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### UNITED STATES ENVIRONMENTAL PROTECTIONAGENCY WASHINGTON, DC 20460

MEMORANDUM

SUBJECT: OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES



### 04111111

Product chemistry, Environmental Fate and Eco-effects Scoping Document for Registration Review of: Ortho-Benzyl-ParaChlorophenol and Sodium and Potassium Salts

PC Code(s): 062201/ 062202, 062203 DP Barcode(s)/No(s): 383098

DecisionNo.: 440814 Reregistration No(s). PetitionNo(s).: NA Regulatory Action: Registration Review Risk Assess Type: Product Case No(s).: 2045 chemistry/environmental fate and ecotoxicity

TXRNo.:NA

MRID No(s).: 5C, 6, and 7

From:

Thru:



### To:

Peer Reviewer: CAS No(s): 120-32-1/ 35471-49-9/3184- 65-4

Please see tables 5A,5B, 40 CFR: NA

A. 

### Najm Shamim, PhD, Chemist 

# f\--

# fi,~----,::- Risk assessment & 

### Science Support

# Brck~h Antimicrobials Division (751OP) , 

# II.

Nader Elkassabany, PhD, Chief 

# i/fl**~** Risk Assessment & 

### Science Support Branch Antimicrobials Division (7510P)

RebeccaVonDem-Hagen, CRM for Ortho-Benzyl-Parachlorophenol and Salts Registration Review Regulatory Management Branch 2 Antimicrobials Division (751 OP).**~** 

### DonnaRandall, Senior Scientist

# ~ 'I"f" RiskAssessment & 

### Science Support Branch Antimicrobials Division (7510P) I 

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### TABLE OF CONTENTS

0-

### Benzyl-p-Chlorophen0

### I 

### and Salts----------------------------------2 A]>]>EN»I}(-------------------------------------------------------------- 16

REGISTRATION REVIEW »OCUMENT
]>RO»UCT CHEMISTRY, ENVIRONMENTALFATE AN» ECOLOGICAL EFFECTS SUMMARYFOR ORTHO-BENZYL- ]>ARACHLORO]>HENOL ImportantNote on the Chemistry ofO-Benzyl-p-Chlorophenol and Sodium and ]>otassium Salts: 0]>]> determined thatthe environmentalfate data indicates the two salts (sodium and potassium) oforthobenzyl-4-chlorophenol rapidly degrade into theparentform in the environment. Therefore, the data supportingtheparent also can be used to supportthepotassium and sodium salts ( RE» on Orthobenzyl-para-chlorophenol, 1995) 

### Regulatory History: These chemicals, orthobenzyl-4-chlorophenol and its sodium and potassium salts, were first registered byEPA in 1948 as disinfectants. The currentregistration ofthese chemicals include: "disinfectant, bacteriostat, sanitizer, and microbiocides for commercial/industrial watercooling systems, metalworking fluids, hard surfaces like decks, food preparation, storage and serving areas, non-food areas like rest room facilities, medical/veterinary settings. These are used as tuberclulocides, virucides, and fungicides on agricultural farm premises, and in mushroom houses and hospital/medical institutions"

Based onthe label review, Table 1below summarizes the use sites and use patterns


### Table 1 Antimicrobial Uses and Use sites ofOrthoBenzyl-Para-Clorophenol 

### Use Site Uses Indoor food Agricultural/farm premises, /farm structures, buildings, and equipment, dairy cattle (lactating/non-lactating or unspecified)

## * , dairy farm milkhandling facilities/equipment; eating establishments: equipments/utensils (food contact), food handling areas (food contact), food serving areas (food contact), food service areas (food contact),egg packingplants (commercial)food dispensing equipment/vending machines, food marketing/storage/distribution equipment/utensils (food contact), food processing plant equipment

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### (food contact, food processing plantpremises (nonfood contact), food/grocery/marketing/storage/distribution facility premise, hog/pig/swine meat, household domestic dwelling indoor food handling areas, human drinking water systems, (water related surfaces, livestock, meat processing plant equipment, (food contact), poultry (egg/meat), poultry (meat), poultry processing plant equipment( food contact), poultry processing plantpremises (nonfood contact), *site term to general: could mean: indicate premise treatment, animal feeding/watering equipment treatment, equipment treatment
or transportation vehicle treatment. Indoor-Non-food Animal kennels/sleeping quarters (commercial; animals (lab research; carpets (commercial sanitizer); commercial transportation facilities- nonfood; commercial/institutional/industrial floors; commercial/institutional/industrial premises/equipment (indoor); eating establishments, food handling areas (nonfood contact; eating establishments food serving areas (nonfood contact); egg handling equipment (hatching); egg plantslhatcherieslbrooderrooms/shoe baths (hatching); egg washing treatment (hatching);horses (how/race/special/ponies); laundry (commercial); leather/leather products; metalworking fluids (MWF);refuse/solid waste containers (garbage cans); rubberproducts; site term too general; specialized animals, textiles/textile fiber/cordage. Indoor Medical Baberlbeauty shop instruments )shavers/scissors); carpets (hospital santizer); diapers (hospitallaundry);hospital conductive floors; hospital critical items( surgical instruments/pacemakers); hospital noncritical items (bedpans/furniture); hospital semi critical items(catheters/inhalation equipment); hospital/medical institutionsnonconductive floors; hospital/medical institutions critical premises; hospital/medical institutions patientpremises;;hospital/medical institutions premises (human/veterinary); household sickrooms premises/contents/utensils; human waste (typhoid stools/feces/urine; laundry (hospital); site termtoo general Indoor residential Bathroompremiseslhard surfaces; birds; carpets (household saniziters); diaper pails (empty); household/domestic dwellings; household/domestic dwellings contents; household/ domestic dwellings indoor premises; human grooming instruments (brushes, combs); laundry (household/coin-operated); pet living(sleeping quarters; refuse /solid waste containers; refuse/solid waste sites (indoor); refuse/solid waste transportation facilities/handling equipment; residential floors, site too general; toilet bowls (interior surfaces);toilettanks (water closets; urinals (interior surfaces). Industrial process Industrial recirculating water systems, industrial cooling towers and and water systems evaporative condensers* *Sodium salt oforthobenzyl-para-chlorophenol

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### Formulation types registered: TGAI,MUP and EUP Formulations forms: Emulsifiable concentrate, soluble concentrate,/liquid; liquidREU; pressurized liquid; solid: forms notidentified.

