Document ID: EPA-HQ-OPPT-2013-0399-0217
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2019-07-24T04:00Z

SN-15-0009
Chemical Name: 

Updated on Oct 31[st], 2018
ASSIGNMENTS
NAME
DATE
SAT Chair
Becky Daiss
SAT Date
HH Hazard Assessor (A)
Sailesh Surapureddi
SAT Date
HH Hazard QC Reviewer (A)
Cal Baier-Anderson
7/16/18
HH Risk Assessor FOCUS (B)
Sailesh Surapureddi
07/27/2018
HH Risk QC Reviewer (B)
Cal Baier-Anderson
Date Reviewed

Human Health Report Status: 
DATE COMPLETED
                                       X
 HAZARD DRAFT- Pending Review
                                  2018-07-13
                                       X
 HAZARD REVIEWED
                                    7/16/18
                                       X
 HAZARD FINAL
                                    7/16/18
                                       X
 RISK DRAFT- pending review
                                    7/27/18
                                       X
 RISK REVIEWED
                                    7/30/18
                                       X
 RISK-FOCUS FINAL- Uploaded
                                    7/30/18
                                       X
 POST-FOCUS UPDATE DRAFT
                                  10/31/2018
                                       X
 POST-FOCUS UPDATE FINAL- Uploaded
                                  10/31/2018
      Updated on Oct 31[st], 2018:
      
         * Concern for irritation is removed based on submitted data.
         * A 28 day repeated dose study is submitted and the NOAEL in males and females was 1000 mg/kg-bw/day, based on no treatment-related adverse effects at the highest dose tested.

HUMAN HEALTH SUMMARY 
The risk estimates for this chemical are for the intended conditions of use.  

Hazard Summary
   * Absorption of the neat material is nil through the skin, but poor through the skin for the material in solution, absorption is poor through the lung and GI tract, based on physical/chemical properties.
   * No systemic health concerns identified based on chemical structure and data on the new chemical substance.
      

Risk Summary
Workers
 Risks were not identified for workers based on no effects at the highest dose/concentration tested via inhalation and dermal exposure based on quantitative hazard data for the new chemical, (inhalation MOE = 533, dermal MOE=172; benchmark MOE = 100).
      
      
      
General Population
Risks were not identified for general population based on no effects at the highest dose/concentration tested via all routes of exposures based on quantitative hazard data for the new chemical, (Fish MOE =350; adult MOE=68,700; infant MOE= 16,300; Fugitive inhalation MOE=3,760; benchmark MOE = 100).
      
Consumers
Risks to consumers were not evaluated because consumer uses were not identified as conditions of use

Potentially Useful Information: 
Assumptions and Uncertainties
Absorption of the PMN is based on p-chem properties and/or analogs
Health effects are based on structure and submitted data

Potentially Useful Information
No Potentially useful information would be required.

HUMAN HEALTH HAZARD- PART A
Chemistry Summary

   .1 SAT Summary
Absorption
      Absorption of the neat material is nil through the skin, but poor through the skin for the material in solution, while absorption is poor through the lung and GI tract, based on physical/chemical properties.
SAT Health Summary
      Irritation to the eyes, skin and respiratory tract and mucous membranes as stated in SDS. No systemic health concerns, no repeated dose studies available. NOTE: 28-day repeat dose study was provided and determined to have no effects at the highest test dose.
LVE  Data (Study summary, POD)
      Updated on oct 31[st], 2018:
      
      Mutagenicity: Negative with Salmonella and E.coli with and without S9 metabolic activation.
      Mouse Micronucleus Assay : Negative
      Acute toxicity Oral: LD50= >2000mg/kg-bw (female rats)- Red/brown staining of the snout and/or hunched posture were noted in one animal one and two days after dosing.
      
      Acute dermal LD50+ >2000 mg/kg-bw
      Eye irritation: Negative
      Dermal irritation: Negative (in vitro)
      Dermal Sensitizer: Not a dermal sensitizer
      28 day oral toxicity in rodents- NOAEL in males and females was 1000 mg/kg-bw/day, based on no treatment-related adverse effects at the highest dose tested.  
      
