Final Report on the Safety Assessment of Ppg-5 Lanolin Wax and Ppg-5 Lanolin Wax Glyceride

1997 ◽  
Vol 16 (3) ◽  
pp. 307-315 ◽  
Keyword(s):  
Patch Test ◽  
Safety Assessment ◽  
Expert Panel ◽  
Final Report ◽  
Polypropylene Glycol ◽  
Clinical Testing ◽  
Cosmetic Products ◽  
Limited Data ◽  
Ocular Irritation ◽  
Dermal Irritation

PPG-5 Lanolin Wax and PPG-5 Lanolin Wax Glyceride are used in cosmetic formualations as skin conditioning agents–emollients. The basic components of these polypropylene glycol (PPG) derivatives were reviewed by the CIR Expert Panel. PPG was found to be safe for use in cosmetic products as concentrations of up to 50%. Lanolin Wax was found to be safe for topical application in the present practices of use and concentration (which ranged from 0.1% to 50%). Subchronic oral studies on the two PPG derivatives covered in this report indicate no systemic toxicity in rats. Ocular irritation in animals was reported to be minimal, as was dermal irritation. Clinical testing found no irritation upon treatment with 7.5% PPG-5 Lanolin Wax (as contained in an eye shadow formulation), and no sensitization in a repeated insult patch test using 3.9% PPG-5 Lanolin Wax (as contained in a lipstick). In addition to these limited data on PPG-5 Lanolin Wax and PPG-5 Lanolin Wax Glyceride, the previous reports were reviewed and synopses of relevant sections included in this report. On the basis of the available data specific to these twoingredients, as well as the data previously considered in the reports on PPG and Lanolin Wax, it is concluded that PPG-5 Lanolin Wax and PPG-5 Lanolin Wax Glyceride are safe as used in cosmetics.

Final Report On the Safety Assessment of Benzoxiquine1

1997 ◽  
Vol 16 (1_suppl) ◽  
pp. 117-122
Author(s):  
F. Alan Andersen
Keyword(s):  
Safety Assessment ◽  
Safety Data ◽  
Metabolic Activation ◽  
Final Report ◽  
Cosmetic Products ◽  
Over The Counter ◽  
Drug Products ◽  
Ocular Irritation ◽  
Dermal Irritation ◽  
Mammalian System

Benzoxiquine is described as a biocide for use in cosmetic products. It is currently reported to be used in only one product. In a separate finding, the Food and Drug Administration determined that Benzoxiquine is not generally recognized as safe and effective in over-the-counter topical antifungal drug products. The only data available on the toxicity of Benzoxiquine indicates that it is mutagenic in the Ames test without metabolic activation. Because of the lack of data, the safety of Benzoxiquine could not be substantiated. The data needed to make a safety assessment include purity/impurities, ultraviolet absorption (if there is absorption, then photosensitization data will be needed), 28-day dermal toxicity, dermal teratogenicity, ocular irritation (if already available only), dermal irritation and sensitization, and two different genotoxicity studies (one using a mammalian system). If the latter data are positive, dermal carcinogenesis data using the methods of the National Toxicology Program will be needed. It cannot be concluded that Benzoxiquine is safe for use in cosmetic products until these safety data have been obtained and evaluated.

Final Report on the Safety Assessment of Pentaerythritol Rosinate

1994 ◽  
Vol 13 (5) ◽  
pp. 395-399 ◽  
Keyword(s):  
Safety Assessment ◽  
Chronic Toxicity ◽  
Historical Data ◽  
Final Report ◽  
Uvb Radiation ◽  
Cosmetic Products ◽  
Ocular Irritation ◽  
Dermal Irritation ◽  
Animal Data ◽  
Rosin Acids

Pentaerythritol Rosinate is the ester of rosin acids derived from Rosin with the polyol, pentaerythritol, used as a skin conditioning and viscosity increasing agent in mascaras. Animal data indicate little evidence of sub-chronic toxicity in feeding studies with Pentaerythritol Rosinate at concentrations up to 5%, or of chronic toxicity in feeding studies with the ingredient at 0.05%. No evidence of carcinogenicity was found in the chronic feeding studies. Historical data indicate that Pentaerythritol Rosinate may be used in cosmetics at concentrations up to 10%. The safety of use of this concentration of Pentaerythritol Rosinate has not been demonstrated. The data needed to evaluate safety include current concentration of use, source and method of manufacture, chemistry (UV spectral analysis, pH, and impurities), ocular irritation, human dermal irritation, sensitization, and photosensitization (only if the ingredient is found to absorb UVA or UVB radiation). It cannot be concluded that this ingredient is safe for use in cosmetic products until the cited data have been obtained and evaluated.