Table 2 summarizes the types ofapplications along with the rates ofapplication for various indoor, and outdoor sues.


### Table 2 Type ofApplications and Rates ofApplications 

### Type ofApplications Rates fApplications Indoor food Disinfectant for hard surfaces: 43-1122 ppm active byvol; 97-1091 ppm active by

### wt; Food contact surfaces require potable waterrinse 

### Indoor-nonfood Disinfectant for hard surfaces: 43-2941 ppm active by vol; 97-2657 ppm active by 

### wt; Sanitizerfor laundry: 233 ppm active byvol; 102 ppm-278 ppm active by

### wt; Residential bacteriostatic for odor causing bacteriain laundry: 0.3 ppm active by

### wt; Carpet sanitizers: 180 ppm active by vol; Fungicide (mold/mildew): 18,000 ppm active by 

### wt. Indoor medical Disinfectant for hard surfaces: 202-3820 ppm active by vol; 97-3713 ppm active by 

### wt; Diaper sanitizer: 102 ppm active by 

### wt; Carpet sanitizer: 523 ppm active by vol; Sanitary disposal ofhuman waste: 769 ppm active by vol 

### Indoor Residential Disinfectant for hard surfaces: 202-2941 ppm active by volume; 97-39,400 ppm active by 

### wt; Toiletbowls and urinals (interior surfaces): 2.3 -35,000 ppm active by 

### wt. Laundry sanitizer: 105-209 ppm active byvol. 

### Aquatic non-food Disinfectantfor water-related hard surfaces: 769-1409 ppm 

### residential active byvol; 1400 ppm active by 

### wt. Terrestrial non-food Disinfectant for refuse/waste waste sites (outdoor): 623 ppm active by vol. 

### Industrialprocess and Recirculating cooling towers as a microbiocide: 261-521 

### water systems ppm
Table 3 the list ofregistered active products, productidentification, percent ofthe active and the corresponding registrants.

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### Table 3: Registered Active Products for Ortho-Benzyl-para-chlorophenol and its Sodium and Potassium Salts EPAReg. ProductName % Active Registrant Number Ingredient 

### 211-62 LowpH Phenolic 6.65 Central solutions, Inc 

### 256 303-223 Beaucoup Germicidal 5.32 Huntington Professional Product Detergent 303-225 MATAR 10.6 Huntington Professional Products 675-19 Bulk Amphyl Brand 2.7 Reckitt Benckiser, Inc Disinfectant 675-43 Amhpyl 5.11 Reckitt Benckiser, Inc 675-LA Lysol Brand 5.5 Reckitt Disinfectnat Conc (formula # 269-005) 777-94 Lysol Brand 5.5 Reckitt Benckiser, Inc Disinfectant Conc 954-13 Spacide 4.75 King research, Inc 1043-19 Staphene Disinfectant 0.077 Steris Corporation Spray and Deodorizer 1043-26 I-Stroke Environ 8.5 Steris Corporation 1043-118 LPH® 6.4 Steris Corporation 1677-128 Sani-Glide 1.4 Ecolab, Inc 2212-17 Legphene 3.8 Walter G. Legge Company, Inc 2296-102 NAC Pine Odor 3.6 National Chemical Laboratories, Inc Disinfectant 2296-105 Pine- Act 2.0 National Chemical Laboratories, Inc 2296-106 NAC-Mint Disinfectant 5.2 National Chemical Laboratories, Inc 3862-177 TEK-Trol Disinfectant 10 ABC Compounding Co., Inc Cleaner Conc 3862-178 TEK-Phene 6.5 ABC Compounding Co., Inc 3862-179 Opti-Phene cleaner 3.0 ABC Compounding Co., Inc Disinfectant Deodorant 3862-18- PhenO-TEK 5.06 ABC Compounding Co., Inc 5741-22 Stephene II Brand 0.071 Spartan Chemical Co., Inc Disinfectant Deodorant 6836-252 Phenocide 256 9.5 Lonza Inc 6836-253 4.75 Lonza Inc 33176-6 Airsol Brand Multi- 0.08 Amrep, Inc Purpose Disinfectant Cleaner 34810-8 Wex-cide Concentrated 5.76 Wexford Labs., Inc Germicidal Detergent 34810-21 Ready to Use Wex-Cide 0.023 Wexford Labs., Inc 34810-31 Wex-cide 128 3.03 Wexford Labs., Inc 39967-5 Preventol BP Technical 98.6 LANXESS Corporation 39967-6 Preventol, BP, 75% in 75.0 LANXESS Corporation Isopropanol 39967-81 Hospital BroadBrand 5.0 LANXESS Corporation 39967-83 Ocide Hospital Cleaner- 10.10 LANXESS Corporation Disinfectant 46851-1 OMNI-II 1.0 Certol International Products



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46851-5 OMC II Spray 0.03 Certol International Products 46851-10 Prospray TM Wipe, 0.03 Certol International Products Disinfectant Towletts 61282-53 Bio-Phene Liquid 9.97 HACCO, Inc Disinfectant 62296-1 Let's Touch 5.25 RBR Productions, Inc 66171-1 Advantage 256 Cleaner 3.0 Preserve International disinfectant deodorant 70385-7 Clean Carpet Sanitizer 4.9 Prorestore Products 70627-6 Phenolic Disinfectant 10.5 Diversey, Inc HG 211-25 Pheno CEN Germicidal 8.03 Central solutions, Inc Detergent' 4313-41 Pine II Pine Odor Disinfectant ' 2.4 Carroll Company

74655-24 WRICOBGN 23.5 Hercules Incorporated 211-36 TRI-CEN2 4.4 Central solutions, Inc 1769-374 Ancocide 40102 19.85 NCH Corporation 3862-11 Pine OdorDisinfectanf 5.1 ABC Coml'ounding Co., Inc 3862-136 Vita-Pine (Coeff5)2 3.93 ABC Compounding Co., Inc 34810-16 Phenex-CELL 7.15 Wexford Labs., Inc


