studied for the wettable powder formulation of B.t.k. In addition, toxicity of the wettable powder formulation was also studied in fresh water fish ( Gambussia affinis). The results of these studies indicate that this wettable powder formulation of B.t.k. is nontoxic and nonirritant to rats, rabbits, and fish.

N-Methyl-N'-Nitroguanidine: Irritation, Sensitization, and Acute Oral Toxicity, Genotoxicity, and Methods for Analysis in Biological Samples

1993 ◽  
Vol 9 (3) ◽  
pp. 457-477 ◽  
Author(s):  
E.R. Kinkead ◽  
R.E. Wolfe ◽  
S.A. Salins ◽  
C.S. Godin ◽  
P.P. Lu ◽  
...  
Keyword(s):  
Corn Oil ◽  
Skin Irritation ◽  
Genetic Material ◽  
Acute Oral Toxicity ◽  
Oral Toxicity ◽  
Fischer 344 ◽  
Chemical Impurities ◽  
Mammalian Toxicity ◽  
Observation Period

Currently. N-methyl-N'-nitroguanidine (MNG) is being considered by the U.S. Air Force Armament Laboratory for use in explosive formulations. A mammalian toxicity profile has been performed which includes the analysis of chemical impurities and an assessment of the potential for the metabolism of MNG to 1-methyl-3-nitro-1-nitrosoguanidine (MNNG). Potential in situ gastric conversion of MNG to MNNG is a toxicological concern because MNNG is both mutagenic and carcinogenic. The compound was also evaluated in several bioassays to assess its potential genotoxic activity. The acute oral toxicity was determined in male and female Fischer 344 rats administered a single dose of MNG in corn oil. The maximum suspension of MNG that could be delivered, 1 mg MNG/kg body weight, produced no signs of toxic stress during the 14-day observation period. The primary eye and skin irritation potential of MNG was determined in female New Zealand white rabbits using the Draize technique. MNG produced no irritation to intact skin but did produce mild conjunctival irritation. The response of a single guinea pig to the dermal sensitization evaluation indicated that MNG is a weak sensitizer. The results of three genetic tests indicated that MNG does not interact with genetic material. Gastric contents and feces from treated animals showed no evidence of conversion of MNG to MNNG.

8 Final Report on the Safety Assessment of Butylene Glycol, Hexylene Glycol, Ethoxydiglycol, and Dipropylene Glycol

1985 ◽  
Vol 4 (5) ◽  
pp. 223-248 ◽  
Keyword(s):  
Skin Irritation ◽  
Final Report ◽  
Oral Toxicity ◽  
Cutaneous Toxicity ◽  
Patch Tests ◽  
Ocular Irritation ◽  
Toxicity Studies ◽  
Hexylene Glycol ◽  
Dipropylene Glycol ◽  
Low Order

Butylene Glycol, Hexylene Glycol, Ethoxydiglycol, and Dipropylene Glycol are viscous liquids used in the cosmetic industry as humectants, emulsifiers, plasticizers, and solvents. The results of acute, subchronic, and chronic oral toxicity studies using a variety of animal species indicate a low order of toxicity for the Glycols. Results of parenteral injection, inhalation, and acute and subchronic cutaneous toxicity studies likewise support a low order of toxicity. Butylene Glycol, Ethoxydiglycol, and Dipropylene Glycol caused minimal to mild irritation of rabbit skin, whereas Hexylene Glycol was moderately irritating. The Glycols produced mild to severe ocular irritation when tested in rabbits, with Hexylene Glycol producing the most severe irritation. Although undiluted Hexylene Glycol produced severe ocular irritation, a 25 percent aqueous solution produced no signs of irritation. Undiluted Butylene Glycol was not an eye irritant to rabbits but was to humans. Human skin patch tests on undiluted Butylene Glycol and undiluted Hexylene Glycol produced a very low order of primary skin irritation. A repeated insult patch test on Butylene Glycol produced no evidence of skin sensitization. Based on the available data it is concluded the Butylene Glycol, Hexylene Glycol, Ethoxydiglycol, and Dipropylene Glycol are safe as presently used in cosmetics.

1: Final Report on the Safety Assessment of Sodium Lauryl Sulfoacetate

1987 ◽  
Vol 6 (3) ◽  
pp. 261-277 ◽  
Keyword(s):  
Clinical Studies ◽  
Guinea Pigs ◽  
Safety Assessment ◽  
Sodium Lauryl Sulfate ◽  
Skin Irritation ◽  
Final Report ◽  
Lauryl Sulfate ◽  
Cosmetic Products ◽  
Cosmetic Product ◽  
Ocular Irritation

