Assessment of lead in cosmetic products

Regulatory Toxicology and Pharmacology 54 (2009) 105–113

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Assessment of lead in cosmetic products Iman Al-Saleh *, Sami Al-Enazi, Neptune Shinwari Environmental Health Section, Biological & Medical Research Department, King Faisal Specialist Hospital & Research Centre, P.O. Box 3354, Riyadh 11211, Saudi Arabia

a r t i c l e

i n f o

Article history: Received 19 August 2008 Available online 27 February 2009 Keywords: Lead exposure Lipsticks Eye shadow Cosmetics Saudi Arabia

a b s t r a c t There have been a number of recent reports in the media and on the internet about the presence of lead in brand-names lipsticks. This has drawn our attention to assess the safety of various cheap brands of cosmetics sold at 2-riyals stores in Saudi market that are imported from countries where safety regulations are poorly enforced as well as they lack perfect conditions for manufacturing. Lead contents were determined in 26 and eight different brands of lipsticks and eye shadows using the Zeeman atomic absorption spectrophotometer coupled to graphite tube atomizer after an acid digestion procedure. Lead was detected in all the studied samples. The median (25th–75th percentile) lead content in 72 lipsticks samples was 0.73 (0.49–1.793) PPM wet wt. in the range of 0.27–3760 PPM wet wt. There were four brands of lipsticks with lead content above the FDA lead limit as impurities in color additives (20 PPM). The FDA does not set a limit for lead in lipstick. Three of them were extremely high points and considered outliers. The median (25th–75th percentile) lead contents in pressed powder eye shadow was 1.38 (0.944–1.854) PPM wet wt. (n = 22) in the range of 0.42–58.7 PPM wet wt. One brand was above 20 PPM the US FDA’s lead limit as impurities. The overall results indicate that lead in lipsticks and eye shadows are below the FDA lead limit as impurities and, thus, probably have no significant toxicological effects. Nevertheless, few brands had lead content above 20 PPM that might put consumers at the risk of lead poisoning. Lead is a cumulative, and applying lead-containing cosmetics several times a day or every day, can potentially add up to significant exposure levels. Pregnant and nursing mothers are vulnerable population because lead passes through placenta and human milk and affect fetus or infant’s developments. Our findings call for an immediate mandatory regular testing program to check lead and other toxic metals in lipsticks and other cosmetic products imported to Saudi Arabia in order to curtail their excess and safeguard consumer health. Ó 2009 Elsevier Inc. All rights reserved.

1. Introduction Lead is a naturally occurring element in the earth’s crust. It is widely distributed through the environment because it has been extensively used worldwide in gasoline, consumer products, recycling old products and manufacturing processes (CDC, 1991). Although important measures have been implemented in a number of countries to decrease environmental lead exposure such as the use of unleaded gasoline, removal of lead from paint, solder of canned foods and glazed ceramics used for storage and preparation of food, it is still a major environmental health problem in specific communities and targeted high-risk populations. Lead affects virtually every system in the body such as the reproductive, neurological, hematopoietic, hepatic, and renal systems (Meyer et al., 2008). More than 90% of the lead body burden is localized in bone with an average half-life of more than 20 years (WHO, 1995). Bone releases lead during periods of increased bone turnover in wo* Corresponding author. E-mail address: [email protected] (I. Al-Saleh). 0273-2300/$ - see front matter Ó 2009 Elsevier Inc. All rights reserved. doi:10.1016/j.yrtph.2009.02.005

men’s lives, such as pregnancy, lactation, and menopause (Gulson et al., 1998; Vahter et al., 2004; Ettinger et al., 2007). It is well established that lead can cross the placenta during pregnancy and has been associated with intrauterine fetal death, premature delivery and low birth weight (Papanikolaou et al., 2005). Maternal blood lead levels of approximately 10 lg/dl have been linked to increased risks of pregnancy hypertension, spontaneous abortion, and reduced offspring neurobehavioral development (Bellinger, 2005). Furthermore, the consequences of accelerated bone loss during menopause due to decrease in estrogen production may place women at increased risk for elevated lead levels (Vahter et al., 2007). There are numerous reports and research papers on other potential sources for lead exposure that are hidden and need to be addressed. These include ethnic folk remedies and cosmetics, Mexican terra cotta pottery, toys and certain imported candies and spices (Al-Saleh et al., 1996; Baer et al., 1998; Lekouch et al., 2001; CDC, 2002, 2004; Ernst, 2002a, b; CDC, 2004; Woolf and Woolf, 2005; Kales et al., 2007; Meyer et al., 2008). Recently, the Campaign for Safe Cosmetics in the United States raised another

