NICNAS: IMAP Framework Attachment A—Example 1: Placing a chemical in the Tier I human health matrix assessment and prioritisation Chemical 1 Exposure Information There is no Australian use and volume information available for the chemical, therefore default and/or surrogate information is used. The chemical has reported (international) site-limited use as a chemical reactant used to manufacture products and is in commercial use as a lubricant and grease additive. A default value of 100 tonnes is allocated for volume (imported or manufactured in a year). Matrix: Allocating an Exposure band Derivation of use multiplier The chemical has (international) identified commercial and site-limited uses. Therefore the use multipliers of 0.01 and 0.001 are applicable for the chemical. As the chemical fits into more than one use category, the highest multiplier (0.01) is used to calculate the exposure score. Calculating the exposure score volume × use multiplier = exposure score. The default volume of 100 tonnes is used and, as the chemical fits into more than one use category, the highest use multiplier (0.01) is used to calculate the exposure score. Therefore the exposure score for the chemical is calculated as 100[tonnes] x 0.01 = 1 Exposure band Based on the exposure score of 1 the chemical is assigned into Exposure band 2. Hazard Information Empirical hazard data, obtained from the OECD QSAR Toolbox, indicated that the chemical is a skin sensitiser. Matrix: Allocating a Hazard band Hazard indicator criteria (see Table 3) for Hazard band 2 (skin sensitiser) was met, therefore the chemical is assigned to Hazard band 2. Matrix outcome Based on the position in the matrix—Exposure Band 2; Hazard Band 2 (see Figure 1)—the chemical is not expected to pose a concern. NOTE: Before a final assessment is published, the chemical will undergo a Tier I validation to determine if the chemical requires further assessment for other reasons. NICNAS: IMAP Framework Attachment A—Example 1: Placing a chemical in the Tier I human health matrix assessment and prioritisation Chemical 2 Exposure Information There is no Australian use or volume information available for the chemical, therefore default and/or surrogate information is used. The chemical has reported cosmetic use including as a component of perfuming agents. The chemical has reported domestic use including: in polishes and wax blends; as a component of washing and cleaning products (including solvent-based products); as a component of disinfectants and pest control products; and in finger paints, scented clothes, erasers and paper articles. The chemical has reported commercial use including: in coatings and paints, thinners, and paint removers; as a component of inks and toners; and in fillers, putties, plasters and modelling clay. The chemical has reported site-limited use including as a reactant chemical for synthesising vitamin A. Matrix: Allocating an Exposure band Derivation of use multiplier The chemical has identified cosmetic, domestic, commercial and site-limited uses. Therefore the use multipliers of 1, 0.1, 0.01 and 0.001 are applicable the chemical. As the chemical fits into more than one use category, the highest multiplier (1) is used to calculate the exposure score. Calculating the exposure score volume × use multiplier = exposure score The default volume of 100 tonnes is used and, as the chemical fits into more than one use category, the highest multiplier (1) is used to calculate the exposure score. Therefore the exposure score for the chemical is calculated to be 100 × 1 = 100. Exposure band Based on the exposure score of 100 the chemical is assigned into Exposure band 4. NICNAS: IMAP Framework Attachment A—Example 1: Placing a chemical in the Tier I human health matrix assessment and prioritisation Figure 1: Tier I human health assessment and prioritisation matrix Increasing exposure Hazard band Increasing hazard Exposure band 0 (no exposure) 1 2 3 4 0 (no indication of hazard) Not expected to pose a concerni Not expected to pose a concerni Not expected to pose a concerni Not expected to pose a concerni Not expected to pose a concerni 1 Not expected to pose a concerni Not expected to pose a concerni Not expected to pose a concerni Not expected to pose a concerni Requiring further assessmentii 2 Not expected to pose a concerni Not expected to pose a concerni Not expected to pose a concerni Chemical 1 Requiring further assessmentii Requiring further assessmentii Chemical 2 3 Not expected to pose a concerni Not expected to pose a concerni Requiring further assessmentii Requiring further assessmentii Requiring further assessmentii 4 Not expected to pose a concerni Requiring further assessmentii Requiring further assessmentii Requiring further assessmentii Requiring further assessmentii i Tier I assessment complete ii Tier II assessment required NICNAS: IMAP Framework Attachment B—Example 2: Determining environmental risk—Tier I risk characterisation Chemical 3 Environmental exposure (Predicted environmental concentration— PEC) Information There is no Australian use or volume information available for the chemical, therefore default information is used. A default value of 100 tonnes is allocated for the volume of chemical imported and/or manufactured in a year. The chemical is reported to be used in cosmetics, solvents, paints and adhesives overseas. Calculating the PEC The highest environmental exposure would result from the