TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0126
Number: P-18-0126
TSCA Section 5(a)(3) Determination: The chemical substance is not likely to present an
unreasonable risk (5(a)(3)(C))
Chemical Name:
Specific: Calcium manganese titanium oxide; CASRN: 153728-36-0.
Conditions of Use (intended, known, or reasonably foreseen)1:
Intended conditions of use (specific): Manufacture, processing, and use as a black pigment for
architectural paint (e.g. roof and walls of buildings), consistent with the manufacturing,
processing, use, distribution, and disposal information described in the PMN.
Known conditions of use: Applying such factors as described in footnote 1, EPA evaluated
whether there are known conditions of use and found none.
Reasonably foreseen conditions of use: Applying such factors as described in footnote 1, EPA
has identified manufacture, processing, or use of the new chemical substance for an
additive in coating film, IR reflective particle for polyether-imide fiber, IR reflective
pigment for automotive coatings, additive in synthetic resin with low reflectivity, in a
method for preparing oxygen gas, component of thermistor element, for purification of
exhaust gas, and nonmagnetic ceramic as reasonably foreseen based on patents for the
chemical substance.
Summary: The chemical substance is not likely to present an unreasonable risk of injury to
health or the environment, without consideration of costs or other nonrisk factors, including an
unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by
the Administrator under the conditions of use, based on the risk assessment presented below and
the terms of the proposed Significant New Use Rule (SNUR) signed by EPA.2 Although EPA
1	Under TSCA  3(4), the term "conditions of use" means "the circumstances, as determined by the Administrator,
under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed,
distributed in commerce, used, or disposed of." In general, EPA considers the intended conditions of use of a new
chemical substance to be those identified in the section 5(a) notification. Known conditions of use include activities
within the United States that result from manufacture that is exempt from PMN submission requirements.
Reasonably foreseen conditions of use are future circumstances, distinct from known or intended conditions of use,
under which the Administrator expects the chemical substance to be manufactured, processed, distributed, used, or
disposed of. The identification of "reasonably foreseen" conditions of use will necessarily be a case-by-case
determination and will be highly fact-specific. Reasonably foreseen conditions of use will not be based on
hypotheticals or conjecture. EPA's identification of conditions of use includes the expectation of compliance with
federal and state laws, such as worker protection standards or disposal restrictions, unless case-specific facts indicate
otherwise. Accordingly, EPA will apply its professional judgment, experience, and discretion when considering such
factors as evidence of current use of the new chemical substance outside the United States, evidence that the PMN
substance is sufficiently likely to be used for the same purposes as existing chemical substances that are structurally
analogous to the new chemical substance, and conditions of use identified in an initial PMN submission that the
submitter omits in a revised PMN. The sources EPA uses to identify reasonably foreseen conditions of use include
searches of internal confidential EPA PMN databases (containing use information on analogue chemicals), other
U.S. government public sources, the National Library of Medicine's Hazardous Substances Data Bank (HSDB), the
Chemical Abstract Service STN Platform, REACH Dossiers, technical encyclopedias (e.g., Kirk-Othmer and
Ullmann), and Internet searches.
2	Reasonably foreseen conditions of use subject to a proposed SNUR are not likely to present an unreasonable risk
of injury to health or the environment. Based on EPA's experience, it is the Agency's judgment that a new use

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0126
estimated that the new chemical substance could be very persistent, the substance does not
bioaccumulate by lipophilic partitioning and there is low concern that it will accumulate in
organisms by other mechanisms; thus, repeated exposures are not expected to cause food-chain
effects via accumulation in exposed organisms. Based on available test data for the new
chemical substance, estimated physical/chemical properties, and test data on analogous chemical
substances, EPA estimates that the chemical substance has moderate environmental hazard and
potential for the following human health hazards: lung effects (overload), carcinogenicity, and
neurotoxicity. The PMN describes conditions of use that mitigate the human health and
environmental risks. Therefore, EPA concludes that the new chemical is not likely to present
unreasonable risk to human health or the environment under the intended conditions of use.
As set forth below, the information available to EPA is sufficient to permit the Agency to
conduct a reasoned evaluation of the health and environmental effects of the chemical substance
under the conditions of use that are not subject to the proposed SNUR, in order to determine that
the chemical substance is not likely to present an unreasonable risk under those conditions of
use. As such, EPA does not need to impose testing requirements to conduct this evaluation.
Whether testing is needed to evaluate the effects of the intended, known, or reasonably foreseen
conditions of use of a chemical substance subject to a PMN is determined on a case-by-case
basis. To the extent that testing may be necessary to conduct a reasoned evaluation of the health
or environmental effects of the reasonably foreseen conditions of use that are subject to the
proposed SNUR, EPA will make the appropriate determination if a SNUN is submitted
following finalization of the SNUR.