### 1. Potassium Salt oforthobenzyl-para-chlorophenol 2. Sodium Salt oforthobenzyl-para-chlorophenol

Table4A. ChemicalIdentity



### CommonName Ortho-Benzyl-para-Chlorophenol 

## ._- Chemical Name Ortho-Benzyl-para-chlorophenol (also 2-Benzyl-4-chhlorophenol) 

### ._- IUPACName Ortho-Benzyl-para-chlorophenol



### -- MolecularWeight 218.5 

### ._- PC Code 062201 

### ._- CAS Registry Number 120-32-1
.-- 

### Molecular FormulalEmpirical C 13

### Hll

### CIO Formula 

### ._- Registration Review Case No. 2045

.-- 

### Registration Review CaseName Ortho-Benzyl-para-chlorophenol 

### ._- Classification: Organic

.- 

### Structure:

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HO



### Table4B.·

### Cleiaiealldentity

CommonName 2-Benzyl-4-chlorophenate, sodium salt 

### ._- Chemical Name Ortho-Benzyl-para-chlorophenate, sodium salt 

### ._- IUPACName Ortho-Benzyl-para-chlorophenate, sodium salt 

### ._- Molecular Weight 240.5 

### ._- PC Code 0662202 

### ._- CAS Registry Number 3184-65-4



### ._- Molecular Formula/Empirical C 13

### H IO

### CIONa Formula 

### ._- Registration Review Case No. 2045 

### ._- Registration Review Case Name 2-Benzyl-4-chlorophenate, sodium salt 

### ._- Classification: Organic 

### ._-**Tabte4C.C.hemi~l4entity**


### CommonName 2-Benzyl-4-chlorophenate, potassium salt

.-- 

### Chemical Name Ortho-Benzyl-para-chlorophenate, potassium salt 

### ._- IUPACName Ortho-Benzyl-para-chlorophenate, potassium salt

.-- 

### Molecular Weight 236.5 

### ._- PC Code 0662203 

### ._- CAS Registry Number 35471-49-9



### ._- Molecular Formula/Empirical C I3

### H IO

### CIOK Formula 

### ._- Registration Review Case No. 2045

.-- 

### Registration Review Case Name 2-Benzyl-4-chlorophenate, potassium salt 

### ._- Classification: Organic



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### Science Findings: Following tables summarize the science data for each discipline, and lists some possible data gaps. 

### ProductChemistry Summary

T bl SA Ph . I d Ch

a e : 

### lYSlca an emlcaIP ropertles 0

### fO h B rt 0- 

### I 

### enzyl-para-c hi h 

### orop enoI Guideline Physical and ChemicalProperties Value No. 830.1550 Product identity and composition Refer to Table 2A1 MRlD# 470262-05 830.1600 Description ofmaterials usedto CBVMRlD#: 470262-05 produce the product 830.1620 Description ofproduction process CBIIMRlD#:470262-02 830.1650 Description offormulation process CBVMRlD#470262-05 830.1670 Discussion offormation ofimpurities CBII MRlD#:470262-05 830.1700 Preliminary analysis CBII MRlD#:470262-05 830.1750 Certified limits CBII MRlD#470262-05 830.1800 Enforcement analytical method CBIIMRlD#;470262-05 830.1900 Submittal ofsamples CBI 830.6302 Color White to light gray: MRlD# 470953-01 830.6303 Physical State solid; MRlD#: 4709353-01 830.6304 Odor Slightly phenolic: MRlD#: 470953-01 830.6313 Stability to sunlight, normal and elevated temperature 830.6314 OxidationlReduction: Chemical MRlD#:470262-05 Incompatibility 830.6315 Flammability MRlD#:470262-05 Flash Point 830.6316 Explodability MRlD#:470262-05 830.6317 Storage Stability No observed difference in the material at the start and after 30 days (Interim report for 30-day study); MRlD#:470953-01

830.6319 Miscibility MRlD#:470262-05 830.6320 Corrosion Characteristic MRlD#:470953-01 830.6321 Dielectric breakdown voltage MRlD#: 470262-05 830.7000 pH 5.3 (saturated aqueous solution) MRlD#:470262- 05 830.7050 UVNisible absorption spectra 830.7100 Viscosity MRlD#: 470262-05 830.7200 Melting Point 49°C 830.7220 Boiling point 175 ° C 830.7300 Densityl Bulk density 0.49 g/cm3 /30.5 lbs/ft3 MRlD#: 470967-02 830.7370 Dissociation Constants in water 10.8 +0.2 at 20 °C 830.7520 Particle size NA 830.7550 OctanoVwaterpartition coefficient Log Kow= 4.3 (Kow) (Log Kow ) 830.7840 Solubility in water 0.007 g/100g 830-7840 Solubility in organic solvents in gil00 Methyl ethyl ketone: 656 ml Isopropyl alcohol: 601 Ethyl alcohol: 422 Benzene: 219 Carbon tetrachloride: 92



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Guideline Physical and ChemicalProperties Value No. Mineral oil: 2.3 830.7950 Vaporpressure 0.075 mm Hg at 100 

### °c

Note: CBI: ConfidentIal Busmess InformatIOn 

### Table 5B: Physical and ChemicalProperties ofOrthobenzyl-parachloro-phenol, sodium salt Guideline Physical and ChemicalProperties Value No. 830.1550 Product identity and composition Referto Table 2a 830.1600 Description ofmaterials usedto CBI producethe product 830.1620 Description ofproductionprocess CBI 830.1650 Description offormulation process CBI 830.1670 Discussion offormation ofimpurities CBI 830.1700 Preliminary analysis CBI 830.1750 Certified limits CBI 830.1800 Enforcement analytical method CBI 830.1900 Submittal ofsamples CBI 830.6302 Color Grayish white: MRID:46052702 830.6303 Physical State solid; MRID 46052702 830.6304 Odor Odorless: MRID: 46052702 830.6313 Stabilityto sunlight, normal and Notreported elevated temperature 830.6314 OxidationlReduction: Chemical Notreported; MRID# 46052702 Incompatibility 830.6315 Flammability NA: MRID# 46052702 Flash Point 830.6316 Explodability NA: MRID#: 46052702 830.6317 Storage Stability MRID#: 46052702