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concern about the presence of lead in lipsticks. They found that more than half of the tested 33 brand-name red lipsticks (61%) contained detectable lead in the range of 0.03–0.65 PPM (CSC, 2007). Since the US Food and Drug Administration has not set a limit for lead in lipsticks, the CSC’s results was evaluated based on the acceptable FDA limit of lead in candy assuming that lipstick can be ingested like candy. They found that one third of the tested lipsticks had lead levels exceeded 0.1 PPM FDA’s lead limit in candy (US FDA, 2006a). According to the FDA, this is not a fair comparison because candy is intended for ingestion and which may be consumed on a regular basis. While lead levels in lipstick, a product intended for topical use and which is ingested in much smaller quantities than candy (US FDA, 2007a). Eye cosmetics could be another source of heavy metals exposure. For example, various colors are used in manufacturing eye shadows and the US FDA has allowed the use of some natural colors or inorganic pigments such as iron oxide, carmine, Mica, titanium dioxide, copper powder, bronze powder, aluminum powder, manganese violet etc. (US FDA, 2007b). Though the US FDA has not set a specific limit for lead content but has set a limit for its content that is considered to be safe in color additives which is typically between 10 and 20 PPM. There have been several reports on the presence of lead and other metals in traditional eye cosmetics such as Kohl and Surma (Al-Saleh, 1998; Hardy et al., 2004, 2006; Lekouch et al., 2001; Al-Ashban et al., 2004). While Kohl is allowed in a number of countries, the Federal Food, Drug, and Cosmetic Act (FD&C Act) defined it as a color additive and there is no regulation permitting its use in a cosmetic or in any other FDA-regulated product (US FDA, 2006b). On the other hand, there are hardly studies on metal contents in eye cosmetics apart from the study of Sainio et al.’s (2000). They screened various brands of eye shadows for heavy metals and found the levels of lead and arsenic were less than 20 PPM, but higher levels of cobalt and nickel were detected. Authors recommended that good manufacturing practice of cosmetic products should be applied in order to ensure the absence of harmful levels of impurities in the ingredients. Though, the European Union (EU) laws for cosmetics banned lead and lead compounds in cosmetics since 1976 (Council Directive 76/768/EEC, 1976), trace amounts of lead are unavoidable under conditions of good manufacturing practice. Cosmetic products and ingredients are not subject to the US FDA pre-market approval authority, with the exception of color additives (US FDA, 2007a). However, the Federal Food, Drug, and Cosmetic Act (FD&C Act) collects samples for examination and analysis as part of its plant inspections, import inspections, and follow-up to complaints of adverse reactions. They may also conduct research on cosmetic products and ingredients to address safety concerns (US FDA, 2005). Therefore, the US FDA lays the responsibility on the cosmetic firms for checking the safety of their products and ingredients before introducing it into the market. Most of developing countries lack safety regulations for cosmetics and other products that comply with the US FDA’s requirement such as labeling violations, the illegal use of color additives, and the presence of poisonous or deleterious substances, such as pathogenic microorganisms (US FDA, 2002b, 2006c). There have been various reports in the media and on the internet discussing whether lipsticks with lead levels ranging from 0.03 to 0.65 PPM reported by the CSC in 2007 should be of concern. The claims that these levels are well below the FDA limit for lead as impurities in color additives (20 PPM). Reports about lead in lipsticks are not new and in the 1990s, the FDA checked a similar claim from a commercial testing laboratory and found no action was necessary because the laboratory used an un-validated and inappropriate testing method. Such periodic allegations have urged the FDA to establish an intramural research program that is con-

