Availability and chemical composition of traditional eye cosmetics (&ldquo;kohls&rdquo;) used in the United Arab Emirates of Dubai, Sharjah, Ajman, Umm AI-Quwain, Ras AI-Khaimah, and Fujairah

Andrew D. Hardy; Richard I. Walton; Kathryn A. Myers; Ragini Vaishnav

Table IV Other Analyses of Kohl Samples No. containing n Made in Purchased in lead (%) Non-lead elements/ compounds 11 India and Pakistan Midlands (UK) 6 (55%) Zn,C/Menthol, Herbs, Pearls 13 Not given Kuwait 11 (85%) C/Fe2OyH2O, Herbs 17 Nigeria Nigeria 17 (100%) C/Herbs 21 Saudi Arabia and India Saudi Arabia 14 (67%) C,O,S,Si,Ca,Fe,Al,Ti,Sb,Na,Zn,Cl,K 47 Mostly India, Pakistan and Mostly Oman (39) 15 (32%) Mostly compounds based on Fe, Oman Ca, Zn, and B. Also, various C compounds. 23 Mostly India and Pakistan United Arab Emirates 11 (48%) Various largely as above. (Mostly Abu Dhabi, 18) 18 Egypt (11), India (4), China, Cairo 6 (33%) Various largely as above. Sudan and Saudi Arabia Kohl analyses using only AA (atomic absorption): 22 Mostly India, Pakistan and World-wide6 13a (59%) Not given Morroco 21 Mostly India, Pakistan and Bahrain r (33%) Not given Saudi Arabia 6 Mostly India and Saudi Arabia Saudi Arabia 4a (67%) Sb (at less than 10%) in five samples 10 Pakistan Pakistan (Karachi) 8 (80%) Zn (in the 2 non-lead samples), SiO2 (all) 8 Mostly Saudi Arabia Saudia Arabia 6a (75%) Sb, As, Cd and Pt (all at less than 1 % ) 28 Egypt (18), imported (10) Egypt (Greater Cairo) W (50%) Not given 10 Morocco (6), imported (4) Morroco (Marrakech) 10 (100%) Not given 107 Saudi Arabia, India, Pakistan, Saudi Arabia 62 (58%) Al, Sb (each at less than 1 %) and Iran Camphor/Menthol found in a few samples a Above 1 % lead. 6 America, UK, Morocco, and Mauritania. Method(s) used AA,XRPD AA, XRPD, SEM AA, XRPD, SEM SEM XRPD, SEM XRPD, SEM XRPD, SEM AA AA AA AA AA AA AA AA Year and reference (1979) (18) (1981) (19) (1984) (20) (1995) (15) (1998) (2) (2002) (1) (2004) (3) (1991) (21) (1992) (22) (1993) (16) (1994) (23) (1995) (17) (1997) (24) (2001) (25) (2004) (14) - r - r ..., z u 0 � 0 - 0 z 0 'Tl � 0 r � """"' tv VJ

124 JOURNAL OF COSMETIC SCIENCE samples having it present as a minor phase). Therefore, almost half (43%) of these 53 available samples contain a lead compound. Sixteen more were based on amorphous carbon, seven on zincite, five on sassolite, two on the iron compounds hematite and goethite, two on calcium carbonate, and one on talc. This study shows that traditional eye cosmetics, "kohls," are still readily available in the souks of Dubai, Sharjah, Ajman, Umm Al-Quwain, Ras Al-Khaimah, and Fujairah and that, unfortunately, many do still contain the toxic element lead (as PbS). The largest three emirates (Dubai, Sharjah, and RAK) have, as expected, the largest souks and thus the largest number of available kohl samples for purchase. If three kohl samples were bought in any one of these three emirates' souks, then there would be a high probability that one would contain lead, and in all likelihood there would be no clear indication of this on its container or enclosed leaflet. Moreover, some of the most available kohls not only contain lead, but contain it in a form (i.e., small particle size) that makes it more easily absorbed into the human gut. Finally, we can only reiterate that this element has no known biological value and is an insidious cumulative poison having potentially devastating cognitive effects if applied regularly to young children. ACKNOWLEDGMENTS We thank the following people for their help in the course of this study: Mr. P. Auchterlonie (Librarian for Middle East Studies, Exeter University, UK) for his help in translating phrases found, in various languages, on leaflets/containers of some of the samples mentioned in this article, and Dr. E. Berner (American University of Dubai, Dubai, UAE) for her local knowledge and help in arranging "field trips" to some of the more distant souks of the UAE. Also, we thank the staff of the