EPA found no known conditions of use, assessed the intended conditions of use, and addressed
reasonably foreseen conditions of use by proposing a SNUR. Therefore, EPA determines the
new chemical substance is not likely to present unreasonable risk to human health or the
environment.
Fate: Environmental fate is the determination of which environmental compartment(s) a
chemical moves to, the expected residence time in the environmental compartment(s) and
removal and degradation processes. Environmental fate is an important factor in determining
exposure and thus in determining whether a chemical may present an unreasonable risk. EPA
estimated physical/chemical and fate properties of the new chemical substance using data for
analogues (metal oxides). In wastewater treatment, the new chemical substance is expected to be
would not commence during the pendency of a proposed SNUR because web posting of a proposed SNUR serves as
the cut-off date for a significant new use. Therefore, manufacturers and processors would not commence a
prohibited new use that would be legally required to cease upon the finalization of the SNUR. Once a SNUR is final
and effective, no manufacturer or processor - including the PMN submitter - may undertake the conditions of use
identified as a significant new use of the PMN substance in the SNUR. EPA must first evaluate the new use in
accordance with the requirements of TSCA Section 5 and (a) either conclude that the new use is not likely to present
an unreasonable risk under the conditions of use; or (b) take appropriate action under section 5(e) or 5(f). If EPA
were not to finalize the proposed SNUR, then that decision would be based on information and data provided to the
Agency during the comment period demonstrating that the reasonably foreseen conditions of use subject to the
proposed SNUR are not likely to present an unreasonable risk. Under either scenario, the reasonably foreseen
condition of use is not likely present an unreasonable risk.

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0126
removed with an efficiency of 90% due to sorption. Removal of the new chemical substance by
biodegradation is negligible. Sorption of the new chemical substance to sludge is expected to be
strong and to soil and sediment is expected to be very strong. Migration of the new chemical
substance to groundwater is expected to be negligible due to very strong sorption to soil and
sediment. Due to low estimated vapor pressure and Henry's law constant, the new chemical
substance is expected to undergo negligible volatilization to air. Overall, these estimates indicate
that the new chemical substance has low potential to volatilize to air or migrate to groundwater.
-2
Persistence : Persistence is relevant to whether a new chemical substance is likely to present an
unreasonable risk because chemicals that are not degraded in the environment at rates that
prevent substantial buildup in the environment, and thus increase potential for exposure, may
present a risk if the substance presents a hazard to human health or the environment. EPA
estimated degradation half-lives of the new chemical substance using data for analogues (metal
oxides). EPA estimated that the new chemical substance's aerobic and anaerobic biodegradation
half-lives are > 6 months. These estimates indicate that the new chemical substance may be very
persistent in aerobic environments (e.g., surface water) and anaerobic environments (e.g.,
sediment).
Bioaccumulation4: Bioaccumulation is relevant to whether a new chemical substance is likely
to present an unreasonable risk because substances that bioaccumulate in aquatic and/or
terrestrial species pose the potential for elevated exposures to humans and other organisms via
food chains. EPA estimated the potential for the new chemical substance to bioaccumulate using
data for analogues (metal oxides). EPA estimated that the new chemical substance does not
bioaccumulate by lipophilic partitioning, and there is low concern that it may accumulate in
organisms by other mechanisms. Although EPA estimated that the new chemical substance could
be very persistent, the substance does not bioaccumulate by lipophilic partitioning and there is
low concern that it will accumulate in organisms by other mechanisms; thus, repeated exposures
are not expected to cause food-chain effects via accumulation in exposed organisms.
Human Health Hazard5: EPA estimated the human health hazard of this chemical substance
based on its estimated physical/chemical properties and available data on the new chemical
3	Persistence: A chemical substance is considered to have limited persistence if it has a half-life in water, soil or
sediment of less than 2 months or there are equivalent or analogous data. A chemical substance is considered to be
persistent if it has a half-life in water, soil or sediments of greater than 2 months but less than or equal to 6 months
or if there are equivalent or analogous data. A chemical substance is considered to be very persistent if it has a half-
life in water, soil or sediments of greater than 6 months or there are equivalent or analogous data. (64 FR 60194;
November 4, 1999)
4	Bioaccumulation: A chemical substance is considered to have a low potential for bioaccumulation if there are
bioconcentration factors (BCF) or bioaccumulation factors (BAF) of less than 1,000 or there are equivalent or
analogous data. A chemical substance is considered to be bioaccumulative if there are BCFs or BAFs of 1,000 or
greater and less than or equal to 5,000 or there are equivalent or analogous data. A chemical substance is considered
to be very bioaccumulative if there are BCFs or BAFs of 5,000 or greater or there are equivalent or analogous data.