ducted by researchers of the Center for Food Safety and Applied Nutrition (CFSAN). They are currently working on developing and validating a method for measuring the amount of lead in lipsticks. The method will permit FDA to make an independent evaluation of the hazard suggested by media reports (US FDA 2007a, 2008). An enforcement action will be taken if health hazard is found. Nevertheless, the CSC’s reported results should be taken seriously until the results are scientifically verified by the FDA for two reasons. First lead is not an ingredient in lipstick but found as impurities in the raw materials or be acquired during the manufacturing process. Second most of the latest studies emphasize that there is no safe level of lead exposure (Bellinger, 2008). Lead exposure assessments were always based on its intake from food, water, or air. Depending on the source, the concentration of lead and its bioavailability, the relative contribution of each source may vary considerably (WHO, 1995). WHO (1995) estimated a range of 14.4–28 lg/day total daily lead intake from air, food dust, and water in adults. The major source of lead for nonoccupationally exposed adults is food and drink. For example, total lead intakes from food by adults in the range of 26–282 lg/day from various countries as estimated by WHO (1995). O’Rourke et al. (1999) assessed lead exposure from multi-pathway (air, soil, house dust, food, beverage, and water) in the US adult population and found daily exposure of 36 lg/day (range: 11-107 lg/day). Lead in lipsticks represents a very minor source of lead exposure compared to other sources because the amount of lipstick that one applies daily is actually very small compare to the amount of water, food or air one takes. Nonetheless, one should not exclude the fact that lead accumulates in the body over time and repetitive lead-containing lipstick application can lead to significant exposure levels. However, the consequences of these products can only be properly verified by conducting population risk assessment exposure study. The CSC’s findings raised a concern about the safety of cheap priced lipsticks that are sold widely in 2-riyals stores around Riyadh City. Most of their products are imported from countries where there is a lack of regulatory inspection as well as perfect conditions for manufacturing. The absence of regulations relevant to the import of cosmetics in Saudi Arabia allows the sell of products with harmful ingredients that jeopardizes consumer health. Saudi Arabia remains the main market for cosmetic and beauty products in the region. In 2005, sales of cosmetics and toiletries was SR 5 billion (USD 1.3 billion; EUR 1.04 billion) representing a 6% increase over the previous year. This growth is partly explained by the blooming economy and the increase in the number of hypermarkets and specialist shops (www.beauty-on-line.com, 2006). Furthermore, the demographic nature of the country where 58% of the populations are under the age of 24, accompanied by dramatic changes in lifestyles and increasing numbers of Saudis joining the workforce, also played an important role in driving sales of such products (http://www.euromonitor.com/Cosmetics_And_Toiletries_in_Saudi_Arabia, 2007). In the present study, we determined lead content in different brands of lipstick and eye shadow samples which were collected from various 2-riyals stores in Riyadh market in order to check their safety.

2. Materials and methods 2.1. Samples and reagents Like dollar stores in America, there are many 2-riyals shops in Riyadh and other parts of Saudi Arabia where most items in these stores are sold for 2-riyals (1 riyal  0.26 US dollar). At these shops, one can buy anything from cooking utensils, cloths, office supplies,

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cosmetics. They are very popular and most of its products are imported mainly from developing countries where no quality control measures are applied. We purchased all the 26 different lipsticks and eight pressed powder eye shadows brands that were available in these stores at the time of the study. Each brand has a manufacturing LOT number which represents either one or more color/ shade. In this study, we collected also all the available different LOT numbers for each brand. Total LOT numbers for lipsticks and pressed powder eye shadows were 48 and 22, respectively. We collected 38 and 15 different colors or shades of lipsticks and eye shadows, respectively. Two to four batches per each brand of lipstick or eye shadow with the same LOT number were selected. Selection of LOT number and batches were based on their availability in stores at the time of study. Based on the brand’s label, country of origin was specified. Lipsticks were imported from seven different countries (China, Thailand, Taiwan, USA, France, Italy, and Germany). Two brands were of unknown origin. Fig. 1 shows few samples of the studied lipsticks. On the other hand, the selected eye shadows were imported from China, France, and USA as written on the label. Most of the tested products were either un-labeled or inadequately labeled. Lead reference solution (1000 PPM) and 30% hydrogen peroxide (H2O2) were obtained from Fisher ChemAlert Guide, Fisher Scientific Co. Trace metal free ‘‘selectipur” nitric acid and ammonium dihydrogen phosphate modifier were obtained from E. Merck, D6100 Darmstaot, Frankfurter Strasse 250 Germany. 2.2. Sample treatment A weighed sample of 0.2 g lipstick was placed into a Teflon vessel and reacted with 4 ml concentrated nitric acid, left at room temperature for 4 h then placed in the oven overnight at 85 °C. After digestion, the sample was allowed to cool to room temperature. Furthermore, after adding 1 ml of 30% hydrogen peroxide, the sample solutions were heated at 85 °C for another hour. The clear supernatant was transferred to polypropylene tubes and diluted to 10 ml with deionized water. Metal contents were expressed as part per million wet weight (PPM wet wt.). 2.3. Instrumentation Lead analysis was performed using a Varian AA-280 Zeeman atomic absorption spectrophotometer with a hollow cathode lamp