Chemical and Materials Analysis Unit (University of Newcastle, UK) for the experimental SEM work mentioned in this article. REFERENCES (l) A. D. Hardy, H. H. Sutherland, and R. Vaishnav, A study of the composition of some eye cosmetics (kohls) used in the United Arab Emirates,]. Ethnopharrnacol., 80, 137-145 (2002). (2) A. D. Hardy, R. Vaishnav, S.S. Z. Al-Kharusi, H. H. Sutherland, and M.A. Worthing, Composition of eye cosmetics (kohls) used in Oman, J. Ethnopharmacol., 60, 223-234 (1998). (3) A. D. Hardy, R. I. Walton, and R. Vaishnav, Composition of eye cosmetics (kohls) used in Cairo, Int. J. Environ. Health Res., 14, 83-91 (2004). (4) (Marcus) Vitruvius (Pollio), De Architectura, Book 8, Chapter 6, Passages 10 and 11 (http://www.ukans . edu!history!index/ettropelancient_rome/EIRornan!Texts!Vitruvim/8. html). (5) R. L. Canfield, C.R. Henderson, D. A. Cory-Slechta, C. Cox, T. A. Jusko, and B. P. Lanphear, Intel- lectual impairment in children with blood lead concentrations below 10 µg per deciliter, New Engl.]. Med., 348, 1517-1526 (2003). (6) R. A. Goyer, Lead toxicity: From overt to subclinical to subtle health effects, Environ. Health Perspect., 86, 177-181 (1990). (7) H. L. Needleman, A. Schell, D. Bellinger, and E. N. Alfred, The long term effects of exposure to low doses of lead in childhood: An eleven year follow-up report, N. Engl. J. Med., 332, 83-88 (1990). (8) J. Schwartz and D. Otto, Lead and minor hearing impairment, Arch. Environ. Health, 46, 300-306 (1991). (9) C. D. Klaasen, Casarett and Dou/l's Toxicology, the Basic Science of Poisons, 5th ed. (McGraw-Hill, New York, 1996).

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122 JOURNAL OF COSMETIC SCIENCE in the UAE. By contrast, in a very recent study in Saudi Arabia (14), all the samples labelled "hot"/"cold" did/did not have lead present. COMPARISON WITH OTHER STUDIES Of the 5 3 observably different kohl samples available in the six emirates studied here, it was found that twenty (38%) contain a lead compound (galena, PbS) as the major phase. This percentage is identical to that found for lead-containing samples in all the samples available in the souks of both Dubai and Sharjah it is slightly higher than that found (36%) for the souk of RAK and is substantially different from the values found for the much smaller souks of Umm Al-Quwain (14%) and Ajman (57%). For the Fujairah city souk, it was found that while 40% of the samples purchased contained galena as a major phase, this value was calculated for only two of five samples purchased (a "selection"), and so is possibly not a true representation for that emirate. The overall percentage (38%) is also smaller than that found by us for Abu Dhabi city (50% (1)), but is higher than our values found for Oman (32% (2)) and Cairo (33% (3)). By comparison, the lead-containing percentages given in Table IV, for other previous publications where kohl samples were analyzed, are almost all 2::50% (the one exception being the kohls purchased in Bahrain, where only 33% of the samples studied contained lead). The fifteen studies listed in Table IV, done over the twenty-five year period 1979-2004, have a range of 32% to 100% for those samples that contain lead. The "average" is 63% of samples found to contain lead. The non-lead elements or compounds found in our present study (Figure 1 and Tables I and II) are broadly similar to those found in the previous studies of Table IV. However, several authors (14-17) did find antimony (usually in small/very small amounts) in some of their kohl samples, whereas we found no antimony whatsoever despite the verbal assurances of several Emirati shopkeepers and from information on enclosed leaflets. Also, in the fifteen previous studies listed in Table IV it can be seen that India and/or Pakistan are mentioned as the origin of at least some of the kohl samples in ten of the studies. In Abu Dhabi city the percentage of samples originating in India and