Final Report on the Safety Assessment of 3-Methylamino-4-Nitrophenoxyethanol as Used in Hair Dyes

2008 ◽  
Vol 27 (2_suppl) ◽  
pp. 41-51 ◽  
Keyword(s):  
Human Skin ◽  
Expert Panel ◽  
Chinese Hamster Ovary Cells ◽  
High Dose ◽  
Final Report ◽  
Toxicity Data ◽  
Hair Dyes ◽  
Hair Dye ◽  
Skin Contact

3-Methylamino-4-Nitrophenoxyethanol is a semipermanent (direct) hair colorant used in 21 hair dyes and colors at use concentrations up to 0.15%. When applied to human skin in vitro, 0.42% of the applied 3-Methylamino-4-Nitrophenoxyethanol was recovered in the receptor fluid. In an acute toxicity study using rats, 3-Methylamino-4-Nitrophenoxyethanol at 1000 mg/kg resulted in hypoactivity, piloerection, dyspnea, and lateral recumbency in animals that later died. The surviving rats exhibited none of these signs. No abnormalities were found at necropsy. Subchronic toxic-ity tests using rats fed 25, 100, or 400 mg/kg day-1 3-Methylamino-4-Nitrophenoxyethanol for up to 93 days resulted in yellow urine and tails with all three dose levels and yellow fur occurred in the two high-dose groups. The no observed adverse effect level (NOAEL) for 3-Methyl-amino-4-Nitrophenoxyethanol was 100 mg/kg day-1. Two percent 3-Methylamino-4-Nitrophenoxyethanol was a slight ocular irritant but not a dermal irritant using rabbits and it was not a sensitizer using the murine local lymph node Assay. There were no embryotoxic or teratogenic effects observed in doses up to 750 mg/kg day-1 in rats; the NOAEL was defined as 100 mg/kg. 3-Methylamino-4-Nitrophenoxyethanol was not genotoxic in in vitro assays including multiple strains of Salmonela typhimurium and Escherichia coli, Chinese Hamster ovary cells, and human lymphocyte cultures. No carcinogenicity studies were available, nor were any clinical tests reported. As reviewed by the Cosmetic Ingredient Review (CIR) Expert Panel, there are gaps in the data available for of 3-Methylamino-4-Nitrophenoxyethanol. In particular, there is an absence of data from chronic animal studies. The Expert Panel considered that the low percutaneous absorption and that the available developmental toxicity data and the subchronic toxicity data, both of which resulted in relatively high NOAEL values, alleviate concern about the absence of chronic exposure data. In addition, several studies demonstrated that 3-Methylamino-4-Nitrophenoxyethanol is not genotoxic. Direct hair dyes, of which 3-Methylamino-4-Nitro-phenoxyethanol is one, although not the focus in all investigations, appear to have little evidence of an association with adverse events as reported in hair dye epidemiology studies. The lack of phototoxicity data was not considered to be a concern because this is a direct hair dye ingredient, which has little skin contact and residual color is attached to hair, not normally to skin. No human skin sensitization or irritation data were available. However, hair dyes containing 3-Methylamino-4-Nitrophenoxyethanol, as coal tar hair dye products, are exempt from the principal adulteration provision and from the color additive provisions in sections 601 and 706 of the Federal Food, Drug, and Cosmetic Act, when the label bears a caution statement and patch test instructions for determining whether the product causes skin irritation. The Expert Panel expects that following this procedure will prospectively identify individuals who would have an irritation/sensitization reaction and allow them to avoid significant exposures and concluded that 3-Methylamino-4-Nitrophenoxyethanol is safe as a cosmetic ingredient in the practices of use and use concentrations described in this safety report.

Final Report on the Safety Assessment of 6-Amino-m-Cresol, 6-Amino-o-Cresol, 4-Amino-m-Cresol, 5-Amino-4-Chloro-o-Cresol, 5-Amino-6-Chloro-o-Cresol, and 4-Chloro-2-Aminophenol1

2004 ◽  
Vol 23 (2_suppl) ◽  
pp. 1-22 ◽  
Keyword(s):  
Test Data ◽  
Expert Panel ◽  
Skin Irritation ◽  
Percutaneous Penetration ◽  
Final Report ◽  
Toxicity Data ◽  
Hair Dyes ◽  
Animal Skin