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and a deuterium lamp for background correction, coupled to GTA120 electrothermal atomizer and a programmable sample dispenser (Varian Techtron PTY. Ltd., Australia). The optimized heating programs followed for the analysis of lead were that described by the instrument manufacturer. Lead was analyzed by mixing one volume of digest (usually 3 ll) with an equal volume of 1% (w/v) ammonium dihydrogen phosphate modifier. Injection volume was 6 ll. Quadruplicate determinations were made on all samples. Method’s detection limit was 0.25 PPM wet wt. The detection limit was calculated as the mean plus 3 times the SD of the blank sample. Calibration lead standards were prepared each day using a manual standard addition procedure where lipstick or eye shadow samples were divided into six equal portions. Known amounts of aqueous lead solutions were added to these to give final concentrations in the range of 0.25–4.0 PPM. There was a good linear relation between absorbance and standard concentration of lead. Linearity was evaluated by calculating the linear correlation coefficients (r) for 7 runs of spiked lipsticks, which was 0.999 ± 0.0001 and 2 runs for spiked eye shadow (r = 0.999). Due to the unavailability of certified material for lipstick or eye shadow analysis, the accuracy of the method was determined by measuring the recovery of lead added to either matrix. These spiked samples were run with the test samples using the same analytical procedure. The analytical recovery for seven spiked lipstick samples with 0.4, 0.8, and 1.6 PPM lead were 99.7 ± 6.22%, 104.9 ± 5.71%, and 103.8 ± 1.66%, respectively. The recovery of two sets of spiked eye shadows with 0.4, 0.8, and 1.6 PPM lead were 109.3%, 103.9%, and 104.5%, respectively. The results for coefficient of variation (CV) of within-day precision for 0.3 and 0.6 PPM wet wt. concentrations of lead were 6.8% and 3.9%, respectively. 2.4. Data analysis Results of similar LOT numbers for each brand of the lipstick or eye shadow were pooled and reported as average lead content in PPM wet wt. Values in the text are presented as means ± SD and median (with the 25th and the 75th percentiles). For health risk assessment, Loretz et al.’s (2005) calculated the daily usage of lipsticks by 360 women, ages 18–65 years based on 2.35 number of application per day. The means of lipstick usage per day was 24 mg. Based on Loretz’s assumptions; we calculated the weekly lead exposure from lipsticks. Spearman’s rank correlation coeffi-

Fig. 1. Few samples of the tested lipsticks.

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Table 1 Lead contents (PPM wet wt.) in various lipstick samples. Brand #

Country of origin

LOT NO.

Color

Lead content (PPM wet wt.)

1

China

14 17 08 23

Rose Bright rose Shimmering beige Shimmering mauve

1.67 1.69 0.54 2.69

2.93 1.47 0.87 3.46

2.30 1.58 0.70 3.08

2

China

17 16 06 02 01

Mocha Red brown Copper Shimmering violet Mocha

0.53 0.59 0.47 0.23 0.53

0.82 0.91 0.62 0.43 1.06

0.67 0.75 0.54 0.33 0.80

3

Unknown

04 11 03 04

Shimmering pink Shimmering orange Chocolate/Shimmering pink Shimmering pink/peach

0.37 0.33 1.09 1.49

0.78 0.79 1.34 1.55

0.57 0.56 1.21 1.52

4

China

63 81

Shimmering beige Rose

1985.0 1.97

2070.0 1.55

2027.50 1.76

5

China

02 03 05 08 07 19 05 12 03 12 01 10 08 07

Light mocha Mocha Red Shimmering beige Light rose Shimmering beige Rose Chocolate Red Dark Rose Shimmering peach Shimmering rose Shimmering bronze Green

0.39 0.52 0.24 1.81 0.55 0.40 0.66 39.80 1.04 0.36 0.41 0.50 1.68 0.57

0.36 1.33 0.31 2.43 0.78 0.57 0.74 34.0 0.18 0.24

0.38 0.92 0.28 2.12 0.66 0.48 0.70 36.90 0.61 0.30

0.50 1.95 0.49

0.50 1.82 0.53

Batch # 1

Batch # 2

Mean lead content (PPM wet wt.)