chemical being used in cosmetics. It is therefore assumed that the entire quantity of the chemical is used in cosmetics leading to a wide dispersal into sewers. Estimations are based on a highest exposure/worst-case scenario for maximum environmental protection. A predicted environmental concentration is calculated assuming the entire volume of chemical is released to sewers with no removal of the chemical in sewage treatment plants (STPs). The PECs are calculated to be 85 μg/L and 8.50 μg/L in the riverine and marine compartments, respectively (refer to the IMAP Framework document Model used to calculate the PEC at Tier I for details). PEC = 85 μg/l—MODERATE AQUATIC EXPOSURE Environmental hazard (Predicted no-effect concentration—PNEC) Information Calculating the PNEC The PNEC for the chemical has been calculated as 1,050 μg/L based on the estimated acute toxicity to fish (96 hours LC50 = 105 mg/L) and an assessment factor of 100. PNEC = 1,050 μg/l—LOW ECOTOXICITY* PBT categorisation Persistence: Bioaccumulation: (eco)Toxicity: Ready biodegradable (predicted by QSAR models) log Kow = 1.2 (predicted by QSAR models) 96 hours fish LC50 = 105 mg/L (predicted by QSAR models) Based on the pivotal indicators, the chemical does not exceed the persistence, bioaccumulation or ecotoxicity criteria for PBT chemicals. Therefore the substance is not categorised as a PBT chemical in Australia. *Note that the lower the PNEC the higher the ecotoxicity. NICNAS: IMAP Framework Attachment B—Example 2: Determining environmental risk—Tier I risk characterisation Environmental risk assessment Based on the above PEC and PNEC values, the following risk quotients (RQs) have been calculated. RIVER PEC ÷ PNEC = RQ 85 μg/L ÷ 1050 μg/L = 0.081 OCEAN PEC ÷ PNEC = RQ 8.50 μg/L ÷ 1050 μg/L = 0.0081 Therefore, RQ <1 (see Figure 2) It was assumed that annually 100 tonnes of Chemical 3 would be manufactured or imported into Australia and that it would be used in cosmetics, with a consequential wide dispersal into the sewerage system. The risk quotient was determined to be <1 for both the riverine and marine compartments, using conservative assumptions. Therefore the chemical is unlikely to reach ecotoxicologically significant concentrations in the aquatic environment. The chemical is not categorised as PBT in Australia and there are no other causes of concern to the environment. Tier I assessment outcome The chemical is not expected to pose an unreasonable risk to the environment based on the assumed yearly use volume and reasonable worst-case use pattern. No further assessment is required. NICNAS: IMAP Framework Attachment B—Example 2: Determining environmental risk—Tier I risk characterisation Chemical 4 Environmental exposure (Predicted environmental concentration— PEC) Information The chemical is used in Australia in detergents with a reported use quantity of 3,000 tonnes a year. Calculating the PEC A predicted environmental concentration was calculated assuming the entire volume of chemical used annually in Australia is released to sewers with no removal of the chemical in sewage treatment plants (STPs). The PECs were calculated to be 2,551 μg/L and 255.1 μg/L in the riverine and marine compartments, respectively (refer to the IMAP Framework document Model used to calculate the PEC at Tier I for details). PEC = 2,551 μg/l—HIGH AQUATIC EXPOSURE Environmental hazard (Predicted no-effect concentration—PNEC) Information No measured aquatic ecotoxicological indicators for Chemical 4 are available. Ecotoxicological indicators are therefore calculated using reliable QSAR (Quantitative Structural Activity Relationship) models. The most sensitive organisms in this environment are aquatic invertebrates with a calculated 48 hours EC50 of 20 mg/L. Calculating the PNEC The PNEC for the chemical has been calculated as 200 μg/L based on the estimated acute toxicity to daphnia (48 hours LC50 = 20 mg/L) and an assessment factor of 100. PNEC = 200 μg/l—MODERATE ECOTOXICITY* PBT categorisation Persistence: Bioaccumulation: (eco)Toxicity: Ready biodegradable (predicted by QSAR models) log Kow = 2.4 (predicted by QSAR models) 48 hours daphnia EC50 = 20 mg/L (predicted by QSAR models) Based on the pivotal indicators, the chemical does not exceed the persistence, bioaccumulation or ecotoxicity criteria for PBT chemicals. Therefore the substance is not categorised as a PBT chemical in Australia. NICNAS: IMAP Framework Attachment B—Example 2: Determining environmental risk—Tier I risk characterisation Environmental risk assessment Based on the above PEC and PNEC values, the following Risk Quotients (RQ) have been calculated. RIVER PEC ÷ PNEC = RQ 2,551 μg/L ÷ 200 μg/L = 12.8 OCEAN PEC ÷ PNEC = RQ 255.1 μg/L ÷ 200 μg/L = 1.28 Therefore RQ >1 (see Figure 2). The environmental risk assessment of Chemical 4 assumes that all 3,000 tonnes will be used in detergent products leading to a wide dispersal into the sewerage system. The risk quotient has been calculated to be > 1 for the riverine and marine compartments which indicates that the chemical could pose an unreasonable risk to the environment. The chemical is not categorised as PBT in Australia. Tier I assessment outcome The chemical could pose an unreasonable risk to the environment based on the reported yearly use volume and use pattern. The environmental risks of the chemical will be evaluated in more detail at Tier II level. Figure 2: Determining the Environmental Risk Quotient