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Expert opinion

Addendum to the Opinion on the use as preservative o-Phenylphenol, Sodium o-phenylphenate and Potassium o-phenylphenate ref. SCCS/1555/15

Final Opinion

Details

Publication date
22 February 2018
Author
Scientific Committee on Consumer Safety (SCCS)

Description

WG on Cosmetic Ingredients
SCCS members: U. Bernauer (Rapporteur), L. Bodin, Q. Chaudhry, P. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, E. Panteri, V. Rogiers, C. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven
Contact:SANTE-C2-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1597/18
Adopted on: 21-22 February 2018

Conclusion of the opinion:

1. Does SCCS consider Sodium o-phenylphenate, Potassium o-phenylphenate and MEA o-Phenylphenate safe at the current use as preservatives with a maximum concentration of 0.2 % (as phenol)?

Due to the lack of relevant information, the SCCS is unable to answer the question on the safe use level of sodium-OPP, potassium-OPP and MEA-OPP. In SCCS view, a direct comparison between the safety of o-phenylphenate (OPP) and its 3 compounds cannot be made due to the following concerns:

• From the limited available information, it is clear that both sodium and potassium salts of OPP have much higher water solubility than OPP (no information available on MEAOPP). This can potentially alter their absorption and biokinetics, compared to OPP.

• From the available information, the SCCS has noted that, compared to the strongly skin irritating nature of OPP, both sodium OPP and potassium-OPP are corrosive to the skin, and sodium OPP is also corrosive to the eye. This indicates that both sodium and potassium salts of OPP may have greater skin penetration and potentially more potent toxic effects than OPP due to higher systemic exposure. No relevant information on skin irritation is available for MEA-OPP but the presence of monoethyleneamine (MEA) moiety can also be expected to alter the skin absorption and biokinetics of MEA-OPP compared to OPP, and as a consequence also systemic exposure. For OPP, the SCCS has derived dermal absorption value of 45% from toxicokinetic information. However, such information is not available for sodium-OPP, potassium-OPP or MEA-OPP, and data would be needed to allow drawing any comparisons from the safe use levels of OPP.

• The available in vivo studies in rat have also indicated that the adverse effects of OPP and its sodium salt are different. For the sodium salt, there is clear indication that the substance is more potent with respect to urinary bladder carcinoma and data point to mechanistic differences between OPP and SOPP. Amongst other factors, SOPP leads to higher sodium concentrations in urine and also to higher urinary pH. There is insufficient dose-response data available to draw a conclusion on the possibility of setting a threshold for sodium-OPP induced toxicity. The currently available data are also not sufficient to exclude such a possibility for the other two compounds (potassium-OPP and MEA-OPP). Long-term repeat dose studies have pointed out to a threshold between 35 and 40 mg/kg bw/d for OPP, but due to the lack of dose-response data, a threshold for sodium-OPP, potassium-OPP or MEA-OPP cannot be derived.

2. Does the SCCS consider that the same conclusion for OPP, as reported in SCCS/1555/15, may also be applied to Sodium o-phenylphenate, Potassium ophenylphenate and MEA o-Phenylphenate concerning the proposed maximum use concentration (i.e. 0.15% in leave-on and 0.2% in rinse-off cosmetic products as preservatives)?

For the reasons given above, the SCCS considers that the same conclusions on the safe use levels of OPP cannot be applied as such to sodium-OPP, potassium-OPP or MEA-OPP for use in rinse-off and leave-on cosmetic products.

Based on the available information, the SCCS is of the opinion that a potential risk to human health from the use of sodium-OPP and potassium-OPP as preservatives in cosmetic products cannot be excluded.

Although the safety of MEA-OPP was not evaluated in the Opinion SCCS/1555/15, the SCCS has a similar view that a potential risk from its use as preservative in cosmetic products cannot be excluded in the absence of relevant data.

Keywords:

SCCS, scientific opinion, preservative, Sodium o-phenylphenate, Potassium ophenylphenate, MEA o-Phenylphenate, Regulation 1223/2009, CAS n. 132-27-4, 13707-65- 8, 84145-04-0

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Addendum to the scientific opinion on the use as preservative of o-Phenylphenol, Sodium ophenylphenate and Potassium o-phenylphenate- Here: the use as preservative of Sodium o-phenylphenate, Potassium o-phenylphenate, MEA o-Phenylphenate 21- 22/02/2018, SCCS/1597/18.

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