Parabens Tentative Amended Final Report Issued By CIR

The Cosmetic Ingredient Review Expert Panel is initiating a 90-day comment period on a tentative amended final safety assessment for parabens, which the panel issued during its Dec. 12-13 meeting in Washington, D.C.

CIR will accept comments until mid-March and likely will issue a tentative final report during its June meeting, according to CIR Director Alan Andersen, PhD.

The panel's decision was based on a slew of safety data it has received since re-opening its safety assessment on the substances. During a September meeting, the panel requested quantitative exposure data for products used on babies and pregnant and nursing women, but little information was submitted (¹ (Also see "CIR Requests Parabens Exposure Data, Reaffirms Phthalates Safety" - HBW Insight, 19 Sep, 2005.), p. 3).

Based on existing metabolism studies, however, "if there were any concern about accumulation of parabens in breast milk, we think we've alleviated that," cosmetic industry representative George Daston, PhD said. He presented a summary of parabens safety data during the meeting on behalf of a Cosmetic, Toiletry and Fragrance Association and European Cosmetic, Toiletry and Perfumery Association task force.

Unlike the original report, published in 1984, the new safety assessment includes significant endocrine disruption studies.

Additionally, the report features a 2001 CIR safety assessment for benzyl paraben, for which there previously was a lack of sufficient data, CIR said. The safety assessment reviewed benzyl alcohol and benzoic acid, substances which are metabolites of benzyl paraben, the panel noted.

Team leader James Marks, MD, Pennsylvania State University College of Medicine, noted while the panel originally was concerned benzyl paraben was an endocrine active chemical, the ingredient can "now be considered safe" based on "margins of safety calculations and adult and baby exposure" data.

CIR re-opened its review of parabens in June 2004 after a British study linked the substances to breast cancer (² (Also see "CIR Panel To Reopen Parabens Review To Consider New Data" - HBW Insight, 5 Jul, 2004.), p. 4). Since then, the ingredients have been subject to increasing scrutiny by consumer advocacy groups and regulatory agencies. In August, the National Toxicology Program Board of Scientific Counselors recommended toxicity tests be conducted on butyl paraben (³ (Also see "Butylparaben Toxicity Testing Recommended By NTP Board" - HBW Insight, 29 Aug, 2005.), p. 3).

Separately, a tentative amended final assessment also was issued for hair and skin care ingredient cocamidopropylamine oxide in rinse-off products, as well as for drometrizole, which is used in a limited number of formulas (see chart: " ⁴ Cosmetic Ingredient Review Report Status ").

In line with its re-review process, CIR decided to re-open a safety assessment on cosmetic ingredient cyclomethicone and its individual chain length polymers due to concerns over reproductive toxicity. The substance was identified as a candidate for re-review in 2001 (⁵ (Also see "CIR "Proactive" Approach To Seeking Controversial Ingredients Data Urged" - HBW Insight, 17 Sep, 2001.), p. 3). Cyclomethicone is a mixture of chain length polymers D3, D4, D5, D6 and D7, and is used as a spreading or wetting agent in hair and skin formulas.

Covered by a 1991 safety assessment, cyclomethicone became a candidate for re-review in part because its polymers D4, D5 and D6 are increasingly being used as individual ingredients in cosmetic products, the panel noted.

During the meeting, the Silicone Environmental Health and Safety Council presented papers on D4, D5 and D6, stressing to the panel that the ingredients should be evaluated for safety individually rather than as a group.

SEHSC rat studies on D4 found that while the ingredient was not mutagenic or genotoxic, it did show reproductive effects in female rats, as well as the growth of uterine tumors and enlarged liver. Rat studies on D5 revealed the polymer similarly caused an increase in liver weight and growth of uterine tumors, while studies on D6 found "no adverse" effects, SEHSC stated.

In addition to those papers, the group submitted to CIR 63 studies on D4, 21 studies on D5 and eight studies on D6. The panel noted it will summarize all available studies on the polymers for a future meeting.

CIR also decided to re-open a safety review of the combination of preservative ingredients methylisothiazaoline (MI) and methychloroisothiazolinone (MCI). The substances received a safety assessment in 1992.

Ingredient manufacturer Rohm and Haas requested CIR conduct an independent scientific review of MI, which the firm uses as the sole active ingredient in a new preservative, adding its individual use is increasing in cosmetics. Rohm and Haas is expected to provide CIR unpublished safety data.

The panel reaffirmed a safe as used ruling for the cetearyl alcohol group, which is used in hair dyes and moisturizers.

CIR also issued two final safety assessments during the meeting, including one for n-butyl alcohol, with an addendum incorporating the use of the substance in non-nail care products. Found to be safe as used in nail care formulas in 1987, n-butyl alcohol's safety report was re-opened in June so CIR could assess its safety in non nail-care uses (⁶ (Also see "CIR Reopens N-Butyl Alcohol Review To Address Non-Nail Uses" - HBW Insight, 20 Jun, 2005.), p. 3).

Tentative final reports were issued for ingredients 3-methylamino-4-nitrophenoxyethanol and HC red no. 7 for use in hair dye formulas. The reports will contain CIR's new hair dye epidemiology language (see ⁷ (Also see "CIR Revised Hair Dye Statement More “Accessible” To Public – Panel" - HBW Insight, 19 Dec, 2005.) ).

Nail care ingredients amyl and isoamyl acetate were tabled during the meeting while CIR awaits information from the American Chemistry Council, and cinnamal was tabled so the panel can collect data on the substance's uses.

At the request of FDA, CIR decided it will designate nail enhancement ingredient xylene a high-priority ingredient, but has not yet set a date for review.

- Eileen Francis