Each of these ingredients function as hair colorants. 5-Amino-4-Chloro-o-Cresol and 5-Amino-6-Chloro-o-Cresol are identified as oxidative hair dyes, that is, they are combined with an oxidizing agent before being applied to the hair. 6-Amino-m-Cresol, 6-Amino-o-Cresol, 4-Amino-m-Cresol, and 5-Amino-4-Chloro-o-Cresol are used in oxidative hair dyes, but it is not known if they are also used in nonoxidative (semipermanent) hair dyes. No toxicologically significant impurities are present with these two ingredients. To supplement the safety test data on these ingredients, available data on related ingredients (4-amino-2-hydroxytoluene and p-, m-, and o-aminophenol) previously found safe as used by the Cosmetic Ingredient Review (CIR) Expert Panel were summarized. 5-Amino-4-Chloro-o-Cresol and 5-Amino-6-Chloro-o-Cresol do not absorb significant ultraviolet radiation in the UVB region and none in the UVA region, although 4-Amino-m-Cresol had a symmetrical UV absorption peak at 300 nm. Percutaneous penetration of 5-Amino-4-Chloro-o-Cresol and 5-Amino-6-Chloro-o-Cresol alone was significant, but when combined with oxidative developer, skin absorption was extremely low. Both of these dyes are excreted rapidly via the urine. Repeated exposure of animal skin to 5-Amino-4-Chloro-o-Cresol and 5-Amino-6-Chloro-o-Cresol failed to produce any cumulative irritation and single exposures up to 10% were not irritating to animal skin. 5-Amino-4-Chloro-o-Cresol and 5-Amino-6-Chloro-o-Cresol combined with oxidizer were not sensitizers in guinea pig maximization tests. Ocular irritation resulted from exposure of animals to undiluted 5-Amino-4-Chloro-o-Cresol, but not to a 5% solution. Only minor irritation was observed with 5% 5-Amino-6-Chloro-o-Cresol. Subchronic toxicity testing in animals using 5-Amino-4-Chloro-o-Cresol, 5-Amino-6-Chloro-o-Cresol, and 4-Amino-m-Cresol did not yield any adverse reactions. 6-Amino-m-Cresol and 4-Amino-m-Cresol were generally not mutagenic in in vitro and in vivo tests. Exposure to 5-Amino-4-Chloro-o-Cresol, 5-Amino-6-Chloro-o-Cresol, 6-Amino-m-Cresol and 4-Amino-m-Cresol from cosmetics were several orders of magnitude below developmental toxicity no-observed-adverse-effect levels (NOAELs). Although irritation data on several ingredients are absent, products containing these ingredients must include a caution statement and patch test instructions for determining whether the product causes skin irritation. The Expert Panel expects that following this procedure would identify individuals who would have an adverse reaction and allow them to avoid significant exposures. These compounds, when tested alone, are moderate skin sensitizers, but when combined with the developer, these ingredients are not sensitizers in animal tests. This information, coupled with the available animal test data, supports the safety of these ingredients in oxidative hair dyes. In the absence of systemic toxicity data, however, the available data are insufficient to support the safety of 6-Amino-o-Cresol and 4-Chloro-2-Aminophenol in semipermanent hair dyes. The types of data required for these two ingredients for this use include (1) physical and chemical properties, including the octanol/water partition coefficient; (2) impurities data, especially regarding the presence of m-cresol, other organic molecules, and heavy metals; (3) data demonstrating that the metabolism is similar to that of 4-amino-2-hydroxytoluene and/or p-, m-, and o-aminophenol, or 28-day dermal toxicity with histopathology, dermal reproductive toxicity data, and an in vitro genotoxicity study for 6-Amino-o-Cresol and one genotoxicity study in a mammalian system; if positive, a 2-year dermal carcinogenicity study using National Toxicology Program methods may be needed.