Amended Final Report On the Safety Assessment of Pentaerythrityl Rosinate

1998 ◽  
Vol 17 (4_suppl) ◽  
pp. 83-94
Author(s):  
F.A. Andersen
Keyword(s):  
Chemical Structure ◽  
Safety Assessment ◽  
Additional Data ◽  
Developmental Toxicity ◽  
Toxicity Study ◽  
Final Report ◽  
Cosmetic Products ◽  
Carcinogenicity Study ◽  
Ocular Irritation ◽  
Dermal Irritation

Pentaterythrityl Rosinate (previously called Pentaerythritol Rosinate) is the ester of rosin acids with the polyol pentaerythritol. It is used as a skin conditioning agent-emollient and viscosity increasing agent-nonaqueous in a few cosmetic formulations. In a previous safety assessment, it was concluded that the available data were insufficient to support the safety of this ingredient in cosmetic products. Additional data needed included: concentration of use, source and method of manufacture, chemistry (ultraviolet [UV] spectral analysis, pH, and impurities), ocular irritation, human dermal irritation and sensitization, and photosensitization (only if Pentaerythritol Rosinate absorbs UVA or UVB light). It was also noted that the carcinogenic potential of this ingredient was still of concern because of the low concentration tested in the available carcinogenicity study. Additional data were received. This ingredient is produced by the fractional distillation of crude tall oil to form rosin, which is then esterified with monopentaerythritol. It is typically used at concentrations of 0. 5-10%. It does not significantly absorb in the UVA or UVB portion of the spectrum. Formulations with 10% Pentaerythrityl Rosinate produced only minimal ocular irritation. Likewise tests of formulations with the ingredient at concentations of 7-9.2% resulted in minimal dermal irritation. The ingredient was nonsensitizing in animal maximization tests. Clinical tests of formulations with the ingredient at concentrations of 7-9.6% resulted in neither irritation nor sensitization. No data, however, were provided on possible impurities. Absent information on the actual chemical structure, the lack of information on impurities was considered significant. On further review, a single carcinogenicity study with negative results reported in the earlier safety assessment was considered inadequate. The absence of genotoxicity data was also considered significant. The lack of impurity and chemical structure information also raised a concern about the need for reproductive and developmental toxicity data. On the basis of this further review, it was concluded that the available data are still insufficient to support the safety of this ingredient in cosmetic products. Additional data needed include: (1) two genotoxicity assays, at least one in a mammalian system; if positive, then a 2-year dermal carcinogenicity study using National Toxicology Program (NTP) methods is needed; (2) dermal absorption; if significantly absorbed, then both a 28-day dermal toxicity study and a reproductive and developmental toxicity study may be needed; and (3) chemical properties, including structure and impurities.

Final Report on the Safety Assessment of Dimethyl Lauramine

1995 ◽  
Vol 14 (3) ◽  
pp. 193-195
Keyword(s):  
Safety Assessment ◽  
Aliphatic Amine ◽  
Safety Data ◽  
Final Report ◽  
Cosmetic Products ◽  
Dermal Toxicity ◽  
Ocular Irritation ◽  
Dermal Irritation ◽  
Cosmetic Formulations ◽  
Genotoxicity Tests

Dimethyl Lauramine is a tertiary aliphatic amine intended for use in cosmetics as an antistatic agent, but no actual uses were reported in 1993. The antimicrobial and fungicidal properties of Dimethyl Lauramine are well documented. Because of a lack of other data, however, the safety of Dimethyl Lauramine for use in cosmetic formulations has not been substantiated. The data needed to make a safety assessment include the basic chemistry (p H, impurities, and UV spectral analysis), 28-day dermal toxicity, ocular irritation, human dermal irritation and sensitization, human photosensitization if the material absorbs in the UVA or UVB region of the spectrum, genotoxicity evaluated in two different assays, and carcinogenicity tests if the genotoxicity tests are positive. It cannot be concluded that this ingredient is safe for use in cosmetic products until these safety data have been obtained and evaluated.

