IUR Petition Review Report

December 22, 2004

CASRNs and TSCA Inventory Chemical Names:

56-81-5 1,2,3-propanetriol

Alternate Chemical Names Used in Petitions: 

glycerol

glycerin

Petitioners and Docket Numbers:

P&G Company OPPT-2003-0059

Dow Chemical Company OPPT-2003-0059

Keller & Heckman OPPT-2004-0071

Note: Other chemicals were included in the Keller & Heckman petition, and these other

chemicals are addressed in other petition review reports.

Summary of Decision: The petition review group determined that, at this time, EPA has a low

current interest in the processing and use information collected under the Inventory Update Rule

(IUR, 40 CFR Part 710) for 1,2,3-propanetriol (CASRN 56-81-5) and therefore is recommending

a grant for this petition. This recommendation is based primarily on Considerations B and C. 

EPA will initiate rulemaking to add 1,2,3-propanetriol (CASRN 56-81-5) to the partial

exemption list at 40 CFR 710.46(b)(2)(iv). The final listing decision is pending, based on

responses to the FR notice. EPA may reevaluate the IUR reporting status of 1,2,3-propanetriol

(CASRN 56-81-5) if the Agency obtains new information indicating a need for processing and

use information.

Please note that IUR submitters can still report processing and use information even if a chemical

is partially exempt, so that their chemicals can be considered for safer substitute analyses.

Background: EPA received a petition requesting that 1,2,3-propanetriol (CASRN 56-81-5) be

exempted from reporting processing and use information under the Inventory Update Reporting

rule (IUR) (See 40 CFR 710.46(b)(2)(iv)). The chemical substances included on this “partial

exemption” list are substances for which EPA has previously determined that there is a low

current interest in the IUR processing and use information. However, as stated in the preamble

to the amendment to the IUR promulgated on January 7, 2003 (68 FR 854), “...the need for

processing and use information ... changes over time. The inclusion of a chemical substance

under this partial exemption is not based on the potential risks of a chemical. This partial

exemption is solely intended to provide a tool to assist the Agency in better managing the

collection of processing and use information...” and is also “based on the Agency’s current need

for collecting IURA processing and use information.” (68 FR 855) Additionally, the preamble

states “In determining whether there is low current interest in IURA processing and use

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information related to a specific chemical substance, EPA will look to the specific circumstances

surrounding the chemical in question, and may use one or more of the considerations identified

below, and/or considerations not identified below, to make an informed decision.” The

considerations used by EPA in reviewing this petition and an analysis of how those

considerations relate to the chemicals identified in this petition are set forth below.

Discussion: The petition review group considered information submitted with the petition, as

well as other information including (but not limited to): whether the petition substances are

included in TRI, IRIS, or IARC; OECD SIDS program status; and HPV Challenge Program

status and other regulatory programs administered by EPA. 

1

The petition from Proctor and Gamble (docket number OPPT-2003-0059) linked information

provided in the petition to specific considerations cited in 40 CFR 710.46(b)(2)(ii), providing a

citation to a SIAR and other information. While there were two other petitions submitted, EPA

relied upon the information submitted by Proctor and Gamble for this review.

Consideration A: Production volume.

The petition review group found that there was at least one site reporting in 2002 with a

production volume for 1,2,3-propanetriol (CASRN 56-81-5) of 300,000 pounds or greater.

Consideration B: The substance’s chemical and physical properties or potential for persistence,

bioaccumulation, health effects, or environmental effects.

The petition included the SIAR (dated 01/02/2002) for 1,2,3-propanetriol (CASRN 56-81-5), and

provided a summary of specific, pertinent details. The SIAR concluded that there is a low hazard

potential for 1,2,3-propanetriol (CASRN 56-81-5) (Ref 1). According to the SIAP, dated March

2002, the “weight of evidence indicates that 1,2,3-propanetriol (CASRN 56-81-5) is of low

toxicity when ingested, inhaled, or in contact with the skin” (Ref 2). The petition summary of

the SIAR stated that 1,2,3-propanetriol (CASRN 56-81-5) has low hazard to the aquatic

environment. 

Additionally, the petition noted that “the SIAR concluded that based on the available data,

glycerol: 

1. Is considered to be readily biodegradable in the aquatic environment. (Section 2.1.5,

p.5) 

2. Is not expected to bioaccumulate. (Section 2.1.6, p.5) 

3. Is approved for use as a direct food additive, indirect food additive and is recognized as

generally safe for use in food. (Section 2.2, p.6) 

4. Is of very low acute toxicity to mammals. (Section 3.1.2.2, p. 8) 

5. Has no in vitro or in vivo data indicating a genotoxic potential. (Section 3.1.4, p. 12) 

See the attached list of acronyms at the end of this report.