Pakistan was 89%. This value is similar to the values found in this study for five of the individual emirates: 81 % each for Dubai and Sharjah, 86% for Ajman, 100% for Umm Al-Quwain, and for RAK only 68%. In Fujairah city souk's "selection," all (100%) originated in Pakistan, but this is probably not a true representation for that emirate. By contrast, the percentages in Oman and Egypt (Cairo) were only 40% and 22%, respectively. The reason for this difference in values between the UAE and these other two Middle Eastern countries is that samples were made locally in both Oman (38%) and Egypt (61 %), unlike the UAE where only one such sample ("Zikra Al Haramain," which was made in Dubai) has ever been encountered. The eight samples seen before by us in previous studies, but re-analyzed here (Table II), were all found to have essentially the same chemical composition regardless of locations of purchase. CONCLUSIONS In the 5 3 observably different kohl samples, found overall in the six emirates covered in this study, the main component of twenty was determined to be galena (with three more

Table IV Other Analyses of Kohl Samples No. containing n Made in Purchased in lead (%) Non-lead elements/ compounds 11 India and Pakistan Midlands (UK) 6 (55%) Zn,C/Menthol, Herbs, Pearls 13 Not given Kuwait 11 (85%) C/Fe2OyH2O, Herbs 17 Nigeria Nigeria 17 (100%) C/Herbs 21 Saudi Arabia and India Saudi Arabia 14 (67%) C,O,S,Si,Ca,Fe,Al,Ti,Sb,Na,Zn,Cl,K 47 Mostly India, Pakistan and Mostly Oman (39) 15 (32%) Mostly compounds based on Fe, Oman Ca, Zn, and B. Also, various C compounds. 23 Mostly India and Pakistan United Arab Emirates 11 (48%) Various largely as above. (Mostly Abu Dhabi, 18) 18 Egypt (11), India (4), China, Cairo 6 (33%) Various largely as above. Sudan and Saudi Arabia Kohl analyses using only AA (atomic absorption): 22 Mostly India, Pakistan and World-wide6 13a (59%) Not given Morroco 21 Mostly India, Pakistan and Bahrain r (33%) Not given Saudi Arabia 6 Mostly India and Saudi Arabia Saudi Arabia 4a (67%) Sb (at less than 10%) in five samples 10 Pakistan Pakistan (Karachi) 8 (80%) Zn (in the 2 non-lead samples), SiO2 (all) 8 Mostly Saudi Arabia Saudia Arabia 6a (75%) Sb, As, Cd and Pt (all at less than 1 % ) 28 Egypt (18), imported (10) Egypt (Greater Cairo) W (50%) Not given 10 Morocco (6), imported (4) Morroco (Marrakech) 10 (100%) Not given 107 Saudi Arabia, India, Pakistan, Saudi Arabia 62 (58%) Al, Sb (each at less than 1 %) and Iran Camphor/Menthol found in a few samples a Above 1 % lead. 6 America, UK, Morocco, and Mauritania. Method(s) used AA,XRPD AA, XRPD, SEM AA, XRPD, SEM SEM XRPD, SEM XRPD, SEM XRPD, SEM AA AA AA AA AA AA AA AA Year and reference (1979) (18) (1981) (19) (1984) (20) (1995) (15) (1998) (2) (2002) (1) (2004) (3) (1991) (21) (1992) (22) (1993) (16) (1994) (23) (1995) (17) (1997) (24) (2001) (25) (2004) (14) - r - r ..., z u 0 � 0 - 0 z 0 'Tl � 0 r � """"' tv VJ

Help

AVAILABILITY AND COMPOSITION OF "KOHLS" 121 the positive (and mostly correct) medicinal effects of antimony. However, as already stated, this sample has no antimony (sulphide) present, only lead sulphide-which most certainly does not have the stated positive medicinal effects mentioned (i.e., acting as an anti-parasitic/bacterial material). The remaining five such samples from Table I (i.e., "Nimco No. 96. Neem Ka Tez Surma (Special)" and two each of the "Surma Harmain Al Sherfain" and "Surma Noor- Ul-Ain" samples), plus the sample "Surma Al-Sherifain" from Table II, were all found to have the same statement of medicinal effects on usage: "Most helpful in the treatment of all kinds of eye troubles such as: eye weakness, haziness, tears, eye dirt, burning eyes, scratching and redishness etc. Strengthens the vision and gives a cooling effect to the eyes while it fights disease. Used daily or once a week, helps keep eye ailments away in both young and old alike." Four of these six samples are made in India (by three