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Colorants in transferable picture tattoos for the skin

5 Risk assessment

The present investigation concerns transferable picture tattoos for the skin. They are sold as tattoo pictures fixed on a paper, where from they usually are transferred on to the skin with the help of water, without use of glue, and these can be washed off. As the picture tattoos are in contact with the skin, they can cause contact allergy if they contain allergenic substances, i.e. colorants within the context of the present investigation. Skin contact with the picture tattoos can last for hours or days.

The Danish EPA has received a few complaints about children getting skin reactions by the use of picture tattoos on the skin. The reason for such reactions is not known. A survey of the scientific literature in PubMed did not reveal any information on skin allergy from picture tattoos. Furthermore, no cases of skin reactions to tattoo stickers have been registered, so far, at the Dermatology Departments at University Hospitals in Gentofte and Odense (personal communication). Normally, only the severe cases of skin allergy are referred to the Dermatology Departments in the hospitals. Similarly, only severe cases of allergy are reported in scientific journals. So, there may be undocumented cases of skin reactions to transferable picture tattoos. The skin reactions may be both allergic as well as non-allergic type. However, the Danish Consumer Association, which has direct contact with the general population, has also not registered or notified any case of skin reactions to tattoo stickers (personal communication). Thus, it is stipulated that the potential of tattoo stickers to induce skin reactions is very limited.

As described earlier (se 2.2 Legislation), transferable picture tattoos are cosmetic products, and therefore, they should comply with the Danish Statutory Order on Cosmetic Products/EU Cosmetic Directive (4).

The colorants, which are permitted for the use in the formulation of cosmetic products, are listed in the Annex IV, part 1 of the Cosmetic Directive. For an unequivocal identification of the colorants, they are described in the Annex IV as Colour Index (CI) Numbers. In the present investigation, the contents of 7 of the colorants in the picture tattoos were > 12 ppm. A literature survey on these 7 colorants, with respect to their potential for causing allergic skin reaction, has been performed. The literature survey was performed in PubMed and in Toxline using both their CI No. and CAS No. with the search codes: allergy and/or sensitisation. Furthermore, reference books on allergy were used (6,7).

The most commonly used colorant in the picture tattoos, i.e. CI 15850 was present in 31/33 (94%) of the samples at a concentration up to 2391 ppm. The EU Scientific Committee of Cosmetic Products and Non-Food Products (SCCNFP) has performed a risk assessment of this colorant in May 2004. The summary of an unpublished study on the evaluation of sensitisation potential of CI 15850 by use of “ The Local Lymph Node Assay (LLNA)” in mice is described in the SCCNFP Opinion (8). The Committee found that the study was satisfactorily performed according to OECD Guideline 429, and concluded on the basis of the results of the study that CI 15850 was not a sensitiser. Further literature search revealed that the sensitisation potential of CI 15850 had been studied in two additional investigations. In an animal study in mice employing a modified LLNA (not an official standard method), CI 15850 was shown to cause sensitization under the experimental conditions used (9). CI 15850 is also used as pigment (pigment 57). In a Japanese report, single cases of allergy lipstick containing this pigment have been described (10). In one case the allergic reaction was due to impurities in the pigment.

The colorant CI 11920 was present in 12 out of 33 picture tattoos (36%) at a concentration up to 4479 ppm. The literature search did not reveal any investigation concerning sensitisation potential of this colorant in animals, or allergic reactions from the colorant in humans. However, CI 11920 is classified as moderate to strong sensitiser in a QSAR (Quantitative Structure Activity Relationships) study based on the chemical structure of the substance (11). Further studies are required to confirm the allergenic potential of the colorant.

Ten of the 33 picture tattoos were found to contain CI 45220 at a concentration up to 103 ppm. No animal study concerning sensitisation potential of this colorant, or any study concerning allergic reaction by the colorant in humans were found in the literature. According to the Cosmetic Directive, CI 45220 should only be used in those cosmetic products, which remain in contact with the skin for a short period.

CI 75300, also known as curcumin (12), was present in 4 of the 33 investigated tattoo stickers at a concentration up to 35 ppm. This colorant is widely used in food, where it is a component of curry powder. Curcumin is also used for the coloration of the disinfecting liquids that are used before surgery. There are a few reports of allergy from this colorant in association with food/spice production (13, 14). In a study in which 25 patients were investigated for allergy to anaesthetics, allergy in two patients was recorded due to curcumin (CI 75300) present in the disinfecting liquid that was used before the surgery. The concentration of the colorant in the disinfecting liquid causing allergic reaction was 0.05% (500 ppm) (15). The maximum concentration of CI 75300 in the picture tattoos was found to be 35 ppm, which is at least 10 times lower than the concentration of the colorant in disinfecting liquid responsible for allergic reaction. There is no report of curcumin allergy by the use of picture tattoos, possibly due to less frequent use and low concentration of this colorant in picture tattoos compared to that in the disinfecting liquids that are used before surgery.

Both CI 13015 and CI 45100 were present in 3 out of 33 (9%) picture tattoos. Literature search did not reveal any information concerning allergy to CI 13015.

The SCCNFP has performed the risk assessment of CI 45100 (16). In the Opinion of the SCCNFP, a summary of an unpublished animal study of Guinea Pig Maximisation test (GPMT) is described. Negative results were obtained in this study, which was performed according to OECD Guideline 406. The SCCNFP considered that CI 45100 was not a sensitiser. In a QSAR study, based on the chemical structure of hair dyes, CI 45100 was classified as a weak allergen (11). CI 45100 should, according to the Cosmetic Directive, only be used in those cosmetic products, which remain in contact with the skin for a short period (4). No further information on this colorant was found in the literature.

CI 15525 was found at a concentration level of 215 ppm, but only in one of the investigated tattoo stickers. The literature search did not reveal any information on the allergenic potential of this colorant.

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Version 1.0 August 2005, © Danish Environmental Protection Agency