2014-09-18_GENERAL DOCUMENTS - M1977493

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MATERIAL SAFETY DATA SHEET Product Name: TERGITOL(TM) NP-4 SURFACTANT Effective Date: 02/10/2003 MSDS#: 1918 Page 9 of 17 IRRITATION Skin: Rabbit; unoccluded contact; 0.01 Results: minimal capillary dilatation at 24 hr Eye: Rabbit; 0.005 ml; undiluted Results: severe corneal injury (chemical burns)within 24 hr, healing by 7 days Eye: Rabbit; 0.5 ml; 15% in water Results: moderate corneal injury (chemical burns) Eye: Rabbit; 0.5 ml; 40% in water Results: severe corneal injury (chemical burns)within 24 hr, healing by 7 days SIGNIFICANT DATA WITH POSSIBLE RELEVANCE TO HUMANS In two-year feeding studies, the 4-mole ethoxylate of nonylphenol (NPE4) at doses of 200 mg/kg/day or 40 mg/kg/day in rats and dogs, respectively, produced no significant effects. The 9-mole ethoxylate (NPE9) at doses of 140 or 30 mg/kg/day in the diet of rats or dogs, respectively, produced no adverse effects. Parameters evaluated included body and organ weights and histopathology of 28 tissues. A dose of 1000 mg/kg/day of NPE9 resulted in reduced body weights and enlarged livers in rats and reduced weight, emesis, and minimal blood changes in dogs. A dose of 88 mg/kg/day NPE9 produced increased liver to body weight ratios in dogs which was attributed to decreased food consumption. Rats fed dietary concentrations of a related alkylphenol ethoxylate, the 40-mole ethoxylate of octylphenol (OPE40), up to 14000 ppm (700 mg/kg/day)for two years showed no adverse effects on growth or survival, feed consumption, hematologic values, urine measurements, organ weights or histopathologic lesions. Alkylphenol Ethoxylate Toxicity: In studies with rabbits, sustained occluded skin contact of some undiluted surfactants caused inflammatory changes in the lung. This material can cause lung injury if deposited as a liquid directly into the lung. Some deaths have occurred in rats exposed to high aerosol concentrations of this material for 4 hours. However, there were no histopathological findings in the lungs of rats that died, suggesting that the deaths were not caused by chemical toxicity, but likely related to some non-specific physical cause such as suffocation. Developmental effects including extra ribs and other skeletal variations were observed in the fetuses of rats treated with maternally toxic levels of a 9-mole ethoxylate of octylphenol, or a 4-mole or 9-mole ethoxylate of nonylphenol. The significance of these findings to humans is unclear as several human studies did not show any association of congenital effects in children and maternal exposure to spermicides containing octyl or nonylphenol ethoxylates. Alkylphenol Toxicity: Several studies with nonylphenol have resulted in slightly increased kidney weights in male rats continuously exposed to dietary concentrations of 200 ppm or greater (approximately >10 mg/kg/body weight/day). No histological lesions of the kidney were observed in one study but histopathological lesions, primarily tubule mineralization, were observed at 2000 ppm in one study and in a dose-related manner at concentrations >=200 ppm in a third study. These results indicate that continuous exposure to high concentrations of nonylphenol may be toxic to the kidney. While nonylphenol has been shown to bind to the estrogen receptor and to have weak estrogen mimetic activity in several in vitro and in vivo screening assays, treatment of rats at dietary concentrations of nonylphenol up to 2000 ppm in