SUPPLEMENT. Alpha Amino Acid. Chlorphenesin. Panax Ginseng NEW DATA

Transcription

1 SUPPLEMENT Alpha Amino Acid Chlorphenesin Panax Ginseng NEW DATA CIR EXPERT PANEL MEETING JUNE 10-11, 2012

2 Memorandum To: From: CIR Expert Panel Members and Liaisons Christina Burnett Scientific Analyst/Writer Date: August 30, 2012 Subject: Wave 2 data on α-amino Acid Ingredients as Used in Cosmetics Additional comments regarding the tentative report on α-amino acids were received from the Personal Care Products Council and will be incorporated into the report. Please see the attached memo from the Council. CIR Supplement Page 1

3 α-amino Acid Ingredients page Distributed for Comment Only - Do Not Cite or Quote Table 4. Frequency and concentration of use according to duration and type of exposure # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Alanine a Arginine Arginine HCl Totals* 294 (265) 3.0x (440) (69) Duration of Use Leave-On 252 (223) 3.0x (328) (45) Rinse-Off x (107) (24) Diluted for (Bath) Use NR NR 5 NR NR NR Exposure Type Eye Area 20 (15) (36) NR Incidental Ingestion NR NR NR Incidental Inhalation-Spray NR 3.0x10-7 ; aerosols; pump sprays NR 0.2; aerosols; pumps 6 NR Incidental Inhalation-Powder NR NR 1 (NR) NR NR NR Dermal Contact 263 (234) 3.0x (358) (37) 0.02 Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring x (72) (32) Hair-Coloring NR NR NR Nail NR NR NR Mucous Membrane (25) NR NR Baby Products NR NR NR NR NR NR Asparagine Aspartic Acid b Calcium Glycinate Totals* 9 NR 165 (148) NR 3 Duration of Use Leave-On 4 NR 117 (105) NR 3 Rinse Off 5 NR 48 (43) NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area NR NR 10 (9) 0.2 NR NR Incidental Ingestion NR NR NR NR NR NR Incidental Inhalation-Spray NR NR NR aerosols NR NR Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact 3 NR 120 (111) NR 3 Deodorant (underarm) NR NR NR NR NR 3 (not spray) Hair - Non-Coloring 6 NR 45 (37) NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR NR NR NR NR NR Baby Products NR NR NR NR NR NR Cysteine c Cysteine HCl d Cystine Totals* 25 (20) (10) Duration of Use Leave-On 18 (17) Rinse-Off 7 (3) (5) 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 Incidental Inhalation-Powder NR 0.05 NR NR NR NR Dermal Contact 10 (8) NR Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 11 (8) (7) Hair-Coloring NR NR 1 NR NR NR Nail 4 NR NR NR NR NR Mucous Membrane NR NR NR NR NR NR Baby Products NR NR NR NR NR NR CIR Supplement Page 2

4 α-amino Acid Ingredients page Distributed for Comment Only - Do Not Cite or Quote Table 4. Frequency and concentration of use according to duration and type of exposure # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Glutamic Acid e Glutamine f Glycine Totals 308 (274) (17) (323) Duration of Use Leave-On 217 (190) (221) Rinse Off 91 (84) (2) (102) Diluted for (Bath) Use NR 0.1 NR NR NR Exposure Type Eye Area 21 (17) NR Incidental Ingestion NR NR NR Incidental Inhalation-Spray NR NR NR NR aerosols; pump sprays Incidental Inhalation-Aerosol NR NR NR NR 1 NR Dermal Contact 208 (184) (239) Deodorant (underarm) NR NR NR NR (not spray) Hair - Non-Coloring 89 (81) (2) NR 83 (82) Hair-Coloring NR NR 8 (NR) Nail NR NR NR NR NR Mucous Membrane NR NR 5 (6) Baby Products NR NR NR NR 1 NR Histidine Histidine HCl g Isoleucine h Totals* 66 (59) (8) (28) Duration of Use Leave-On 51 (43) (8) (23) Rinse-Off 15 (16) NR NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 4 (2) NR NR Incidental Ingestion NR NR NR Incidental Inhalation-Spray NR aerosols; NR NR NR aerosols pump sprays Incidental Inhalation-Powder NR NR 1 (NR) NR NR NR Dermal Contact 41 (33) (8) (24) Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 25 (26) NR NR Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR NR NR Baby Products NR NR NR NR NR NR Leucine i Lysine j Lysine HCl k Totals* (132) 1.0x (46) Duration of Use Leave-On 28 (27) (119) (30) Rinse-Off 5 (6) NR 12 (13) 1.0x (16) Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area NR NR 10 (8) (1) Incidental Ingestion NR NR 1 (2) Incidental Inhalation-Spray NR NR NR NR 1 NR Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact 28 (27) (120) 1.0x (11) Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring 5 (6) NR 10 (11) (33) Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR NR 1 (2) Baby Products NR NR NR NR NR NR CIR Supplement Page 3

5 α-amino Acid Ingredients page Distributed for Comment Only - Do Not Cite or Quote Table 4. Frequency and concentration of use according to duration and type of exposure # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Magnesium Aspartate Methionine l Phenylalanine Totals* 107 (94) (24) (36) Duration of Use Leave-On 87 (76) (18) (27) Rinse-Off 19 (18) (5) Diluted for (Bath) Use 1 (NR) NR NR (1) NR NR NR Exposure Type Eye Area 19 (16) NR NR Incidental Ingestion NR (1) NR NR NR NR Incidental Inhalation-Spray NR NR NR NR NR aerosols Incidental Inhalation-Powder NR NR NR 1 (NR) NR Dermal Contact 106 (92) (18) (26) Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring (6) Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR Mucous Membrane NR (1) NR NR NR Baby Products NR NR NR NR NR # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Potassium Aspartate Proline m Serine n Totals* 14 (15) (273) (298) Duration of Use Leave-On 9 (10) (210) (258) Rinse-Off (59) (40) Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area NR NR 14 (11) (28) Incidental Ingestion NR (1) NR NR Incidental Inhalation-Spray NR NR 4 (NR) aerosols NR 0.08; aerosols Incidental Inhalation-Powder NR NR NR 9 NR Dermal Contact (219) (275) Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring (18) Hair-Coloring NR NR 29 NR NR NR Nail NR NR Mucous Membrane NR (1) NR Baby Products NR NR (2) NR 1 NR # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Sodium Glutamate Sodium Glycinate Threonine o Totals* (15) NR 170 (146) Duration of Use Leave-On NR NR 126 (102) Rinse-Off (15) NR Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area NR NR 10 (6) Incidental Ingestion NR 0.2 NR NR NR Incidental Inhalation-Spray NR NR NR NR NR aerosols Incidental Inhalation-Powder NR NR NR NR NR NR Dermal Contact NR NR 130 (106) Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring NR 1 NR NR Hair-Coloring NR (15) NR Nail NR NR NR NR Mucous Membrane NR NR Baby Products NR NR NR NR NR NR CIR Supplement Page 4