Sodium Lauryl Sulfoacetate is a detergent used in cosmetic products. A 12% solution of the ingredient was slightly toxic to rats in an acute oral study. No treatment-related effects of significance were noted in rats in a subchronic study at a dose of 75 mg/kg/day. Some effects were observed at 250 and 750 mg/kg/day. Minimal to slight ocular irritation occurred in rabbits when tested with 3.0% Sodium Lauryl Sulfoacetate. A diluted product tested at 1% Sodium Lauryl Sulfate was nonirritating to the genital mucosa of rabbits. No skin irritation, sensitization, or phototoxicity was noted in guinea pigs exposed to a cosmetic product containing 2% Sodium Lauryl Sulfoacetate. Cosmetic products containing up to 16% Sodium Lauryl Sulfoacetate were nonmutagenic in the Ames Salmonella/microsome assay, both with and without activation. In clinical studies, Sodium Lauryl Sulfoacetate was a mild to strong skin irritant but not a sensitizer at concentrations up to 2.0%. The irritant effects are similar to those produced by other detergents, and the severity of the irritation appears to increase directly with concentration. It is concluded that Sodium Lauryl Sulfoacetate is safe for use in cosmetic products in the present practices of use and concentration.

scholarly journals Final Report on the Safety Assessment of Biotin

2001 ◽  
Vol 20 (4_suppl) ◽  
pp. 1-12
Keyword(s):  
Subcutaneous Injection ◽  
Micronucleus Test ◽  
Skin Irritation ◽  
Daily Basis ◽  
Intradermal Injection ◽  
Water Soluble ◽  
Final Report ◽  
Oral Toxicity ◽  
Treatment Groups ◽  
Ocular Irritation

Biotin is a water-soluble vitamin used as a hair-conditioning agent and a skin-conditioning agent in many cosmetic products at concentrations ranging from 0.0001% to 0.6%. Although Biotin does absorb some ultraviolet (UV) radiation, the absorption shows no peaks in the UVA or UVB region. Biotin is rapidly metabolized and excreted in urine. Little acute oral toxicity is seen in animal tests. Short-term and subchronic toxicity studies likewise found no evidence of toxicity. Although intradermal injection of a small quantity of Biotin (0.1 ml) into guinea pig skin did not produce skin irritation, Biotin (0.1% at pH 7.3) did produce slight, transient ocular irritation in rabbit eyes. Biotin was not mutagenic in bacterial tests, but positive results were found in a Tradescantia micronucleus test. There was evidence of an increase in the number of resorptions in rats receiving Biotin by subcutaneous injection, with concomitant decreases in fetal, uterine, and placental weights. Another study of mice receiving Biotin orally or by subcutaneous injection found no differences between control and treatment groups. Although there is one case study reporting an urticarial reaction in the literature, there are a very large number of individuals exposed to Biotin on a daily basis, and there is not a parallel appearance of irritation, sensitization, or other adverse reactions. Based on these available data, it was concluded that Biotin is safe as used in cosmetic formulations.

7 Final Report on the Safety Assessment of Polyvinylpyrrolidone/Vinyl Acetate Copolymer

1983 ◽  
Vol 2 (5) ◽  
pp. 141-159 ◽  
Keyword(s):  
Vinyl Acetate ◽  
Skin Irritation ◽  
Vinyl Pyrrolidone ◽  
Final Report ◽  
Oral Toxicity ◽  
Intact Skin ◽  
Patch Tests ◽  
Ocular Irritation ◽  
Available Information ◽  
Acetate Copolymer

Polyvinylpyrrolidone/Vinyl Acetate Copolymer (PVP/VA Copolymer) is the copolymer of vinyl pyrrolidone (VP) and vinyl acetate (VA) monomers. The ingredient is used primarily in hair care products and secondly in skin and nail products. Acute oral toxicity studies on mice and rats showed low to no toxicity. Chronic oral and inhalation studies produced no effects. The acute ocular irritation of PVP/VA Copolymer at concentrations ranging from 25% to 50% in alcohol produced no reaction to severe irritation. Acute skin irritation studies of 50% PVP/VA Copolymer in alcohol on abraded and intact skin produced mild skin irritation. PVP/VA Copolymer was not a sensitizer to guinea pigs after intracutaneous injections. Formulations containing 1.75%, 4.0%, and 5.0% PVP/VA Copolymer produced no irritation in 24-hour clinical patch tests nor any evidence of sensitization in a repeated insult patch test at a concentration of 5.0%. On the basis of the available information, it is concluded that Polyvinylpyrrolidone/Vinyl Acetate Copolymer is safe as a cosmetic ingredient under present conditions of concentration and use.