2 Final Report on the Safety Assessment of p-Aminophenol, m-Aminophenol, and o-Aminophenol

1988 ◽  
Vol 7 (3) ◽  
pp. 279-333 ◽  
Keyword(s):  
Topical Application ◽  
Guinea Pigs ◽  
Safety Assessment ◽  
Mutagenic Activity ◽  
Skin Irritation ◽  
Final Report ◽  
Hair Dyes ◽  
Hair Dye ◽  
Mutagenicity Tests

p-Aminophenol (PAP), m-Aminophenol (MAP), and o-Aminophenol (OAP) are used in permanent (oxidative) hair dyes at concentrations from 0.1 to 5%. In vivo and in vitro skin absorption studies indicated that 11% of the dermally applied 14C-PAP was detected in the excreta, viscera, and skin of the test animals. The oral LD50s of PAP, MAP, and OAP in rats ranged from 600 to 1300 mg/kg. Topical application of PAP at concentrations up to 8.00 g/kg to the skin of New Zealand white (NZW) rabbits produced no skin irritation and no mortality. PAP, MAP, and OAP were irritating to eyes of NZW rabbits at a concentration of 2.5%. MAP at 3% was nonsensitizing in guinea pigs; PAP at 2% sensitized 9 of 10 guinea pigs. Neither PAP nor MAP produced photosensitization in guinea pigs. No treatment-related toxicity was found in three separate four-generation chronic dermal toxicity and reproduction studies of hair dye formulations containing the three Aminophenols. Additional studies on the pure ingredients were also nonteratogenic; embryotoxicity was reported. A range of results was obtained from studies assessing the mutagenic activity of the Aminophenols. PAP tested positive in six of eight mutagenicity tests. MAP and OAP gave positive results in two of eight and five of seven mutagenicity tests, respectively. Oxidative hair dye formulations containing PAP, MAP, and OAP did not produce gross or microscopic alterations or have carcinogenic effects after chronic topical application to mice. Feeding of OAP-HCl and PAP to rats at a dose of 8 mmol/kg produced neither hepatic cirrhosis nor neoplastic lesions. A 3% solution of MAP in an aqueous vehicle was neither a significant irritant nor sensitizer in two clinical studies. A variety of epidemiological studies have not indicated that occupational exposure to, and personal use of, hair dyes containing the Aminophenols presented a carcinogenic risk. A discussion of the significance of the mutagenic data in the safety assessment and the potential for human effects is presented. On the basis of the available animal and clinical data presented in this report it is concluded that p-, m-, and o-Aminophenols are safe as cosmetic ingredients in the present practices of use and concentrations.

Final Report on the Safety Assessment of Hydroxybenzomorpholine

1991 ◽  
Vol 10 (1) ◽  
pp. 205-213 ◽  
Keyword(s):  
Safety Assessment ◽  
Micronucleus Test ◽  
Coal Tar ◽  
Skin Irritation ◽  
High Dose ◽  
Final Report ◽  
Oral Toxicity ◽  
Hair Dyes ◽  
Hair Dye ◽  
Rabbit Eye

Hydroxybenzomorpholine (HBM) is a heterocyclic compound that is used in cosmetics as a coupler in coal tar hair dyes. No deaths were reported in a subchronic oral toxicity study in rats. Some degenerative changes in the cortical tubules of the kidneys were observed in the mid and high-dose groups. HBM was considered to be practically nonirritating to the rabbit eye and produced only slight skin irritation. HBM was neither a sensitizer nor a photoallergen. HBM was not mutagenic in either the Ames assay or in the mouse micronucleus test. On the basis of the data included in the report, Hydroxybenzomorpholine is considered to be safe as a hair dye ingredient at the current concentrations of use.

Final Report of the Safety Assessment of Urea1

2005 ◽  
Vol 24 (3_suppl) ◽  
pp. 1-56 ◽  
Keyword(s):  
Human Skin ◽  
Expert Panel ◽  
Female Rats ◽  
In Vitro Assays ◽  
Control Group ◽  
Final Report ◽  
Cosmetic Products ◽  
High Concentration ◽  
Diseased Skin

