Hazardous impurities: Chemical name : Methanol (ND) CAS number 67-56-1 Weight % < 0.1 Hazardous properties Based on the HCIS this chemical has the following classification: Acute toxicity, oral (Category 3) H301 - Toxic if swallowed Acute toxicity, dermal (Category 3) H311 - Toxic in contact with skin Acute toxicity, inhalation (Category 3) H331 - Toxic if inhaled Specific target organ toxicity (single exposure) (Category 1) H370 - Causes damage to organs Other impurities (≥ 1% by weight) Weight % Chemical name Glucamide 24 (ND) E-4194.01 Range SN 134/13 N-methylglucamine (CAS number: 6284-40-8) < 4 1.4 2 Fatty acid methyl ester (CAS number unknown) < 1 < 0.1 1 Fatty acid (CAS number unknown) < 8 1.5 - Ester amides (CAS number unknown) - - 1 Propylene glycol (CAS number unknown) < 2 0.4 - Water (CAS number: 7732-18-5) < 3 0.8 - Sodium soap (CAS number unknown) - - 3 Unknown constituents (CAS number unknown) < 2 1.9 - 2.3 Physical and chemical properties The physical and chemical data for the notified chemical (E-4194.01) assessed by NICNAS in the new chemical assessment report (NICNAS, 2000) are shown in the table below with
Direct dermal exposure Cosmetic products Product type Use Amount (mg/day) C (%) RF DA (%) Daily Systemic Exposure (mg/kg bw/day) Facial cleanser 800 7 0.01 10 0.0009 Shampoo 10,460 7 0.01 10 0.0114 Conditioner 3,920 7 0.01 10 0.0043 Shower gel 18,670 7 0.01 10 0.0204 Hand wash soap 20,000 7 0.01 10 0.0219 Total 0.0589 Daily systemic exposure = (Use amount × C × RF × DA)/BW, where C = use concentration, RF = retention factor, DA = dermal absorption rate, BW = average bodyweight Household cleaning products Product type Frequency (use/day) C (%) Contact Area (cm2) Product Use C (g/cm3) Film (cm) Time Scale Factor DA (%) Daily systemic exposure (mg/kg bw/day) Laundry liquid 1.43 12 1980 0.01 0.01 0.007 10 0.0004 Dishwashing liquid 3 12 1980 0.009 0.01 0.03 10 0.0030 All-purpose cleaner 1 12 1980 1 0.01 0.007 10 0.0260 Total 0.0294 Daily systemic exposure = (frequency × C × contact area × product use C × film thickness × time scale factor × DA)/BW, where C = concentration, DA = dermal absorption rate, BW = average bodyweight Indirect dermal exposure (from wearing clothes) Household cleaning products Product type Amount (g/use) C (%) PR (%) PT (%) DA (%) Daily systemic exposure (mg/kg bw/day) Laundry liquid 230 12 0.95 10 10 0.0410
C.2.3 Chronic toxicity to fish Test Substance Notified chemical (44.7% purity) Method US EPA TSCA – 40CFR 797-1600 (1987) – Protocol For Conducting an Early Stage Toxicity Test with Fathead Minnow (Pimephales promelas) Species Pimephales promelas (fathead minnow) Exposure period 35 days Auxiliary solvent None Water hardness 24–56 mg CaCO3/L Analytical monitoring HPLC Remarks - Method No significant protocol deviations. A preliminary range finding test resulted in 0% survival after 13 days of exposure to 10 mg/L. The definitive test involved 35 days of continuous exposure, which included a 5 day hatching period and a 30 day period. Results Concentration (mg/L) Number of embryos % Embryo hatching success % Larval survival at termination Nominal Actual* Control Control 60 81 98 0.63 0.69 60 78 94 1.3 1.5 60 88 95 2.5 2.5 60 80 94 5.0 4.8 60 89 93 10.0 10.0 60 0 0 * Mean measured concentrations LOEC 10 mg/L at 35 days NOEC 4.8. mg/L at 35 days Remarks - Results At 10 mg/L of the test substance, no animals survived the hatching period. Those organisms exposed to concentrations of the test substance at a nominal concentration of 5 mg/L (measured 4.8 mg/L) and below had a survival rate of 93 to 95