(64 FR 60194; November 4 1999)
5	A chemical substance is considered to have low human health hazard if effects are observed in animal studies with
a No Observed Adverse Effect Level (NOAEL) equal to or greater than 1,000 mg/kg/day or if there are equivalent
data on analogous chemical substances; a chemical substance is considered to have moderate human health hazard if
effects are observed in animal studies with a NOAEL less than 1,000 mg/kg/day or if there are equivalent data on

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0126
substance and its components. Absorption of the new chemical substance is expected to be nil for
all routes as the neat material and poor absorption through the skin, lung and GI tract when in
solution based on physical/chemical properties. For the new chemical substance, EPA identified
lung effects (overload)/carcinogenicity as hazards based on particle size distribution data (0.2 -
1.80 microns) and presence of titanium dioxide as a component and neurotoxicity as a hazard
based on the presence of manganese as a component. Submitted test data on the new chemical
substance indicated low acute oral and dermal toxicity, not irritating to skin or eyes and negative
results for skin sensitization and genotoxicity. EPA identified a New Chemical Effect Level
"3
(NCEL) of 5 mg/m based on lung effects for an analogue (TiC^) which was used as the
exposure route-specific point of departure for quantitative risk assessment.
Environmental Hazard6: Environmental Hazard: Environmental hazard is relevant to whether
a new chemical substance is likely to present unreasonable risk because the significance of the
risk is dependent upon both the hazard (or toxicity) of the chemical substance and the extent of
exposure to the substance. EPA determined the environmental hazard for this new chemical
substance based on acute toxicity data submitted for the substance and on the negligible water
solubility of P-18-0126 (mixed metal oxides; MW 100,000). Acute toxicity values measured for
fish, aquatic invertebrates, and algae are no effects at saturation (NES; data on PMN), NES (data
on PMN), and 59 mg/L (data on PMN), respectively. Chronic toxicity values measured for fish,
aquatic invertebrates, and algae are NES (negligible water solubility), NES (negligible water
solubility), and 5.7 mg/L (data on PMN), respectively. These toxicity values indicate that the
new chemical substance is expected to have moderate environmental hazard. Application of
assessment factors of 4 and 10 to acute and chronic toxicity values, respectively, results in acute
and chronic concentrations of concern of 14.75 mg/L (14,750 ppb) and 0.57 mg/L (570 ppb),
respectively.
analogous chemical substances; a chemical substance is considered to have high human health hazard if there is
evidence of adverse effects in humans or conclusive evidence of severe effects in animal studies with a NOAEL of
less than or equal to 10 mg/kg/day or if there are equivalent data on analogous chemical substances. EPA may also
use Benchmark Dose Levels (BMDL) derived from benchmark dose (BMD) modeling as points of departure for
toxic effects. See https://www.epa.gov/bmds/what-benchmark-dose-software-bmds. Using this approach, a BMDL
is associated with a benchmark response, for example a 5 or 10 % incidence of effect. The aforementioned
characterizations of hazard (low, medium, high) would also apply to BMDLs. In the absence of animal data on a
chemical or analogous chemical substance, EPA may use other data or information such as from in vitro assays,
chemical categories (e.g., Organization for Economic Co-operation and Development, 2014 Guidance on Grouping
of Chemicals, Second Edition. ENV/JM/MONO(2014)4. Series on Testing & Assessment No. 194. Environment
Directorate, Organization for Economic Co-operation and Development, Paris, France.
(http://www.oecd.org/officialdocuments/publicdisplavdocumentpdf/?cote=env/im/mono(2014)4&doclanguage=en)).
structure-activity relationships, and/or structural alerts to support characterizing human health hazards.
6 A chemical substance is considered to have low ecotoxicity hazard if the Fish, Daphnid and Algae LC50 values are
greater than 100 mg/L, or if the Fish and Daphnid chronic values (ChVs) are greater than 10.0 mg/L, or there are not
effects at saturation (occurs when water solubility of a chemical substance is lower than an effect concentration), or
the log Kow value exceeds QSAR cut-offs. A chemical substance is considered to have moderate ecotoxicity hazard
if the lowest of the Fish, Daphnid or Algae LC50s is greater than 1 mg/L and less than 100 mg/L, or where the Fish
or Daphnid ChVs are greater than 0.1 mg/L and less than 10.0 mg/L. A chemical substance is considered to have
high ecotoxicity hazard, or if either the Fish, Daphnid or Algae LC50s are less than 1 mg/L, or any Fish or Daphnid
ChVs is less than 0.1 mg/L (Sustainable Futures https://www.epa.gov/sustainable-futures/sustainable-futures-p2-
framework-manual).