6

Taiwan

33

Light pink

0.26

0.48

0.37

7

China

501 515 526 535 532 509

Ruby red Shimmering mocha Chocolate Dark rose Light rose Dark red

0.34 0.75 1.66 1.54 0.45 0.54

0.60 1.23 1.83 2.07 0.66 0.55

0.47 0.99 1.74 1.81 0.55 0.55

8

Unknown

08

Shimmering violet

9

China

952 822

Rose Light mocha

10

China

22 13 18 21

Shimmering mocha Red Shimmering mocha Shimmering pink

11

China

12

China

46 37 30 04 40 01

Dark mauve Dark rose Mocha Red Brown Shimmering dark mocha

13

China

804

14

Taiwan

03 05 08

15

Thailand

16

0.76

0.63

0.69

2.17 12.35

2.06 20.80

2.11 16.58

3.44 0.90 0.94 0.75

3.38 0.99 1.55 0.77

3.41 0.94 1.24 0.76

1.13 3.12 2780.0 2.44 1.97 0.59

0.97 2.52 2265.0 2.91 2.03

1.05 2.82 2522.50 2.44 2.44 1.31

Red brown

0.71

0.55

0.63

Dark mocha Dark rose Chocolate

0.64 0.46 0.50

0.61 0.57 0.47

0.63 0.52 0.49

30 121 197

Shimmering red brown Shimmering beige Shimmering beige

0.68 0.46 0.33

0.62 0.56 0.40

0.65 0.51 0.36

Germany

11 60

Red brown Mocha

1.00 2.97

1.38 2.64

1.19 2.80

17

China

10 09

Bright rose Shimmering beige

24.40 3740.0

16.45 3780.0

20.43 3760.0

18

USA

29 12

Cinnamon Pink

0.23 0.30

0.32 0.24

0.28 0.27

19

Taiwan

12 27 28

Orange Light violet Copper

0.33 0.40 0.35

0.30 0.37 0.37

0.31 0.39 0.36

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I. Al-Saleh et al. / Regulatory Toxicology and Pharmacology 54 (2009) 105–113 Table 1 (continued) Brand #

Country of origin

LOT NO.

20

USA

C12 C04

21 22 23

Italy China France

11 20 94

Color

Lead content (PPM wet wt.)

Mean lead content (PPM wet wt.)

Batch # 1

Batch # 2

Shimmering pink Shimmering light beige

1.00 0.43

1.94 0.51

1.47 0.47

Dark mocha Black Dark rose

0.91 3.49 0.24

0.61 2.43 0.29

0.76 2.96 0.27

24

Taiwan

10

Mocha

0.18

0.49

0.33

25

China

04 07

Dark rose Dark rose

0.75 3.68

0.89 2.74

0.82 3.21

26

Taiwan

A9

Mauve

0.49

0.45

0.47

*

LOT NO. It means any number written on the product from which the complete history of the manufacture, control, packaging and distribution of a batch can be determined.

cient was employed to provide an estimate of relationship between different batches of brand with similar LOT number. The data were evaluated using the SPSS for Windows (Version 13.0, SPSS Chicago, IL). Values were considered significant at P < 0.05. 3. Results 3.1. Lead contents in lipsticks Table 1 lists the results of lead analysis in the 26 brands of lipsticks. The mean value of lead in 72 lipstick samples as an average of two batches with the same LOT number was 117.40 ± 576.80 PPM wet wt. The rule is always that any value more than three standard deviations from the mean should be considered as an outlier. In this study, three data points with extremely high lead concentration were found in different lipstick brands. The acid digestion of these samples was repeated three times and the results were consistent. As for the possibility of matrix interferences, our recovery results is an indication of how efficient our analytical procedure. Since we do not have special cause for this unusual deviation and it is also not advisable to delete these points because they might be representing true observations, we decided to keep the suspected outliers. However, our lead data was presented as median (25th–75th percentile). The median is less sensitive to outliers and better measure than the mean for highly skewed distributions. Our median (25th–75th percentile) values for lead levels as an average of the two batches of lipstick were 0.73 (0.489–1.793) PPM wet wt. in the range of 0.27–3760 PPM wet wt. There was consistency in the lead contents of the two different batches of the same brand (r = 0.87, P = 0). When we looked at the lead contents according to the color of lipsticks (Fig. 2), it seems the highest lead content was found in shimmering colored lipsticks in the range: 0.33–3760 PPM wet wt. 3.2. Lead contents in eye shadow In the eight different brands of pressed powder eye shadows that we analyzed in this study, our median (25th–75th percentile) values for lead levels as an average of two to four batches of eye shadows were 1.38 (0.944–1.854) PPM wet wt. in the range of 0.42–58.7 PPM wet wt. Only single product gave lead content higher than 20 PPM (FDA’s set specification for impurities). As indicated in Table 2, the lead content in the various batches of the same brand and LOT number were consistent. Correlation test gave r-value of 0.79 (P = 0). 3.3. Weekly lead intake Based on Loretz et al.’s data and the assumption in 2005 that lipstick can be ingested; we calculated our results in terms of the