6 α-amino Acid Ingredients page Distributed for Comment Only - Do Not Cite or Quote Table 4. Frequency and concentration of use according to duration and type of exposure # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) # of Uses Max Conc of Use (%) Tryptophan Tyrosine Valine Totals* 15 (10) (54) (31) Duration of Use Leave-On 13 (8) NR 49 (47) (25) Rinse-Off Diluted for (Bath) Use NR NR NR NR NR NR Exposure Type Eye Area 2 (NR) NR NR Incidental Ingestion NR NR NR NR NR Incidental Inhalation-Spray NR NR 9 NR NR aerosols Incidental Inhalation-Powder NR NR 1 (NR) 0.05 NR NR Dermal Contact 13 (8) NR 47 (45) (27) Deodorant (underarm) NR NR NR NR NR NR Hair - Non-Coloring Hair-Coloring NR NR NR NR NR NR Nail NR NR NR NR NR NR Mucous Membrane NR NR NR NR NR Baby Products NR NR NR NR NR 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 a The VCRP listed separate entries for Alanine and L-Alanine, which have been combined in this table. L-Alanine has a total of 19 uses, 9 in rinse-off products and 10 in leave-on products. 13 uses lead to a dermal exposure, and 6 uses are to hair (non-coloring). b The VCRP listed separate entries for Aspartic Acid and L-Aspartic Acid, which have been combined in this table. L-Aspartic Acid has a total of 3 uses, 2 in rinse-off products and 1 in leave-on products. 1 use leads to a dermal exposure, and 2 uses are to hair (non-coloring). c The VCRP listed separate entries for Cysteine and L-Cysteine, which have been combined in this table. L-Cysteine has a total of 3 uses, all in rinse-off products. 1 use leads to a dermal exposure, and 2 uses are to hair (non-coloring). d The VCRP only listed an entry for L-Cysteine HCl. This data has been combined with the concentration of use data for Cysteine HCl. e The VCRP listed separate entries for Glutamic Acid, DL-Glutamic Acid, and L-Glutamic Acid, which have been combined in this table. DL- Glutamic Acid has a total of 2 uses, all in leave-on products. Both uses are a dermal exposure. L-Glutamic Acid has a total of 14 uses, 8 uses in leave-on products and 6 uses in rinse-off products. 8 uses are a dermal exposure, and 6 uses are to hair (non-coloring). f The VCRP only listed an entry for L-Glutamine. This data has been combined with the concentration of use data for Glutamine. g The VCRP only listed an entry for L-Histidine HCl. This data has been combined with the concentration of use data for Histidine HCl. h The VCRP only listed an entry for L-Isoleucine. This data has been combined with the concentration of use data for Isoleucine. i The VCRP only listed an entry for L-Leucine. This data has been combined with the concentration of use data for Leucine. j The VCRP listed separate entries for Lysine, DL-Lysine, and L-Lysine, which have been combined in this table. DL-Lysine has 1 use in a leave-on product with dermal exposure. L-Lysine has a total of 16 uses, 13 uses in leave-on products and 3 uses in rinse-off products. 1 use is in the eye area, 13 uses are a dermal exposure, and 3 uses are to hair (non-coloring). k The VCRP only listed an entry for L-Lysine HCl. This data has been combined with the concentration of use data for Lysine HCl. l The VCRP listed separate entries for Methionine and L-Methionine, which have been combined in this table. L-Methionine has a total of 2 uses, both in leave-on products with a dermal exposure. m The VCRP listed separate entries for Proline and DL-Proline, which have been combined in this table. DL-Proline has a total of 9 uses, 3 in leave-on products and 6 in rinse-off products. 1 use may lead to incidental ingestion, 1 use may be to the mucous membranes, 2 uses are dermal exposures, and 6 uses are to the hair (coloring). n The VCRP listed separate entries for Serine and L-Serine, which have been combined in this table. L-Serine has a total of 40 uses, 32 in leaveon products and 8in rinse-off products. 2 uses are in the eye area, 1 use is in nail products, 34 uses are dermal exposures, and 5 uses are to hair (non-coloring). o The VCRP listed separate entries for Threonine and L-Threonine, which have been combined in this table. L-Threonine has a total of 7 uses, 5 in leave-on products and 2 in rinse-off products. 5 uses are dermal exposures and 2 are to the hair (non-coloring). CIR Supplement Page 5

