The Cosmetic Ingredient Review Expert Panel will release a hair dye epidemiology "boilerplate" stating that evidence is insufficient to prove a causal relationship exists between hair dye use and certain types by of cancer in early 2004, the panel announced.

CIR will publish a draft document outlining its position by Sept. 15, at which point comments will be accepted, CIR Director Alan Andersen, PhD, said at a Sept. 8-9 meeting in Washington, D.C. A final draft will be discussed and revised during CIR's Nov. 13-14 meeting, and re-released for public comment before being finalized in January.

The boilerplate, which will incorporate findings from a group of studies examining a potential link between the use of hair dye and various forms of cancer, will be included in all future hair dye safety assessments, according to CIR. However, the panel will not re-review any ingredients unless new data warrants another evaluation, CIR said.

The panel announced it would undertake a comprehensive literature review of hair dye epidemiology earlier this year, since CIR has not reviewed hair dye studies since the 1990s, and a number of differing opinions on the link between dye and cancer currently exist (¹ Also see "Hair Dye Literature Review Will Be Undertaken By CIR In September" - HBW Insight, 16 June, 2003., p. 8).

The literature review, assembled and conducted by Kathy Helzlsouer, MD, Dana Rollinson, PhD, and Susan Pinney, PhD, of Johns Hopkins University, comprised cohort and case-control studies of personal hair dye use and occupational exposures. The studies examined potential connections to diseases including bladder cancer, breast cancer, non-Hodgkin's lymphoma, leukemia, multiple myeloma, and autoimmune disease.

The evaluation covered 83 studies that have become available since the International Agency for Research on Cancer last reviewed hair dye epidemiology literature in 1993.

The researchers concluded findings were insufficient to prove a causal relationship between personal hair dye use and bladder cancer, multiple myeloma or non-Hodgkin's lymphoma, as the associations were not consistently observed across studies.

Only one "well designed" study evaluating hair dye type (oxidative or direct), color and frequency or duration of use showed a causal relationship, according to Helzlsouer et al. Manuela Gago-Dominguez et al., University of Southern California, found that genetically susceptible subgroups might be at risk from hair dye exposure, although these findings are based on small sample sizes in the subgroups, Helzlsouer noted. A connection between hair dye and bladder cancer has been established by Gago-Dominguez in two studies (² 'The Rose Sheet' April 15, 2002, In Brief).

Also included in Helzsouer's review is the IARC study, which concluded that "personal use of hair colorants cannot be evaluated as to its carcinogenicity (Group 3)" due to inadequate evidence, but that "occupation as a hairdresser or barber entails exposures that are probably carcinogenic."

EU's Scientific Committee on Cosmetic Products and Non-Foods Products is another body that recently acknowledged a potential link between permanent hair dye use and bladder cancer (³ Also see "EU Safety Review Of Hair Dyes Requires More Data, Committee Says" - HBW Insight, 21 April, 2003., p. 3).

The Johns Hopkins team advocated replicating the studies to achieve a "more definitive" understanding of the association between hair dye and cancer, as the "available evidence is insufficient to conclude the association between personal hair dye use and these health outcomes is causal," according to Helzlsouer.

The CIR panel agreed that studies reviewed by the panel should be replicated, and additional studies should be conducted to examine potential susceptible subpopulations.

In addition to the review of hair dye use, CIR issued an informal data request for Phytantriol, soliciting impurities data and mammalian genotoxicity studies (see chart: " ⁴ Cosmetic Ingredient Review Report Status "). The ingredient, which currently is used in products such as hair conditioners and shampoos, is supported by "scant" genotoxicity data, FDA Office of Cosmetics and Colors Director Linda Katz, MD, remarked.

The group also re-reviewed 2-Bromo-2-Nitropropane-1, 3-Diol, determining the ingredient is safe as used. The panel upheld a 1984 decision, which found the ingredient is "safe in cosmetics in concentrations up to and including .1% except under circumstances where its action with amines or amides can result in the formation of nitrosamines or nitrosamides."

Isostearyl Neopentanoate also was determined by the panel to be safe as used. CIR noted the ingredient had been added to lipstick since it was last assessed in 1985, but agreed the new use does not raise safety concerns, and the existing conclusion remains valid.

CIR issued a tentative final report with insufficient data on Coal Tar, citing the need for information on the ingredient's concentration as a biocide.

The group additionally voted to table the Alcohol Denat. group, which appeared on CIR's priority list because of high frequency of use, reports of adverse biological effects and TopKat structure/activity software predictions of developmental toxicity and skin damage. The panel concluded additional data was needed, and tabling the review would allow CIR to decide how to address the ingredients.

According to Cosmetic, Toiletry and Fragrance Association VP-Science Gerald McEwen, PhD/JD, CIR's first task is to categorize the Alcohol Denat. group, eliminating those ingredients not approved for use in cosmetics and not listed in the CTFA International Cosmetic Ingredient Dictionary and Handbook.

The panel also released a scientific literature review on Methoxyisopropanol and Methoxyisopropanol Acetate on July 31. CIR will accept comments for 90 days, and will review the ingredients at a future meeting. Meth-oxyisopropanol had two reported uses in 2002, as base coats and undercoats and in nail polish enamels, while Methoxyisopropanol Acetate, a solvent in cosmetic formulations, had no reported uses in 2002, according to FDA. The ingredients are included on CIR's "high priority for review" list.

CIR Hair Dye Epidemiology Position Will Be Solidified By Early 2004

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