830.6319 Miscibility Notreported; MRID: 46052702 830.6320 Corrosion Characteristic Not corrosive; MRID#: 46052702 830.6321 Dielectricbreakdownvoltage NA 830.7000 pH 12.5 ; MRID#: 46052702 830.7050 UV Nisible absorption spectra MRID#: 45266603 830.7100 Viscosity Not <lllplicable 830.7200 Melting Point No Report 830.7220 Boilingpoint No Report 830.7300 Density/ Bulk density 3.2-3.34 glcc MRID#: 56052702 830.7370 Dissociation Constants in water Not applicable 830.7520 Particle size No Report 830.7550 Octanollwaterpartition coefficient Not applicable for salt forms as the salt degrades (Kow) (Log Kow ) into the parent form 830.7840 Solubility in water 1730 gIL at20 0 C; 0.185 glI00 ml at 0 0C; 0.077 g/100 ml at 100 

### °C; MRID#: 46052702 830-7840 Solubility in organic solvents in g/lOO No Report ml 830.7950 Vaporpressure It is a solid, vapor pressure is likely negligible



### CBI: Confidential Business Information



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### Table 5C: Physical and Chemical Properties ofOrthobenzyl-parachloro-phenol,

potassium salt (as a 23.5% aqueous solution ofthe salt). Some ofthe P/chem.

properties reported in the following table are those ofthe parent molecule: orthobenzyl-papra-chlorophenol)

Guideline Physical and ChemicalProperties Value No. 830.1550 Product identity and composition Refer to Table 2a 830.1600 Description ofmaterials usedto CBI produce the product 830.1620 Description ofproduction process CBr 830.1650 Description offormulation process CBI 830.1670 Discussion offormation ofimpurities CBI 830.1700 Preliminary analysis CBI 830.1750 Certified limits CBI 830.1800 Enforcement analytical method CBI 830.1900 Submittal ofsamples CBI 830.6302 Color Yellow to Brown: MRlD:447836-01 830.6303 Physical State Clear liquid; MRlD 447836-01 830.6304 Odor Very faint, phenolic: MRlD: 447836-01 830.6313 Stability to sunlight, normal and Notreported elevated temperature 830.6314 OxidationlReduction: Chemical Formulation does not exhibit any oxidationIncompatibility reduction action when exposedto metals present in the water systems such as stainless steel, copper, and mild steel at use concentrations; MRlD# 447836-01 830.6315 Flammability NA: MRlD# 447836-01 Flash Point 830.6316**Explodabil~** NA: MRlD#: 447836-01 830.6317 Storage Stability No change in the concentration ofthe active ingredients when stored for one year under ambient warehouse conditions in commercial packaging material composed of high density polyethylene MRlD#:447836-01 830.6319 Miscibility NA; MRlD: 447836-01 830.6320 Corrosion Characteristic No evidence ofcorrosion onthe container bythe formulation for one yearunder ambient conditions;
no effect seen on the packaging materials like PE, PVC, PP, PTFE etc.: MRID#: 447836-01 830.6321 Dielectric breakdown voltage NA; the product is notto beused around electrical equipment; MRID#: 447836-01 830.7000 pH (1% solution) 11-13; MRID#:447836-01 830.7050 UVNisible absorption spectra MRlD#: 447836-01 830.7100 Viscosity 21 cps: MRlD#: 447836-01 830.7200 Melting Point 45 0 C (forthe Orthobenzyl-para-chlorophenol component): MRlD# 447836-01 830.7220 Boilingpoint NA 830.7300 Density/ Bulk density 9.450 bls/gallon at 20° C; 1.12-1.15 glcc; MRlD#: 447836-01 830.7370 Dissociation Constants in water Not applicable 830.7520 Particle size No Report 830.7550 Octanol/water partition coefficient; Not applicable fro salt form, as the salt dissociates (Log Kow) into the parent for m. It is 4.4 for the orthobenzyl

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Guideline Physical and Chemical Properties Value No. para-phenol component; MRID#; 447836-01 830.7840 Solubility inwater Highly water soluble; MRID#: 447836-01 830-7840 Solubility in organic solvents in g/100 No Report ml 830.7950 Vaporpressure 17.5 mm Hg (for the orthobenzyl-parachlorophenol component); MRID#: 447836-01 

### CBI: Confidential Business Information



### EnvironmentalFate and TransportData Summary:

The following environmental fate and transport data are present inthe Agency database. The data is summarized in the table below:

Table 6 Environmental Fate and Transport Summary

Guideline Study Reference Results/Conclusions No./Study Type 835.4100 MRID 00086320: Degradationpathway is through Aerobic Soil Uniroyal Chemical adsorption by the parent molecule and Metabolism (1977); soil persistence the degrades into organic soil fraction. study (sandy loam soil) 8% ofthe product degraded into unidentified product(s) after eight months. Halflife ofthe product at 25 0 

### C was 480 days. Conclusions: The productis persistent in sandy loam soil under aerobic conditions Anaerobic Aquatic MRID 00125971 The product was found degradable in: 1) Metabolism R. Swisher, W. Gledhill, unacclimated river water (0.1 mg/L, 1973: Biodegradation of degraded completely in six days); 2) o-benzyl-para- acclimated activated sludge (1.0 mg/L, chlorophenol:Applied 

### degraded 80% in 8 hours); and 100% in Microbiology, 

### 26(3); pp 24 hours; 3) effluent from semi394-398 continuous activated sludge ca 

### 60% of the CO2 

### was from the product; 4) sewage(0.5 and 1.0 mg/L degraded in
one day Conclusions: the product appears readily biodegradable under anaerobic conditions

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### EnvironmentalFate and TransportData Gaps The Agency has not conducted environmental fate risk assessment. For a complete risk assessment for these chemicals, based onthe use sites/ use patterns, the Agency anticipates to require the following environmental fate and transport data:

835.2120 Hydrolysis 835.2240 Photodegradation inwater 835.1110 Activated sludge, Respiration Inhibition Test 

### Ecological Effects Data Summary:

Table 7 summarizes the eco-toxicity data oforthobenzyl-para-chloro-phenol and salts



### Guideline#/Study type
850.1010: Acute Toxicity to Freshwater Invertebrates

850.1075 Acute Toxicity to Freshwater fish

850.1075 Acute Toxicity to Fresh water fish

850.2100 Avian Acute Oral Toxicity Table 7 Ecotoxicity Data



### MRID#lReference Dosing/Organism Comments/Study Information Classification MRID#: Concentrations: 2, 133336/92008007 1.2,0.75,0.43,0.26 Toxicity of or 0.16 mg/l000 ml. Nipacide BCP to 15 Daphnia magna Daphnia magna 

### 100% purity

No classification made

MRID#: 00133334: Static Bioassay; Toxicity of Concentrations:5, Nipacide to Bluegill 2, 1.2,0.72,0.43" 0.62 ppm 

### Core Percent purity: 95%

MRID#: 00133335: Static Bioassay; Toxicity of Concentrations: 2, Nipacide to 1.2,0.72,0.43,0.26 Rainbowtrout ppm a.i. 