7 α-amino Acid Ingredients page Distributed for Comment Only - Do Not Cite or Quote 2012 FDA VCRP RAW DATA 03C - Eye Shadow ALANINE 1 03D - Eye Lotion ALANINE 4 03F - Mascara ALANINE 1 03G - Other Eye Makeup Preparations ALANINE 14 05A - Hair Conditioner ALANINE 12 05C - Hair Straighteners ALANINE 1 05F - Shampoos (non-coloring) ALANINE 4 05G - Tonics, Dressings, and Other Hair ALANINE 6 Grooming Aids 05I - Other Hair Preparations ALANINE 1 07C - Foundations ALANINE 10 07H - Makeup Fixatives ALANINE 1 07I - Other Makeup Preparations ALANINE 3 10E - Other Personal Cleanliness Products ALANINE 2 11A - Aftershave Lotion ALANINE 2 11G - Other Shaving Preparation Products ALANINE 1 12A - Cleansing ALANINE 6 12C - Face and Neck (exc shave) ALANINE 56 12D - Body and Hand (exc shave) ALANINE 28 12F - Moisturizing ALANINE 88 12G - Night ALANINE 10 12H - Paste Masks (mud packs) ALANINE 7 12I - Skin Fresheners ALANINE 5 12J - Other Skin Care Preps ALANINE 12 05A - Hair Conditioner ALANINE, L- 2 05D - Permanent Waves ALANINE, L- 1 05F - Shampoos (non-coloring) ALANINE, L- 2 05H - Wave Sets ALANINE, L- 1 07C - Foundations ALANINE, L- 2 12A - Cleansing ALANINE, L- 2 12C - Face and Neck (exc shave) ALANINE, L- 3 12F - Moisturizing ALANINE, L- 5 12H - Paste Masks (mud packs) ALANINE, L- 1 02B - Bubble Baths ARGININE 5 03B - Eyeliner ARGININE 2 03D - Eye Lotion ARGININE 16 03E - Eye Makeup Remover ARGININE 2 03F - Mascara ARGININE 16 03G - Other Eye Makeup Preparations ARGININE 22 05A - Hair Conditioner ARGININE 19 05C - Hair Straighteners ARGININE 3 05E - Rinses (non-coloring) ARGININE 2 05F - Shampoos (non-coloring) ARGININE 19 05G - Tonics, Dressings, and Other Hair ARGININE 13 Grooming Aids 05I - Other Hair Preparations ARGININE 15 CIR Supplement Page 6

8 α-amino Acid Ingredients page Distributed for Comment Only - Do Not Cite or Quote 06A - Hair Dyes and Colors (all types ARGININE 1 requiring caution statements and patch tests) 07B - Face Powders ARGININE 1 07C - Foundations ARGININE 5 07E - Lipstick ARGININE 1 07I - Other Makeup Preparations ARGININE 3 08B - Cuticle Softeners ARGININE 1 10A - Bath Soaps and Detergents ARGININE 4 10E - Other Personal Cleanliness Products ARGININE 4 11G - Other Shaving Preparation Products ARGININE 1 12A - Cleansing ARGININE 26 12C - Face and Neck (exc shave) ARGININE 93 12D - Body and Hand (exc shave) ARGININE 16 12F - Moisturizing ARGININE G - Night ARGININE 24 12H - Paste Masks (mud packs) ARGININE 8 12I - Skin Fresheners ARGININE 12 12J - Other Skin Care Preps ARGININE 40 03D - Eye Lotion ARGININE HYDROCHLORIDE 4 05A - Hair Conditioner ARGININE HYDROCHLORIDE 6 05E - Rinses (non-coloring) ARGININE HYDROCHLORIDE 1 05F - Shampoos (non-coloring) ARGININE HYDROCHLORIDE 11 05G - Tonics, Dressings, and Other Hair ARGININE HYDROCHLORIDE 1 Grooming Aids 05I - Other Hair Preparations ARGININE HYDROCHLORIDE 7 12C - Face and Neck (exc shave) ARGININE HYDROCHLORIDE 10 12F - Moisturizing ARGININE HYDROCHLORIDE 3 12G - Night ARGININE HYDROCHLORIDE 1 12H - Paste Masks (mud packs) ARGININE HYDROCHLORIDE 1 12J - Other Skin Care Preps ARGININE HYDROCHLORIDE 1 13B - Indoor Tanning Preparations ARGININE HYDROCHLORIDE 6 05A - Hair Conditioner ASPARAGINE 2 05F - Shampoos (non-coloring) ASPARAGINE 3 05G - Tonics, Dressings, and Other Hair ASPARAGINE 1 Grooming Aids 12J - Other Skin Care Preps ASPARAGINE 3 03C - Eye Shadow ASPARTIC ACID 1 03D - Eye Lotion ASPARTIC ACID 3 03G - Other Eye Makeup Preparations ASPARTIC ACID 6 05A - Hair Conditioner ASPARTIC ACID 33 05F - Shampoos (non-coloring) ASPARTIC ACID 4 05G - Tonics, Dressings, and Other Hair ASPARTIC ACID 2 Grooming Aids 05H - Wave Sets ASPARTIC ACID 1 05I - Other Hair Preparations ASPARTIC ACID 3 07C - Foundations ASPARTIC ACID 10 CIR Supplement Page 7