weekly lead exposure. Based on median value, the weekly lead exposure is 0.12 lg/week in the range of 0.045–631.68 lg/week. 4. Discussion Lead was detected in all tested lipstick samples in the range of 0.27–3760 PPM wet wt. If we exclude the three questionable outliers, the mean lead contents in lipsticks dropped from 117.40 to 2.07 PPM wet wt. (range: 0.27–36.90 PPM wet wt.) with only two brands with lead content above 20 PPM the FDA limit for lead as impurities in color additives used in cosmetics (US FDA, 2002a). Since there was no valid reason to remove these values, we found four brands of lipsticks with lead contents around or above 20 PPM. In the absence of legislative regulation concerning the limit of lead in lipstick, the CSC used the 0.1 PPM US FDA permissible lead level in candy (CSC, 2007) assuming that lipstick can be directly ingested. Using this benchmark, all tested lipstick samples contained lead content much higher than the FDA’s permissible lead limit in candy. However, there is still some a debate that this is not a valid limit because candy is intended for ingestion and which may be consumed on a regular basis, while lipstick, is used topically and might be ingested in much smaller quantities (US FDA, 2007a). Indeed, the results of this study are much higher than lead contents in the 33 brand-name lipsticks tested in the USA with lead levels ranging from 0.03 to 0.65 PPM (CSC, 2007). Comparable to the CSC results, we found lead in seven expensive brand-names lipsticks in the range of 0.36–1.07 PPM wet wt. (unpublished result) as shown in Table 3 which reinforces their findings. The primary ingredients found in lipstick are wax, oil, alcohol, and dye. Though, lead is not an ingredient of the lipsticks, it might be present as impurities in the color additives. According to the US FDA, trace amount of lead in cosmetics is unavoidable under conditions of good manufacturing practice. Therefore, the US FDA has established a limit for lead that gets into the cosmetics as an ingredient of dye. For example, lead in D&C Red No. 6 dye should not be more than 20 PPM (US FDA, 2002a). In the USA, any cosmetics contain a color additive, they should adhere to the FDA’s requirements: (1) approval. Any color additives used in cosmetics must be approved by FDA where a clear regulation specifically addressing a substance’s use as a color additive, specifications, and restrictions; (2) certification. A number of color additives must be batch certified by FDA if they are to be used in cosmetics marketed in the US; (3) identity and specifications. All color additives must meet the requirements for identity and specifications stated in the Code of Federal Regulations (CFR); and (4) use and restrictions. Color additives may be used only for the intended uses stated in the regulations that pertain to them. The regulations also specify other restrictions for certain colors, such as the maximum permissible concentration in the finished product (US FDA, 2007c). These regulations are applied also on imported cosmetics (US FDA, 2006c). Color additives can be natural or

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6.76%

16.22%

36.49%

6.76%

33.78%

Red colors

Shimmering colors Light colors

Brown colors Dark colors

1.81 0.72* (0.27-20.43) 242.18 0.87* (0.33-3760) 0.37 0.37* (0.27-0.53) 212.18 0.72* (0.33-2522.5) 8.90 2.44* (0.49-36.90)

Fig. 2. Lead contents (PPM wet wt.) in 26 brands lipsticks categorized according to colors. Vales with asterisk () are the median.

synthetic. Natural dyes are those extracted from natural herbs and vegetables such b-carotene, caramel, henna etc., while mineral based pigments include iron oxide, aluminum oxide, titanium oxide etc. The US FDA exempts natural color additives from batch certification (US FDA, 2007b). Hence they might contain traces of lead or mercury or arsenic. In this study, the highest lead content was found in shimmering colored lipsticks in the range of 0.33– 3760 PPM wet wt. The glittery and metallic shimmering look in these lipsticks might come from Mica which is a group of silicate minerals that are widely used in cosmetics industry. Because it is naturally occurring earth’s minerals, they are distributed in various types of rocks. Therefore, Mica may contain traces of heavy metals

(MSD, 2002). The US FDA approved the use of Mica in amounts consistent with good manufacturing practice with lead content should not exceed 4 PPM in food and ingested drugs while in external used drugs, dentifrices, and cosmetics should be not more than 20 PPM (US FDA, 2002c, 2007b). If Mica or any color additives of mineral origin is an ingredient of our tested lipsticks, then one should not dismiss the presence of other toxic metals such as arsenic, mercury etc. (Sainio et al., 2000; Nnorom et al., 2005). Pressed powder eye shadows are the most popular eye cosmetics and usually applied to the eyelid by lightly stroking a soft sponge-tipped applicator across the skin. Their main ingredients are talc with pigments and zinc or magnesium stearate used as a

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I. Al-Saleh et al. / Regulatory Toxicology and Pharmacology 54 (2009) 105–113 Table 2 Lead contents (PPM wet wt) in various eye shadows. Brands #

Country of origin

LOT NO.

