Safety Assessment of Carbonate Salts as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 6 carbonate salts which function as absorbents, bulking agents, opacifying agents, pH adjusters, buffering agents, abrasives, and oral care agents in cosmetic products. The Panel reviewed relevant data relating to the safety of these ingredients, and concluded that these carbonate salts are safe in the present practices of use and concentration in cosmetics when formulated to be non-irritating.

Quantitative human health risk assessment along the lifecycle of nano-scale copper-based wood preservatives.

The use of nano-scale copper oxide (CuO) and basic copper carbonate (Cu2(OH)2CO3) in both ionic and micronized wood preservatives has raised concerns about the potential of these substances to cause adverse humans health effects. To address these concerns, we performed quantitative (probabilistic) human health risk assessment (HHRA) along the lifecycles of these formulations used in antibacterial and antifungal wood coatings and impregnations by means of the EU FP7 SUN project's Decision Support System (SUNDS, www.sunds.gd). The results from the risk analysis revealed inhalation risks from CuO in exposure scenarios involving workers handling dry powders and performing sanding operations as well as potential ingestion risks for children exposed to nano Cu2(OH)2CO3 in a scenario involving hand-to-mouth transfer of the substance released from impregnated wood. There are, however, substantial uncertainties in these results, so some of the identified risks may stem from the safety margin of extrapolation to fill data gaps and might be resolved by additional testing. Our stochastic approach successfully communicated the contribution of different sources of uncertainty in the risk assessment. The main source of uncertainty was the extrapolation from short to long-term exposure, which was necessary due to the lack of (sub)chronic in vivo studies with CuO and Cu2(OH)2CO3. Considerable uncertainties also stemmed from the use of default inter- and intra-species extrapolation factors.

Clinical use of NISR 440 polycarbonate membrane for hemodialysis.

1. In order to accredit the NISR440 Polycarbonate Membrane for clinical studies, the following was accomplished and/or established: a. Casting and synthesis were increased from the laboratory level to production scale. b. Quality control of permeabilities and physical properties was within +/- 5%, from membrane lot to lot and within the same roll. c. The target properties of the Artificial Kidney Program (NIH) were reached(7): 1) Middle M. W. solute permeability of marked molecules was established by 3 different laboratories and averaged: Vitamin B12 - 296 x Cuprophan¿; Inulin 3.6 x Cuprophan¿; Bacitracin 2.94 x Cuprophan¿. 2) Low M. W. species permeabilities were approximately the same as Cuprophan¿, to avoid a depletion syndrome. 3) Hydraulic permeability was essentially the same as Cuprophan¿ (UF rate 1.25 to 2.0 x Cuprophan¿) to avoid dehydration and hypotension. 4) Burst strength was 1.5 to 2.0 x Cuprophan¿. d. Toxicology studies were all negative in spot and in serial lot testing. e. Non-thrombogenicity tests (Lindholm test) were up to 36.6% better than Cuprophan¿. f. No protein adsorption was found. g. The membrane could be produced in the wet and dry state with the same permeability and physical properties. 2. In an earlier clinical study at USC, it was established that: a. There were no toxic effects manifested in patients in 25 episodic studies. b. Clearances forlow M. W. solutes and hydraulic permeabilities were, as targeted, approximately the same as Cuprophan¿. c. In 4 1/2 mos of a double blind study of 6 patients, no significant toxic effects were noted for either the patients on Cuprophan¿ or NISR 440 Polycarbonate Membrane. Two patients had an increase of hematocrit. 3. The ability to heat seal the membrane in the periphery and in channels through many layers, combined with its relative rigidity when wet, make possible clinical hemodialyzer designs approximately the size of a package of cigarettes and inexpensive to produce.