### Core Percent purity: 95%

MRID#: 00138112; Single oral dose Toxicity of exposure study: Nipacide to Bob Concentrations: white 398,631,1000, 

### Core 1590, 2510 mglkgbw 

### Results

24 hour LC50: 

### 1.3 mglL 48 hour LC50: 0.59 mg/L No discernable effect concentration through 48 hours: 

# o. 16 mglL Highly toxic 96 hour LCso: 

### 0.33 ppm Highly toxic

96 hour LC50: 

### 0.72 ppm Highly Toxic

LD 50: 

### > 2510 mg/kg Practically nontoxic

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### Percentpurity: 95% 8502200: Avian MRID#: 00138888; Dietary: LCso> 5620 ppm Acute Dietary Toxicity of Concentrations: Toxicity Nipacide to Mallard 562, 1000, 1780, Practically nonDuck 3160, 5620 ppm- toxic 

### Core diet 850.2200: Avian MRID#: 00138887; Dietary: LCso > 5620 ppm Acute Dietary Toxicity of Concentrations: Toxicity Nipacide to 562, 1000, 1780, Practically nonBobwhite 3160, 5620 ppm- toxic 

### Core diet



### Notes on Table 7:

1. The study review of850.1010 (acute toxicity offreshwater invertebrate) did not establishthe classification ofthe study (core or supplemental, or invalid). Therefore this study is being regarded as a data gap, and the Agency is including it in the gaps for the ecological datarequirements. 2. These studies were conductedby independent labs, under individual labs SOPs before the Agency test Guideline Series 850 were instituted. The reviews ofthese studies
were also carried before the establishment ofthe 850 Test Guidelines. The Agency has not revisited these studies and reviewed again inthe light ofthe established Test Guideline (Series 850) since then. Atthe time of reregistration and the risk assessment process ofthese pesticides, the Agency will reviewthese studies again based onthe 850 Test Guidelines, and iffound deficient may classify them as supplemental. Ifthese studies are classified as supplemental, the effect ofany uncertainties introduced inthe assessment will be discussed. 

### 3. Acute oral toxicity (rat) and two yearrat reproduction study results for mammalian toxicity values are summarized below:

870.1100 Acute Oral Toxicity (Rat) Toxicity Category IIILDso = 4462/3852 mg/kg (M/F)

870.3800 Reproduction and Fertility Effects Toxicity category missing, no end points established 4. 

### The acute toxicity and two-generation mammaliantoxicity (reproduction and fertility effects) onterrestrial and aquatic animals will also be included inthe ecological risk assessment

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### Table 8 Ecotoxicty Categories Birds and Mammals Category Aquatic animals LDso(mg/kg) LCso(ppm) LCso (ppm); ECso(ppm) <10 < 50 Very highly toxic < 0.1 10-50 50-500 Highly toxic 0.1-1 51-500 501-1000 Moderately toxic > 1-10 501-2000 1001-5000 Slightly toxic >10-100 >2000 >5000 Practically non-toxic > 100



### Ecotoxicity Data Gaps: 850.1010 Acute Toxicity to Freshwater Invertebrates 850.1025 or 850.1055: Mollusc shell Deposition or Embryo/Larval Toxicity 850.1035 Mysid Acute Toxicity 850.1300 Freshwater Invertebrate Life-Cycle 850.1400 FishEarly-Life-Cycle 850.5400 Aquatic growth, green algae 850.1710] Aquatic organisms, bioavailability, biomagnifications toxicitytests 850.1730] for all three tests



### Environmental Fate and Transport and EcologicalEffects Conclusions: Orthobenzyl-para-chlorophenol is persistent under aerobic conditions in sandy loam soils with a halflife ofgreater than one year. The parent has a very high Log 

## Kow value (4.4), and therefore it has the potential to bioaccumulate. Orthobenzyl-para-chlorophenol is highly toxic to freshwater invertebrates, Rainbow trout and Bluegill, and practically non-toxic (orally, and dietary) to Bobwhite and Mallard.

AD has reviewed the previous fate and effects risk assessment in the 1995 Reregistration Eligibility Decision (RED) document oforthophenol-para-chlorophenol and its sodium and potassium salts. No quantitative ecological risk assessments were performed at that time because pool uses were considered to result in minimal to no exposure based on infrequent draining ofpools and all other uses would be dealt withNational Pollution Discharge Elimination System (NPDES) permitting ofthe Office ofWater. Based onthe change in datarequirements, evolution ofthe Agency science and regulatory policies, and development ofmany exposure models which are now used for risk assessments, it is anticipated thatthese assessments need to be updated. 

### Endangered Species Determination: The Agency has not conducted an ecological risk assessment that supports a complete endangered species effects determination for orthobenzyl-para-chlorophenol and salts. The ecological risk assessmentplanned during the registration review will allowthe Agency to determine whether THPS's use has "no effect" or "may affect" federally listed threatened or endangered species (listed species) ortheir designed critical habitats. When effects determination concludes that a pesticide's use "may affect" a listed species or its

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### designated critical habitat, the Agency will consult withthe US Fish and Wildlife Service and/or National Marine Fisheries Services as appropriate



### Water Quality Orthobenzyl-para-chlorophenol and its sodium and potassium salts are not identified as a cause ofimpairmentfor any water bodies listed as impaired under section 303(d) ofthe Clean Water Act, based oninformation provided atthe Agency'sNationalPesticides Cause ofImpairmentofWater website (searched Apri111, 2011)1. In addition, no Total Maximum Daily Loads (TMDL) has been developed for orthobenzyl-para-chlorophenol and its sodium and potassium salts, based on informationprovided at the Agency's National Pesticides TMDL website (searched April 11. 2011i 

