Source Amino Acids as Used in Cosmetics

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0

Scientific Literature Review

Source Amino Acids as Used in Cosmetics

May 23, 2012

The 2012 Cosmetic Ingredient Review Expert Panel members are: Chairman, Wilma F. Bergfeld, M.D., F.A.C.P.;

Donald V. Belsito, M.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; Ronald A. Hill, Ph.D. James G.

Marks, Jr., M.D.; Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR

Director is F. Alan Andersen, Ph.D. This report was prepared by Christina L. Burnett, Scientific Analyst/Writer,

and Bart Heldreth, Ph.D., Chemist CIR.

© Cosmetic Ingredient Review

1101 17

th

_{Street, NW, Suite 412}

_"

_{Washington, DC 20036-4702}

_"

_{ph 202.331.0651}

_"

_{fax 202.331.0088}

_"

cirinfo@cir-safety.org

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Table

of

Introduction

...

1 Chemistry

...

1 Impurities

...

1 Use

...

1 Cosmetic

...

1 Toxicological

Studies

...

1 Irritation

and

Sensitization

...

1 Data

Needs

...

2 Tables

and

Figures

...

3

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1 INTRODUCTION

This scientific literature review covers 21 ingredients, that are each mixtures of amino acids, derived from

specific plant and animal sources. Accordingly, the group is given the name: source amino acids – indicating that

they come from specific sources. These ingredients function as skin and hair conditioning agents in personal care

products. The full list of ingredients in this report is found in Table 1.

Concurrent reviews of the safety of

α

-amino acids and hydrolyzed proteins from plant and animal sources

are being performed by the Cosmetic Ingredient Review (CIR) Expert Panel.

CHEMISTRY

The ingredients in this group are related because they each are prepared from proteins by complete

hydrolysis to yield cosmetic grade amino acid mixtures. The most frequently used method for hydrolyzing proteins

to amino acids appears to be heating to at least 110°C with concentrated hydrochloric acid.

1,2

_{However, some amino}

acids, including tryptophan, are readily destroyed or are only partially hydrolyzed by hydrochloric acid oxidation,

so alternate hydrolysis agents, like sulfonic acid, are used in place of hydrochloric acid, or alkaline hydrolysis is

performed.

2-4

_{It is important to note that although these amino acids are produced from proteins, the hydrolysis}

process commonly racemizes the amino acids and the end product is not primarily in the L- form of the

stereoisomers, but is a mixture of L- and D-.

The composition of amino acids may be analyzed by chromatographic separation and detection of the

residues, such as liquid-liquid chromatography on ion-exchange columns, after adequate hydrolysis of the

substrate.

1,2

_{Table 2 presents composition data for commercial protein derivative from collagen keratin, silk, and}

soy hydrolysates.

Impurities

No data were found in the published literature on the impurities of source amino acids. Unconfirmed

composition analyses were found for collagen, keratin, silk, and soy hydrolysate. No composition data were

discovered for the remaining source amino acid ingredients.

USE

Cosmetic

The source amino acids in this safety assessment function primarily as hair conditioning and skin

conditioning agents in cosmetic formulations.

5

Table 3 presents the current product formulation data for source amino acids. According to information

supplied to the Food and Drug Administration (FDA) by industry as part of the Voluntary Cosmetic Registration

Program (VCRP), silk amino acids have the most reported uses in cosmetic and personal care products, with a total

of 324; approximately half of those uses are in non-coloring hair products.

6

_{Wheat amino acids have the second}

greatest number of overall uses reported, with a total of 257; again, approximately half of those uses are in

non-coloring hair products. At this time, the Personal Care Products Council is performing a use concentration survey

and CIR is awaiting those results.

The European Commission’s Scientific Committee on Consumer Products (SCCP) concluded that the risk

of exposure to viruses, such as avian influenza virus or papillomavirus, is negligible through topical application of

cosmetic products containing amino acids from the hydrolysis of human hair or chicken feathers.

7

TOXICOLOGICAL STUDIES

Many of the source amino acids in this assessment are found in the foods we consume daily, and the daily

exposure from food use would result in a much larger systemic dose than that resulting from use in cosmetic

products. These ingredients would be safe if absorbed into the body. Consequently, single dose toxicity, repeated

dose toxicity, or other systemic toxicity studies are not addressed in this report.

The safety focus of use of these amino acids as cosmetic ingredients is on the potential for irritation and

sensitization.

IRRITATION AND SENSITIZATION

No data were found in the published literature on irritation or sensitization through dermal application of

source amino acids.

