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Fragrance and Cologne

For the most part, FDA regulatory action to ban use of an ingredient in cosmetics means that ingredient is exempt from CIR review. In the case of Methylene Chloride, CIR’s safety assessment that preceded FDA’s regulation is now superceded. In the case of Tallow and tallow derivatives, the FDA identification of prohibited cattle material does not ban Tallow and tallow derivatives use in cosmetics. In the case of Trichloroethane, the EPA (except for essential uses) and the FDA determination of non-essential use appears to relate to aerosol cosmetics only.

Ingredient CIR Conclusion FDA Regulation
Bithionol Exempt from CIR review because of FDA regulation Cosmetics containing bithionol are deemed to be adulterated under section 601 (a) of the Federal Food, Drug, and Cosmetic Act(21 CFR 700.11)
Chlorofluorocarbon propellants Exempt from CIR review because of FDA regulation FDA has prohibited the use of Chlorofluorocarbon propellants in cosmetic products with self-pressurized containers (21 CFR 700.23)
Chloroform Exempt from CIR review because of FDA regulation FDA has prohibited the use of Chloroform, except if present in residual amounts from its use as a processing solvent during manufacture, or as a byproduct from the synthesis of an ingredient (21 CFR 700.18)
Halogenated salicylanilides Exempt from CIR review because of FDA regulation FDA has prohibited (21 CFR 700.15) the use of four halogenated salicylanilides:
  • tribromsalan (TBS,3,4 Œ,5-tribromosalicylanilide)
  • dibromsalan (DBS,4 Œ,5-dibromosalicylanilide)
  • metabromsalan (MBS,3,5-dibromosalicylanilide)
  • 3,3 Œ,4,5 Œ-tetrachlorosalicylanilide(TCSA)
Hexachlorophene Exempt from CIR review because of FDA regulation (have reviewed Chlorophene and Dichlorophene - data insufficient to support safety in cosmetics) Not allowed as a preservative in cosmetics where normal use may be applied to mucous membranes or which are intended to be used on mucous membranes. For all other cosmetic uses, OK at a level that is no higher than necessary to achieve the intended preservative function, and in no event higher than 0.1 percent. Such use of hexachlorophene shall be limited to situations where an alternative preservative has not yet been shown to be as effective or where adequate integrity and stability data for the reformulated product are not yet available.
Mercury Exempt from CIR review from FDA regulation FDA has prohibited Mercury in cosmetic products, except for trace amount below 1 ppm and except for use as a preservative in eye-area cosmetic products at concentrations up to 65 ppm (21 CFR 700.13)
Methylene Chloride Safe for brief, discontinuous use only FDA has prohibited the use of Methylene Chloride in cosmetic products, actions which supercedes the CIR conclusion (21 CFR 700.19)
Prohibited  cattle material Tallow, Tallow Glyceride, Tallow Glycerides, Hydrogenated Tallow Glyceride, and Hydrogenated Tallow. Glycerides are safe as used in cosmetics FDA has prohibited the use in cosmetics of specified risk materials, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed, or MS (Beef). Prohibited cattle materials do not include tallow that contains no more than 0.15 percent hexane insoluble impurities and tallow derivatives. (21 CFR 700.27)
Trichloroethane Safe for use as a solvent The U.S. Environmental Protection Agency has banned the production of Trichloroethane because it is considered a Class I ozone-depleting substance, except for essential uses, medical devices, and aviation safety. FDA has determined that the use of Trichloroethane in an aerosol cosmetic product is not essential.
Vinyl Chloride Exempt from CIR review because of FDA regulation Cosmetics containing vinyl chloride (including use as a propellant) are deemed to be adulterated under section 601 (a) of the Federal Food, Drug, and Cosmetic Act (21 CFR 700.14)
Zirconium Exempt from CIR review because of FDA regulation Aerosol cosmetics containing zirconium are deemed to be adulterated under section 601 (a) of the Federal Food, Drug, and Cosmetic Act (21 CFR 700.16)