1

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6. Does not raise concern for carcinogenic potential. (Section 3.1.5, p.12) 

7. Does not have any adverse effects on reproductive parameters. (Section 3.1.6 p.13) 

8. Is not irritating when in contact with the skin. (Section 3.1.7.1, p.13) 

9. Is not irritating to the eyes. (section 3.1.7.2, p.14) 

10. Has no human or animal data indicating it is a skin sensitizer. (Section 3.1.7.3, p. 14) 

11. Is of low acute toxicity to fish and aquatic invertebrates. (Section 4.1.l, p. 15) 

12. Is of low acute or chronic toxicity to algae. (Section 4.1.2, p. 16) 

13. Is of low toxicity to bacteria. (Section 4.1.3, p.17) 

14. Is of low hazard to the aquatic environment. (Section 4.1.5, p. 17)”

EPA has reviewed this information and concludes at this time that there is no evidence of

concerns about persistence, bioaccumulation, human health effects or environmental effects.

Consideration C: The information needs of EPA, other federal agencies, tribes, states, and local

governments, as well as members of the public.

1,2,3-Propanetriol (CASRN 56-81-5) was originally excluded by EPA from the Agency’s HPV

Challenge program based on a preliminary EPA review indicating that testing using the SIDS

base set would not further our understanding of the chemical's properties, but was voluntarily

sponsored by the ICCA APAG Glycerol Group and therefore is part of the HPV Challenge

program. Because it was sponsored, EPA did not list this chemical on the initial list of partially

exempt substances at 40 CFR 710.46(b)(2)(iv) (see Methodology Used for the Initial Selection of

Chemicals for the Inventory Update Rule Amendments (IURA) ‘Low Current Interest’ Partial

Reporting Exemption for additional information). However, EPA continues to believe that more

information on 1,2,3-propanetriol (CASRN 56-81-5) would not further our understanding of this

chemical. As demonstrated in consideration B, there is no evidence of concerns about

persistence, bioaccumulation, human health effects, or environmental effects, and therefore the

IUR processing and use information is of low current interest. 

As of the writing of this report, other current needs for IUR processing and use information for

1,2,3-propanetriol (CASRN 56-81-5) were not identified. This petition was circulated among the

Interagency Testing Committee members; no one identified a current interest in the IUR

processing and use information for this chemical. The process for adding this chemical to the

partial exemption list involves publishing a Federal Register notice asking for comment,

including asking if there is interest in the IUR processing and use information for this chemical.

Consideration D: The availability of other complementary risk screening information.

The petition noted that the completed SIAR contains risk screening information, which serves as

a source of complementary risk screening information. The petition also listed other sources of

additional risk screening information, and that the conclusions of those other sources agreed with

the conclusion in the SIAR. As noted in consideration B, EPA believes that, due to the

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extremely low hazard of this chemical, additional risk screening information is not needed at this

time. 

Consideration E: The availability of comparable processing and use information. 

The petition noted that there were several sources of processing and use data and stated that data

from those sources are comparable to the IUR processing and use data. EPA has reviewed those

sources and disagrees that the data are comparable. In light of the extremely low hazard of this

chemical, however, the petition review group believes the IUR processing and use information

for 1,2,3-propanetriol (CASRN 56-81-5) is of low current interest at this time. EPA may

reevaluate the IUR reporting status of this chemical in the future if the Agency obtains new

information indicating a need for processing and use information. 

Consideration F: Whether the potential risks for the chemical substance are adequately managed

by EPA or another agency or authority. 

The petition states that 1,2,3-propanetriol (CASRN 56-81-5) use and manufacturing would

primarily fall under the authority of EPA, FDA, OSHA, and CPSC. The petition did not provide

specific information on this point, and therefore EPA could not evaluate this consideration. 

However, in light of the considerations discussed above, the workgroup believes the IUR

processing and use information is of low current interest.

Other Considerations:

Additionally, the petitioner notes that 1,2,3-propanetriol (CASRN 56-81-5) is a component part

of all natural triglycerides and related mono/diglycerides, such as the animal fats and vegetable

oils that are also currently listed on the partial exemption. This rationale is not compelling - a

“natural” chemical is not necessarily a safe chemical and therefore any “natural” aspect is not

germane to the determination of interest.

Cited References:

1. Screening Information Data Set (SIDS) Initial Assessment Report (SIAR) for SIAM 14, January 2, 2002, EPA Docket #

OPPT-2003-0059-0003.

2. Screening Information Data Set (SIDS) Initial Assessment Profile (SIAP), March 2002, available at

http://cs3-hq.oecd.org/scripts/hpv/Status/DownloadFile.ASP?CASNUM=56815&StatusCode=SIARC&DataNo=1

Sources Searched:

(Note: These sources are typically searched or reviewed to gather information presented in the petition review report).

American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Values (TLV-TWA). 2003. ACGIH,

Cincinnati OH. pp. 12-61.

