### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND POLUTION PREVENTION/OFFICE OF PESTICIDE PROGRAMS 

### MEMORANDUM **DATE:** June 1 , 2012 **SUBJECT** : Preliminary Human Health Assessment for the Registration Review of Potassium bicarbonate and Sodium bicarbonate **Registration Review Case #: 4048**  **PC Code: 07358, 073505**  **CAS #: 298**  **- 14**  **- 6, 144**  **- 55**  **- 8**  **Chem ical Class:**  Biochemi cal s 

### FROM: Sadaf Shaukat , Biologist

Biochemical Pesticides Branch Biopesticides & Pollution Prevention Division (7511P) **TO:** Leonard Cole , Regulatory Action L eader Biochemical Pesticides Branch Biopesticides & Pollution Prevention Division (7511P)
**THE FOLLOWING CONTAINS CONFIDENTIAL BUSINESS INFORMATION ACTION REQUESTED**  The following is a preliminary human h e alth assessment for Potassium bicarbonate and Sodium bicarbonate in support of the development of the Registration Review Work Plan
.2



### RECOMMENDATIONS AND CONCLUSIONS **Executive Summary** Based on the available data and information, the Agency does not foresee the need for new data or for a new human health risk assessment for these active ingredient s . Hazard and exposure information as w ell as Agency risk assessments on Potassium bicarb onate and Sodium bicarbonate were evaluated against current safety standards established by

the Agency ’s scientific policies and regulations and it was determined that there is no need to conduct an additio nal human health risk assessment. These two compounds are found throughout nature in living sy stems and in non
- living environments. They are an integral part of humans, other animals, plants, and virtually

all living organisms, and are crucial for normal f unction. They

are also present in soils, water, rocks, and other parts of the environment. They are found in many consumer products. B oth compounds degrade rapidly into non
- toxic components. There is reasonable certainty

that no harm will result to the gen eral population from exposure to these bicarbonates in the products containing them as active ingredients when they are used according to label instructions. **I. Background** Products containing Potassium or Sodium bicarbonate as the active ingredient are being used as fungicides
. Currently , there are eight products that are regist ered with BPPD containing Potassium bicarbonate as the active ingredient
. Three out of the eight products are technical grade active ingredients (TGAI ). There is one TGAIreg istered with BPPD containing Sodium bicarbonate. **II. Tolerances §**  **180.1177 Potassium bicarbonate; exemption from the requirement of a tolerance.**  The biochemical pesticide potassium bicarbonate is exempted from the requirement of a tolerance in or on al l raw agricultural commodities when applied as a fungicide or post
- harvest fungicide in accordance with good agricultural practices. [61 FR 67473, Dec. 23, 1996] **§ 180.1176**  **Sodium bicarbonate; exemption from the requirement of a tolerance.**3



### The biochemica l pesticide sodium bicarbonate is exempted from the requirement of a tolerance in or on all raw agricultural commodities when applied as a fungicide or post
- harvest fungicide in accordance with good agricultural practices. [61 FR 67473, Dec. 23, 1996] **I II**  **. Incidents** There were no incidents reported from the use of products containing Sodium bicarbonate. There were five incidents reported from the use of products containing Potassium bicarbonate. No details were reported to the Agency involving incidents fr om the use of the Potassium bicarbonate products. **I V**  **. Toxicity Profile** Potassium bicarbonate and Sodium bicarbonate are a naturally
- occurring substance s and are not expected to have adverse effects on human health. All toxicology data requirements have been satisfied and it is unlikely that any additional data will be required . Toxicology data and or rationale to fulfill or waive these requirements are available on the currently registered EPs; all of which indicate that these products are of low toxic ity
. Please see the tables below for detailed information regarding the toxicity data requirements. Available toxicity

data as required by

40 CFR 158.2050 reg arding Potassium and Sodium bicarbonate are summarized below in Tables 1
- 7.
T able 1. Potassium and Sodium bicarbonate : Acute Oral Toxicity/OPPTS 870.1100

**Active Ingredient LD**  **50 Toxicity Category**  **MRID** Potassium bicarbonate 2900 mg/kg (males) 2600 mg/kg (females) 2700 mg/kg (sexes combined) III 44001001 Potassium bicarbonate 3822 m g/kg (mal es) 2931 m g/kg (females) 3358 m g/kg (sexes combined) III 44092504 Sodium bicarbonate 7937 m g/kg (males)

6618 m g/kg (females) 7334 m g/kg (sexes combined) IV 43297202 Sodium bicarbonate 5000 mg/kg IV 43463104 Sodium bicarbonate 5000 mg/kg IV 434632044

Table 2. Potassium and Sodium bicarbonate : Acute Dermal Toxicity/OPPTS 870.1200

**Active Ingredient LD**  **50 Toxicity Category**  **MRID** Potassium bicarbonate 2,700 mg/kg III 44001002 Potassium bicarbonate >2020 mg/kg III 44092505 Sodium bicarbonate >2000 mg/kg* III 123051 Sodium bicarbonate >2000 mg/kg* III 43297203 Sodium bicarbonate >2000 mg/kg* III 43463105 Sodium bicarbonate >2000 mg/kg* III 43643205 *highest dose tested Table 3. Potassium and Sodium bicarbonate : Acute Inhalation Toxicity/OPPTS 8 70.1300

**Active Ingredient LC**  **50 Toxicity Category**  **MRID** Potassium bicarbonate >2.3 mg/L IV 44001006 Sodium bicarbonate 4.74 ± 1.03 mg/L IV 43297204 Table 4. Potassium and Sodium bicarbonate : Acute Eye Irritation/OPPTS 870.2400 **Active Ingredient Results**  **Toxicity Category MRID**  Potassium bicarbonate Iritis cleared by day 3, conjunctival irri t ation cleared by day 7 III 44001004 Potassium bicarbonate Conjunctival redness and swelling cleared by 72 hours III 44092507 Sodium bicarbonate Iritis and c onjunctival irritation cleared by day

4 III 43297205 Sodium bicarbonate Iritis and conjunctival irritation cleared by day

7 III 43463106 Sodium bicarbonate Iritis and conjunctival irritation cleared by day

6 III 434632065

Table 5. Potassium and Sodium bicarbonate : Acute Dermal Irritation/OPPTS 870.2500

**Active Ingredient Results at 72 hrs**  **Toxicity Category MRID**  Potassium bicarbonate No irritation IV 44001003 Sodium bicarbonate Slight irritation cleared by 48 hours III 43297206 Sodium bicar

bonate Very slight irritation

cleared by 48 hours III 43463107 Sodium bicarbonate Very slight irritation cleared by 48 hours III 43463207 Table 6. Potassium and Sodium bicarbonate : Skin Sensitization/OPPTS 870.2600

**Active Ingredient Results**  **MRID** Po tassium bicarbonate Not a sensitizer 44001005 Potassium bicarbonate Not a sensitizer 44092509 Sodium bicarbonate Not a sensitizer 43297207 Sodium bicarbonate Not a sensitizer 43480301



### Based on the information presented above, the Agency does not foresee the need for new data or for a new human health risk assessment. There is reasonable certainty that no harm will result to the general population from exposure to Potassium or Sodium bicarbonate in the products containing this active ingredient when they are used according to label instructions
.

cc: S. Shaukat, L. Cole , BPPD Science Review File6



### S. Shaukat, FT, PY
- S: 6/1/12