1 Final Report on the Safety Assessment of Stearyl Alcohol, Oleyl Alcohol, and Octyl Dodecanol

1985 ◽  
Vol 4 (5) ◽  
pp. 1-29 ◽  
Keyword(s):  
Safety Assessment ◽  
Oleyl Alcohol ◽  
Skin Irritation ◽  
Final Report ◽  
Stearyl Alcohol ◽  
Contact Sensitization ◽  
Oral Toxicity ◽  
Product Categories ◽  
Ocular Irritation ◽  
Low Order

Stearyl Alcohol, Oleyl Alcohol, and Octyl Dodecanol are long-chain saturated or unsaturated (Oleyl) fatty alcohols. They are used in numerous cosmetic product categories at concentrations of less than 0.1 percent to greater than 50 percent. The metabolism of Stearyl Alcohol and Oleyl Alcohol in rats is described. The results of acute oral toxicity studies indicate a very low order of toxicity. In rabbit irritation tests, these alcohols produced minimal ocular irritation and minimal to mild cutaneous irritation. Stearyl Alcohol produced no evidence of contact sensitization or comedogenicity. Clinical patch testing indicates a very low order of skin irritation potential and sensitization. Photoreactivity studies on products containing these ingredients were negative for phototoxicity or photosensitization. Based on the available data, it is concluded that Stearyl Alcohol, Oleyl Alcohol, and Octyl Dodecanol are safe as currently used in cosmetics.

THE EFFECT OF OINTMENTS WITH ANTIOXIDANT ACTIVITY ON THE MORPHOLOGICAL STRUCTURES OF SKIN OF GUINEA PIGS EXPOSED TO LOCAL ULTRAVIOLET IRRADIATION

2019 ◽  
pp. 64-72
Author(s):  
T. V. Zvyagintseva ◽  
S. I. Myronchenko ◽  
N. I. Kytsyuk ◽  
O. V. Naumova
Keyword(s):  
Antioxidant Activity ◽  
Silver Nanoparticles ◽  
Ultraviolet Irradiation ◽  
Guinea Pigs ◽  
Main Group ◽  
The State ◽  
Elastic Fibers ◽  
Control Group ◽  
General Tendency ◽  
Skin Reactions

Considering the particular danger of remote skin reactions to ultraviolet irradiation (UVI), it is advisable to use ointments with antioxidant activity to reduce its negative effect on the skin. The rationale for the choice of ointments with antioxidant activity was the fact that they reduce the damaging effect of ultraviolet radiation in the erythemal and early post-erythemal period. The presence of a regular connection between the development of the early and late periods has given reason to assume the protective effect of ointments on the remote skin reactions. Objective: to study the effect of thiotriazoline ointment and thiotriazoline ointment with silver nanoparticles on the state of the morphological structures of the skin of guinea pigs after local UVI. Material and methods of research. The study involved 132 albino guinea pigs weighing 400-500 g, divided into 4 groups: 1 - intact, 2 - control (guinea pigs subjected to local UVI), 3 and 4 main ones. The third main group included guinea pigs that after UVI were administered thiotriazoline ointment in the treatment and prophylactic regime, the fourth main group included guinea pigs that after UVI were administered thiotriazoline ointment with silver nanoparticles in the same mode as Group 3. Ointments were applied 1 hour before irradiation and daily until erythema disappeared. Ultraviolet erythema was caused by irradiation in 1 minimum erythemal dose. After 2, 4 hours, on the 3rd, 8th, 15th, 21st, 28th day, the fragments of irradiated skin were investigated using histochemical and morphometric methods (fibroblast density and epidermis thickness). Results. Morphological changes in the skin after applying ointments with antioxidant activity were unidirectional. It was revealed that in the early periods after irradiation, thiotrazoline ointment and thiotrazoline ointment with silver nanoparticles do not affect changes in the thickness of the epidermis, but statistically significantly reduce the density of fibroblasts in the dermis on the 3rd day of the experiment compared to the control group. In the later periods, under the influence of thiotriazoline ointment, a gradual decrease in the thickness of the epidermis, which reached the norm by the end of the experiment, was observed. On the 8th day, the maximum density of fibroblasts was recorded, in the subsequent periods of the experiment, the index gradually decreased, which was accompanied by collagenization of the papillary layer in the loci of damage to collagen and elastic fibers detected in 50% of cases. In later times, under the influence of thiotriazoline ointment with silver nanoparticles, the processes of restoring the morphological structures of the skin occurred faster. In parallel with the decrease in the density of fibroblasts in the loci of the previous damage to the collagen and elastic fibers of the papillary layer, thickening of collagen fibers was observed, replacing them with segments of destruction of elastic fibers. In this group, at the end of the experiment, the collagenization locus was small, single, occurring in 16.7% of cases. Conclusions Ointments with antioxidant activity exert a positive effect on the state of morphological structures of the skin, damaged as a result of local UVI, in erythemal and post-erythemic periods. In the early periods after the local UVI, there was a general tendency for the effect of both ointments, as they reduced the density of fibroblasts on the 3rd day, but did not result in complete normalization. In the late period after local UVI , under the influence of thiotriazoline ointment and thiotriazoline ointment with silver nanoparticles, thickness of the epidermis (by 21st and 15th day, respectively) and density of fibroblasts (by the 28th day) decreased to normal while without treatment both indicators exceeded the norm by several times for 28 days of the experiment.

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