Although Urea is officially described as a buffering agent, humectant, and skin-conditioning agent—humectant for use in cosmetic products, there is a report stating that Urea also is used in cosmetics for its desquamating and antimicrobial action. In 2001, the Food and Drug Administration (FDA) reported that Urea was used in 239 formulations. Concentrations of use for Urea ranged from 0.01% to 10%. Urea is generally recognized as safe by FDA for the following uses: side-seam cements for food contact; an inhibitor or stabilizer in pesticide formulations and formulations applied to animals; internal sizing for paper and paperboard and surface sizing and coating of paper and paper board that contact water-in-oil dairy emulsions, low-moisture fats and oils, moist bakery products, dry solids with surface containing no free fats or oil, and dry solids with the surface of fat or oil; and to facilitate fermentation of wine. Urea is the end product of mammalian protein metabolism and the chief nitrogenous compound of urine. Urea concentrations in muscle, liver, and fetuses of rats increased after a subcutaneous injection of Urea. Urea diffused readily through the placenta and into other maternal and fetal organs. The half-life of Urea injected into rabbits was on the order of several hours, and the reutilization rate was 32.2% to 88.8%. Urea given to rats by a bolus injection or continuous infusion resulted in distribution to the following brain regions: frontal lobe, caudate nucleus, hippocampus, thalamus plus hypothalamus, pons and white matter (corpus callosum). The permeability constant after treatment with Urea of whole skin and the dermis of rabbits was 2.37 ±0.13 (x 106) and 1.20 ±0.09 (x103) cm/min, respectively. The absorption of Urea across normal and abraded human skin was 9.5% ±2.3% and 67.9% ±5.6%, respectively. Urea increased the skin penetration of other compounds, including hydrocortisone. No toxicity was observed for Urea at levels as high as 2000 mg/kg in acute oral studies using female rats or mice. No signs of toxicity were observed in male piglets dosed orally with up to 4 g/kg Urea for 5 days. Dogs dosed orally with 5 to 30 g/L Urea for 4 to 10 days had signs of toxicity, including weakness, anorexia, vomiting and retching, diarrhea and a decreased body temperature, which led to a deep torpor or coma. No significant microscopic changes were observed in the skin of male nude mice dermally exposed to 100% Urea for 24 h. No observable effect on fetal development was seen in rats and mice dosed orally with an aqueous solution of Urea (2000 mg/kg) on days 10 and 12 of gestation. The mean number of implants, live fetuses, percent fetal résorptions, mean fetal weight, and percent fetuses malformed were comparable to control group. A detergent containing 15% Urea was injected into pregnant ICR-JC1 mice and dams and fetuses had no significant differences when compared to control animals. Urea given orally did not enhance the developmental toxicity of N-nitrosomethylurea. Female Sprague-Dawley rats injected in the uterine horn with 0.05 ml Urea on day 3 (preimplantation) or on day 7 (post implantation) exhibited no maternal mortality or morbidity; a dose-dependent reduction in embryo survival was seen with preimplantation treatment. Urea injected intra-amniotically induces mid-trimester abortions in humans. Urea was not genotoxic in several bacterial and mammalian assays; although in assays where Urea was used at a high concentration, genotoxicity was found, many in in vitro assays. Urea is commonly used in studies of DNA because it causes uncoiling of DNA molecules. Urea was not carcinogenic in Fisher 344 rats or C57B1/6 mice fed diets containing up to 4.5% Urea. Exposure of normal human skin to 60% Urea produced no significant irritation in one study, but 5% Urea was slightly irritating and 20% Urea was irritating in other reports. Burning sensations are the most frequently reported effect of Urea used alone or with other agents in treatment of diseased skin. Overall, there are few reports of sensitization among the many clinical studies that report use of Urea in treatment of diseased skin. The Cosmetic Ingredient Review (CIR) Expert Panel determined the data provided in this report to be sufficient to assess the safety of Urea. The Panel did note that Urea can cause uncoiling of DNA, a property used in many DNA studies, but concluded that this in vitro activity is not linked to any in vivo genotoxic activity. Although noting that formulators should be aware that Urea can increase the percutaneous absorption of other chemicals, the CIR Expert Panel concluded that Urea is safe as used in cosmetic products.

scholarly journals 5 Final Report on the Safety Assessment of 2-Nitro-p-Phenylenediamine and 4-Nitro-o-Phenylenediamine

1985 ◽  
Vol 4 (3) ◽  
pp. 161-202 ◽  
Keyword(s):  
Animal Studies ◽  
Human Subjects ◽  
Epidemiological Data ◽  
Final Report ◽  
Hair Dyes ◽  
Carcinogenic Effect ◽  
Hair Dye ◽  
Patch Tests ◽  
Pure Compounds

Animal data on 2NPPD and 4NOPD and cosmetic hair dyes containing these ingredients suggest that both compounds were nonirritating to rabbit skin and eyes, but were sensitizers on guinea pig skin. The results of repeated insult patch tests with hair dye products containing these ingredients indicated that neither was an irritant or a sensitizer to human subjects as normally used. In the absence of human data on the pure compounds, however, 2NPPD and 4NOPD are considered to be potential human sensitizers. Topically applied 2NPPD and 4NOPD are absorbed by experimental animals. Neither embryotoxicity nor teratogenicity was observed in animal studies when hair dyes containing 2NPPD and 4NOPD were applied to the skin. Both ingredients were mutagenic in some bacterial and in vitro mammalian systems; both compounds had some genotoxic activity. In feeding studies in mice and rats, only 2NPPD induced hepatocellular tumors in female mice. Both compounds were noncarcinogenic in male mice and in rats of either sex. Epidemiological data have not demonstrated a carcinogenic effect in man for hair dyes. For those persons not sensitized, it is concluded that 2NPPD and 4NOPD are safe as hair dye ingredients at the current concentration of use.

