Document ID: EPA-HQ-OPP-2012-0407-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2012-07-06T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

 		     WASHINGTON, D.C. 20460

 ADVANCE \d61 	OFF		ICE OF PREVENTION,

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

				Chemical Class: Biochemicals

FROM:		Sadaf Shaukat, Biologist

Biochemical Pesticides Branch

Biopesticides & Pollution Prevention Division (7511P)

TO:			Leonard Cole, Regulatory Action Leader

				Biochemical Pesticides Branch

Biopesticides & Pollution Prevention Division (7511P)

THE FOLLOWING CONTAINS CONFIDENTIAL BUSINESS INFORMATION 

ACTION REQUESTED

The following is a preliminary human health assessment for Potassium
bicarbonate and Sodium bicarbonate in support of the development of the
Registration Review Work Plan.  

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 ingredients. Hazard and exposure information as well as
Agency risk assessments on Potassium bicarbonate 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 additional human health risk
assessment. These two compounds are found throughout nature in living
systems 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 function. They are also present in soils, water,
rocks, and other parts of the environment. They are found in many
consumer products. Both compounds degrade rapidly into non-toxic
components. There is reasonable certainty that no harm will result to
the general 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 registered with BPPD containing Potassium bicarbonate
as the active ingredient.  Three out of the eight products are technical
grade active ingredients (TGAI).  There is one TGAI registered 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 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]

§ 180.1176   Sodium bicarbonate; exemption from the requirement of
a tolerance.

The biochemical 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]

III. 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 from the use of the Potassium bicarbonate
products.  

IV. Toxicity Profile

Potassium bicarbonate and Sodium bicarbonate area naturally-occurring
substances 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 toxicity.  

Please see the tables below for detailed information regarding the
toxicity data requirements.

Available toxicity data as required by 40 CFR 158.2050 regarding
Potassium and Sodium bicarbonate are summarized below in Tables 1-7.

Table 1. Potassium and Sodium bicarbonate: Acute Oral Toxicity/OPPTS
870.1100

Active Ingredient	

LD50	

Toxicity Category	MRID

Potassium bicarbonate	2900 mg/kg (males)

2600 mg/kg  (females)

2700 mg/kg (sexes combined)	

III	44001001

Potassium bicarbonate	3822 mg/kg (males)

2931 mg/kg (females)

3358 mg/kg (sexes combined)	III	44092504

Sodium bicarbonate	7937 mg/kg (males)

6618 mg/kg (females)

7334 mg/kg (sexes combined)	IV	43297202

Sodium bicarbonate	5000 mg/kg	IV	43463104

Sodium bicarbonate	5000 mg/kg	IV	43463204

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

	

Active Ingredient	

LD50	

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 870.1300

Active Ingredient	

LC50	

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 irritation
cleared by day 7	III	44001004

Potassium bicarbonate	Conjunctival redness and swelling cleared by 72
hours	III	44092507

Sodium bicarbonate	Iritis and conjunctival 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	43463206

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 bicarbonate	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

Potassium 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 File

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

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