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DATA NEEDS

The data needs in order to prepare a safety assessment of source amino acids includes: method of

manufacturing, impurities and approximate composition for cosmetic grade ingredients, physical properties, and

dermal irritation and sensitization data. Data will be obtained from an industry survey of current uses and use

concentrations as a function of cosmetic product type.

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3 TABLES AND FIGURES

Table 1. Definitions and functions of the ingredients in this safety assessment.5

(The italicized text below represents additions made by CIR staff.)

Ingredient CAS No. Definition Function

Apricot Kernel Amino Acids

65072-01-7 [generic to any amino acids mixture]

Apricot Kernel Amino Acids is a mixture of amino acids derived from the complete hydrolysis of apricot kernels.

Skin-Conditioning Agent-Misc.

Collagen Amino Acids Collagen Amino Acids is the mixture of amino acids resulting from the complete

hydrolysis of collagen. It is characterized by containing a significant level of hydroxyproline. Hair Conditioning Agent; Skin-Conditioning Agent-Misc. Corn Gluten Amino

Acids 65072-01-7

Corn Gluten Amino Acids is the mixture of amino acids resulting from the complete hydrolysis of corn gluten protein.

Skin-Conditioning Agent-Misc. Elastin Amino Acids

65072-01-7

Elastin Amino Acids is the mixture of amino acids resulting from the complete hydrolysis of elastin. Hair Conditioning Agent; Skin-Conditioning Agent-Misc. Garcinia Mangostana Amino Acids

Garcinia Mangostana Amino Acids are the amino acids obtained by the complete hydrolysis of the protein from the pericarp of Garcinia mangostana.

Hair Conditioning Agent; Skin-Conditioning Agent-Misc. Hair Keratin Amino

Acids 65072-01-7

Hair Keratin Amino Acids are the keratin amino acids obtained by the hydrolysis of human hair. Hair Conditioning Agent; Skin-Conditioning Agent-Misc. Jojoba Amino Acids

333338-07-1 65072-01-7

Jojoba Amino Acids is the mixture of amino acids obtained by the complete hydrolysis of jojoba seed protein.

Humectants; Hair Conditioning Agent; Skin-Conditioning Agent-Emollient Keratin Amino Acids

65072-01-7

Keratin Amino Acids is the mixture of amino acids resulting from the complete hydrolysis of Keratin. Hair Conditioning Agent; Skin-Conditioning Agent-Misc.

Lupine Amino Acids Lupine Amino Acids is a mixture of amino acids derived from the complete hydrolysis

of lupine protein. Hair Conditioning Agent; Skin-Conditioning Agent-Humectant Lycium Barbarum Amino Acids

Lycium Barbarum Amino Acids is a mixture of amino acids derived by the complete hydrolysis of the protein isolated from the whole plant, Lycium barbarum.

Skin-Conditioning Agent-Misc. Milk Amino Acids

65072-00-6 65072-01-7

Milk Amino Acids is the mixture of amino acids resulting from the complete hydrolysis of Milk Protein. Hair Conditioning Agent; Skin-Conditioning Agent-Misc. Oat Amino Acids

65072-01-7

Oat Amino Acids is a mixture of amino acids derived by the complete hydrolysis of oat protein. Hair Conditioning Agent; Skin-Conditioning Agent-Misc.

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Table 1. Definitions and functions of the ingredients in this safety assessment.5

(The italicized text below represents additions made by CIR staff.)

Ingredient CAS No. Definition Function

Rice Amino Acids 65072-01-7

Rice Amino Acids is the mixture of amino acids derived from the complete hydrolysis of rice protein. Hair Conditioning Agent; Skin-Conditioning Agent-Misc. Sesame Amino Acids

65072-01-7

Sesame Amino Acids are the amino acids obtained from the complete hydrolysis of sesame flour.

Skin-Conditioning Agent-Humectant Silk Amino Acids

65072-01-7

Silk Amino Acids is the mixture of amino acids resulting from the complete hydrolysis

of silk. Hair Conditioning

Agent; Skin-Conditioning Agent-Misc.

Soy Amino Acids Soy Amino Acids is a mixture of amino acids derived from the complete hydrolysis of

soy protein. Hair Conditioning Agent; Skin-Conditioning Agent-Misc.

Spirulina Amino Acids Spirulina Amino Acids is the mixture of amino acids derived from the complete

hydrolysis of the protein obtained from the aquatic plant, Spirulina platensis.