Final Report on the Safety Assessment of HC Red No. 71

2008 ◽  
Vol 27 (1_suppl) ◽  
pp. 45-54
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Chloride Ions ◽  
Toxicity Study ◽  
Final Report ◽  
Oral Toxicity ◽  
Hair Dyes ◽  
Hair Dye ◽  
Effect Level ◽  
Epidemiology Studies

HC Red No. 7 functions as a semipermanent (direct) hair colorant in one cosmetic product at 1%. Analytical studies found the relative purity of HC Red No. 7 to be >98.5%. Impurities may include 2-nitro-benzene-1,4-diamine; 3-(4-amino-3-nitro-phenyl)oxazolin-2-one; 2-chloroethyl 4-amino-3-nitrophenylcarbamate; residual solvents ethanol, DMF, or isopropyl acetate; chloride ions; and heavy metals. Around 0.10% of the applied HC Red No. 7 was absorbed in human dermatomed skin samples. In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg. The no observed effect level (NOEL) in a subchronic oral toxicity study in rats was 50 mg/kg day-1 . HC Red No. 7 was not a dermal or ocular irritant in rabbits, but lymphoproliferative responses in mice indicated that HC Red No. 7 should be considered a moderate sensitizer. The NOEL for maternal toxicity was 50 mg/kg/day and the no observed adverse effect level (NOAEL) for embryonic development was 200 mg/kg/day in a prenatal toxicity study of HC Red No. 7 using rats. HC Red No. 7 was nonmutagenic at the hprt locus but mutagenic at the TK locus in mouse lymphoma cells, was mutagenic in several Salmonella typhimurium strains, was not active in an unscheduled DNA synthesis assay, and was unclear in a micronucleus assay in human lymphocyte cultures. No carcinogenicity studies were available, nor were any clinical tests reported. Available hair dye epidemiology studies are insufficient to conclude a causal relationship between hair dye use and cancer or other diseases, but more relevant is that direct hair dyes, although not the focus in all investigations, appear to have little evidence of an association with adverse events as reported in epidemiology studies. As reviewed by the Cosmetic Ingredient Review (CIR) Expert Panel, HC Red No. 7 appears to be a moderate sensitizer in animals. No human sensitivity data concerning this ingredient have been reported. However, hair dyes containing HC Red No. 7, as coal tar hair dye products, are exempt from the principal adulteration provision and from the color additive provisions in sections 601 and 706 of the Federal Food, Drug, and Cosmetic Act, when the label bears a caution statement and patch test instructions for determining whether the product causes contact dermatitis. The Expert Panel expects that following this procedure will identify prospective individuals who would have an irritation/sensitization reaction and allow them to avoid significant exposures. The CIR Expert Panel also noted that mutagenicity studies available for HC Red No. 7 gave both positive and negative results. Based on the available data, it was concluded that, at most, this ingredient is a weak mutagen. Due to its low dermal absorption potential and its use as a semipermanent hair dye, the CIR Expert Panel believes there is low risk of genotoxicity and that HC Red No. 7 is safe as a hair dye ingredient in the practices of use and concentrations as described in this safety assessment.

Final Report On the Safety Assessment of Hc Orange No. 11

1998 ◽  
Vol 17 (4_suppl) ◽  
pp. 21-37 ◽  
Author(s):  
Monice Zondlo Fiume
Keyword(s):  
Expert Panel ◽  
Developmental Toxicity ◽  
Skin Irritation ◽  
Skin Penetration ◽  
Oral Exposure ◽  
Final Report ◽  
Clinical Tests ◽  
Hair Dyes ◽  
Hair Dye ◽  
Carcinogenicity Study

