2021-02-05_PERMIT FILE - M2021007

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AEROSOL®OT-75%Surfactant SDS: 0000006 Date Prepared: 07/23/2014 Page 6 of 11 ACUTE TOXICITY DATA oral rat Acute LD50 >2000 mg/kg dermal rabbit Acute LD50 >2000 mg/kg inhalation rat Acute LC50 4 hr >20 mg/I (Vapors) LOCAL EFFECTS ON SKIN AND EYE Acute Irritation skin Irritating Acute Irritation eye Causes serious damage ALLERGIC SENSITIZATION Sensitization skin Not sensitizing Sensitization inhalation Not sensitizing GENOTOXICITY Assays for Gene Mutations Ames Salmonella Assay No data OTHER INFORMATION The product toxicity information above has been estimated. HAZARDOUS INGREDIENT TOXICITY DATA Sodium dioctyl sulfosuccinate(DSS) has an average oral (rat) LD50 >2000 mg/kg based on multiple test values. The dermal (rabbit) LD50 is>10 g/kg. DSS has caused skin and eye irritation in animals, to varying extents, depending on the formulation of the tested material (e.g. solid vs. solution), the tested concentration, and the exposure duration. Following 24-hour dermal application (rabbits)of 8- 10 g/kg solid DSS, the only effect observed was mild erythema. In other rabbit skin irritation tests, the primary irritation score for 100% DSS was-4 and that for 80% DSS with propylene glycol was-3, both resulting in a moderate irritant classification. In another study, a volume of 0.5 mL Docusate sodium (70% solution in ethanol/methanol and water)was applied on 6 cm2 shaved skin of 3 male rabbits by occlusive application. After this period, the skin area was washed with warm water and observed after 1, 24, 48, 72 hours and 6, 8, 10 and 14 days. The results showed that there was an irritation index of 7.8/8 over the 1 -72 hour period and some effects were still visible at 14 days. In rabbits, a concentration of 1%was the lowest reported effective dose necessary to produce slight dermal erythema and at concentrations from 5-25% moderate dermal irritation occurred. Solid DSS applied to the eyes of rabbits produced moderate irritation. Mild eye irritation in rabbits occurred following treatment with concentrations between 0.1 and 0.5% DSS. In one study, a volume of 0.1 mL Docusate sodium (mixture of 70% docusate sodium, ethanol in methanol, water)was applied to the eyes of 3 male rabbits.After 72 hours, fluorescein solution was applied for cornea evaluation and rinsing was performed with warm physiological solution. Evaluation after 1, 24, 48 and 72 hours and 6, 8, 10, 13, 17 and 21 days after application showed severe eye irritation and irreversible damage(including turbidity of the cornea). The mean overall irritation score for 1 -72 hours was 46,67/110. Humans appear to be less sensitive to DSS for skin irritation. In humans, a concentration of 1%was the highest no-effect level observed for skin irritation following a 24-hr patch test. In a modified Draize-Shelanski repeat-insult patch test, DSS showed little evidence of irritation and no evidence of eliciting an allergic response in human subjects. Results from a 90-day subacute oral diet (rat) study indicate a NOEL of 0.94 g/kg/day and results from a 6-month subchronic oral diet(rat) study indicate a LOEL of 0.87 g/kg/day. No indication of significant gross or microscopic adverse effects were reported. This material was not mutagenic in the Ames Assay. Chronic toxicity studies in rats (2-yr) and dogs (1-yr) also reported no significant adverse effects at the doses administered. No adverse effect on reproductive function or fetal development were observed in rats treated with DSS at 0.5 and 1.0%doses, which were not maternally toxic.