Hair Conditioning Agent; Skin-Conditioning Agent-Humectant Sweet Almond Amino

Acids

Sweet Almond Amino Acids is a mixture of amino acids derived from the complete hydrolysis of Prunus Amygdalus Dulcis (Sweet Almond) Protein.

Skin Protectants; Skin-Conditioning Agent-Humectant Vegetable Amino Acids

65072-01-7

Vegetable Amino Acids are the amino acids obtained by the complete hydrolysis of Hydrolyzed Vegetable Protein

Skin-Conditioning Agent-Humectant Wheat Amino Acids

65072-01-7

Wheat Amino Acids is a mixture of amino acids resulting from the complete hydrolysis of wheat protein. Hair Conditioning Agent; Skin-Conditioning Agent-Misc. Yeast Amino Acids

65072-01-7

Yeast Amino Acids are the amino acids derived from Yeast.

Skin-Conditioning Agent-Humectant

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5

Table 2. Composition of commercialized protein derivatives.1,8

Collagen hydrolysate (g/100 g protein) Keratin hydrolysate (g/100 g protein) Silk hydrolysate (g/100 g protein)

Isolated soy protein (g/16 g nitrogen) Cysteic acid 0 0.3 0 0.23-0.27 Hydroxyproline 12.8 0 0 NR Aspartic acid 6.2 7.8 7.4 11.3-12.9 Threonine 1.8 6.1 3.9 3.4-3.9 Serine 3.9 8.1 17.4 5.0-5.9 Glutamic acid 5.5 17.0 3.6 19.5-22.0 Proline 13.9 7.6 0.9 4.8-5.2 Glycine 21.7 3.9 20.6 3.9-4.6 Alanine 9.2 7.6 21.0 3.7-4.6 Cystine 0.9 7.2 0 0.25-0.87 Valine 1.9 5.7 3.7 5.0-6.4 Methionine 0.9 1.0 0.4 1.15-1.27 Isoleucine 1.1 3.8 0.8 4.8-5.7 Leucine 3.3 8.1 1.2 7.5-9.7 Tyrosine 1.2 2.0 12.2 3.6-4.5 Phenylalanine 2.4 2.4 2.0 5.3-6.4 Lysine 5.1 3.2 1.6 4.7-5.8 Histidine 0.8 1.0 0.9 2.3-2.4 Arginine 7.3 9.0 2.4 7.5-8.0 Tryptophan NR NR NR 1.1-1.3 Lysinoalanine NR NR NR 0.0-1.71 NR=Not reported.

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Table 3a. Frequency and concentration of use according to duration and type of exposure.6

# of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%)

Collagen Amino Acids Hair Keratin Amino Acids Keratin Amino Acids

Totals* 37 NR 33 NR 158 NR

Duration of Use

Leave-On 27 NR 13 NR 74 NR

Rinse-Off 10 NR 20 NR 84 NR

Diluted for (Bath) Use NR NR NR NR NR NR

Exposure Type Eye Area 1 NR NR NR 2 NR Incidental Ingestion NR NR NR NR NR NR Incidental Inhalation-Spray NR NR NR NR 4 NR Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact 21 NR 1 NR 9 NR Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 10 NR 31 NR 117 NR Hair-Coloring NR NR 1 NR 21 NR Nail 6 NR NR NR 9 NR Mucous Membrane 1 NR 1 NR NR NR Baby Products NR NR NR NR NR NR

Lupine Amino Acids Milk Amino Acids Oat Amino Acids

Totals* 6 NR 18 NR 7 NR

Duration of Use

Leave-On 2 NR 1 NR 4 NR

Rinse Off 4 NR 17 NR 3 NR

Diluted for (Bath) Use NR NR NR NR NR NR

Exposure Type Eye Area NR NR NR NR NR NR Incidental Ingestion NR NR NR NR NR NR Incidental Inhalation-Spray NR NR NR NR NR NR Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact NR NR 17 NR 1 NR Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 6 NR 1 NR 6 NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR NR 16 NR NR NR Baby Products NR NR NR NR NR NR

Rice Amino Acids Silk Amino Acids Soy Amino Acids

Totals* 1 NR 324 NR 20 NR

Duration of Use

Leave-On 1 NR 151 NR 11 NR

Rinse-Off NR NR 173 NR 9 NR

Diluted for (Bath) Use NR NR NR NR NR NR

Exposure Type Eye Area 1 NR 6 NR NR NR Incidental Ingestion NR NR NR NR NR NR Incidental Inhalation-Spray NR NR 17 NR NR NR Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact NR NR 50 NR 3 NR Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR NR 265 NR 16 NR Hair-Coloring NR NR 2 NR NR NR Nail NR NR 4 NR 1 NR Mucous Membrane NR NR 21 NR NR NR