9 α-amino Acid Ingredients page Distributed for Comment Only - Do Not Cite or Quote 07F - Makeup Bases ASPARTIC ACID 1 07H - Makeup Fixatives ASPARTIC ACID 1 11A - Aftershave Lotion ASPARTIC ACID 2 11G - Other Shaving Preparation Products ASPARTIC ACID 1 12A - Cleansing ASPARTIC ACID 1 12C - Face and Neck (exc shave) ASPARTIC ACID 23 12D - Body and Hand (exc shave) ASPARTIC ACID 20 12F - Moisturizing ASPARTIC ACID 31 12G - Night ASPARTIC ACID 2 12H - Paste Masks (mud packs) ASPARTIC ACID 6 12I - Skin Fresheners ASPARTIC ACID 3 12J - Other Skin Care Preps ASPARTIC ACID 8 05A - Hair Conditioner ASPARTIC ACID, L- 1 05D - Permanent Waves ASPARTIC ACID, L- 1 07C - Foundations ASPARTIC ACID, L- 1 02A - Bath Oils, Tablets, and Salts MAGNESIUM ASPARTATE 1 03B - Eyeliner MAGNESIUM ASPARTATE 4 03D - Eye Lotion MAGNESIUM ASPARTATE 4 03G - Other Eye Makeup Preparations MAGNESIUM ASPARTATE 11 05I - Other Hair Preparations MAGNESIUM ASPARTATE 1 07C - Foundations MAGNESIUM ASPARTATE 1 10A - Bath Soaps and Detergents MAGNESIUM ASPARTATE 1 11A - Aftershave Lotion MAGNESIUM ASPARTATE 3 12A - Cleansing MAGNESIUM ASPARTATE 11 12C - Face and Neck (exc shave) MAGNESIUM ASPARTATE 25 12D - Body and Hand (exc shave) MAGNESIUM ASPARTATE 1 12F - Moisturizing MAGNESIUM ASPARTATE 17 12G - Night MAGNESIUM ASPARTATE 11 12H - Paste Masks (mud packs) MAGNESIUM ASPARTATE 7 12I - Skin Fresheners MAGNESIUM ASPARTATE 2 12J - Other Skin Care Preps MAGNESIUM ASPARTATE 7 05I - Other Hair Preparations POTASSIUM ASPARTATE 1 07C - Foundations POTASSIUM ASPARTATE 1 11A - Aftershave Lotion POTASSIUM ASPARTATE 1 12A - Cleansing POTASSIUM ASPARTATE 2 12D - Body and Hand (exc shave) POTASSIUM ASPARTATE 3 12F - Moisturizing POTASSIUM ASPARTATE 1 12H - Paste Masks (mud packs) POTASSIUM ASPARTATE 3 12J - Other Skin Care Preps POTASSIUM ASPARTATE 2 05A - Hair Conditioner CYSTEINE 2 05B - Hair Spray (aerosol fixatives) CYSTEINE 1 05F - Shampoos (non-coloring) CYSTEINE 2 05G - Tonics, Dressings, and Other Hair CYSTEINE 1 Grooming Aids 05I - Other Hair Preparations CYSTEINE 3 CIR Supplement Page 8

10 α-amino Acid Ingredients page Distributed for Comment Only - Do Not Cite or Quote 07C - Foundations CYSTEINE 1 07D - Leg and Body Paints CYSTEINE 1 07I - Other Makeup Preparations CYSTEINE 1 08A - Basecoats and Undercoats CYSTEINE 2 08E - Nail Polish and Enamel CYSTEINE 2 12C - Face and Neck (exc shave) CYSTEINE 2 12D - Body and Hand (exc shave) CYSTEINE 1 12F - Moisturizing CYSTEINE 1 12I - Skin Fresheners CYSTEINE 1 13B - Indoor Tanning Preparations CYSTEINE 1 05A - Hair Conditioner CYSTEINE, L- 1 05C - Hair Straighteners CYSTEINE, L- 1 12H - Paste Masks (mud packs) CYSTEINE, L- 1 05C - Hair Straighteners CYSTEINE HCL MONOHYDRATE 1 05C - Hair Straighteners CYSTEINE, L-, HYDROCHLORIDE 1 05D - Permanent Waves CYSTEINE, L-, HYDROCHLORIDE 1 06A - Hair Dyes and Colors (all types CYSTEINE, L-, HYDROCHLORIDE 1 requiring caution statements and patch tests) 12J - Other Skin Care Preps CYSTEINE, L-, HYDROCHLORIDE 1 05A - Hair Conditioner CYSTINE 3 05F - Shampoos (non-coloring) CYSTINE 3 05G - Tonics, Dressings, and Other Hair CYSTINE 2 Grooming Aids 12C - Face and Neck (exc shave) CYSTINE 3 03C - Eye Shadow GLUTAMIC ACID 1 03D - Eye Lotion GLUTAMIC ACID 2 03F - Mascara GLUTAMIC ACID 6 03G - Other Eye Makeup Preparations GLUTAMIC ACID 12 05A - Hair Conditioner GLUTAMIC ACID 60 05C - Hair Straighteners GLUTAMIC ACID 2 05D - Permanent Waves GLUTAMIC ACID 1 05E - Rinses (non-coloring) GLUTAMIC ACID 1 05F - Shampoos (non-coloring) GLUTAMIC ACID 4 05G - Tonics, Dressings, and Other Hair GLUTAMIC ACID 7 Grooming Aids 05I - Other Hair Preparations GLUTAMIC ACID 8 06H - Other Hair Coloring Preparation GLUTAMIC ACID 5 07C - Foundations GLUTAMIC ACID 9 07H - Makeup Fixatives GLUTAMIC ACID 1 07I - Other Makeup Preparations GLUTAMIC ACID 3 10E - Other Personal Cleanliness Products GLUTAMIC ACID 1 11A - Aftershave Lotion GLUTAMIC ACID 2 11G - Other Shaving Preparation Products GLUTAMIC ACID 1 12A - Cleansing GLUTAMIC ACID 6 12C - Face and Neck (exc shave) GLUTAMIC ACID 50 CIR Supplement Page 9

