INITIAL REVIEW ENGINEERING REPORT Other New Chem:08-0006 Post Focus Draft 8/04/2008

ENGINEER: Arnold \ CLM PV (kg/yr): Import Only

SUBMITTER: MORIMURA BROS (U.S.A.)

USE: High-friction agent for automotive brake pads.

SNUR: Find 56 FR 40204 (Aug. 13, 1991).

OTHER USES:

Analog anode for lithium battery; Analog ion exchange material; fuel cell material; material for pencil leads.

MSDS: Yes Label: No

Gen Eqpt: Use local exhaust ventilation to control airborne levels bellow the exposure guidelines. // Safety glasses // Protective gloves. Respirator: Recommend use of NIOSH/MSHA approved respiratory protection against dust. Health Effects: Prolonged inhalation of excessive concentration of respirable fibers may cause deposition of quantities of fibers in lungs sufficient to cause a tissue response which could be associated with injury. TLV/PEL: none established

CRSS (07/07/2008): Chemical Name: Potassium titanium oxide (K2Ti6O13) S-H20: 1 g/L @ VP: 1.0E-6 torr @ MW: 573.60 %<500 %<1000 Physical State and Misc CRSS Info: Neat: Solid (white powder) Mfg: NK: Imported Proc/Form: Solid: in brake pad formulation End Use: Solid: entrained in brake pad. The submitter has clarified by phone that the substance will be imported into the U.S.

as , and will be fabricated into brake pads in this country. Submitted Data: White powder; MP = 1347°C (Exp.); WS: < 0.1% (Exp.); insoluble in organic solvents; pH = 8-10; specific gravity = 3.6 g/cm3; electrical resistance = 3.3E15 .omega.-cm. Submitted:average particle size = 5.5 μm by laser light diffraction. Particle size analysis by scanning electron microscopy shows an average diameter = 1.4 μm, average length = 6.2 μm, with ca. 15% of particles less than 0.8 μm in diameter and shorter than 20 μm. Estimated Data: VP < 0. 000001 torr (Inorganic oxide). Cont'd on p.6. Consumer Use: No

SAT (concerns) (07/08/2008): Related Cases and Related Cases and Misc SAT Info: RELATED CASES:

Migration to groundwater: Negligible PBT rating: P3B1T1 . Health: 1-2 Inhalation Eco: 1 No releases to Water

OCCUPATIONAL EXPOSURE RATING: 2-3A

NOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER. This PMN contains an element of concern--Titanium--for which separate release estimates are provided for each activity.

The PMN is import-only; therefore, manufacturing is not assessed although the submission provides detailed information on manufacturing which occurs in Japan. Raw materials, titanium dioxide and potassium carbonate, are mixed in a vibration mill before they are calcined at 1100 C for 4 hours. The reaction product is cooled, forming lumps which are crushed and milled to obtain the commercial product, TOFIX-S, which is exported to the United States.

According to information provided in an attachment to the PMN, S-08-0006 (trade name:TOFIX-S) is identified as dipotassium hexatitanate (K2O.6TiO2). There are fibrous and non-fibrous particles in the new chemical substance. About 9.8% are fibrous particles (aspect ratio >3). About 15% of the fibers are <0.8 ?m in diameter; no fibers are longer than 20 ?m.

Referenced three same use cases assessed all releases to incineration because it is the only required release estimate, and the PMN contained an element of concern (consistent with this IRER). estimated all releases to landfill. All three past cases estimated exposures to particulate from Unloading Solid Raw Material from Transport Containers (consistent with this IRER).

POLLUTION PREVENTION CONSIDERATIONS: P2 Claims: Currently, needle-shaped fibers (e.g. whiskers) of potassium titanium oxide (potassium octatitanate) are used in automobile brake pads. In 2006, the World Health Organization (WHO) reviewed potential health effects of potassium octatitanate fibers and advised that respirable potassium octatitanate fibers are likely to pose a high hazard to humans after inhalation exposure. Because of the WHO advisory, "TOFIX-S" wasdeveloped to reduce and eventually eliminate such risks. This product "TOFIX-S" is potassium hexatitanate and is in the form of a powder or a stick shape, both of which are different from potassium octatitanate fibers or whiskers.

EXPOSURE-BASED REVIEW:

INITIAL REVIEW ENGINEERING REPORT Other New Chem:08-0006

Use: Molding of automotive brake pads

Number of Sites/ Location: 2 unknown sites Days/yr: 200 Basis: Submission specifies 2 sites, 200 days/yr, and

Process Description: Import PMN

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY IRER Note: The daily releases listed for any source below may coincide with daily releases from the other sources to the same medium. This IRER conservatively presents all releases to incineration due to presence of element of concern. Other release media not required, per SAT (no releases to water, negl. migration, and VP<0.01 torr).

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Incineration Output 2: 1.1E+0 kg/site-day over 200 days/yr from 2 sites or 4.5E+2 kg/yr to: incineration (submission) from: Unloading Solid Raw Material from Transport Containers basis: User-Defined Loss Rate Model. CEB dust model estimates 0.5% release to water, incin, air, or land fromsolids transfer activities. Note, submission estimates 0. 5 kg/day from unloading (CEB model is more conservative). Per submission, this release is to incineration (consistent with a conservative assessment due to presence of Ti).

Incineration Output 2: 2.3E+0 kg/site-day over 200 days/yr from 2 sites or 9.0E+2 kg/yr to: incineration (worst-case) from: Cleaning Solid/ Powder Residuals from Containers Used to Transport the Raw Material basis: EPA/OPPT Solid Residuals in Transport Containers Model, CEB standard 1% residual.

Incineration Output 2: 2.2E+0 kg/site-day over 200 days/yr from 2 sites or 9.0E+2 kg/yr to: incineration (worst-case) from: Equipment Cleaning Losses of Solids from Process Vessels basis: EPA/OPPT Solid Residuals in Transport Containers Model, CEB standard 1% residual.

RELEASE TOTAL 2.3E+3 kg/yr - all sites

Titanium element of concern:

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: 6 Basis: Submission estimates 2 workers/site. Exposure assessed at more conservative CEB default of 3 workers/site

Inhalation:

Exposure to Particulate (Class I) Upper Bound: 1.5E+1 mg/day over 200 days/yr Number of workers (all sites) with inhalation exposure: 6 Basis: Unloading Solid Raw Material from Transport Containers; OSHA PNOR PEL-Limiting Model. NOTE: The respirator class is: I. Particulate (including solid or liquid droplets).

INHALATION MONITORING DATA REVIEW 1) Uncertainty (estimate based on model, regulatory limit or data not specific to industry): Yes 2)a) Exposure level > 1 mg/day? YesOR b) Hazard Rating for health of 2 or greater? 1-2 No Inhalation Monitoring Data Desired? Yes (both criteria met)

Dermal: Not required, per SAT.

CBI:

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