Low MW Polyester Manufactured from Allowable Reactants Not applicable The notified polymer meets the PLC criteria. PHYSICAL AND CHEMICAL PROPERTIES Appearance at 20 °C and 101.3 kPa Cream Paste Not determined Density 850 kg/m3 at 20 °C Water Solubility 0.05 g/L at 23 °C. In-house methods. The solubility was evaluated by observation of the presence of little particles after the notified polymer was homogenised with water at different concentrations. Reactivity Stable under normal environmental conditions Degradation Products None under normal conditions of use INTRODUCTION AND USE INFORMATION Maximum Introduction Volume of Notified Chemical (100%) Over Next 5 Years Year 1 2 3 4 5 Tonnes < 10 < 10 < 10 < 10 < 10 Use The notified polymer is a film forming ingredient, binder and viscosity increasing agent used in cosmetic products (including spray products) such as lipsticks, mascaras and foundations. The notified polymer will be imported into Australia as the raw material or as a component of finished cosmetic products. The finished cosmetic products will contain up to 15% notified polymer. HUMAN HEALTH RISK ASSESSMENT The notified polymer meets the PLC criteria and is therefore assumed to be of low hazard. This is supported by tests submitted on the following toxicological endpoints. Endpoint Result Effects Test Guideline Observed? 1. Rat, acute oral LD50 > 2000 mg/kg no OECD TG 420 bw; low toxicity 2. Rat, acute dermal LD50 > 2000 mg/kg no OECD TG 402 bw; low toxicity 3. Rabbit, skin irritation slightly irritating yes OECD TG 404 4. Rabbit, eye irritation slightly irritating yes OECD TG 405 5. Skin sensitisation LLNA. no evidence of no OECD TG 429 – sensitisation at up to 50% concentration. 6. Genotoxicity bacterial non mutagenic no OECD TG 471 472 – – reverse mutation 7. Genotoxicity in vitro non genotoxic no OECD TG 487 – L5178Y TK+/- mouse lymphoma cells All results were indicative of low hazard. Some slight skin and eye irritation was noted but was not sufficient for classification.
Low MW Polyester Manufactured from Allowable Reactants Not applicable The notified polymer meets the PLC criteria. PHYSICAL AND CHEMICAL PROPERTIES Appearance at 20 °C and 101.3 kPa Cream Paste Not determined Density 850 kg/m3 at 20 °C Water Solubility 0.05 g/L at 23 °C. In-house methods. The solubility was evaluated by observation of the presence of little particles after the notified polymer was homogenised with water at different concentrations. Reactivity Stable under normal environmental conditions Degradation Products None under normal conditions of use INTRODUCTION AND USE INFORMATION Maximum Introduction Volume of Notified Chemical (100%) Over Next 5 Years Year 1 2 3 4 5 Tonnes < 10 < 10 < 10 < 10 < 10 Use The notified polymer is a film forming ingredient, binder and viscosity increasing agent used in cosmetic products (including spray products) such as lipsticks, mascaras and foundations. The notified polymer will be imported into Australia as the raw material or as a component of finished cosmetic products. The finished cosmetic products will contain up to 15% notified polymer. HUMAN HEALTH RISK ASSESSMENT The notified polymer meets the PLC criteria and is therefore assumed to be of low hazard. This is supported by tests submitted on the following toxicological endpoints. Endpoint Result Effects Observed? Test Guideline 1. Rat, acute oral LD50 > 2000 mg/kg bw; low toxicity no OECD TG 420 2. Rat, acute dermal LD50 > 2000 mg/kg bw; low toxicity no OECD TG 402 3. Rabbit, skin irritation slightly irritating yes OECD TG 404 4. Rabbit, eye irritation slightly irritating yes OECD TG 405 5. Skin sensitisation – LLNA. no evidence of sensitisation at up to 50% concentration. no OECD TG 429 6. Genotoxicity – bacterial reverse mutation non mutagenic no OECD TG 471 – 472 7. Genotoxicity – in vitro L5178Y TK+/- mouse lymphoma cells non genotoxic no OECD TG 487 All results were indicative of low hazard. Some slight skin and eye irritation was noted but was not sufficient for classification.
PLC1141-FR-Final.docx