11 α-amino Acid Ingredients page Distributed for Comment Only - Do Not Cite or Quote 12D - Body and Hand (exc shave) GLUTAMIC ACID 21 12F - Moisturizing GLUTAMIC ACID 63 12G - Night GLUTAMIC ACID 9 12H - Paste Masks (mud packs) GLUTAMIC ACID 4 12I - Skin Fresheners GLUTAMIC ACID 3 12J - Other Skin Care Preps GLUTAMIC ACID 10 12C - Face and Neck (exc shave) GLUTAMIC ACID, DL- 2 05A - Hair Conditioner GLUTAMIC ACID, L- 3 05D - Permanent Waves GLUTAMIC ACID, L- 1 05F - Shampoos (non-coloring) GLUTAMIC ACID, L- 1 05G - Tonics, Dressings, and Other Hair GLUTAMIC ACID, L- 1 Grooming Aids 07C - Foundations GLUTAMIC ACID, L- 2 12C - Face and Neck (exc shave) GLUTAMIC ACID, L- 2 12F - Moisturizing GLUTAMIC ACID, L- 3 12H - Paste Masks (mud packs) GLUTAMIC ACID, L- 1 03B - Eyeliner GLUTAMINE, L- 1 05G - Tonics, Dressings, and Other Hair GLUTAMINE, L- 1 Grooming Aids 12C - Face and Neck (exc shave) GLUTAMINE, L- 2 12D - Body and Hand (exc shave) GLUTAMINE, L- 4 12F - Moisturizing GLUTAMINE, L- 2 12G - Night GLUTAMINE, L- 2 12H - Paste Masks (mud packs) GLUTAMINE, L- 1 12I - Skin Fresheners GLUTAMINE, L- 1 12J - Other Skin Care Preps GLUTAMINE, L- 2 01B - Baby Lotions, Oils, Powders, and GLYCINE 1 Creams 03D - Eye Lotion GLYCINE 13 03F - Mascara GLYCINE 1 03G - Other Eye Makeup Preparations GLYCINE 7 04E - Other Fragrance Preparation GLYCINE 1 05A - Hair Conditioner GLYCINE 34 05C - Hair Straighteners GLYCINE 1 05D - Permanent Waves GLYCINE 2 05E - Rinses (non-coloring) GLYCINE 1 05F - Shampoos (non-coloring) GLYCINE 37 05G - Tonics, Dressings, and Other Hair GLYCINE 5 Grooming Aids 05H - Wave Sets GLYCINE 1 05I - Other Hair Preparations GLYCINE 2 06A - Hair Dyes and Colors (all types GLYCINE 8 requiring caution statements and patch tests) 07C - Foundations GLYCINE 1 07E - Lipstick GLYCINE 1 07I - Other Makeup Preparations GLYCINE 3 CIR Supplement Page 10

12 α-amino Acid Ingredients page Distributed for Comment Only - Do Not Cite or Quote 10A - Bath Soaps and Detergents GLYCINE 1 10B - Deodorants (underarm) GLYCINE 4 10E - Other Personal Cleanliness Products GLYCINE 3 11A - Aftershave Lotion GLYCINE 1 11G - Other Shaving Preparation Products GLYCINE 1 12A - Cleansing GLYCINE 15 12C - Face and Neck (exc shave) GLYCINE 64 12D - Body and Hand (exc shave) GLYCINE 26 12F - Moisturizing GLYCINE 82 12G - Night GLYCINE 10 12H - Paste Masks (mud packs) GLYCINE 8 12I - Skin Fresheners GLYCINE 5 12J - Other Skin Care Preps GLYCINE 22 13B - Indoor Tanning Preparations GLYCINE 2 13C - Other Suntan Preparations GLYCINE 1 06A - Hair Dyes and Colors (all types requiring caution statements and patch tests) SODIUM GLYCINATE 16 03D - Eye Lotion HISTIDINE 3 03G - Other Eye Makeup Preparations HISTIDINE 1 05A - Hair Conditioner HISTIDINE 8 05F - Shampoos (non-coloring) HISTIDINE 4 05G - Tonics, Dressings, and Other Hair HISTIDINE 13 Grooming Aids 12C - Face and Neck (exc shave) HISTIDINE 7 12D - Body and Hand (exc shave) HISTIDINE 7 12F - Moisturizing HISTIDINE 8 12G - Night HISTIDINE 1 12H - Paste Masks (mud packs) HISTIDINE 3 12I - Skin Fresheners HISTIDINE 2 12J - Other Skin Care Preps HISTIDINE 9 03D - Eye Lotion HISTIDINE HCL 1 07B - Face Powders HISTIDINE HCL 1 12C - Face and Neck (exc shave) HISTIDINE HCL 2 12F - Moisturizing HISTIDINE HCL 6 12G - Night HISTIDINE HCL 1 03D - Eye Lotion ISOLEUCINE 1 05A - Hair Conditioner ISOLEUCINE 1 05G - Tonics, Dressings, and Other Hair ISOLEUCINE 1 Grooming Aids 05I - Other Hair Preparations ISOLEUCINE 2 12C - Face and Neck (exc shave) ISOLEUCINE 6 12D - Body and Hand (exc shave) ISOLEUCINE 1 12F - Moisturizing ISOLEUCINE 5 12H - Paste Masks (mud packs) ISOLEUCINE 4 12I - Skin Fresheners ISOLEUCINE 3 CIR Supplement Page 11

13 α-amino Acid Ingredients page Distributed for Comment Only - Do Not Cite or Quote 12J - Other Skin Care Preps ISOLEUCINE 6 05A - Hair Conditioner LEUCINE 1 05F - Shampoos (non-coloring) LEUCINE 1 05G - Tonics, Dressings, and Other Hair LEUCINE 1 Grooming Aids 05H - Wave Sets LEUCINE 1 05I - Other Hair Preparations LEUCINE 1 07C - Foundations LEUCINE 1 12C - Face and Neck (exc shave) LEUCINE 10 12D - Body and Hand (exc shave) LEUCINE 2 12G - Night LEUCINE 2 12H - Paste Masks (mud packs) LEUCINE 2 12I - Skin Fresheners LEUCINE 3 12J - Other Skin Care Preps LEUCINE 8 03C - Eye Shadow LYSINE 1 03D - Eye Lotion LYSINE 4 03G - Other Eye Makeup Preparations LYSINE 4 05A - Hair Conditioner LYSINE 2 05C - Hair Straighteners LYSINE 1 05G - Tonics, Dressings, and Other Hair LYSINE 3 Grooming Aids 05I - Other Hair Preparations LYSINE 1 07C - Foundations LYSINE 2 07E - Lipstick LYSINE 1 07F - Makeup Bases LYSINE 1 07I - Other Makeup Preparations LYSINE 6 12A - Cleansing LYSINE 4 12C - Face and Neck (exc shave) LYSINE 41 12D - Body and Hand (exc shave) LYSINE 10 12F - Moisturizing LYSINE 33 12G - Night LYSINE 6 12H - Paste Masks (mud packs) LYSINE 2 12I - Skin Fresheners LYSINE 3 12J - Other Skin Care Preps LYSINE 9 03D - Eye Lotion LYSINE HCL, L- 2 03G - Other Eye Makeup Preparations LYSINE HCL, L- 1 05A - Hair Conditioner LYSINE HCL, L- 9 05F - Shampoos (non-coloring) LYSINE HCL, L- 2 05G - Tonics, Dressings, and Other Hair LYSINE HCL, L- 13 Grooming Aids 05I - Other Hair Preparations LYSINE HCL, L- 4 07E - Lipstick LYSINE HCL, L- 1 12C - Face and Neck (exc shave) LYSINE HCL, L- 3 12F - Moisturizing LYSINE HCL, L- 6 12G - Night LYSINE HCL, L- 2 12I - Skin Fresheners LYSINE HCL, L- 1 CIR Supplement Page 12