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 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.

Final Report on the Safety Assessment of Stearalkonium Chloride

1990 ◽  
Vol 1 (2) ◽  
pp. 57-69 ◽  
Keyword(s):  
Aqueous Solution ◽  
Patch Test ◽  
Quaternary Ammonium ◽  
Safety Assessment ◽  
Antimicrobial Properties ◽  
Final Report ◽  
Cosmetic Products ◽  
Single Application ◽  
Rabbit Eye ◽  
Ld50 Value

Stearalkonium Chloride is a cationic quaternary ammonium salt used in cosmetic products at concentrations of ≤0.1 to 5%. It is used in cosmetics predominantly for its surfactant and antimicrobial properties. Studies have failed to establish with certainty the oral LD50 in rats of Stearalkonium Chloride, the value falling between 0.5 and 1.25 g/kg. In mice, an LD50 value of 0.760-0.113 g/kg was reported in a seven-day oral study. Single application dermal studies with concentrations of up to 25% have shown Stearalkonium Chloride to produce minor irritation in rabbits. Acute eye studies in rabbits have shown a 25% solution of the material to be a severe irritant. Concentrations of 1.25% and less are slightly and transiently irritating to the rabbit eye. A repeated insult patch test with a 1% aqueous solution of Stearalkonium Chloride on 50 subjects showed the material to be neither a primary irritant nor a sensitizer. A single 48-hour patch test with challenge two weeks later indicated that 20% Stearalkonium Chloride is not a sensitizer. On the basis of the evidence at hand, it is concluded that Stearalkonium Chloride is safe when incorporated in cosmetic products in concentrations similar to those presently marketed.

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.

Final Safety Assessment of Thiodipropionic Acid and Its Dialkyl Esters as Used in Cosmetics

2010 ◽  
Vol 29 (4_suppl) ◽  
pp. 137S-150S ◽  
Author(s):  
Catherine Diamante ◽  
Monice Zondlo Fiume ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
...  
Keyword(s):  
Single Dose ◽  
Safety Assessment ◽  
Expert Panel ◽  
The Other ◽  
Repeated Dose ◽  
Clinical Testing ◽  
Cosmetic Products ◽  
Significant Toxicity ◽  
Dose Oral ◽  
Animal Skin

Dilauryl thiodipropionate (DLTDP), dicetyl thiodipropionate, dimyristyl thiodipropionate, distearyl thiodipropionate, and ditridecyl thiodipropionate are dialkyl esters of their respective alcohols and thiodipropionic acid (TDPA) used in cosmetics. Ingested DLTDP was excreted in the urine as TDPA. Single-dose acute oral and parenteral studies and subchronic and chronic repeated dose oral studies did not suggest significant toxicity. Neither DLTDP nor TDPA was irritating to animal skin or eyes and they were not sensitizers. TDPA was neither a teratogen nor a reproductive toxicant. Genotoxicity studies were negative for TDPA and DLTDP. Clinical testing demonstrated some evidence of irritation but no sensitization or photosensitization. The Cosmetic Ingredient Review Expert Panel considered that the data from DLTDP reasonably may be extrapolated to the other dialkyl esters and concluded that these ingredients were safe for use in cosmetic products that are formulated to be nonirritating.

4 Final Report on the Safety Assessment of o-Cymen-5-ol

1984 ◽  
Vol 3 (3) ◽  
pp. 131-138
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Safety Data ◽  
Safety Evaluation ◽  
Final Report ◽  
Cosmetic Products

The safety on o-Cymen-5-ol has not been documented and substantiated. The Cosmetic Ingredient Review Expert Panel cannot conclude that o-Cymen-5-ol is safe for use in cosmetic products until such time that the appropriate safety data have been obtained and evaluated. The data that were available are documented in the report as well as the types of data that are required before a safety evaluation may be undertaken.

Sign in / Sign up

Export Citation Format

Share Document