      
Analog Data (analog, structure, study summary, POD)
      

Data submitted for                     :

Negative in Salmonella with and without activation; Chromosomal aberration test- negative.
Rat  (F) acute (15D) oral (gavage) LD50 > 2000 mg/kg
Other Information (SDS, structural alert or component of interest, basis, etc.)
      SDS submitted
Exposure Routes of Interest 
Route of Interest
X
Inhalation: 
X
Dermal: 
X
Ingestion: 

   

Human Health Category (From US EPA 2010 document)
   Chemical Category:  not applicable.
   Chemical Category Health Concerns:
   Category Testing Strategy: 
Point of Departure Selected and Basis
POD  from the 28day repreated dose study for the SN-15-0009
POD type: (NOAEL/LOAEL/NOAEC/LOAEC/Cancer Slope Factor/IUR/BMD) NOAEL
POD Value: 1000 mg/kg/day
POD Chemical: 
POD Route: Oral
POD Hazard Endpoint: no treatment-related adverse effects 
POD Basis: no treatment-related adverse effects at the limit dose tested (1000 mg/kg/day)
POD Benchmark MOE: 1000
Reference: Submitted 28-day repeated dose oral toxicity study SN-15-0009

HUMAN HEALTH RISK (PART B)
USES and EXPOSURES
Uses
      
      
Worker Exposure

Inhalation
   Exposure to Particulate (non-volatile) (Class I)
         Potential Dose Rate: 1.5E+2 mg/day            Basis: Unloading Solid Raw Material from Transport Containers
         
Dermal
   Exposure to Solid at 100.00% concentration
         Potential Dose Rate: 3.1E+3 mg/day              Basis: Unloading Solid Raw Material from Transport Containers
General Population Exposure:
      
Drinking Water
         ADR as high as 1.04E-02 mg/kg/day
Fish
         ADR as high as 2.04 E+00 mg/kg/day
Air/Inhalation
      Stack Air ADR as high as 4.63E-05 mg/kg/day
      Fugitive Air ADR as high as 1.90E-01 mg/kg/day
      
Exposure Scenario[1]
                                     Water
                                   Landfill
                                   Stack Air
                                 Fugitive Air
Release activity(ies)[2]; exposure calculation(s)[3]
                                Drinking Water
                                Fish Ingestion
                                    7Q10[4]
                                     CC =1
                               PDM Days Exceeded
                                     LADD
                                      ADR
                                     LADD
                                      ADR
                                     LADD

                                      ADR
                                     LADD
                                      ADR
                                     LADD
                                       
                                       
                                       
                                       
                                       
                                       
                                       

                                   mg/kg/day
                                   mg/kg/day
                                   mg/kg/day
                                   mg/kg/day
                                     μg/l
                                    # Days
                                   mg/kg/day
                                   mg/kg/day
                                   mg/kg/day
                                   mg/kg/day
                                   mg/kg/day
USE: Max ADR: max acute eco
                                   1.04E-02
                                      ---
                                   2.04E+00
                                      ---
                                   4.68E+02
                                      ---
                                      ---
                                   4.63E-05
                                      ---
                                   1.90E-01
                                      ---
USE: PDM1
                                      ---
                                      ---
                                      ---
                                      ---
                                   2.81E+02
                                      ---
                                      ---
                                      ---
                                      ---
                                      ---
                                      ---
USE: Max LADD
                                      ---
                                   1.53E-04
                                      ---
                                   7.68E-03
                                      ---
                                      ---
                                   6.65E-04
                                      ---
                                   1.29E-06
                                      ---
                                   3.48E-03

Consumer Exposure
      No Consumer uses were identified.

RISK CALCULATIONS

Worker Calculations

General Population Calculations

      
      
Consumer Calculations
      Risks to consumer were not evaluated because consumer uses were not identified as conditions of use.