14 α-amino Acid Ingredients page Distributed for Comment Only - Do Not Cite or Quote 12J - Other Skin Care Preps LYSINE HCL, L- 2 13B - Indoor Tanning Preparations LYSINE HCL, L- 1 12C - Face and Neck (exc shave) LYSINE, DL- 1 03D - Eye Lotion LYSINE, L- 1 05A - Hair Conditioner LYSINE, L- 1 05F - Shampoos (non-coloring) LYSINE, L- 1 05I - Other Hair Preparations LYSINE, L- 1 12D - Body and Hand (exc shave) LYSINE, L- 1 12F - Moisturizing LYSINE, L- 3 12H - Paste Masks (mud packs) LYSINE, L- 1 12J - Other Skin Care Preps LYSINE, L- 7 05A - Hair Conditioner METHIONINE 3 05F - Shampoos (non-coloring) METHIONINE 1 05G - Tonics, Dressings, and Other Hair METHIONINE 1 Grooming Aids 05I - Other Hair Preparations METHIONINE 2 07C - Foundations METHIONINE 1 12C - Face and Neck (exc shave) METHIONINE 10 12D - Body and Hand (exc shave) METHIONINE 1 12F - Moisturizing METHIONINE 1 12H - Paste Masks (mud packs) METHIONINE 2 12I - Skin Fresheners METHIONINE 2 12J - Other Skin Care Preps METHIONINE 4 12J - Other Skin Care Preps METHIONINE, L- 2 03D - Eye Lotion PHENYLALANINE 1 03F - Mascara PHENYLALANINE 1 05A - Hair Conditioner PHENYLALANINE 3 05F - Shampoos (non-coloring) PHENYLALANINE 3 05G - Tonics, Dressings, and Other Hair PHENYLALANINE 2 Grooming Aids 05I - Other Hair Preparations PHENYLALANINE 1 07B - Face Powders PHENYLALANINE 1 12C - Face and Neck (exc shave) PHENYLALANINE 8 12D - Body and Hand (exc shave) PHENYLALANINE 1 12F - Moisturizing PHENYLALANINE 9 12H - Paste Masks (mud packs) PHENYLALANINE 3 12I - Skin Fresheners PHENYLALANINE 3 12J - Other Skin Care Preps PHENYLALANINE 3 03D - Eye Lotion PROLINE 7 03G - Other Eye Makeup Preparations PROLINE 7 05A - Hair Conditioner PROLINE 7 05C - Hair Straighteners PROLINE 1 05F - Shampoos (non-coloring) PROLINE 1 CIR Supplement Page 13

15 α-amino Acid Ingredients page Distributed for Comment Only - Do Not Cite or Quote 05G - Tonics, Dressings, and Other Hair PROLINE 4 Grooming Aids 05I - Other Hair Preparations PROLINE 2 06A - Hair Dyes and Colors (all types PROLINE 23 requiring caution statements and patch tests) 07C - Foundations PROLINE 2 07I - Other Makeup Preparations PROLINE 3 08B - Cuticle Softeners PROLINE 2 10E - Other Personal Cleanliness Products PROLINE 1 11A - Aftershave Lotion PROLINE 3 12A - Cleansing PROLINE 9 12C - Face and Neck (exc shave) PROLINE 45 12D - Body and Hand (exc shave) PROLINE 21 12F - Moisturizing PROLINE 75 12G - Night PROLINE 17 12H - Paste Masks (mud packs) PROLINE 8 12I - Skin Fresheners PROLINE 7 12J - Other Skin Care Preps PROLINE 21 13A - Suntan Gels, Creams, and Liquids PROLINE 4 06A - Hair Dyes and Colors (all types PROLINE, DL- 6 requiring caution statements and patch tests) 07E - Lipstick PROLINE, DL- 1 12F - Moisturizing PROLINE, DL- 1 12J - Other Skin Care Preps PROLINE, DL- 1 01B - Baby Lotions, Oils, Powders, and SERINE 1 Creams 03D - Eye Lotion SERINE 9 03F - Mascara SERINE 9 03G - Other Eye Makeup Preparations SERINE 18 05A - Hair Conditioner SERINE 3 05C - Hair Straighteners SERINE 1 05G - Tonics, Dressings, and Other Hair SERINE 4 Grooming Aids 05I - Other Hair Preparations SERINE 1 07B - Face Powders SERINE 8 07C - Foundations SERINE 1 07I - Other Makeup Preparations SERINE 4 08B - Cuticle Softeners SERINE 1 10E - Other Personal Cleanliness Products SERINE 2 11A - Aftershave Lotion SERINE 2 12A - Cleansing SERINE 13 12C - Face and Neck (exc shave) SERINE 72 12D - Body and Hand (exc shave) SERINE 12 12F - Moisturizing SERINE 89 12G - Night SERINE 13 12H - Paste Masks (mud packs) SERINE 8 12I - Skin Fresheners SERINE 3 12J - Other Skin Care Preps SERINE 20 CIR Supplement Page 14