### More information on impaired water bodies and TMDLs can be found at http://www.epa.gov/owow/tmdll. 

### The Agency invites submission ofwater quality data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix A ofthe 

### OPP Standard OperatingProcedure: Inclusion of Impaired Water BodyandOther Water QualityData in OPP'sRegistration Review RiskAssessmentandManagement Process (see: http://www

### .epa.govI 

### oppfead11cb/ppdc/2006/november061

### sessionI-sop.pdf), in orderto ensure they canbe used quantitatively or qualitatively inpesticide risk assessments. l:http://iaspub.epa.gov/tmdl_waterslO/attains_nation_cy.cause_detaiC303?p_cause_grou p_id=885 2:http://iaspub_epa.goc/tmdl_waters10/attains

_nation.tmdlJ>ollutant_ detail?pJ>ollutant_ group_id=885&pJ>ollutant_group

_name=PESTICIDES


### Incidence Reports on Aquatic, Terrestrial,Avian Organisms. There are no reported incidences inthe Agency's Ecological Incidence Information System (EllS) regarding orthobenzyl-para chlorophenol (searched Apri112, 2011); database last updated 101. 

### The absence ofdocumented incidents does notnecessarily
mean that such incidences did not occur.

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### APPENDIX A

DataJustifications for Ecotoxicity and Environmental Fate and Transport of Orthobenzyl-Para-Chloro-Phenol (OBCP) 

### I and Sodium and Potassium Salts. The datajustifications is for the parent (orthobenxyl-para-chlorophenol) only. OBCP stands for: Orthobenzyl-para-chlorphenol

GuidelineNumber: 850.5400 StudyTitle: Al2al toxicity ...i;"· >t\"··**~** forRequiringtheData As part ofa Tier I risk assessment, one indicator plant species is tested for phytotoxicity. This study would allow the Agency to categorize OBCP and its salts as toxic or non-toxic to plants. Iftoxic, additional higher tier plant tests would be needed. An endangered species assessment for endangered or threatened plants is not possible withoutthis study. PracticalUtility oftheData 1. Howwill thedata be used? This study would be used to evaluate the toxicity of OBCP and its salts to non-targetplants in terrestrial and aquatic ecosystems. 2. How could the data impacttheAgency's future decision-making? Adverse effects to non-target plants in terrestrial and aquatic ecosystems may result in mitigation to protect species at risk. Mitigation might include reduced label dosages, neutralization ofeffluents prior to discharge into water, restrictions on use in sensitive ecosystems or where endangered species are present, or other mitigation measures. 3. Whatis triggering the need for this data? Increased concern from state regulators and the public to evaluate impacts on WWTP operations, endangered species, and persistence in the environment, since initial registration, have triggered the need for this study. Green algae are critical to ecosystem health and productivity.



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._- GuidelineNumber: 835.1110 StudyTitle: Activated Sludge SorptionIsotherm RationaleforReQuirine; theData The results from activated sludge sorption study would allow EPA to assess the distribution ofthe antimicrobial among the solid, aqueous, and vapor phases ofWWTPs. Specifically, this study identifies those chemicals which sorb to sludge biomass. PractiealUtilityoftheData 1. Howwill the data be used? The data would be used to determine the sorption potential ofOBCP and its salts to activated sludge biomass and in biological wastewater treatment systems. 2. How could the dataimpactthe Agency's future decision-making? IfOBCP and its salts is not sorbed or biodegradedthen, it would pass through a biological treatment system unaffected and it may contaminate surface and drinking waters and also may have potential adverse effects to nontarget organisms. 3. Whatis triggering the need for this data? Studies are needed to conduct environmental fate assessment and to determine the sorption potential of activated sludge for the removal ofspecific chemical compounds in biological wastewater treatment systems. ._-**~~~~~~~--~~~~------------------------------------------------------.--** GuidelineNumber: 835.2120 StudyTitle: Hydrolysis RationaleforRequirine; theData**~--~--~----------~----~~~==~~~~~~~~~~--------------------------** Results from the hydrolysis study will indicate the stability and persistence ofOBCP and its salts, indicating the potential for this chemical to contaminate water discharged to WWTPs. In aquatic effluents, WWTPs may discharge directly to surface waters. The Agenc)' will evaluate.IJotential risks ofconcern.**r-~~~--------~------------------------------------------------------------** 

## ..--- PracticalUtilityoftheData**~--------------------------~~~~~~~~~~~~--------------------------.--** 1. How will the data be used? Datawould showlhelp in establishing chemical hydrolysis as a route for degradation ofa pesticide and to identify, ifpossible, the hydrolytic products formed which may adversely affect non-target organisms and may contaminate water and food source ofaquatic organisms. 2. How could the data impactthe Agency's future decision-making? The results ofhydrolysis data would indicate ifOBCP and its salts is persistent or it degrades into degradation products which may adversely affect non-target organisms and may contaminate their food and water and possibly soil. 3. Whatis triggeringthe need for this data? Hydrolysis data is needed to conductthe fate assessmentto support indoor uses for OBCP.**~~--~----------------------------------------~-------------------------------**



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### ._- GuidelineNumber: 

### 835.2240 DataRequirement: Photode2radationinwater

. RationaleforRequiringtheData Biocides introduced into aqueous systems in the environment can undergo photolytic transformation by sunlight. Results from the photolysis study will indicate the stability and persistence ofOBCP and its salts and potential degradates in an aquatic environment when exposed to sunlight. For outdoorwood preservative uses, OBCP and its salts can reach surface water through direct contact or discharge to WWTPs. OBCP and its salts may also reach surface water or groundwaterthrough run-offor leaching processes. The Agency will evaluate the potential risks ofconcern.



### --

..... .( PracticalUtility oftheData 1. Howwill the data be used? The data would establish the significance ofchemical photolysis as a route for degradation and identify, ifpossible, the photolytic degradation products formed that may adversely affectnon-target organisms and may contaminate water and food source ofaquatic organisms. The data would also help establish the photolytic halflife ofOBCP and its salts and possibly degradates, and assist in developing a degradation pathway. 

