### 2-Amino-2-methyl-1-propanol (AMP) Mammalian Toxicology Summary (CAS=124-68-5) 2-Amino-2-Methyl-1-Propanol (AMPTM) Tox 124-68-5

23-May-12 Linda Troester Physical Properties pH for 1% aqueous solution of AMP base: 11.3 Considered combustible liquid down to 90% AMP; 10% water solution flash pt : 85.6C (186.1F) Log Pow: -0.63 Vapor Pressure: 0.34 mm Hg @ 20C
Environmental Toxicology Aquatic Toxicity Material is practically non-toxic to aquatic organisms on an acute basis (LC50/EC50/EL50/LL50 >100 mg/L in the most sensitive species tested). May increase pH of aquatic systems to > pH 10 which may be toxic to aquatic organisms. Persistance & Biodegradability Material is readily biodegradable. Passes OECD test(s) for ready biodegradability. OECD-301F Test: 89.3% biodegraded in 28-days. Bioconcentration Bioconcentration potential is low (BCF < 100 or Log Pow < 3). Bioconcentration Factor = < 1; fish; Measured. Mobility in Soil Potential for mobility in soil is very high (Koc between 0 and 50). Koc = 18 Estimated. Henry's Law Constant 6.82E-08 atm*m3/mole; 25 °C Estimated. This value indicates a low tendency to volatilize from water solution.
Mammalian Toxicology Acute Oral Toxicity Moderate toxicity if swallowed. Swallowing may result in irritation or burns of the mouth, throat, and gastrointestinal tract. LD 50, Rat, 2900 mg/kg LD 50, Mouse 2150 mg/kg Eye Irritation Eye irritation tests indicated that AMP is a severe eye irritant. When tested by the Draize method in rabbits, undiluted test material produced a Draize index score of 110. Additional tests, also with undiluted material, using a 30 second application followed by a 30 second wash produced a score of 89.3; and a test with a 15 second application and a 30 second wash produced a score of 69.3. Skin Irritation Skin irritation and corrosivity tests were conducted on a sample of an AMP product containing approximately 5% water. In these tests, AMP was classified as a severe irritant (score 6.37) in the Draize test on rabbits. In a skin corrosion test conducted according to the Department of Transportation (D.O.T.) Test with a 4-hour exposure, 49 CFR 173.240, AMP was found to be "non-corrosive." Date: 9/7/2012 Page: 1

### 2-Amino-2-methyl-1-propanol (AMP) Mammalian Toxicology Summary (CAS=124-68-5)

Skin Sensitization Samples of AMP did not cause allergic skin reactions when tested in guinea pigs. AMP was determined to be a nonsensitizer in a topical sensitization test in guinea pigs (Buehler Delayed Contact Hypersensitivity Method) and it was considered to be a nonsensitizer in an intradermal sensitization test in guinea pigs (Landsteiner and Jacobs Method). Skin Absorption Prolonged skin contact is unlikely to result in absorption of harmful amounts. LD50, Rabbit >2000 mg'kg Inhalation At room temperature, exposure to vapor is minimal due to low volatility. There is a no available data specifically for acute lethality of inhaled AMP. However, studies of the potential irritant characteristics of inhaled AMP have been undertaken using the ATSM E981 sensory irritation methodology. Restrained mice were head-only exposed up to 1160 mg/m3 aerosolized AMP for 3 hours followed by a 20 minute recovery period. No deaths were recorded but sensory and pulmonary irritation was noted. Also, there is acute inhalation toxicity information available for a relatively close analogue of AMP, monoisopropanolamine, where exposure of rats in mutiple studies to saturated atmospheres of monoisopropanolamine did not result in any mortality within the 14 day observation periods. Repeated Dose Toxicity Oral repeated-dose mammalian toxicity studies have been conducted on AMP using a variety of study designs in several species of test animals. The duration of studies ranged from four weeks to one year in rats, rabbits, mice and dogs, and the findings were relatively consistent across species. No in-life observations have been reported that would indicate systemic toxicity and food consumption and body weights have been unaffected by treatment. The most consistent findings were changes in liver weights, liver histopathologic changes, and associated changes in clinical chemistry parameters. Developmental Toxicity In a screening study in rats, AMP hydrochloride salt was toxic to the fetus when administered at high oral doses. However, this material did not cause birth defects or any other effects on the fetus when high doses were administered dermally, the most likely route of exposure, in a definitive rat developmental toxicity study. Reproductive Toxicology In animal studies, did not interfere with reproduction. Genetic Toxicology Carcinogenicity No specific bioassay for potential AMP carcinogenic activity has been conducted. Data from a one-year dog study and a variety of genotoxicity assays; however, have indicated no evidence suggestive of a carcinogenic potential of AMP. In addition, a number of repeated dose toxicity studies of AMP in rats and dogs have produced no evidence of preneoplastic lesions. These data suggest that AMP is not likely to pose a carcinogenic hazard.
Pharmacokinetics AMP is slowly dermally absorbed and quickly eliminated unchanged principally in the urine. In vitro genetic toxicity studies were negative. Animal genetic toxicity studies were negative.

Date: 9/7/2012 Page: 2

### 2-Amino-2-methyl-1-propanol (AMP) Mammalian Toxicology Summary (CAS=124-68-5)
Other The Cosmetic Ingredient Review (CIR) group reviewed the data on 2-Amino-2-methyl-1-propanol for use in the preparation of a technical publication entitled "Final Report on the Safety of Aminomethylpropanol and Aminomethylpropanediol" published in the Journal of the American College of Toxicology 9:203-228, 1990. This report also includes data on various formulations containing 2-Amino-2-methyl-1-propanol in small amounts. The Cosmetics Ingredients Review Board (CIR) is a scientific review board of the USA organization which used to be called the Cosmetics, Toiletries and Fragrances Association (CTFA), and is now known as the Personal Care Products Council (PCPC). Since the publication of the CIR technical review in 1990, a few studies have been conducted with some confirming and additional data. ANGUS provided these additional data to CIR, and the complete data package was reviewed again in June, 2007, and an updated "Final Amended Report on Safety Assessment on Aminomethyl Propanol and Aminomethyl Propanediol" was published in the International Journal of Toxicology (2009): 28 (Suppl. 2); 141S - 161S. Burnett, CL et al. This journal article is also covered by copyright. More detailed information and data is available from the Cosmetic Ingredient Review, 1101 17th Street, NW, Suite 412, Washington, DC 20036-4702, TEL: 202-331- Note Please refer to the product SDS for physical properties and hazard information on specific AMP products.

Date: 9/7/2012 Page: 3