KH® 

KELLERAND HE KMAN LLP 

Sen ,ing Business through l.ow em I Science® 

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Suite 500 West 

Washington, D.C. 20001 

tel. 202.434.4100 

fax 202.434.4646 

April21, 2014 

Via Certified Mail 

OPPT IUR Submission Coordinator 

(7407M) Attention: Chemical Data 

Reporting Office of Pollution Prevention and 

Toxics U.S. Environmental Protection 

Agency 1200 Pennsylvania Ave., NW 

Washington, DC 20460-0001 

Writer's Direct Access 

Herbert Estreicher, J.D., Ph.D. 

(202) 434-4334 

e strei cher @ kh I aw . com 

Re: REQUEST FOR EXEMPTION OF FRUCTOSE FROM TSCA 

CHEMICAL DATA REPORTING (CDR) PROCESSING AND USE 

INFORMATION REPORTING REQUIREMENTS IN 2016 

Dear Sir or Madam: 

The Com Refiners Association (CRA) hereby requests the U.S. Environmental Protection 

Agency (EPA) to exempt fructose (CASRN 57-48-7) from the Toxic Substances Control Act 

(TSCA) Chemical Data Reporting (CDR) processing and use reporting requirements (Part III of 

the reporting form, Form U) pursuant to 40 C.F.R. 711.15(b)(2)(iii). Fructose is predominantly 

used in animal feed and is of low risk to human health and the environment. 

I BASIS FOR PETITION 

EPA regulations at 40 C.F.R. § 711.15(b)(2)(iii) permit any person to request that the 

EPA amend the list of substances of "low current interest" that are partially exempt from CDR 

requirements, specifically from the processing and use reporting requirements contained in 40 

C.F.R. § 711.15(b)(4). EPA states that in making the determination ofwhether this partial 

exemption should apply to a particular chemical substance, EPA will consider the totality of 

information available for the chemical substance in question, including but not limited to, certain 

enumerated considerations at 40 C.F.R. § 711.15(b)(2)(ii). 

Moreover, fructose is listed in Annex IV of the EU REACH Regulation as a substance 

that is exempt from Registration because "sufficient information is known" to conclude that the 

substance is "considered to cause minimum risk because of [its] intrinsic properties." 

The supporting attachments to this petition address each of the six exemption 

considerations for fructose. Most importantly, our petition demonstrates that there is "low current 

interest" in CDR processing and use data for this product because it is of low potential human 

________ __:_:_ W.::: ashing.=t=on.:..:. =D-=-=. C:.:.... - - --=B=r=us=se=ls:___ San Francisco Shangh:.;.:;a;;_i ____ __ _ 

This document was delivered electronically. www.khlaw.com 
KELLER AND HECKMAN LLP 

OPPT IUR Submission Coordinator 

April21 , 2014 

Page 2 

and environmental risk, is comprehensively regulated by other state and federal agencies, in 

particular the U.S. Food and Drug Administration, has a long history of safe use in both food and 

non-food products, and offers great promise for environmentally beneficial and sustainable 

alternatives to traditional synthetic chemistry. 

Based on these and the other considerations discussed below, we are confident that the 

EPA will conclude that these substances should be added to the list of CDR partially exempt 

substances. 

II TSCA REGULATED USES 

According to the CDR reports IUR the TSCA regulated uses include use as a chemical 

intermediate and as a filler in paper mills. 

Even though the subject request is to partially exempt fructose for the 2016 CDR 

reporting cycle, the Coalition requests that the EPA provide its response to this petition within 

the 120 days contemplated under 40 C.F .R. 711.15(b )(2)(iii)(A). The Coalition has a number of 

other food related substances for which it intends to submit similar requests and is anxious to 

receive the Agency's feedback on its general approach as reflected in the subject petitions. 

Sincerely, 

Partner 

Enclosures 

This document was delivered electronically. 
CDR Petition for Certain Food-Use Substances 

40 C.F.R. § 711.415(b)(2)(ii)(A) Criterion Information 

(Whether the chemical qualifies or has qualified in past IUR collections for the reporting of 

the information described in§ 711.1S(b)(4)). 