Color

Batch # 1

Batch # 2

1

China

1.00 2.00 3.00 6.00

Dark gray Shimmering pink Shimmering beige Shimmering beige

1.60 93.50 2.73 2.36

1.50 23.90 2.76

3.24

2.58

2

China

3.00 2.00 4.00

Purple Shimmering dark blue Shimmering gray

0.96 1.29 0.47

1.09 1.40 0.76

1.15

1.15

3

China

3.00 5.00

Shimmering light blue Brown

1.39 1.69

1.23 1.59

1.82

1.90

5.00 5.00 4.00 3.00 5.00 1.00 4.00 4.00

Brown Light green Shimmering Shimmering Pink Rose Shimmering Shimmering

1.07 0.42 0.75 1.00 1.21 1.31 0.61 0.84

4

China

France

Lead content (PPM wet wt)

green rose

rose green

1.83 0.50 1.27 0.42 0.87

Mean Lead (PPM wet wt.) Batch # 3

Batch # 4 1.55 58.70 2.73 2.73 2.17 1.34 0.62 1.39 1.75 1.07 0.42 1.47 0.75 1.24 1.31 0.52 0.86

1.84

0.81

5

USA

13.00 1.00

Dark gray Brown

1.53 1.66

1.67 1.58

6

France

40.00

Shimmering peach

17.93

17.43

7

China

2.00

Pink

1.02

0.99

1.00

0.90

0.97

1.00

Shimmering gray

1.33

1.29

1.48

1.38

1.37

8

1.60 1.62 17.68

Table 3 Lead contents (PPM wet wt.) in seven expensive red colored lipstick brands. Brand #

Country of origin

LOT NO.

1 2 3 4 5 6 7

Belgium Japan Belgium France France France France

140 SL7 30 15 282 168 18

binder (Draelos, 2001). Looking at the lead contents in the eight different brands of pressed powder eye shadows, only brand # 1 had one product with 58.70 PPM wet wt. lead contents above 20 PPM the US FDA’s permissible limit for lead as impurities in dye for externally used cosmetics under good manufacturing practice (US FDA, 2007b). On the other hand, the rest of samples were in the range of 0.42–17.68 PPM (Fig. 3). Tsankov et al. (1982) determined lead contents in various cosmetic products such as creams, cleansing milk, shampoos, hair dyes, eye shadows, rouge, lipsticks, powders, fond de teint, tooth pastes. The majority of their cosmetic products contained lead 2.08 PPM. However, in only some decorative cosmetic, lead content was considerably high (41.1 PPM). Authors related to an inadequate purification of the initial raw materials. Based on sub-acute dermal toxicity study on albino rats, Tsankov et al. (1982) proposed that the maximum allowable concentration of lead should be 10 PPM. If we follow his proposed permissible level, only two of our tested eye shadows had lead contents >10 PPM. Another study by Sainio et al. (2000), reported lead content (<20 PPM) in 49 eye shadow products. In this study, China is the major manufacturer of our tested lipsticks and eye shadows. There have been a number of recent incidents where imported products from China to the US markets such as toys, jewelry, bibs, and lunch boxes were found to have dangerously high lead contents. In 2007, the US Consumer Product Safety Commission (CPSC) signed an agreement with the Chinese

Lead levels (PPM wet wt.)

Mean lead levels (PPM wet wt.)

