None IDENTITY OF CHEMICAL GlucoTain Care (product containing the notified chemical at ~40% concentration) GlucoPure Foam (product containing the notified chemical at ~40% concentration) CAS 1591783-13-9 D-glucitol, 1-deoxy-1-(methylamino)-, N-coco acyl derivs. Cocoyl Methyl Glucamide (INCI Name) Unspecified 321.4 to 461.7 Da Reference NMR, IR and UV-Vis spectra were provided COMPOSITION > 75% PHYSICAL AND CHEMICAL PROPERTIES Appearance at 20 ºC and 101.3 kPa: white waxy solid Property Value Data Source/Justification Melting Point 70 – 71 °C Measured Boiling Point Decomposes without boiling Measured Density 1,110 kg/m3 at 20 °C Measured Vapour Pressure < 1 × 10-4 kPa at up to 110 °C Measured Water Solubility 0.061 ± 0.015 g/L at pH 6.13 at 20 °C 0.049 ± 0.012 g/L at pH 6.13 at 20 °C (active content) Measured Fat (or n-octanol) Solubility 47 g/L at 20 °C Measured Hydrolysis as a Function of pH Not determined Contains no hydrolysable functionalities Partition Coefficient (n-octanol/water) log Pow = 2.90 at pH 6.13 at 20 °C Calculated from measured solubilities in n-octanol and water; expected to partition to phase boundaries based on surfactant properties Surface Tension 32.9 mN/m at 20 °C Measured. The notified chemical is surface active Adsorption/Desorption Not determined Expected to adsorb strongly to soil and sediment based on surfactant properties
Group Number and Sex of Animals Dose (mg/kg bw) Mortality 1 5 M 2,000 0/5 2 5 F 2,000 0/5 LD50 > 2,000 mg/kg bw Signs of Toxicity - Local Irritation signs including erythema, oedema, desquamation and crust were observed in test animals. All signs were reversible within the observation period. Signs of Toxicity - Systemic No treatment-related effects were observed. Effects in Organs No treatment-related effects were observed. Remarks - Results Under the conditions of the test, the notified chemical was not associated with mortality and signs of systemic toxicity, although local irritation effects were recorded. The notified chemical is of low toxicity via the dermal route. BSL (2015b) Irritation – skin (in vitro) Notified chemical OECD TG 439 In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method EC Commission Regulation No 640/2012 B.46. In Skin Irritation: - Reconstructed Human Epidermis Test Method Vehicle Distilled Remarks - Method No significant deviation of the protocol was noted. The Model™ (EPISKIN-SM™), a reconstituted three-dimensional human epidermis model, was used in the test. The purity of the test substance was reported as 81%. Test material Mean of triplicate tissues Relative mean Viability (%) SD of relative mean viability Negative control 0.814 100 5.0 Test substance 0.660 81.1 8.5 Positive control 0.062 7.6 5.8 OD = optical density; SD = standard deviation Remarks - Results The relative mean tissue viability after 15 minutes of exposure and 42 hours post incubation was > 50%. The notified chemical was a non-irritant under the conditions of the test. BSL Irritation – eye (in Notified chemical OECD TG 437 Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants Vehicle Physiological saline (0.9% sodium chloride in water) Remarks - Method No significant deviation of the protocol was noted. The purity of the test substance was reported as 81%.