apparently different companies) and two are made in Pakistan (by the same company). Having identical medicinal effects of usage "statements" implies either common own- ership of the various companies and/or common employment of the same "copywriter." Also, three of these six samples have galena present as the major phase and another two have it present as a minor phase. Thus for the three samples with galena as the major phase, the above-listed medicinal effects are highly suspect, and for the other three samples (having talc, calcium carbonate, or zincite as their major phases), they are merely very questionable. Additionally, the sample named "Surma" in Table I was said (by the Fujairah city souk shopkeeper) to be "very good for sore eyes." It was a white powder whose major and minor phases were calcite and quartz, respectively. Even given the general non-toxicity of these compounds, we would question this therapeutic claim. Four samples had the words "hot" or "cold" on their labels, and another, while not so labelled, was said by the shopkeeper to be "hot" (one of two "Surma Noor-Ul-Ain" samples purchased). A "hot" symbol (in Arabic) or word (in English and/or Arabic) on the sample's container/box is often used to indicate that the kohl can be used as an eye medicine and so will sometimes be placed inside the eye, while a "cold" symbol/word indicates that it is to be used solely for beautification and so is usually placed on the outside of the eye. The "hot" kohl often contains, or is thought to contain, a special "active ingredient" that acts as the eye medicine. This "active ingredient" is often stated (verbally by the shopkeeper or in writing on an enclosed leaflet) to be antimony sulphide (stibnite), but is nearly always found to be lead sulphide (galena) when the sample is chemically analyzed. The sample "Al Athmad" ("Eyes Kuhl." "Cold") contains no galena as expected, but "Kohl Original Stone. With Zam Zem water. Cold" does contain galena as its main phase. Also, for our only clearly labelled pair (i.e., one labelled "hot" and one "cold" on their container boxes) of samples ("Surma Harmain Al-Sherfain"), both were found to contain galena as their major phases and to have identical minor phases (anglesite and cerussite, both lead compounds). Also, these two samples had identical quantitative "contents data" on enclosed leaflets (see Table III). However, the two samples of "Surma Noor-Ul-Ain," which had containers that were almost identical and were labelled neither "hot" nor "cold," were found to have different chemical composi- tions. The sample stated to be "hot" by the shopkeeper was found to contain galena as a minor phase (zincite being the main phase), and the other sample (by implication "cold") had no galena present (calcium carbonate being the main phase). On the basis of these findings, it should be clear that such labelling is not to be trusted when trying to determine if an "active ingredient" is actually present in a sample purchased

122 JOURNAL OF COSMETIC SCIENCE in the UAE. By contrast, in a very recent study in Saudi Arabia (14), all the samples labelled "hot"/"cold" did/did not have lead present. COMPARISON WITH OTHER STUDIES Of the 5 3 observably different kohl samples available in the six emirates studied here, it was found that twenty (38%) contain a lead compound (galena, PbS) as the major phase. This percentage is identical to that found for lead-containing samples in all the samples available in the souks of both Dubai and Sharjah it is slightly higher than that found (36%) for the souk of RAK and is substantially different from the values found for the much smaller souks of Umm Al-Quwain (14%) and Ajman (57%). For the Fujairah city souk, it was found that while 40% of the samples purchased contained galena as a major phase, this value was calculated for only two of five samples purchased (a "selection"), and so is possibly not a true representation for that emirate. The