  • Acetyl ethyl tetramethyl tetralin (AETT) – In a subchronic toxicity study in rats conducted in 1977, AETT was found to cause serious neurotoxic disorders and discoloration of internal organs. It was also determined to penetrate human skin. The fragrance industry voluntarily discontinued the use of AETT in 1978.
  • 6-Methylcoumarin (6-MC) – 60MC, a fragrance ingredient, is a potent photocontact sensitizer which may cause serious skin and systemic disorders in some consumers on contact in the presence of sunlight. Between 1976 & 1978, the FDA received many reports of adverse reactions associated with the use of 6-MC containing suntan preparations. The photocontact allergenicity of 6-MC was subsequently confirmed in clinical studies. In 1978, the FDA asked manufacturers of suntan and sunscreen products to discontinue the use of 6-MC. Two firms voluntarily recalled their 6-MC containing suntan products from the market.
  • Musk Ambrette – Musk ambrette, a fragrance ingredient, may cause photocontact sensitization, i.e., allergic reaction of the skin on exposure to musk ambrette and sunlight. Animal studies demonstrated that musk ambrette may cause neurotoxic effects. The International Fragrance Association has recommended that musk ambrette should not be used in products applied to the skin, particularly in products used on skin that is customarily also exposed to sunlight.
  • Nitrosamines – Cosmetics containing as ingredients amines and amino derivatives, particularly di- & triethanolamine (DEA & TEA) may form nitrosamines, if they also contain an ingredient which acts as a nitrosating agent as for example, 2-bromo-2-nitroproane-1,3-diol (Bronopol, Onyxide 500), 5-bromo-5-nitro-13-dioxane (Bronidox C) or tris (hydroxymethyl) nitro-methane (Tris Nitro); or if they are contaminated with a nitrosating agent, e.g., sodium nitrite. Amines and their derivatives are mostly present in creams, cream lotions, hair shampoos and cream hair conditioners. The nitrosatin may occur during manufacture as well as product storage. Many nitorsamines have been determined to cause cancer in laboratory animals. They have also been shown to penetrate the skin. Nitrosamine contamination of cosmetics became an issue in early 1977. In a study of 29 cosmetic creams and lotions, N-Nitrosodiethanolamine (NDELA) was determined in 27. The levels of NDELA contamination ranged from less than 10 ppb to 50 ppm. Of the more than 300 cosmetic samples analyzed in 1978, 1979 and early 1980 in FDA laboratories, 7% contained less than 30 ppb NDELA, 26% contained 30 ppb to 2 ppm, and 7% contained between 2 ppm and 150 ppm. The FDA expressed its concern about the contamination of cosmetics with nitrosamines in a Federal Register notice dated April 10, 1979, which stated that cosmetics containing nitrosamines may be considered adulterated and subject to enforcement action in surveys of cosmetic products conducted in 1991-92, NDELA was found in 65% of the samples at levels up to 3 ppm.
  • Dioxane – Cosmetics containing as ingredients ethoxylated surface active agents, i.e., detergents, foaming agents, emulsifiers and certain solvents identifiable by the prefix, word or syllable “PEG”, “Polyethylene”, “Polyethylene glycol”, “Polyoxyetheylene”, “-eth-“, or “-oxynol-“, may be contaminated with 1,4-dioxane. It may be removed from ethoxylated compounds by means of vacuum stripping at the end of the polymerization process without an unreasonable increase in raw material cost. IN rodent feeding studies conducted for the National Cancer Institute, 1,4-dioxane was found to produce cancer of the liver and the nasal turbinates. It also caused systemic cancer in a skin painting study. Skin absorption studies demonstrated that dioxane readily penetrates animal and human skin from various types of vehicles. However, it was also determined that most the dioxane applied to the skin in a vehicle evaporates into the environment and may not be available for skin absorption. The contamination of ethoxylated surface-active agents with dioxane was first reported in 1978. Many of the raw materials analyzed since then have been found to contain dioxane; some contained as much as, or more than, 100 ppm. In finished cosmetic products containing ethoxylated surface-active agents, the incidence and level of dioxane contamination was significantly lower.