Batch # 1

Batch # 2

1.11 0.77 0.90 0.89 0.44 0.36 0.44

1.03 0.75 0.90 0.77 0.46 0.36 0.41

1.07 0.76 0.90 0.83 0.45 0.36 0.42

authorities to introduce safety checks on products such as toys, cigarettes, electrics and fire-works before imported to the US (CPSC, 2007). Of course regulation might be enforced by the requirement of the importing countries. As for cosmetics, there were a series of recalls when chromium and neodymium were found in nine SK-II products (http://www.bpfk.gov.my/pdfworddownload/ skII.pdf) as well as ten Chinese cosmetics had dexamethasone, chloramphenicol and metronidazole (http://www.chinaretailnews.com/2007/11/27/931-ministry-of-health-recalls-ten-chinese-cosmetics/). Since then there were few announcements to tighten the safety of cosmetics in order to be in compliance with international regulatory standards (http://www.export.gov/china/ exporting_to_china/cosmetics.asp, 2007). There should be always certificate export with each cosmetic to assure that it complies with regulations in the destination country. Significant differences in regulations exist among different countries. There have been two incidents where imported products from China such as toothpaste and toys because of diethylene glycol and lead content, respectively, were removed from the Saudi markets (http://www.reuters.com/article/newsOne/idUSL2372574020070823, 2007; http:// www.iht.com/articles/ap/2007/08/25/africa/ME-GEN-Saudi-ChinaToy-Recall.php, 2007). The Saudi officials have introduced a routine check on Chinese toothpaste before going on the market. Though lead in lipsticks might not cause an immediate health problem but its cumulative effect due to repeated application can-

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Brand# 1

1.37 0.97

2 3

16.43

4 17.68

5 6 7 8

1.61

1.38

0.95

1.57

Fig. 3. Lead contents (PPM wet wt.) in eight different brands of eye shadows.

not be ruled out. As we know, lead builds up in the body over time and lead-containing lipstick whether applied a number of times a day or on daily basis can contribute to significant lead exposure levels. Nevertheless, the use of lipsticks varies from one woman to another. When we compared our results to the provisional tolerable weekly intake (PTWI) proposed by the FAO/WHO Joint Expert Committee on Food Additives and Contaminants to assess the risk of lead exposure to human health (WHO, 2000), only three lipstick samples exceeded the PTWI of 25 lg/Kg body weight. Unlike lipsticks, eye shadows are applied externally and previous studies reported insignificant skin absorption of lead (WHO, 1995). Furthermore, Lilley et al. (1988) suggested that lead absorbed through the skin may be eliminated via sweat and other extracellular fluids, and hence not be as great a health hazard as ingested lead. There are few studies on lead dermal absorption. Gorter et al. (2005) revealed that no toxic risk was observed when commonly prescribed lead-containing ointment Plumbum metallicum 0.4% in humans was applied on skin. The highest lead content (0.006%) found in our tested eye shadows was much lower than the cream used in Gorter et al.’s study. Therefore, we do not expect significant systematic toxicological effects. Pregnant women and young children are particularly vulnerable to lead exposure. The use of lead contaminated lipstick or eye shadows by pregnant or /and lactating women could expose the fetus and infants to the risk of lead poisoning. Latest studies show there is no safe level of lead exposure (Bellinger, 2008). Gilbert and Weiss (2006) emphasized the importance of lowering the CDC blood lead action limit to 2 lg/dl arguing that there is now sufficient and compelling scientific evidence showing that blood lead levels below 10 lg/dl may impair neurobehavioral development in children. Lead has also been linked to infertility and miscarriage. A recent review article by Mendola et al. (2008)

examined published studies and research reports from 1999 to 2007 indexed in PubMed and found that exposure to lead is the strongest environmental contaminant that interferes with healthy reproductive function in adult females. As it is known, lead is a dangerous heavy metal that we are not supposed to have it in our body. In addition to the primary sources of lead exposure that we are likely expose to, there seems to be many recent studies and reports revealing the presence of lead in numerous other products such as toys, jewelry, herbal remedies, candy etc. that put the vulnerable population at risk of lead poisoning (Medlin, 2004; US CPSC, 2005; Weidenhamer and Clement, 2007). To be exposed to lead from cosmetics raise another concern. Scientists and health care workers are aware of the long-term health effect of lead exposure. It is asymptomatic that builds up in the body giving the chance of developing different health problems such as high blood pressure, kidney damage, anemia, infertility, and neurobehavioral/learning disabilities. The overall results indicate that lead in lipsticks and eye shadows are below lead limit as impurities and, thus, probably have no significant toxicological effects. Nevertheless, few brands had lead content above 20 PPM the US FDA’s lead limit as impurities. These might put consumers at the risk of lead poisoning. Our findings call for an immediate mandatory regular testing program to check lead and other toxic metals in lipsticks and other cosmetic products imported to Saudi Arabia in order to curtail their excess and safeguard consumer health. References Al-Ashban, R.M., Aslam, M., Shah, A.H., 2004. Kohl (surma): a toxic traditional eye cosmetic study in Saudi Arabia. Public Health 118, 292–298.

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