### 2. How could the data affect the risk assessment? The results ofphotolysis data would indicate ifOBPC and its salts is persistent or ifit degrades into degradation products that may adversely affect non-target organisms and may contaminate their food. The results ofthe photolysis data would expand the understanding ofthe results ofthe hydrolysis data since environmental aquatic conditions usually involve exposure to sunlight. 3. What is triggering the need for this data? Aqueous photo-degradation data is needed to conductthe fate assessmentto support indoor and outdoor wood preservative uses for OBCP and its salts. 

### ._-

Guideline Number: 850.1010 Study Title: Acute Aquatic Invertebrate Rationalefor Requiringthe Data
This study will allow the Agencyto determine the toxicity of OBCP to freshwater daphnids. An endangered species assessment for endangered orthreatened freshwater daphnids is not possible withoutthis study. Therefore, this study is required. PracticalUtility oftheData 1. How did the Agency make its re-registration decision withoutthis data?
The Agency imposed risk mitigation through labeling changes as an interim measure.
2. Howwill the data be used?
The study will be used for hazard labeling in the event a spill ofmanufacturing use product occurs. This studywill be used to generate a freshwater invertebrate endpoint so thatthe Agency can evaluate the toxicity of OBCP to non-target and endangered/threatened freshwater daphnids in freshwater aquatic ecosystems.
3. How could the dataimpacttheAgency's future decision-making?

Ifthe acute freshwater fish toxicity is 1.0 mgIL or less, the label must state: "This pesticide is toxic to fish." A freshwater fish endpoint will allow the Agency to determine ifendangered orthreatened



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species are at risk or iffreshwater fish are impacted after residues pass through waste watertreatment plants into surface waters. Mitigation might include reduced label dosages, neutralization ofeffluents priorto discharge into water, restrictions on use in sensitive ecosystems orwhere endangered species
are present, or other mitigation measures which require refined scientific assessments.

GuidelineNumber: 850.1300 DataRequirement: Aquatic invertebratechronic NOAEC using

### Daphniamagna

..Rationale forRequiringtheData Invertebrates serve as food for fish, birds, crustaceans, and even whales. Theprotection ofnontarget invertebrates is essential to the food chain in any healthy ecosystem. The value in the Daphnid (850.1300) chronic toxicity tests are that they provide information onthe effects ofpesticides on mortality, growth, and reproduction over a longerterm (21 days for Daphnids compared to acute studies. Data are obtained from the first generation (G1) and the second generation (G2), thus allowing examination ofthe complete invertebrate life cycle for toxicity. PracticalUtilityoftheData 1. Howwill the data be used? Datawould be used to calculate LC50's for mortality, EC50's for growth, a NOEC, and a MATC (maximum acceptable toxicant concentration). The data would allow the Agency to determine chronic effects, including effects on reproductive success and growth, to freshwater invertebrates from water column exposure to OBCP and its salts. 2. How could the data affect the risk assessment? Because acute toxicity data alone are not a reliable indicator ofchronic toxicity, chronic toxicity data are also required. The Agency cannot make the assumption that a chemical is not chronically toxic at much lower concentrations than some ratio ofthe LC50 value would suggest. The results would be used to determine the likelihood thatthe chronic risks can potentially impact aquatic communities, eitherby direct effects on invertebrates or by indirect effects on organisms which feed on them. Daphniamagna (for fresh water) are used to represent all invertebrate species living in the water column in the risk assessmentprocess. Additionally, the use ofthe most sensitive species ensures the protection ofother species within thattaxon. As part ofthe chronic risk assessment for aquatic animals, the lowestNOEC for estuarine/marine invertebrates is used in the RQ equation. A chronic LOC is defined by an RQ > 1, and would indicate thatthere is the potential for chronic risk that may warrant regulatory action and that endangered species may potentially be affected through chronic exposure. 3. What is triggering the need for this data? Data are needed in orderto conduct an ecological risk assessment for the proposed use ofOBCP and its salts as a wood preservative and determine the chronic toxicity ofOBCP to freshwater and marine invertebrates using life-cycle studies. L-

____________**~**____ L_

________________________________________________________ .. ___



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--- GuidelineNumber: 850.1400 DataRequirement: Fish early-life sta2etoxicity test (freshwater)

... RationaleforRequiringtheData Fish early-life stage study is less expensive to conductthan the full life cycle study. Fish early-life stage study gives us some indications ifthe pesticide is toxic to fish reproduction and survival. In the fish early-life stage study, fertilized eggs are placed in test chambers and exposed to the pesticide in water at least until all the control fish are free-feeding. Lethal and sub lethal effects are assessed and compared with control values to determine the LOEC andthe NOEC.

-- PracticalUtilityoftheData 1. Howwill the databe used? The data are used to determine embryo hatch rate, time to hatch, time to swim-up, growth (length and weight), and any clinical orpathology findings 2. How could the data affect the risk assessment? Aspart ofthe chronic risk assessment for aquatic animals, the lowestNOEC for estuarine/marine fish is used in the RQ equation. A chronic LOC is defined by an RQ > 1, and would indicate that there is the potential for chronic risk that may warrantregulatory action and that endangered specit:s maypotentially be affected through chronic exposure. 3. What is triggering the need for this data? Data are needed in orderto conduct an ecological risk assessment for the proposed use ofOBCP and determine the effects ofOBCP and its salts on fish develoQment and survival during early life stages.

--- GuidelineNumber: 850.1025 DataRequirement: Acute oystertoxicity test (shell deposition) RationaleforRequirin2theData Oysters are important economic species to the United States economy. This acute toxicity test measures shell deposition in Eastern oysters (Crassostrea virginica) across a range ofconcentrations to determine ifgrowth is inhibited by short-term (96-h) exposure to OBCP in estuarine/marine waters. PracticalUtility oftheData 1. How would the data be used? Datawould be used to characterize the concentration-response curve and determine the NOEC (no observable effect concentration) and an ECSO with 9S% confidence interval. The ECSO is the concentration ofthe pesticide in water that is calculatedto reduce growth (as measured by shell deposition) by SO% compared to the controls. 2. How could the data affect the risk assessment? There are many mussel species that are listed as threatened and endangered inthe United States. Crassostreavirginica is considered as a surrogate species torepresent all estuarine/marine invertebrates intherisk assessmentprocess. Aspart ofthe acute risk assessment ofaquatic animals" the lowestECSO orLCSO for estuarine/marine invertebrates are used as inputs to the Risk Quotient (RQ) method for expressingrisk. An acute RQ > O.S would indicate an acute level ofconcern (LOC), defined as the potential for acute riskto non-target organisms whichmay warrantregulatory action inadditionto restricted use classification. An acute RQ 

### > 0.1 wouldresult in an acute restricteduse LOC, defined as the potential for acute riskto non-target organisms, whichmaybe mitigatedthroughrestricted use classification. An acute RQ > O.OS would fall underthe LOC for acute endangered species. 3. What is triggering the need for this data? Data are needed in orderto conduct an ecological risk assessment for the proposed use ofOBCP as a wood preservative and determine the effects ofOBCP on shell deposition in Eastern oysters.