Publicly available information on the 1986-2006 IUR database and the 2012 CDR database was 

searched for fructose to determine whether the substance meets the criteria of "whether the 

chemical qualifies or has qualified in past IUR collections for the reporting of information 

described in §711.15(b)(4)." See 40 C.F.R. § 711.15(b)(2)(ii)(A). It was reported in the 2006 

IUR and the 2012 CDR. 

Processing and use data was provided by 8 companies in the 2012 CDR. The 2012 CDR 

volume was reported as 10 to 50 million lbs per year. Data reported to EPA for purposes of 

IUR on a confidential basis is not necessarily reflected in this submission. The Agency is 

respectfully requested to review the IUR database for confidential data to supplement the data 

provided. 
CDR Petition for Certain Food-Use Substances 

40 C.F.R. § 711.415(b)(2)(ii)(B) Criterion Information 

(The chemical substance's chemical and physical properties or potential for persistence, 

bioaccumulation, health effects, or environmental effects (considered independently or 

together). 

Data are available to EPA for fructose FDA Food Additives Summary Report and from 

modeling results. 

The following provides a summary of the data from these sources. 

Data Available on Fructose (CASRN 66071-94-1) 

1) Substance identity profile 

a. Substance identifiers 

IUPAC name: Fructose 

CAS name: Fructose 

Other names: 1,3,4,5,6-Pentahydroxyhex-2-one, 

Fruit sugar, levulose, D-fructose, 

D-arahin-2-hexulose 

CASRN: 57-48-7 

EC number: 200-333-3 

Molecular formula: C6H1206 

Molecular weight 180.16 g/mol 

b. Physical properties' 

Appearance: white crystalline powder 

Melting point: 103 degC 

Boiling point: 372 degC 

Relative density 1.665 at 20 degC 

Vapour pressure 1.9 x 10-" mmHg 

Partition coefficient (log Kowl Log Pow= -1.55 at 20°C (calculated) 

Solubility: 790 g/L at 20 degC 

Density 1.694 g/cmj 

Flash point 301 degC 

Henry's Law Constant 9.72E-015 atm-m3/mole (calculated) 

c. Manufacturing 

Commercially, fructose is frequently derived from sugar cane, sugar beets, and 

corn. Crystalline fructose is the monosaccharide, dried, ground, and of high 

purity. Through complete hydrolysis, sugar is split into its constituents, glucose 

and fructose. Subsequently, the fructose is separated chromatically from the 
glucose by use of an ion exchanger. In the use of corn, glucose from corn syrup 

is transformed into fructose by use of the enzyme, glucose-isomerase. 

d. Uses 

The primary use of fructose is as a nutrient sweetener in food. All 

forms of fructose, including fruits and juices, are commonly added to 

foods and drinks for palatability and taste enhancement. A small 

amount of fructose is used as a chemical intermediate and as a filler in 

paper mills. 

2) Toxicological profile 

a. Human Toxicity 

Fructose is found in many plants and is consumed on a daily basis. Numerous 

studies are reported in the FDA Food Additive Report Summary (Attachment 1) 

and show the high concentrations required for any effect. Fructose is recognized 

as safe by FDA for use as a sweetener. 

b. Ecological Toxicity and Environmental Fate 

Because of the natural derivation of fructose, specific guideline ecotoxicity 

studies are not available, nor are they necessary. Fructose is not expected to 

exhibit toxicity to fish or other aquatic organisms. The primary use of fructose is 

as a nutrient sweetener in food, and has a long history of safe use. Fructose 

would not inhibit microorganism growth, and in fact, would serve as a nutrient 

source. 

Fructose is water soluble and it would be expected that it would be present 

largely in the water compartment in the environment. It is a natural nutrient, so 

would rapidly be assimilated as an energy source in normal cellular processes. 

The modeling results for environmental fate of fructose (Attachment 2) show 

that it is readily biodegradable. 

c. Exposure 

Fructose is an important and widespread dietary carbohydrate source of energy 

in human food. It is present in its free form in fruits, together with glucose in the 

disaccharide sucrose, and as part of olig- and polysaccharides in many plants. 

Fructose is present as a commercial sweetener in sweets, confectionery and soft 

drinks. Fructose is consumed safely every day by virtually the entire population. 