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7

Table 3a. Frequency and concentration of use according to duration and type of exposure.6

# of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%)

Vegetable Amino Acids Wheat Amino Acids

Totals 1 NR 257 NR

Duration of Use

Leave-On NR NR 89 NR

Rinse Off 1 NR 168 NR

Diluted for (Bath) Use NR NR NR NR

Exposure Type Eye Area NR NR 1 NR Incidental Ingestion NR NR NR NR Incidental Inhalation-Spray NR NR 6 NR Incidental Inhalation-Aerosol NR NR NR NR Dermal Contact NR NR 11 NR Deodorant (underarm) NR NR NR NR Hair - Non-Coloring 1 NR 193 NR Hair-Coloring NR NR 51 NR Nail NR NR 1 NR Mucous Membrane NR NR 5 NR Baby Products NR NR 1 NR

* Because each ingredient may be used in cosmetics with multiple exposure types, the sum of all exposure types my not equal the sum of total uses.

NR – no reported uses

Table 3b. Ingredients not reported to be in use. Apricot Kernel Amino Acids

Corn Gluten Amino Acids Elastin Amino Acids

Garcinia Mangostana Amino Acids Jojoba Amino Acids

Keratin Amino Acids

Lycium Barbarum Amino Acids Sesame Amino Acids

Spirulina Amino Acids Sweet Almond Amino Acids Yeast Amino Acids

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Source Amino Acids as Used in Cosmetics

0

Scientific Literature Review

Source Amino Acids as Used in Cosmetics

May 23, 2012

The 2012 Cosmetic Ingredient Review Expert Panel members are: Chairman, Wilma F. Bergfeld, M.D., F.A.C.P.;

Donald V. Belsito, M.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; Ronald A. Hill, Ph.D. James G.

Marks, Jr., M.D.; Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR

Director is F. Alan Andersen, Ph.D. This report was prepared by Christina L. Burnett, Scientific Analyst/Writer,

and Bart Heldreth, Ph.D., Chemist CIR.

© Cosmetic Ingredient Review

1101 17

Street, NW, Suite 412

"

Washington, DC 20036-4702

"

ph 202.331.0651

"

fax 202.331.0088

"

cirinfo@cir-safety.org

Table

of

Contents

Introduction

...

1

Chemistry

...

1

Impurities

...

1

Use

...

1

Cosmetic

...

1

Toxicological

Studies

...

1

Irritation

and

Sensitization

...

1

Data

Needs

...

2

Tables

and

Figures

...

3

1

INTRODUCTION

This scientific literature review covers 21 ingredients, that are each mixtures of amino acids, derived from

specific plant and animal sources. Accordingly, the group is given the name: source amino acids – indicating that

they come from specific sources. These ingredients function as skin and hair conditioning agents in personal care

products. The full list of ingredients in this report is found in Table 1.

Concurrent reviews of the safety of

α

-amino acids and hydrolyzed proteins from plant and animal sources

are being performed by the Cosmetic Ingredient Review (CIR) Expert Panel.

CHEMISTRY

The ingredients in this group are related because they each are prepared from proteins by complete

hydrolysis to yield cosmetic grade amino acid mixtures. The most frequently used method for hydrolyzing proteins

to amino acids appears to be heating to at least 110°C with concentrated hydrochloric acid.

However, some amino

acids, including tryptophan, are readily destroyed or are only partially hydrolyzed by hydrochloric acid oxidation,

so alternate hydrolysis agents, like sulfonic acid, are used in place of hydrochloric acid, or alkaline hydrolysis is

performed.

It is important to note that although these amino acids are produced from proteins, the hydrolysis

process commonly racemizes the amino acids and the end product is not primarily in the L- form of the

stereoisomers, but is a mixture of L- and D-.

The composition of amino acids may be analyzed by chromatographic separation and detection of the

residues, such as liquid-liquid chromatography on ion-exchange columns, after adequate hydrolysis of the

_{Street, NW, Suite 412}

_"

_{Washington, DC 20036-4702}

_"

_{ph 202.331.0651}

_"

_{fax 202.331.0088}

_"

_{However, some amino}

_{It is important to note that although these amino acids are produced from proteins, the hydrolysis}

_{Table 2 presents composition data for commercial protein derivative from collagen keratin, silk, and}

_{Wheat amino acids have the second}