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0126
Exposure: The exposure to a new chemical substance is potentially relevant to whether a new
chemical substance is likely to present unreasonable risks because the significance of the risk is
dependent upon both the hazard (or toxicity) of the chemical substance and the extent of
exposure to the substance.
EPA estimates occupational exposure and environmental release of the new chemical substance
under the intended conditions of use described in the PMN using ChemSTEER (Chemical
Screening Tool for Exposures and Environmental Releases; https://www.epa.gov/tsca-screening-
tools/chemsteer-chemical-screening-tool-exposures-and-environmental-releases). EPA uses
EFAST (the Exposure and Fate Assessment Screening Tool; https://www.epa.gov/tsca-
screening-tools/e-fast-exposure-and-fate-assessment-screening-tool-version-2014) to estimate
general population, consumer, and environmental exposures.
EPA considers workers to be a potentially exposed or susceptible subpopulation (PESS) on the
basis of greater exposure potential compared to the general population. EPA also considers PESS
in conducting general population drinking water exposures by evaluating risks associated with
water intake rates for multiple age groups, ranging from infants to adults. EPA considers
consumers of specific products to be a potentially exposed or susceptible subpopulation on the
basis of greater exposure potential compared to the general population who do not use specific
products.
For this assessment, EPA assessed worker exposure via dermal exposure and inhalation
exposures. Releases to water, air, and landfill were estimated. Exposure to the general population
was assessed via inhalation. Exposure to the general population via drinking water and fish
ingestion were not assessed because no acute oral hazards were identified. Exposure to the
general population via landfill leachate were not assessed because releases were expected to be
negligible (below modeling thresholds). Consumer exposures were not assessed because
consumer uses were not identified as conditions of use.
Risk Characterization: Risks to human health for the new chemical substances were evaluated
using the route-specific effect levels (i.e., NCEL). EPA assesses risks to workers considering
engineering controls described in the PMN but in the absence of personal protective equipment
(PPE) such as gloves and respirators. If risks are preliminarily identified, EPA then considers
whether the risks would be mitigated by the use of PPE (e.g., impervious gloves, respirator).
Risks were not identified for workers for lung effects via inhalation exposure based on
quantitative hazard data for a component of the new chemical substance, titanium dioxide
(Exposure TWA of 1 mg/m3 does not exceed the NCEL of 5 mg/m3). No relevant hazards were
identified for dermal exposures for the new chemical substance; therefore, dermal risks were not
calculated. Based on no identified hazards, risks are not expected via dermal exposure.
Risks were not evaluated quantitatively for the general population for lung effects via inhalation
exposure because only acute exposures (1 day/year) are expected and the only inhalation hazard
identified (lung overload due to respirable, poorly soluble particulates) is a chronic effect. Risks
from chronic exposure were not evaluated because they are expected to be negligible (below
modeling thresholds). Risks were not evaluated quantitatively for the general population via

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0126
ingestion of drinking water because the expected releases to water are only 1 day/yr and no acute
oral hazards were identified. Hence, risks are expected to be negligible for acute oral exposures.
Risks to consumer were not evaluated because consumer uses were not identified as conditions
of use.
Risks to the environment were evaluated by comparing estimated surface water concentrations
with the acute and chronic concentrations of concern. Risks from acute and chronic exposures to
the environment were not identified due to releases to water that did not exceed the acute or
chronic COC.
It is reasonably foreseen, based on patent information for the PMN substance, that the new
chemical substance could be used for other industrial and commercial applications, consumer
products, and at a higher production volume. The SNUR that has been proposed for this
chemical substance defines certain conditions of use as significant new uses. The proposed
significant new uses include use other than as a black pigment for architectural paint (e.g. roof
and walls of buildings), consumer use, and an annual production volume greater than 15,000
kilograms. Conditions of use that fall under the restrictions of the proposed SNUR are not likely
to present unreasonable risk of injury to health or the environment because (1) those conditions
of use are not likely to be commenced during the pendency of the proposed SNUR, and (2) upon
finalization of the SNUR, those conditions of use would be prohibited unless and until EPA
makes an affirmative determination that the significant new use is not likely to present an
unreasonable risk or takes appropriate action under section 5(e) or 5(f).
1/31/2020		IsL
Date:	Tala R. Henry, Ph.D.
Deputy Director for Programs
Office of Pollution Prevention and Toxics

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