 

Standards Prohibited:

  • Acetyl isovaleryl (5-Methyl-2,3-hexanedione)
  • Acetyl ethyl tetramethyl tetralin
  • Alantroot oil
  • Allyl heptine carbonate
  • Allyl isothiocyanate
  • a-Methyl anisylidene acetone
  • Amylcyclopentenone
  • Anisylidene acetone (4-(p-methoxyphenyl)-3-butene-2-one)
  • Benzene
  • Benzyl cyanide
  • Boldo oil
  • 3-Bromo-1,7,7-tirmethylbicyclo[2.2.1]heptane-2-one
  • Bromostyrene
  • Carvone oxide
  • Chenopodium oil
  • Cinnamylidene acetone
  • cis- and trans-Asarone
  • Colophony
  • Costus root oil absolute and concrete
  • 2,4-Decadienal
  • 1,3-Dibromo-2-methoxy-4-methyl-5-nitrobenzene (Musk KS)
  • 1,3-Dibromo-2methoxy-4-nitro-5-(1,1-dimethylethyl)-6-methyl-benzene ( Musk alpha)
  • 2,2-Dichloro-1-methylcyclopropylbenzene
  • Diethyl maleate
  • Dihydrocoumarin
  • 2,4-Dihydroxy-3-methylbenzaldehyde
  • Dimethyl citraconate
  • 3,7-Dimethyl-2-octen-1-ol
  • 4,6-Dimethyl-8-tert-butylcoumarin
  • Diphenylamine
  • Esters of 2-nonynoic acid (except methyl octane carbonate)
  • Esters of 2-octynoic acid (except for methyl heptine carbonate)
  • Ethyl acrylate
  • Ethylene glycol monoethyl ether and its acetate
  • Ethylene glycol mommethyl ether and its acetate
  • Fig leaf absolute
  • Furfuryl alcohol
  • Furfurylidene acetone
  • Geranyl nitrile
  • 2,4-Heptadienal
  • 2,4-Hexadienal
  • Hexahydrocoumarin
  • Hydroabietyl alcohol-Dihydroabietyl alcohol
  • Hydroquinone monoethyl ether
  • Hydroquinone monomethyl ether
  • Isophorone
  • 6-Isopropyl-2-decalol
  • Massoia bark oil
  • Massoia lactone
  • Melissa oil (genuine Melissa officinalis L.)
  • 7-Methoxycoumarin
  • Methyl crotonate
  • Methyl methacrylate
  • 3-Methl-2(3)-nonenenitrile
  • 4-Methyl-7-ethoxycoumarin
  • 6-Methylcoumarin
  • 7-Methycoumarin
  • Moskene (1,1,3,3,5-Pentamethyl-4,6-dinitroindane)
  • Musk ambrette
  • Musk tibetene (1-ter-Butyl-2,5,dinitro-3,4,5-trimethylbenzene)
  • Musk xylene
  • Nitrobenzene
  • 2,4-Nonadienal
  • 2-Penthylidene cyclohexanone
  • Peru balsam crude
  • Phenyl acetone (Methyl benzyl ketone)
  • Phenyl benzoate
  • p-Methylhydrocinnamic aldehyde
  • Pseudo methylionones
  • Pseudoionone (2,6-Dimethylundeca-2,6,8-trien-10-one)
  • p-tert-Butylphenol
  • Quinoline
  • Santolina oil
  • Toluene
  • trans-2-Heptenal
  • trans-2-Hexenal diethyl acetal
  • trans-2-Hexenal dimethyl acetal
  • 2,4-Undecadienal
  • Verbena oil

 

Standards Restricted:

  • 5-Acetyl-1,1,2,3,3,6-hexamethyl indan (AHMI)
  • Allyl phenoxyacetate
  • alpha-Amyl cinnamic alcohol
  • alpha-Amyl cinnamic aldehyde
  • alpha-Hexyl cinammic aldehyde
  • alpha-Hexylidene cyclopentanone
  • alpha-Methyl-1,3,-benzodioxole-5-propionaldehyde (MMDHCA)
  • a-Methyl cinnamic aldehyde
  • 3 and 4-(4-Hydroxy-4-methylpentyl)-3-cyclohexene-1-carboxaldehyde (HMPCC)
  • Angelica root oil
  • Anisyl alcohol
  • Benzaldehyde
  • Benzyl alcohol
  • Benzyl benzoate
  • Benzyl cinnamate
  • Benzyl salicylate
  • Bergamot oil expressed
  • Bitter orange peel oil expressed
  • Carvone
  • Cinnamic alcohol
  • Cinnamic aldehyde
  • Cinammic aldehyde dimethyl acetal
  • Cinnamyl nitrile
  • Citral
  • Citronellol
  • Citrus oils and other furocoumarins containing essential oils
  • Coumarin
  • Cumin oil
  • Dibenzyl ether
  • 1-(5,5-Dimethyl-1-cyclohexen-1-yl) pent-4-en-1-one
  • 2,2-Dimethyl-3-(3-tolyl)propan-1-ol (Majantol)
  • Dimethylcyclohex-3-ene-1-carbaldehyde
  • Estragole
  • 2-Ethoxy-4-methylphenol
  • Eugenol
  • Farnesol
  • Gerarniol
  • Grapefruit oil expressed
  • Hexyl salicylate
  • Hydroxycitronellal
  • Isobutyl N-methylanthranilate
  • Isocyclocitral
  • Isocyclogeraniol
  • Isoeugenol
  • Jasmine absolute (grandiflorum)
  • Jasmine absolute (sambac)
  • Lemon oil cold pressed
  • Lime oil expressed
  • Methadiene-7-methyl formate
  • Methoxy dicyclopentadiene carboxaldehyde (Scentenal)
  • 2-methoxy-4-methylphenol
  • 4-methoxy-alpha-methylbenzene propanal
  • Methyl Beta-naphtyl ketone
  • Methyl eugenol
  • Methyl heptine carbonate
  • Methyl ionone, mixed isomers
  • Methyl N-methylanthranilate
  • Methyl octane carbonate
  • 6-Methyl-3,5-heptadien-2one (Methyl heptadienone)
  • Oakmoss extracts
  • 1-octen-3-yl acetate
  • Opoponax
  • OTNE (1-(1,2,3,4,5,6,7,8 Octahydro-2,3,8,8-tetarmethyl-2-naphthalenyl)ethanone)
  • Peru balsam extracts and distillates
  • Phenylacetaldehyde
  • 3-phenylbutanal
  • 2-Phenylpropionaldehyde
  • p-Isobutyl-a-methyl hydrocinnamaldehyde
  • p-Mentha-1,8-dien-7-al (perilla aldehyde)
  • p-Methyltetrahydroquinoline
  • 3-Propylidenephtalide
  • p-tert-Butyl-alpha-methylhydrocinnamic aldehyde (BMHCA)
  • p-tert-Butyldihydrocinnamaldehyde (Bourgeonal)
  • Rose ketones
  • Rue oil
  • Safrole, Isosafrole, Dihydrosafrole
  • Styrax
  • Tagetes oil and absolute
  • Tea leaf absolute
  • 1,2,3,4,-Tetrahydro-4-methylquinoline
  • trans-2-Hexenal
  • Treemoss extracts
  • 2,6,6-Trimethylcyclohexa-1,3,-dienyl methanol (Safranal)
  • Verbena absolute
  • Vetiveryl acetate
  • Ylang ylang extracts

 

