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 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.

scholarly journals Final Report on the Safety Assessment of Di-t-Butylhydroquinone

1996 ◽  
Vol 15 (4) ◽  
pp. 301-310 ◽  
Keyword(s):  
Developmental Toxicity ◽  
Safety Data ◽  
Skin Penetration ◽  
Uv Absorption ◽  
Final Report ◽  
Cosmetic Products ◽  
Dermal Irritation ◽  
Chronic Study ◽  
Mammalian System ◽  
Additional Safety

Di-t-Butylhydroquinone is an antioxidant that may be used in cosmetic products; currently, however, there are no reported uses. Di-t-Butylhydroquinone is approved for use as an indirect food additive. Very little data relevant to assessing the safety of Di-t-Butylhydroquinone in cosmetics are available. In a study in which rats were exposed to 2% Di-t-Butylhy-droquinone in their feed, all died within 2 weeks. Other studies reported results that vary as a function of the base feed used. In a chronic study, rats fed up to 0.2% Di-t-Butylhydroquinone did not exhibit a significant response. Exposure of male Syrian hamsters to 1% Di-t-Butylhydroquinone in the feed resulted in inflammation, hyperkeratosis, hyperplasia, and papillomas in the non-squamous stomach. Animal tests show that Di-t-Butylhydroquinone as low as 10% can cause erythema, but not sensitization. Di-t-Butylhydroquinone does not appear to cause depigmentation. However, additional safety data are needed. Information is needed on the concentration of its use in cosmetics, the presence of impurities, UV absorption, 28-day dermal toxicity, skin penetration, dermal irritation and sensitization, and genotoxicity, (two different assays, one in a mammalian system). Additionally, if there is UV absorption, photosensitization data are needed; if there is significant skin absorption, reproductive and developmental toxicity data may be needed; and if there is positive mutagenicity, a dermal carcinogenicity assay is needed. In the absence of these data, it was concluded that the available data are not sufficient to support the safety of Di-t-Butylhydroquinone in cosmetic products.

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 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.

scholarly journals 4 Final Report on the Safety Assessment of Phenyl Trimethicone

1986 ◽  
Vol 5 (5) ◽  
pp. 353-371
Keyword(s):  
Absorption Spectrum ◽  
Guinea Pigs ◽  
Safety Assessment ◽  
Metabolic Activation ◽  
Final Report ◽  
Cosmetic Products ◽  
Ames Assay ◽  
Ocular Irritation ◽  
Irritation Test ◽  
Uv Absorption Spectrum

Phenyl Trimethicone is a silicon polymer used in a variety of cosmetic products at concentrations up to 5%. In acute oral studies, Phenyl Trimethicone was relatively nontoxic in rats and was nontoxic in acute and subchronic dermal studies. Phenyl Trimethicone was nonirritating to the skin of rabbits under both intact and abraded conditions and was not a sensitizer to guinea pigs. The ingredient was not an eye irritant when evaluated by the Draize ocular irritation test. Phenyl Trimethicone was nonmutagenic both with and without metabolic activation when evaluated in the Ames assay. Phenyl Trimethicone was not teratogenic in rats and rabbits when applied dermally at doses of up to 500 mg/kg per day, although an increase in the number of resorptions was noted in two of three studies (statistically significant in only one). A dose of 200 mg/kg per day indicated that a fetotoxic dose was being approached. The doses tested are comparatively greater than the concentrations used in cosmetic products. Phenyl Trimethicone is neither an irritant nor a sensitizer to humans. No photosensitization data are available on Phenyl Trimethicone; however, the UV absorption spectrum indicated only weak absorbance at 327 nm. Based on the animal and human data included in this report, it is concluded that Phenyl Trimethicone is safe as a cosmetic ingredient in the present practices of use and concentration.

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 Aldioxa

1993 ◽  
Vol 12 (3) ◽  
pp. 237-242
Keyword(s):  
Organic Compound ◽  
Guinea Pigs ◽  
Safety Assessment ◽  
Safety Data ◽  
Control Group ◽  
Final Report ◽  
Cosmetic Products ◽  
Feeding Study ◽  
Human Volunteers

Aldioxa is a heterocyclic organic compound used in cosmetic products as an astringent and skin conditioning agent. The oral LD50 for mice exceeds 23 mg/kg, and 8 g/kg for rats. All of the toxicologic parameters investigated in a 94-day subchronic feeding study in rats were similar in the test and the control group. No significant macroscopic adverse results were obtained in a three generation study in which rats were fed diets containing 10% Aldioxa. A suspension containing 25% Aldioxa was not a sensitizer when applied to the shaved backs of 3 male guinea pigs, nor when 10 animals were given intradermal injections of a 2% Aldioxa suspension on alternating days for a total of 10 applications and challenged after a 10-day nontreatment period. A hydrophilic unguent containing 4% Aldioxa was neither an irritant nor a sensitizer when evaluated on 200 human volunteers. The safety of Aldioxa has not been completely documented and substantiated. It cannot be concluded that this ingredient is safe for use in cosmetic products until the appropriate needed safety data cited in the report have been obtained and evaluated.

3 Final Report on the Safety Assessment of Polyquaternium-10

1988 ◽  
Vol 7 (3) ◽  
pp. 335-351 ◽  
Keyword(s):  
Stratum Corneum ◽  
Quaternary Ammonium ◽  
Safety Assessment ◽  
Metabolic Activation ◽  
Hydroxyethyl Cellulose ◽  
Final Report ◽  
Cosmetic Products ◽  
Ammonium Derivative ◽  
Quaternary Ammonium Derivative ◽  
Low Degree

Polyquaternium-10 is a polymeric quaternary ammonium derivative of hydroxyethyl cellulose that is used in cosmetics as a conditioner, thickener, and emollient at concentrations of ≤0.1%–5%. Polyquaternium-10 has, at most, only a low potential to penetrate the stratum corneum but is adsorbed by keratinous surfaces. The oral LD50 of Polyquaternium-10 was not obtained at 16 g/kg in rats. Inhalation, dermal, and ocular animal test data indicated, at most, only a low degree of toxicity at test concentrations of Polyquaternium-10 greater than that used in cosmetic products. Polyquaternium-10 with and without metabolic activation was not a mutagen in three separate assay systems. Polyquaternium-10 was neither an irritant nor a human sensitizer when tested at 2.0%. Cosmetic products containing up to 1% Polyquaternium-10 were not human irritants, sensitizers, or photosensitizers. On the basis of the information presented, it is concluded that Polyquaternium-10 is safe as a cosmetic ingredient in the present practices of use.

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.

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