HC Orange No. 1 is used as a colorant in semipermanent hair dyes. The highest concentration reported to be used is 0.15%, but information from manufacturers suggested that higher concentrations may be used in the future. Skin penetration through cadaver skin was 1.28% at 24 hours. In studies using rats, acute oral exposure studies produced little toxicity, and short-term toxicity studies produced reduced body weight and increased liver and kidney weights, relative to controls in animals fed 0.5% HC Orange No. 1. There was no evidence of reproductive or developmental toxicity in rats fed up to 1.25% HC Orange No. 1 or in a multigeneration study using rats in which 0.15% HC Orange No. 1 was painted on the skin. While evidence suggests this ingredient is a mild ocular irritant, no skin irritation, sensitization, or photosensitization was seen in animal or clinical tests. The preponderance of data (four out offive studies) indicate that this ingredient is not genotoxic. Hepatocellular and parathyroid hyperplasia were noted in the dermal carcinogenicity study, but the overall findings were clearly negative. Because the highest concentration tested that produced no significant sensitization in clinical tests was 3%, the Expert Panel concluded that safety could be assured only at levels ≤3%. The Expert Panel recognized that this concentration may be greater than that currently used in hair dye formulations.

5 Final Report on the Safety Assessment of 2-Methyl-5-Hydroxyethylaminophenol

1990 ◽  
Vol 9 (2) ◽  
pp. 185-202
Keyword(s):  
Patch Testing ◽  
Safety Assessment ◽  
Human Studies ◽  
Final Report ◽  
Hair Dyes ◽  
Hair Dye

2-Methyl-5-Hydroxyethylaminophenol is used in oxidative hair dyes as a coupler at concentrations ranging from ≤ 0.1 to 5.0%. Only slight absorption was observed in skin studies. The LD50 of the ingredient in mice ranged from 2.5 to 3.84 g/kg. The ingredient was less of an irritant when tested alone than when tested in hair dye formulations. The compound is neither a mutagen nor a teratogen. 2-Methyl-5-Hydroxyethylaminophenol was classified as a nonirritant and weak sensitizer in human studies. Precautionary statements and instructions for patch testing are required on the label when used in oxidative hair dyes. On the basis of the available data included in the report, 2-Methyl-5-Hydroxyethylaminophenol is considered to be safe for use in the present practices of use and concentrations.

6 Final Report on the Safety Assessment of p-Phenylenediamine

1985 ◽  
Vol 4 (3) ◽  
pp. 203-266 ◽  
Keyword(s):  
Safety Assessment ◽  
Animal Species ◽  
Epidemiological Data ◽  
Test System ◽  
Final Report ◽  
Hair Dyes ◽  
Hair Dye ◽  
Animal Data ◽  
Concentration Test ◽  
Animal Toxicity

p-Phenylenediamine is a cosmetic hair dye intermediate used in permanent hair coloring products at concentrations of up to 5 percent (diluted 1:1 with an oxidizing agent prior to application). The extensive animal toxicity test data on p-Phenylenediamine and permanent cosmetic hair dyes containing this compound show that the degree of toxicity varies with concentration, test system and animal species. Animal data support a conclusion that this compound is neither a teratogen nor a carcinogen. Epidemiological data also support that hair dyes containing this ingredient are not carcinogenic. p-Phenylenediamine is a sensitizer and some persons may be sensitized under intended conditions of use. For those persons not sensitized, it is concluded that p-Phenylenediamine is safe as a hair dye ingredient at the current concentrations of use.

Safety Assessment of 2-Amino-4-Hydroxyethylaminoanisole and 2-Amino-4-Hydroxyethylaminoanisole Sulfate as Used in Cosmetics

2013 ◽  
Vol 32 (3_suppl) ◽  
pp. 25S-35S ◽  
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Nitroso Compounds ◽  
Coupling Agents ◽  
Cosmetic Products ◽  
Hair Dyes ◽  
Hair Dye ◽  
Human Data ◽  
Oxidative Hair Dye

2-Amino-4-hydroxyethylaminoanisole and its salt, 2-amino-4-hydroxyethylaminoanisole sulfate, are used as coupling agents in oxidative hair dyes. The Cosmetic Ingredient Review Expert Panel reviewed relevant animal and human data related to the ingredient. The Expert Panel concluded that 2-amino-4-hydroxyethylaminoanisole and 2-amino-4-hydroxyethylaminoanisole sulfate are safe for use in oxidative hair dye formulations. The Expert Panel cautioned that these ingredients should not be used in cosmetic products in which N-nitroso compounds may be formed.

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