Chemical % of fragrance portion of formula CAS# Reference Material (you must register to access Aldrich  MSDS information...then do a search for the chemical...link will take you to Aldrich's site.
Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,8,8-tetramethyl-2-naphthalenyl)-
(Iso E Super)
11.7 54464-57-2

A search of literature revealed very little available health or toxicology information. This compound is in common use in fragrances often at levels of  25%.
(Perfumery: Practice and Principle)

Hydrocinnamaldehyde, p-tert-butyl-.alpha.-methyl-
(Lilial)
11.6 80-54-6 Irritant
The chemical, physical, and toxicological properties have not been thoroughly investigated. (Aldrich)
Benzoic acid, 2-hydroxy-, phenylmethyl ester
(BENZYL SALICYLATE)
11.1 118-58-1 Irritant
The chemical, physical, and toxicological properties have not been thoroughly investigated. (Aldrich) (Fisher)
Phthalic acid, diethyl ester
(DIETHYL PHTHALATE)
10.5 84-66-2 Irritant, CNS effects, may cause fetal effects  (Aldrich) (Fisher)
3-Buten-2-one, 4-(2,6,6-trimethyl-1-cyclohexen-1-yl)-
(BETA-IONONE)
5.2 14901-07-6 Irritant, respiratory & skin sensitizer
The chemical, physical, and toxicological properties have not been thoroughly investigated. (Aldrich) (Fisher)
3-Cyclohexene-1-carboxaldehyde, 4-(4-hydroxy-4-methylpntyl)-
(LYRAL)
4.8 31906-04-4  
3-Cyclohexene-1-methanol, .alph.,.alpha.,4-trimethyl-
(ALPHA-TERPINEOL)
4.2 98-55-5 Irritant
The chemical, physical, and toxicological properties have not been thoroughly investigated. (Aldrich) (Fisher)
1,3-Benzodioxole-5-carboxaldehyde
(PIPERONAL)
4.0 120-57-0 Irritant, CNS effects
The chemical, physical, and toxicological properties have not been thoroughly investigated. (Aldrich) (Fisher)
Cyclopenta(g) -2-benzopyran, 1,3,4,6,7,8-hexadro-4,6,6,7,8-hexamethyl-
(GALAXOLIDE 50)
3.52 1222-05-5  
Cyclopentaneacetic acid, 3-oxo-2-pentyl-, methyl ester
(METHYLDIHYDROJASMONATE)
3.25 24851-98-7 Irritant
The chemical, physical, and toxicological properties have not been thoroughly investigated. (Aldrich)
1,6-Octadien-3-ol, 3,7-dimethyl-, acetate
(LINALYL ACETATE)
3.0 115-95-7 Irritant
The chemical, physical, and toxicological properties have not been thoroughly investigated (Aldrich)
Benzoic acid, 2-hydroxy-, (3Z)-3-hexenyl ester
(CIS-3-HEXENYL SALICYLATE)
3.0 65405-77-8 Irritant
The chemical, physical, and toxicological properties have not been thoroughly investigated. (Aldrich)
Phenol, 2-methoxy-4-(2-propenyl) -
(EUGENOL)
2.8 97-53-0 Irritant, skin sensitizer
The chemical, physical, and toxicological properties have not been thoroughly investigated (Aldrich) (Fisher)
1,6-Nonadien-3-ol, 3,7-dimethyl-
(ETHYL LINALOOL)
2.4 10339-55-6  
6-Octen-1-ol, 3,7-dimethyl-
(CITRONELLOL)
2.4 106-22-9 Severe Irritant
The chemical, physical, and toxicological properties have not been thoroughly investigated. (Aldrich) (Fisher)
Oxacyclohexadecan-2-one
(CYCLOPENTADECANOLIDE)
2.0 106-02-5 Irritant
The chemical, physical, and toxicological properties have not been thoroughly investigated. (Aldrich)
1,6-Octadien-3-ol, 3,7-dimethyl-
(LINALOOL)
1.9 78-70-6 Irritant
The chemical, physical, and toxicological properties have not been thoroughly investigated. (Aldrich) (Fisher)