overall percentage (38%) is also smaller than that found by us for Abu Dhabi city (50% (1)), but is higher than our values found for Oman (32% (2)) and Cairo (33% (3)). By comparison, the lead-containing percentages given in Table IV, for other previous publications where kohl samples were analyzed, are almost all 2::50% (the one exception being the kohls purchased in Bahrain, where only 33% of the samples studied contained lead). The fifteen studies listed in Table IV, done over the twenty-five year period 1979-2004, have a range of 32% to 100% for those samples that contain lead. The "average" is 63% of samples found to contain lead. The non-lead elements or compounds found in our present study (Figure 1 and Tables I and II) are broadly similar to those found in the previous studies of Table IV. However, several authors (14-17) did find antimony (usually in small/very small amounts) in some of their kohl samples, whereas we found no antimony whatsoever despite the verbal assurances of several Emirati shopkeepers and from information on enclosed leaflets. Also, in the fifteen previous studies listed in Table IV it can be seen that India and/or Pakistan are mentioned as the origin of at least some of the kohl samples in ten of the studies. In Abu Dhabi city the percentage of samples originating in India and Pakistan was 89%. This value is similar to the values found in this study for five of the individual emirates: 81 % each for Dubai and Sharjah, 86% for Ajman, 100% for Umm Al-Quwain, and for RAK only 68%. In Fujairah city souk's "selection," all (100%) originated in Pakistan, but this is probably not a true representation for that emirate. By contrast, the percentages in Oman and Egypt (Cairo) were only 40% and 22%, respectively. The reason for this difference in values between the UAE and these other two Middle Eastern countries is that samples were made locally in both Oman (38%) and Egypt (61 %), unlike the UAE where only one such sample ("Zikra Al Haramain," which was made in Dubai) has ever been encountered. The eight samples seen before by us in previous studies, but re-analyzed here (Table II), were all found to have essentially the same chemical composition regardless of locations of purchase. CONCLUSIONS In the 5 3 observably different kohl samples, found overall in the six emirates covered in this study, the main component of twenty was determined to be galena (with three more

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120 JOURNAL OF COSMETIC SCIENCE lated from Farsi for sample "Surma Farid Ara") and "rose water" and "Greek herbs and rose water" (both translated from Urdu for samples "Lateef Surma 'surma sada mix'" and "Lateef Surma 'sukh chen sada,' " respectively). The other three with qualitative "con- tents data" are more specific about their contents (but give no amounts/percentages). Extra information/translation/interpretation is given in italics (in parentheses) after the (below) "contents data" of these three samples. For the sample "Al Haramain Ethmed": "It is the natural Ithmed stone powder, sulphur of Antinion (black and red)" (this is referring to the often-quoted, but never yet seen by us, idea that antimony sulphide-the mineral stibnite-is the main component of the sample: none was found in this sample, the major phase found being lead sulphide). For the sample "Hashmi ® Kajal" (in tube form, with a cardboard holder on which is printed its "contents data"): "Ingredients: Zinc oxide (B.P.) (zincite, none found), waxes (B.P .) (paraffin wax was found), processed carbon black (amor- phous carbon was found), herbs, clarified butter, cinnamomun, camphora (camphor, none found)." For the sample "Hashmi Surma Sunef' (translated from very fine-print Urdu on its box lid): "Surma Black" (often meaning galena, which was the major phase found here), "Kushta-just" (probably a zinc compound, zincite was found), "Kafoor" (camphor, none found), "Warq Naqra" (coconut, possibly