SUMMARY The following details will be published in the NICNAS Chemical Gazette: ASSESSMENT REFERENCE APPLICANT(S) CHEMICAL OR NAME HAZARDOUS INTRODUCTION VOLUME USE STD/1473 and STD/1474 Ecolab Pty Ltd Component 1 in O3270 and Component 2 in No STD/1473: ≤125 tonnes per annum STD/1474: ≤125 tonnes per annum Component of a scale inhibitor CONCLUSIONS AND REGULATORY OBLIGATIONS Hazard classification on the available information, the notified chemicals are not recommended for classification according to the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS), as adopted for industrial chemicals in Australia, or the Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004). The environmental hazard classification according to the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS) is presented below. Environmental classification under the GHS is not mandated in Australia and carries no legal status but is presented for information purposes. Hazard classification Hazard statement Category 3 H402 - Harmful to aquatic life Chronic Category 3 H411 - Harmful to aquatic life with long lasting effects Human health risk assessment Under the conditions of the occupational settings described, the notified chemicals are not considered to pose an unreasonable risk to the health of workers. When used in the proposed manner, the notified chemicals are not considered to pose an unreasonable risk to public health. Environmental risk assessment On the basis of the marine PEC/PNEC ratio and the assessed use pattern, the notified chemicals are not considered to pose an unreasonable risk to the environment. Recommendations Occupational Health and Safety If products and mixtures containing the notified chemicals are classified as hazardous to health in accordance with the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS) as adopted for industrial chemicals in Australia, workplace practices and control procedures consistent with provisions of State and Territory hazardous substances legislation should be in operation. Environment Disposal
The inseparable mixture of the notified chemicals was not corrosive or a severe eye irritant under the conditions of the test. Harlan Irritation – eye Inseparable mixture of the notified chemicals OECD TG 405 Acute Eye Irritation/Corrosion Species/Strain Rabbit/New Zealand White (Hsdlf) Number of Animals 3 Observation Period 72 hours Remarks - Method No significant protocol deviations. Lesion Mean Score* Animal No. Maximum Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Conjunctiva: redness 1.0 0.3 0.3 2 <72 0 Conjunctiva: chemosis 0.3 0 0.3 2 <48 hours 0 Conjunctiva: discharge 0 0 0 1 <24 hours 0 Corneal opacity 0 0 0 0 - 0 Iridial inflammation 0 0 0 0 - 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. The inseparable mixture of the notified chemicals is slightly irritating to the eye. Harlan (2012i) Skin sensitisation – mouse local lymph node assay (LLNA) Inseparable mixture of the notified chemicals OECD TG 429 Skin Sensitisation: Local Lymph Node Assay Species/Strain Mouse/CBA/Ca Vehicle 1% pluronic L92 in distilled Remarks - Method The highest tested concentration of 10% was noted as being the maximum attainable concentration that was suitable for dosing, although it was not stated whether this was due to solubility or homogeneity. This concentration did not produce systemic toxicity or excessive local irritation in a preliminary screening test. Concentration (% w/w) Proliferative response (DPM/animal) Stimulation Index (Test/Control Ratio) Test Substance 0 (vehicle control) 1177 443 1.00 2.5 1811 487 1.54 5 1179 457 1.00 10 1194 308 1.01 Positive Control (HCA) 85 10957 2949 9.31 Data presented as mean standard deviation HCA, hexylcinnamaldehyde
indicated that the test substance was algistatic in effect. All the test guideline validity criteria were met. The notified chemicals are harmful to freshwater alga Harlan (2013d) Algal growth inhibition test The inseparable mixture of the notified chemicals ISO 1995 – Quality Marine Algal Growth Inhibition Test With Skeletonema costatum and Phaeodactylum tricornutum, ISO 10253 standard method Species Skeletonema costatum Exposure Period 72 hours Concentration Range Nominal: Control, 10, 50, 250 and 1000 mg/L Actual: Not determined Auxiliary Solvent None Water Hardness Not provided Analytical Monitoring N/A Remarks - Method Following a preliminary test, the definitive test was conducted by exposing algae in the test medium at the above nominal concentrations. GLP standards were followed. Growth Biomass ErC50 NOEC NOEC mg/L at 72 h mg/L mg/L at 72 h mg/L 672 250 N/A N/A Remarks - Results All the test guideline validity criteria were met. The notified chemicals are not harmful to marine algae AnalyCen (2009) Inhibition of microbial activity The inseparable mixture of the notified chemicals OECD TG 209 Activated Sludge, Respiration Inhibition Test. EC Directive 88/302/EEC C.11 Biodegradation: Activated Sludge Respiration Inhibition Test. Inoculum Activated sewage sludge Exposure Period 3 Concentration Range Nominal: 10, 100, 1000 mg/L Actual: Not determined Remarks – Method The test was conducted at 10 – 1000 mg/L. Three replicates were established for the top test concentration of 1000 mg/L. 3,5-Dichlorophenol was used for the reference test. The test was conducted according to the test guidelines above with no significant deviation from the protocol. GLP standards were followed. IC50 > 1000 mg/L NOEC 1000 mg/L Remarks – Results All the test guideline validity criteria were met.