Agency for Toxic Substances and Disease Registry (ATSDR) ToxFAQs (Frequently asked questions about contaminants found TM

at hazardous waste sites). Available at http://www.atsdr.cdc.gov/toxfaq.html

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California Air Resources Board List of Toxic Air Contaminant Fact Sheets, available at

http://arbis.arb.ca.gov/toxics/tac/toctbl.htm

California EPA, Safe Drinking Water and Toxic Enforcement Act of 1986: List of chemicals known to the State to cause cancer

or reproductive toxicity. Listing as of Nov. 14, 2003. Available at

http://www.oehha.ca.gov/prop65/CRNR_notices/list_changes/111403lsta.html

International Agency of Research on Cancer (IARC) Overall Evaluations of Carcinogenicity to Humans. Available at

http://monographs.iarc.fr/monoeval/crthall.html

Interagency Testing Committee (ITC) Priority Testing List. Available at http://tsca-itc.syrres.com/Chemicals/

National Advisory Committee Acute Exposure Guideline Levels (AEGLs). Available at http://www.epa.gov/oppt/aegl/index.htm

Organisation for Economic Cooperation and Development (OECD) Integrated HPV Database,

http://cs3-hq.oecd.org/scripts/hpv/index.asp

United Nations Environment Programme (UNEP) persistent organic pollutants (POPs), available at

http://www.chem.unep.ch/pops/default.html

United Nations Environment Programme (UNEP) Ozone Secretariat, Summary Control Measures, available at

http://www.unep.org/ozone/Treaties_and_Ratification/2B_montreal_protocol.asp

U.S. EPA Clean Air Act (CAA) Hazardous Air Pollutants (HAPs). Available in the Clean Air Act, section 112(b), available at

http://www.epa.gov/air/caa/caa112.txt

U.S. EPA. Emergency Planning and Community Right-to-Know Act Section 313, List of Toxic Chemicals. 2001. Office of

Environmental Information, EPA 260-B-01-001, available at http://www.epa.gov/tri/chemical/chemlist2001.pdf

U.S. EPA HPV (High Production Volume) Challenge Program and Voluntary Children's Chemical Evaluation Program

(VCCEP) Web sites under the EPA Chemical Right-to-Know Initiative, http://www.epa.gov/chemrtk

U.S. EPA Integrated Risk Information System (IRIS) Substance List. Available at http://www.epa.gov/iris/subst/index.html

U.S. EPA. National Recommended Water Quality Criteria: 2002. Office of Water. EPA-822-R-02-047. Available at

http://www.epa.gov/waterscience/pc/revcom.pdf

U.S. EPA. 2004 Edition of the Drinking Water Standards and Health Advisories. Office of Water. EPA-822-R-04-005. 

Available at http://www.epa.gov/waterscience/drinking/standards/dwstandards.pdf

U.S. EPA Substance Registry System (SRS). Available at http://www.epa.gov/srs/

U.S. Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs), available at

http://www.osha.gov/SLTC/pel/index.html

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List of Acronyms

ACGIH American Conference of Governmental Industrial Hygienists

AEGL Acute Exposure Guideline Level

ARB Air Resources Board

ATSDR Agency for Toxic Substances and Disease Registry

CAA Clean Air Act

CASRN Chemical Abstract Service Registry Number

CICAD Concise International Chemical Assessment Document

CPSC Consumer Product Safety Commission

EHC Environmental Health Criteria

EPA Environmental Protection Agency

EU European Union

FDA Food and Drug Administration

FFDCA Federal Food, Drug, and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

GRAS Generally Recognized as Safe

HAP Hazardous Air Pollutant

HPV High Production Volume

HSDB Hazardous Substances Databank

IARC International Agency of Research on Cancer

ICCA International Council of Chemical Associations

IFCS International Forum on Chemical Safety

IPCS International Programme on Chemical Safety

IRIS Integrated Risk Information System

IRPTC International Register of Potentially Toxic Chemicals

ITC Interagency Testing Committee

IUCLID International Uniform Chemical Information Database

IUR Inventory Update Reporting Rule

IURA Inventory Update Reporting Rule Amendment

NAICS North American Industry Classification System

NIOSH National Institute for Occupational Safety and Health

OECD Organisation for Economic Cooperation and Development

OECD HPV SIDS or

OECD HPV SIDS

program

OECD/SIDS HPV Chemicals Programme

OPP Office of Pesticide Programs

OPPT Office of Pollution Prevention and Toxics 

OSHA Occupational Safety and Health Administration

PEL Permissible Exposure Limit

POP Persistent Organic Pollutant

SIAM SIDS Initial Assessment Meeting

SIAP SIDS Initial Assessment Profile

SIAR SIDS Initial Assessment Report

SIDS Screening Information Data Set

SRS Substance Registry System

TLV-TWA Threshold Limit Value Time-Weighted Average

TRI Toxics Release Inventory

TSCA Toxic Substances Control Act

UNEP United Nations Environment Programme

VCCEP Voluntary Children’s Chemical Evaluation Program

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