16 α-amino Acid Ingredients page Distributed for Comment Only - Do Not Cite or Quote 03D - Eye Lotion SERINE, L- 2 05A - Hair Conditioner SERINE, L- 2 05F - Shampoos (non-coloring) SERINE, L- 2 05H - Wave Sets SERINE, L- 1 08G - Other Manicuring Preparations SERINE, L- 1 12A - Cleansing SERINE, L- 2 12C - Face and Neck (exc shave) SERINE, L- 9 12D - Body and Hand (exc shave) SERINE, L- 3 12F - Moisturizing SERINE, L H - Paste Masks (mud packs) SERINE, L- 1 12I - Skin Fresheners SERINE, L- 2 12J - Other Skin Care Preps SERINE, L- 5 03D - Eye Lotion THREONINE 3 03G - Other Eye Makeup Preparations THREONINE 7 05A - Hair Conditioner THREONINE 2 05C - Hair Straighteners THREONINE 1 05F - Shampoos (non-coloring) THREONINE 1 05G - Tonics, Dressings, and Other Hair THREONINE 3 Grooming Aids 05I - Other Hair Preparations THREONINE 1 06A - Hair Dyes and Colors (all types THREONINE 29 requiring caution statements and patch tests) 07C - Foundations THREONINE 1 07I - Other Makeup Preparations THREONINE 3 08B - Cuticle Softeners THREONINE 1 10E - Other Personal Cleanliness Products THREONINE 1 12A - Cleansing THREONINE 4 12C - Face and Neck (exc shave) THREONINE 34 12D - Body and Hand (exc shave) THREONINE 10 12F - Moisturizing THREONINE 42 12G - Night THREONINE 7 12H - Paste Masks (mud packs) THREONINE 4 12I - Skin Fresheners THREONINE 1 12J - Other Skin Care Preps THREONINE 8 05A - Hair Conditioner THREONINE, L- 1 05F - Shampoos (non-coloring) THREONINE, L- 1 12F - Moisturizing THREONINE, L- 4 12I - Skin Fresheners THREONINE, L- 1 03D - Eye Lotion TRYPTOPHAN 1 03G - Other Eye Makeup Preparations TRYPTOPHAN 1 05A - Hair Conditioner TRYPTOPHAN 2 12C - Face and Neck (exc shave) TRYPTOPHAN 7 12G - Night TRYPTOPHAN 1 12J - Other Skin Care Preps TRYPTOPHAN 3 CIR Supplement Page 15

17 α-amino Acid Ingredients page Distributed for Comment Only - Do Not Cite or Quote 03D - Eye Lotion TYROSINE 1 03G - Other Eye Makeup Preparations TYROSINE 2 05A - Hair Conditioner TYROSINE 3 05F - Shampoos (non-coloring) TYROSINE 3 05G - Tonics, Dressings, and Other Hair TYROSINE 2 Grooming Aids 05I - Other Hair Preparations TYROSINE 1 07B - Face Powders TYROSINE 1 07C - Foundations TYROSINE 1 07I - Other Makeup Preparations TYROSINE 1 12C - Face and Neck (exc shave) TYROSINE 15 12D - Body and Hand (exc shave) TYROSINE 3 12F - Moisturizing TYROSINE 4 12G - Night TYROSINE 2 12H - Paste Masks (mud packs) TYROSINE 1 12I - Skin Fresheners TYROSINE 2 12J - Other Skin Care Preps TYROSINE 5 13B - Indoor Tanning Preparations TYROSINE 8 13C - Other Suntan Preparations TYROSINE 1 03D - Eye Lotion VALINE 1 05A - Hair Conditioner VALINE 1 05F - Shampoos (non-coloring) VALINE 1 05H - Wave Sets VALINE 1 05I - Other Hair Preparations VALINE 1 07C - Foundations VALINE 1 12C - Face and Neck (exc shave) VALINE 7 12D - Body and Hand (exc shave) VALINE 2 12F - Moisturizing VALINE 5 12G - Night VALINE 2 12H - Paste Masks (mud packs) VALINE 3 12I - Skin Fresheners VALINE 2 12J - Other Skin Care Preps VALINE 5 CIR Supplement Page 16

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19 Memorandum To: From: CIR Expert Panel Members and Liaisons Christina Burnett Scientific Analyst/Writer Date: August 30, 2012 Subject: Wave 2 data on Fatty Acid Amidopropyl Dimethylamines as Used in Cosmetics The Personal Care Products Council has advised CIR that additional studies on Stearamidopropyl Dimethylamine are being performed for the REACH dossier. At this time, we do not know what the studies are. Please see the attached memo from the Council. CIR Supplement Page 18

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21 August 30, 2012 Memorandum To: From: Subject: CIR Expert Panel Wilbur Johnson, Jr. Manager/Lead Specialist Wave 2 Data on Chlorphenesin A mammalian genotoxicity study on chlorphenesin, received from the Council on June 12, 2012, is attached for the Expert Panel s review. Data from this study are summarized in the draft final report; however, the pdf data file was not included with meeting materials mailed earlier this month and the study is not mentioned in the transmittal memorandum for the draft final report. CIR Supplement Page 20

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42 August 30, 2012 MEMORANDUM To: From: Subject: CIR Expert Panel and Liaisons Lillian C. Becker, M.S. Scientific Analyst and Writer Discussion of Ginseng-Root Related Ingredients It came to our attention that the aerosol part of the Discussion was missing from the ginsengroot related ingredient report. The paragraph shown below is provided for the Panel s review and insertion into the Final Report. Because these ingredients were reported to be used in products that may be aerosolized, including deodorants, face powders, foot powders and sprays, and perfumes, the Panel discussed the issue of incidental inhalation exposure. The Panel considered that the preponderance of the data indicate that incidental inhalation exposures to these ingredients in aerosolized cosmetic products would not cause adverse health effects, as follows. The Panel considered other data available to characterize the potential for ginseng root-derived ingredients to cause systemic toxicity, irritation, sensitization, reproductive and developmental toxicity, genotoxicity, and phototoxicity. They noted the lack of systemic toxicity at high doses in acute and subchronic oral exposure studies and no irritation or sensitization in multiple tests of dermal and ocular exposure. There was no genotoxicity in in vitro and in vivo tests. Further, these ingredients are reportedly used at concentrations 0.1% in cosmetic products that may be aerosolized. The Panel noted that 95% 99% of droplets/particles produced in cosmetic aerosols would not be respirable to any appreciable amount. Coupled with the small actual exposure in the breathing zone and the concentrations at which the ingredients are used, the available information indicates that incidental inhalation would not be a significant route of exposure that might lead to local respiratory or systemic effects. A detailed discussion and summary of the Panel s approach to evaluating incidental inhalation exposures to ingredients in cosmetic products that may be aerosolized is available at CIR Supplement Page 41