the ground husk), "Arq Badyan" (currently of unknown meaning) and "Mameera-o-deger Jary Bootiyam" (mixture of herbs). As regards data on the medicinal effects from using a particular kohl sample, it was found that a total of fifteen samples (nine in Table I and six in Table II) had this written information (usually on an enclosed leaflet). Five of the six samples from Table II have had their medicinal effects of usage data discussed in a previous publication (1) and, with one exception (the sample "Surma Al-Sherifain," see below), will not be repeated here. The sixth sample from Table II, "Hind Ka Noor Eye Liner," had a leaflet inside its box that gave some medicinal effects of usage data in (colloquial) Arabic. On translation it was found to say: (this kohl is extremely useful for/against) "reducing cold," "eye ache," "all diseases of the eye," "heat in the eye," "improves eye-sight and strengthens vision," and also "can be used by adults and children. " As this sample consists of amorphous carbon (the major phase), talc, and quartz (minor phases)-none of which are likely to give toxicity-the use of this kohl would be unlikely to make matters worse if used (externally) for the above "conditions. " This kohl sample has been seen by us in many Middle Eastern souks, and only in two cases were enclosed leaflets found (in this study and in our Cairo study (3)). Three of the nine such samples in Table I gave only limited information on their medicinal effects of usage. Such phrases occur as: "It glazes the vision and helps the eyelashes to grow better, treats and removes redness" (sample "Zikra Al Haramain," which has galena as its major phase) "Extremely soothing to the eyes ........It also works as an antidote to eye irritation due to pollution and dust particles .........It is an extremely beneficial tonic for weak eyes" (sample "Khojati® Toop Anjan®," which has amorphous carbon as its major phase) and "Most useful for the diseases of the eye" (translated from Urdu for sample "Shabnami Surma tark Chashma," a white sample with sassolite as its major phase). Commenting on the above it must be said that neither (matte) galena or amorphous carbon (or their associated minor phases) will give the above-stated medicinal effects of usage for the first two of the above samples, and while sassolite is both a mild antiseptic and a bacteriostatic material, its ability to be "useful" for all diseases of the eyes is questionable. A fourth sample from Table I, "Al Haramen Ethmed," has on an enclosed leaflet (in English and Arabic) a lot of information on

AVAILABILITY AND COMPOSITION OF "KOHLS" 121 the positive (and mostly correct) medicinal effects of antimony. However, as already stated, this sample has no antimony (sulphide) present, only lead sulphide-which most certainly does not have the stated positive medicinal effects mentioned (i.e., acting as an anti-parasitic/bacterial material). The remaining five such samples from Table I (i.e., "Nimco No. 96. Neem Ka Tez Surma (Special)" and two each of the "Surma Harmain Al Sherfain" and "Surma Noor- Ul-Ain" samples), plus the sample "Surma Al-Sherifain" from Table II, were all found to have the same statement of medicinal effects on usage: "Most helpful in the treatment of all kinds of eye troubles such as: eye weakness, haziness, tears, eye dirt, burning eyes, scratching and redishness etc. Strengthens the vision and gives a cooling effect to the eyes while it fights disease. Used daily or once a week, helps keep eye ailments away in both young and old alike." Four of these six samples are made in India (by three apparently different companies) and two are made in Pakistan (by the same company). Having identical medicinal effects of usage "statements" implies either common own- ership of the various companies and/or common employment of the same "copywriter." Also, three of these six samples have galena present as the major phase and another two have it present