3-Buten-2-one, 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-
(ALPHA-IONONE)
1.6 127-41-3 Irritant, skin & respiratory sensitizer
The chemical, physical, and toxicological properties have not been thoroughly investigated. (Aldrich)
Acetic acid, phenylmethyl ester
(BENZYL ACETATE)
1.5 140-11-4 Toxic. May cause CNS effects, irritant, may cause cancer based on animal studies. The chemical, physical, and toxicological properties have not been thoroughly investigated. (Aldrich) (Fisher)
2,6-Octadien-1-ol, 3,7-dimethyl-, acetate
(GERANYL ACETATE)
1.0 105-87-3 The chemical, physical, and toxicological properties have not been thoroughly investigated. (Aldrich) (Fisher)
Octanol, 7-hydroxy-3,7-dimethyl- .8 107-75-5 Irritant
The chemical, physical, and toxicological properties have not been thoroughly investigated. (Aldrich) (Fisher)
2-Buten-1-ol, 2-ethyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl)- .7 28219-61-6 The chemical, physical, and toxicological properties have not been thoroughly investigated. (Fisher)
Benzeneethanol .49 60-12-8 Toxic, harmful by all routes, readily absorbed via skin, CNS effects (Aldrich)
1,3-Benzodioxole, 5-(diethoxymethyl)- .32 40527-42-2 RTECS
1-Cyclohexene-1-butanol, 4-(diethoxymethyl)-.alpha.,.alpha.-dimethyl- .21 115217-10-2  
2-Buten-1-one, 1-(2,6,6-trimethyl-1-cyclohexen-1-yl)- .17 23726-92-3  
Benzaldehyde, 4-hydroxy-3-methoxy- .15 121-33-5 Irritant
The chemical, physical, and toxicological properties have not been thoroughly investigated. (Aldrich) (Fisher)
Phenol, 2-methoxy-4-(1-propenyl)- .15 97-54-1 Irritant
The chemical, physical, and toxicological properties have not been thoroughly investigated. (Aldrich)
Oxacycloheptadec-10-en-2-one .13 28645-51-4  
2-Octanol, 8,8-diethoxy-2,6-dimethyl- .12 7779-94-4  
2-Propen-1-ol, 3-phenyl- .08 104-54-1 Irritant
The chemical, physical, and toxicological properties have not been thoroughly investigated. 
6-Octen-3-ol, 3,7-dimethyl-, acetate .08 50373-60-9  
6-Octen-3-ol, 3,7-dimethyl- .07 18479-51-1  
7-Octen-4-one, 2,6-dimethyl- .07 1879-00-1  
Acetic acid, (cyclohexyloxy)-, 2-propenyl ester .06 68901-15-5  
2,6-Octadien-1-ol, 3,7-dimethyl- .05 106-25-2 Irritant
The chemical, physical, and toxicological properties have not been thoroughly investigated. (Aldrich)
Phenol, 2,6-bis(1,1-dimethylethyl)-4-methyl- .05 128-37-0 Irritant, cancer suspect agent, may cause reproductive /fetal effects
The chemical, physical, and toxicological properties have not been thoroughly investigated. (Aldrich) (Fisher)
Benzaldehyde, 4-methoxy- .04 123-11-5 Irritant
The chemical, physical, and toxicological properties have not been thoroughly investigated. (Aldrich) (Fisher)
Benzenemethanol .04 100-51-6 Irritant, skin sensitizer, CNS effect, harmful by all routes of exposure (Aldrich) (Fisher)
1,3,6-Octatriene, 3,7-dimethyl- .04 29714-87-2 The chemical, physical, and toxicological properties have not been thoroughly investigated. (Aldrich)
Benzoic acid, 2-hydroxy-, ethyl ester .02 118-61-6 Irritant
The chemical, physical, and toxicological properties have not been thoroughly investigated. (Aldrich) (Fisher)