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GuidelineNumber: 850.1035 DataRequirement: AcuteMysid toxicity test GuidelineNumber: 850.1045 DataRequirement: AcutePenaeidtoxicity test

••• RationaleforRequiringtheData Shrimp are important economic species to the United States as are lobsters, crabs, and other crustaceans. Shrimp are used as surrogate for all other crustaceans. These acute toxicity tests measure mortality ofestuarine/marine shrimp species, including mysids (OPPTS 850-lO35) and penaeids (OPPTS 850-1045) across a range ofconcentrations to determine ifsurvival is inhibited by short-term (96-h) exposure to OBCP in estuarine/marine waters. PracticalUtility oftheData 1. How would the data be used? Datawouldbe used to describe the concentration-response curves and determine 48- and 96-h LC50's (concentrations calculated to kill 50% ofthe population) along with 95% confidence intervals. 2. How could the data affect the risk assessment? Mysidopsis Bahia is considered as a surrogate species to represent all estuarine/marine invertebrates in the risk assessmentprocess. Aspart ofthe acute risk assessment for aquatic animals, the lowest EC50 or LC50 for estuarine/marine invertebrates is used in the RQ method for expressing risk. An acute RQ 

### > 0.5 would indicate an acute LOC, defined as the potential for acute risk to non-target aquatic organisms which may warrant regulatory action in addition to restricted use classification. An acute RQ 

### > 0.1 would result in an acute restricted use LOC, defined as the potential for acute risk to non-target organisms, which may be mitigated through restricted use classification. An acute RQ 

### > 0.05 would fall underthe LOC for acute endangered species. 3. What is triggering the need for this data? Data are needed in orderto conduct an ecological risk assessment for the proposed use ofOBCP as a wood preservative and determine the acute toxicity ofOBCP to estuarine/marine shrimp. ._-



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._- GuidelineNumber: 850.1055 DataRequirement: Acute oysterembryo larval RationaleforRequiringtbeData Oysters are an importanteconomic species to the United States as are lobsters, crabs, and other crustaceans. The bivalve acute toxicity testmeasures mortality and abnormal development in Eastern oysters (Crassostrea virginica) , Pacific oysters (Crassostrea gigas), quahogs (Mercenaria mercenaria), orbaymussels (Mytilus edulis) exposed to a range ofconcentrations in estuarine/marine waters.

....,

## .. PracticalUtilityoftbeData 1. How would the data be used? Datawould be used to determine a 48-h LC50 for dead larvae and EC50 for abnormally developed larvae (with 95% confidence intervals), along with a LOEC (lowest observable effect concentration) and NOEC. Normal larvae are those that are alive with completely developed shells containing meat. 2. How could the data affect the risk assessment? There are many mussel species that are listed as threatened and endangered inthe United States. Crassostreavirginica is considered as a surrogate speciesto represent all estuarine/marine invertebrates inthe risk assessmentprocess. As part ofthe acute risk assessmentfor aquatic animals, the lowestEC50 orLC50 for estuarine/marine invertebrates is used inthe RQ equation. An acute RQ 

### > 0.5 would indicate an acute LOC, defined as the potential for acute riskto non-targetorganisms whichmay warrantregulatory action in additionto restricted use classification. An acute RQ 

### > 0.11 wouldresult in an acute restricteduse LOC, defined as the potential for acute riskto non-target organisms, which maybe mitigatedthroughrestricted use classification. An acute RQ 

### > 0.05 would fall underthe LOCfor acute endangered species. 3. What is triggering the need for this data? Data are needed in orderto conduct an ecological risk assessment for the proposed use ofOBCP as a wood preservative and determinethe acute toxicity ofOBCP to estuarine/marine mollusks.

. ..-



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--- GuidelineNumber: 850.1710 DataRequirement: AquaticBioavailability: OysterBCF GuidelineNumber: 850.1730 DataRequirement: AquaticBioavailability: FishBCF

RationaleforRequiringtheData The value ofthese studies is that freshwater and/or marine aquatic species ofinvertebrates and vertebrates can be examined to determine ifa pesticide has the potential to accumulate in body tissues directly through bioconcentration from the water and/or indirectly through biomagnification via food transfer up the food chain. PracticalUtilityoftheData 1. Howwill the data be used? In the oyster (850.1710) and fish (850.1730) BCF tests, parameters include mortality, abnormalities, steady-state or maximum bioconcentration factors (BCF) and uptake and depuration rate constants. Additionally, the major degradates can be identified and quantified at steady state. Typically, the categories include insect nymphs, crustaceans, mollusks, and fish (bottom-feeding, cold-water, and warm-water ormarine). 2. How could the data affect the risk assessment? In the risk assessmentprocess, direct effects LOCs for each taxonomic group are used to make inferences concerning the potential for indirect effects upon listed species thatrely upon nonendangered organisms. Information on the bioconcentration from water would assist risk assessors in making the inferences about indirect effects. 3. What is triggering the need for this data? Data are needed in orderto conduct an ecological risk assessment for the proposed use ofOBCP as a wood preservative and determine any potential bioconcentration from the water.

--- Sign-offDate : 04111111 DP Barcode No. : D383098



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062202 062203

# ~ 13544



# R192301

Chemical Name: 2-Benzyl-4-chlorophenol Potassium 2-benzyl-4-chlorophenate Sodium 2-benzyl-4-chlorophenate

PC Code: 062201

HED File Code: Memo Date: File ID: Accession #: 90832 AD RASSB Ecological Environmental Scoping Documents 4/1112011 00000000 000-00-0137

HED Records Reference Center 5/17/2011