IMAP Framework Attachment A

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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
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