as a minor phase. Thus for the three samples with galena as the major phase, the above-listed medicinal effects are highly suspect, and for the other three samples (having talc, calcium carbonate, or zincite as their major phases), they are merely very questionable. Additionally, the sample named "Surma" in Table I was said (by the Fujairah city souk shopkeeper) to be "very good for sore eyes." It was a white powder whose major and minor phases were calcite and quartz, respectively. Even given the general non-toxicity of these compounds, we would question this therapeutic claim. Four samples had the words "hot" or "cold" on their labels, and another, while not so labelled, was said by the shopkeeper to be "hot" (one of two "Surma Noor-Ul-Ain" samples purchased). A "hot" symbol (in Arabic) or word (in English and/or Arabic) on the sample's container/box is often used to indicate that the kohl can be used as an eye medicine and so will sometimes be placed inside the eye, while a "cold" symbol/word indicates that it is to be used solely for beautification and so is usually placed on the outside of the eye. The "hot" kohl often contains, or is thought to contain, a special "active ingredient" that acts as the eye medicine. This "active ingredient" is often stated (verbally by the shopkeeper or in writing on an enclosed leaflet) to be antimony sulphide (stibnite), but is nearly always found to be lead sulphide (galena) when the sample is chemically analyzed. The sample "Al Athmad" ("Eyes Kuhl." "Cold") contains no galena as expected, but "Kohl Original Stone. With Zam Zem water. Cold" does contain galena as its main phase. Also, for our only clearly labelled pair (i.e., one labelled "hot" and one "cold" on their container boxes) of samples ("Surma Harmain Al-Sherfain"), both were found to contain galena as their major phases and to have identical minor phases (anglesite and cerussite, both lead compounds). Also, these two samples had identical quantitative "contents data" on enclosed leaflets (see Table III). However, the two samples of "Surma Noor-Ul-Ain," which had containers that were almost identical and were labelled neither "hot" nor "cold," were found to have different chemical composi- tions. The sample stated to be "hot" by the shopkeeper was found to contain galena as a minor phase (zincite being the main phase), and the other sample (by implication "cold") had no galena present (calcium carbonate being the main phase). On the basis of these findings, it should be clear that such labelling is not to be trusted when trying to determine if an "active ingredient" is actually present in a sample purchased

AVAILABILITY AND COMPOSITION OF "KOHLS" 125 (10) A. Al-Khayat, N. S. Menon, and M. R. Alidina, Acute lead encephalopathy in early infancy-Clinical presentation and outcome, Ann. Trap. Paediatr., 17, 39--44 (1997). (11) H. Narchi, Radiological case of the month, Arch. Pediatr. Ado!. Med., 154, 83-84 (2000). (12) M.A. Healy, P. G. Harrison, M. Aslam, S.S. Davis, and C. G. Wilson, Lead sulphide and traditional preparations: Routes for ingestion, and solubility and reactions in gastric fluid,]. Clin. Hosp. Phann., 7, 169-173 (1982). (13) C. Gardella, Lead exposure in pregnancy: A review of the literature and argument for routine prenatal screening, Obstet. Gynaec. Survey, 56, 231-238 (2001). (14) R. M. Al-Ashban, M. Aslam, and A.H. Shah, Kohl (surma): A toxic traditional eye cosmetic study in Saudi Arabia, Public Health, 118, 292-298 (2004). (15) S. A. F. Al-Hazzaa, and P. M. Krahn, Kohl: A hazardous eyeliner, Int. Ophthalrnol., 19, 83-88 (1995). (16) A. Al-Kaff, A. Al-Rajhi, K. Tabbora, and A. El-Yazigi, Kohl-The traditional eyeliner: Use and analysis, Ann. Saudi Med., 13, 26-30 (1993). (17) I. A. Al-Saleh and L. Coate, Lead exposure in Saudi Arabia from the use of traditional cosmetics and medical remedies, Environ. Geochem. Health, 17, 29-31 (1995). (18) M. Aslam, S.S.Davis, and M.A.Healy, Heavy