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 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 Cetethyl Morpholinium Ethosulfate

2001 ◽  
Vol 20 (3_suppl) ◽  
pp. 99-102 ◽  
Keyword(s):  
Safety Assessment ◽  
Developmental Toxicity ◽  
Quaternary Salt ◽  
Skin Penetration ◽  
Toxicity Study ◽  
Final Report ◽  
Inhalation Toxicity ◽  
Absorption Data ◽  
Dermal Irritation ◽  
Safety Test

Cetethyl Morpholinium Ethosulfate is a quaternary salt used as an antistatic agent and as a surfactant in several hair care products. The concentration at which this ingredient is used is unknown, although data reported in 1984 indicated a maximum concentration of 1%. In an inhalation toxicity study, the approximate lethal concentration of Cetethyl Morpholinium Ethosulfate was 0.403 mg/mm3. This ingredient was shown to be a severe ocular irritant in an animal study. No other safety test data on this ingredient were available. These data were clearly insufficient to support the safety of Cetethyl Morpholinium Ethosulfate in cosmetics. Data available on Morpholine were summarized, but these data themselves were insufficient to support safety. The data needed in order to complete the safety assessment of Cetethyl Morpholinium Ethosulfate include: methods of manufacture and impurities, especially nitrosamines; current concentration of use; 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; two genotoxicity studies, at least one in a mammalian system, if positive, then a 2-year dermal carcinogenisis study using National Toxicology Program (NTP) methods may be needed; ultraviolet (UV) absorption data, if significantly absorbed, then photosensitization data are needed; dermal irritation and sensitization; and ocular toxicity, if available.

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 of the Safety Assessment of Cosmetic Ingredients Derived From Zea Mays (Corn)

2011 ◽  
Vol 30 (3_suppl) ◽  
pp. 17S-39S ◽  
Author(s):  
F. Alan Andersen ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Curtis D. Klaassen ◽  
James G. Marks ◽  
...  
Keyword(s):  
Zea Mays ◽  
Animal Studies ◽  
Corn Oil ◽  
Case Reports ◽  
Developmental Toxicity ◽  
Safety Data ◽  
Final Report ◽  
Dermal Irritation ◽  
Safety Test ◽  
Cosmetic Ingredients

Many cosmetic ingredients are derived from Zea mays (corn). While safety test data were not available for most ingredients, similarities in preparation and the resulting similar composition allowed extrapolation of safety data to all listed ingredients. Animal studies included acute toxicity, ocular and dermal irritation studies, and dermal sensitization studies. Clinical studies included dermal irritation and sensitization. Case reports were available for the starch as used as a donning agent in medical gloves. Studies of many other endpoints, including reproductive and developmental toxicity, use corn oil as a vehicle control with no reported adverse effects at levels used in cosmetics. While industry should continue limiting ingredient impurities such as pesticide residues before blending into a cosmetic formulation, the CIR Expert Panel determined that corn-derived ingredients are safe for use in cosmetics in the practices of use and concentration described in the assessment.

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 Lauramine and Stearamine

1995 ◽  
Vol 14 (3) ◽  
pp. 196-203 ◽  
Keyword(s):  
High Fat Diet ◽  
Safety Data ◽  
Female Rats ◽  
Final Report ◽  
Mesenteric Lymph Nodes ◽  
Feeding Study ◽  
Dermal Irritation ◽  
Cosmetic Formulations ◽  
Carcinogenic Effects ◽  
Mammalian System

Lauramine and Stearamine are aliphatic amines intended for use in cosmetic formulations as antistatic agents, but no current uses have been reported. In a subchronic feeding study in rats, 3,000 ppm of Stearamine in the diet caused weight loss and increased mortality, with an accumulation of histiocytes in the mucosa of the small intestine and mesenteric lymph nodes. A diet of 500 ppm did not produce these effects. Dogs fed Stearamine at 15 mg/kg/day snowed the same histiocyte accumulation. In a 2-year chronic feeding study in rats, Stearamine at concentrations up to 500 ppm (maximum tested) showed no significant increase in the incidence of tumors. Stearamine at 0.01% in a high-fat diet promoted the carcinogenic effects of DMBA in female rats, whereas 0.1% significantly inhibited the production of tumors. Tests in animals showed Lauramine to cause severe dermal irritation and necrosis. Stearamine (in an ether vehicle) applied to the skin of albino mice caused severe hyperplasia at concentrations as low as 3 mg in a 0.2-ml application. These available data were insufficient to support the safety of Lauramine and Stearamine in cosmetic formulations. Additional data considered necessary to evaluate the safety of these ingredients include the following: impurities (especially data on nitrosamines); two different genotoxicity assays (one using a mammalian system and, if positive, a dermal carcinogenesis assay by National Toxicology Program standards may be required); and a human repeat-insult patch test. It cannot be concluded that these ingredients are safe for use in cosmetic products until the listed 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.

Final Report On the Safety Assessment of Sodium Lauraminopropionate and Sodium Lauriminodipropionate

1997 ◽  
Vol 16 (1_suppl) ◽  
pp. 1-9 ◽  
Author(s):  
F. Alan Andersen
Keyword(s):  
Safety Assessment ◽  
Developmental Toxicity ◽  
Safety Data ◽  
Chemical Characterization ◽  
Current Data ◽  
Albino Rats ◽  
Clinical Test ◽  
Final Report ◽  
Dermal Irritation ◽  
Cosmetic Formulations

Sodium Lauraminopropionate and Sodium Lauriminodipropionate are used in a variety of cosmetic formulations as antistatic agents, hair conditioning agents, and surfactants. Current data on concentrations at which these ingredients appear in cosmetic formulations were unavailable. The oral LD50 for Sodium Lauraminopropionate in albino rats was reported to be 8 g/kg. Evidence from limited studies in rabbits suggests that Sodium Lauraminopropionate and Sodium Lauriminodipropionate are both dermal and ocular irritants. No evidence of sensitization was found in guinea pigs with either ingredient. No data were available on the teratogenic, mutagenic, or carcinogenic potential of these ingredients, nor was there any clinical test data available. Because of the lack of data, the safety of Sodium Lauraminopropionate and Sodium Lauriminodipropionate could not be substantiated. The data needed to make a safety assessment include the method of manufacture, chemical characterization (i.e., data on purity / impurities), chemical and physical properties of Sodium Lauraminopropionate, concentration of use in cosmetic formulations, 28-day dermal toxicity, dermal reproductive and developmental toxicity, any available ocular irritation data (no new studies should be undertaken to provide this data), dermal irritation and sensitization at concentration of use, 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 the these ingredients are safe for use in cosmetic products until these safety data have been obtained and evaluated.

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.

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