43 Memorandum To: CIR Expert Panel Members and Liaisons From: Director, CIR Subject: Wave 2 data on triclosan and parabens Date: August 30, 2012 Out of Isaac Pessah s lab at UC Davis comes another study on triclosan (in PNAS early edition), but with an entirely different endpoint. Pessah s current research focuses on the structure, function, and pharmacology of the ryanodine-sensitive calcium channels (RyRs) found in sarcoplasmic and endoplasmic reticulum of muscle cells and neurons. In this study, triclosan (i.p. in mice, in water in larval fathead minnows, and in vitro in murine cardiomyocytes and skeletal muscle cells) reportedly impairs calcium and RyR channel signaling, to affect muscle contractility. In the discussion, the authors challenge some of what we thought was understood about triclosan metabolism to glucuronide and sulfate conjugates. They suggest that some individuals may be less able to clear triclosan and be more at risk of muscle-weakening effects. Additional comments regarding triclosan and parabens were received from the Women s Voices for the Earth. Enclosures: 1. Cherednichenko G, et al. Triclosan impairs excitation-contraction coupling and Ca2+ dynamics in striated muscle. PNAS Women s Voices for the Earth (Alexandra Scranton) . CIR Supplement Page 42

44 Kevin S. Fries From: Sent: To: Subject: Attachments: CIRINFO Monday, August 27, :48 AM Alan Andersen FW: New Data on triclosan and parabens Letter to CIR from WVE.docx To: Cosmetic Ingredient Review Expert Panel Members and Liaisons, In reviewing the agenda for the upcoming CIR meeting in September, we were pleased to see the item regarding new data on triclosan and parabens. It is an excellent practice to bring important new data to the attention of the CIR even when ingredients are not yet up for review. We have reviewed this study as well and have great concern for the impact of these chemicals on the immune system of children. According to the study, children with the highest urine levels of triclosan had nearly twice the risk of environmental allergies as children with the lowest urinary concentrations. Those with highest levels of propyl paraben in the urine had twice the risk of an environmental allergy. Food allergy risk was more than twice as pronounced in children with the highest levels of urinary triclosan as in children with the lowest triclosan levels. As the Director of the CIR stated in his memo, the authors of this study deal only with hypotheses as to the mechanisms causing these effects, and have not established any causal relationships. As you are well aware, this is a trait common to many journal articles when groundbreaking research is being discussed. However, fully understanding the mechanism behind the health impacts is not needed before preventive measures can be taken. (For example, the public health system in the US rightly issued warnings and recommendations against smoking decades before we understood how cigarette smoking actually causes lung cancer.) We are concerned that children with the greatest exposures to these chemicals, (exposure which can and does occur from cosmetic products) are unnecessarily suffering from lifelong allergies. We hope the CIR will study this research closely in your assessment of the safety of these ingredients. Also, we offer the following abstracts of other recent research on parabens and triclosan that we believe are worth the consideration of the CIR at this time. Thank you in advance for your consideration of these concerns, Alexandra Scranton alexs@womensvoices.org Director of Science and Research Women s Voices for the Earth 1 CIR Supplement Page 43

45 J Appl Toxicol Jun 29. doi: /jat [Epub ahead of print] Parabens enable suspension growth of MCF- 10A immortalized, non-transformed human breast epithelial cells. Khanna S, Darbre PD. Source Biomedical Sciences Section, School of Biological Sciences, University of Reading, Reading, RG6 6UB, UK. J Appl Toxicol Mar;32(3): doi: /jat Epub 2012 Jan 12. Measurement of paraben concentrations in human breast tissue at serial locations across the breast from axilla to sternum. Barr L, Metaxas G, Harbach CA, Savoy LA, Darbre PD. Source The Genesis Breast Cancer Prevention Centre, University Hospital of South Manchester NHS Foundation Trust, Wythenshawe, Manchester, M23 9LT, UK. Proc Natl Acad Sci U S A Aug 13. [Epub ahead of print] Triclosan impairs excitation-contraction coupling and Ca2+ dynamics in striated muscle. Cherednichenko G, Zhang R, Bannister RA, Timofeyev V, Li N, Fritsch EB, Feng W, Barrientos GC, Schebb NH, Hammock BD, Beam KG, Chiamvimonvat N, Pessah IN. Source Department of Molecular Biosciences, School of Veterinary Medicine, Division of Cardiovascular Medicine, Department of Internal Medicine, and Department of Entomology and Cancer Center, University of California, Davis, CA CIR Supplement Page 44

46 Triclosan impairs excitation contraction coupling and Ca2+ dynamics in striated muscle Gennady Cherednichenkoa,1, Rui Zhanga,1, Roger A. Bannisterb,1, Valeriy Timofeyevc, Ning Lic, Erika B. Fritscha, Wei Fenga, Genaro C. Barrientosa, Nils H. Schebbd, Bruce D. Hammockd,2, Kurt G. Beame, Nipavan Chiamvimonvatc,f, and Isaac N. Pessaha,2 adepartment of Molecular Biosciences, School of Veterinary Medicine, cdivision of Cardiovascular Medicine, Department of Internal Medicine, and ddepartment of Entomology and Cancer Center, University of California, Davis, CA 95616; bcardiology Division, Department of Medicine, and edepartment of Physiology and Biophysics, University of Colorado Denver-Anschutz Medical Campus, Aurora, CO 80045; and fdepartment of Veterans Affairs, Northern California Health Care System, Mather, CA Contributed by Bruce D. Hammock, July 13, 2012 (sent for review June 18, 2012) CIR Supplement Page 45