metals in some Asian medicines and cosmetics, Public Health, 93, 274-284 (1979). (19) N. P. Fernando, M.A. Healy, M. Aslam, S.S.Davis, and A. Hussein, Lead poisoning and traditional practices: The consequences for world health. A study in Kuwait, Public Health, 95, 250-260 (1981). (20) M.A. Healy, M. Aslam, and 0. A. Bamgboye, Traditional medicine and lead-containing preparations in Nigeria, Public Health, 98, 26-32 (1984). (21) C. Parry and J. Eaton, Kohl: A lead-hazardous eye makeup from the third world to the first world, Environ. Health Perspect., 94, 121-123 (1991). (22) I. M. Madany and M. S. Akhter, Lead levels in some eye cosmetics used in Bahrain, J. Environ. Sci. Health [A}, 27, 1541-1547 (1992). (23) A. M. Syed, M. Qadiruddin, K. Shirin, and Z. B. Hashmi, Determination of inorganic components including minor and trace elements in surma (kohl) formulations, Pak. J. Sci. Ind. Res., 37, 411--413 (1994). (24) R. Chappell, P. Billig, E. Brantly, S. Ault, and H. S. Ezzeldin, Lead Exposure Abatement Plan for Egypt: Results of Environmental Sampling for Lead, Environmental Health Project, Activity Report No. 32 (prepared for the USAID Mission to Egypt under EHP Activity No. 256-CC) (1997). (25) N. Lekouch, A. Sedki, N. Nejmeddine, and S. Gamon, Lead and traditional Moroccan pharmacopoeia, Sci. Total Environ., 280, 39-43 (2001).

J. Cosmet. Sci., 57, 127-137 (March/April 2006) Analysis of consumer cosmetic products for phthalate esters JEAN C. HUBIN GER and DONALD C. HA VERY, U.S. Food and Drug Administration, 5100 Pa int Branch Parkway, C allege Park, MD 20740. Accepted for publication November 17, 2005. Synopsis A rapid and sensitive reverse-phase HPLC method with UV detection was developed for the quantitation of dimethyl phthalate (DMP), diethyl phthalate (DEP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), and di(2-ethylhexyl) phthalate (DEHP) in cosmetic preparations. Average recoveries of the phthalate esters were better than 90%. In a survey of 48 consumer cosmetic products, including hair care products, deodorants, lotions and creams, nail products, fragrances, and body washes, most products were found to contain at least one phthalate ester. DEP was detected most frequently at concentrations up to 38,663 ppm. DBP was found in fewer products, but at levels up to 59,815 ppm. Based on the available exposure and toxicity data, the FDA has concluded that there is insufficient data to conclude that a human health hazard exists from exposure to phthalate esters from cosmetic products. INTRODUCTION Phthalate esters are present in many consumer products, primarily to impart flexibility to rigid polymers such as polyvinyl chloride. They are used in the production of products such as food wrappings, medical devices (e.g., blood bags), children's toys, wood finishes, paints, upholstery, and plastic products, and are subject to a variety of regulatory requirements. As a result of their extensive use, phthalate esters have been found in the environment (1-6), foods (7-9), food supplements (10), medical products (11,12), medical devices (13), plastic materials (14), and cosmetics (15). In cosmetic products, phthalate esters are used as solvents for fragrances, as suspension agents for solids in aerosols, as lubricants for aerosol valves, and as antifoaming agents, skin emollients, and plasticizers in nail polishes and fingernail elongators. Investigations into the levels of phthalate ester metabolites in human urine have shown that exposure to DEP, BBP, DBP, and DEHP from all sources is highly variable from person to person and between different demographic groups (16-19). In one study, women of child-bearing age (20-40 years) were found to have significantly higher levels of monobutyl phthalate, the metabolite of DBP, in their urine than other age/gender groups (16). Several phthalate metabolites have also been found in human breast milk 127

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