3) Other information 

The Decernis FDA Food Additive Summary Report and the the EPI Suite Modeling 

Summary Results are attached to this document. 
CDR Petition for Certain Food-Use Substances 

40 C.F.R. § 711.15(b)(2)(ii)(C) Criterion Information 

(The information needs of EPA, other federal agencies, tribes, states, and local 

governments, as well as members of the public). 

Fructose has not been the subject of or considered for information collection requirements by 

EPA under TSCA (other than the TSCA IUR), the Interagency Testing Committee (lTC), or the 

Agency for Toxic Substances and Disease Registry (ATSDR). Fructose has not been or is it the 

subject of any proposed or final regulation by the EPA under the following programs: 

TSCA 4 Test Rules 

TSCA 4(F) Required Actions 

TSCA 5(A)(2) Chemicals Subject to Significant New Use Rules (SNURS) 

TSCA 5(B) Data Gathering Requirements 

TSCA 5(E) Testing Consent Order Chemicals 

TSCA 5(F) Immediately Effective Rules 

TSCA 6(A) Hazardous Chemical Control Rules 

TSCA 8(A) Toxic Substances Subject to Reporting Rules on Production 

TSCA 8(A) CAIR Comprehensive Assessment Information Rules 

TSCA 8(A) Pair Preliminary Assessment Information Rules 

TSCA 8(C) Records of Allegations of Significant Adverse Reactions 

TSCA 8(D) Health and Safety Reporting Rules 

TSCA 8(D) Health and Safety Reporting Rules Termination 

TSCA 12(B) Notices of Export 

SARA 313 Chemicals Regulated Under §313 of EPCRA 

See http:/ /www.epa.gov/opptintr/CORR/index.htm. 

The petitioning associations are not aware of any unmet information needs of the EPA, other 

federal agencies, tribes, states, local governments, or members of the public in light of: 

0 FDA regulatory clearances currently available for these petitioned substances which 

acknowledge that their use in food applications is safe; 

CRA would like the opportunity to respond and submit additional information needs identified 

by EPA during the petition process, if any, prior to EPA's final action on the petition request. 
CDR Petition for Certain Food-Use Substances 

40 C.F.R. § 711.15(b)(2)(ii)(D) Criterion Information 

(The availability of other complementary risk screening information). 

The following table provides the status of the petitioned substances on the Annex IV exemption 

determinations by the European Union for the REACH program, the status under the REACH 

registration program and the voluntary EPA High Production Volume (HPV) Chemical 

Challenge Program, and the EPA safety determinations for low toxicity pesticide inerts. 

CA. EU [EUREACH HPV Pesticid 

Numb :r 

Chemical Index Name REACH Registration List e 

Ex_emptioo LAeit"

1 

57-48-7 D-Fructose Annex IV !Exempt 0 4B 

The categorization for the 1990 and 1994 HPV lists are as follows: 

0 =Chemical is within the scope of the HPV Challenge Program and may be sponsored. 

1 = Chemical is not considered a candidate for testing under the HPV Challenge Program, based 

on preliminary EPA review indicating that testing using the SIDS base set would not further 

EPA's understanding ofthe chemical's properties. 

2 = Chemical is otherwise being handled under the Organization for Economic Co-operation 

and Development (OECD) Screening Information Data Set (SIDS) Program. 

3 = Chemical is not subject to the HPV Challenge Program because it is a polymer or inorganic 

substance. 

4 = A company or consortium has clearly indicated to and has had confirmed by ICCA its 

sponsorship ofthis chemical in the Global HPV Initiative ofthe International Council of 

Chemical Associations, and all information essentially equivalent to a Full Commitment under 

the HPV Challenge Program (i.e., chemical name, CAS number, start year for each chemical, 

technical contact person and telephone number) has been provided to EPA. 

The key to EPA's Pesticide and Inert listings are as follows: 

1 =Inert Ingredients of Toxicological Concern 

2 =Potentially Toxic Inert Ingredients/High Priority for Testing Inerts 

3 = Inerts ofUnknown Toxicity 

4A =Minimal Risk Inert Ingredients 

4B = Inerts which have sufficient data to substantiate they can be used safely in pesticide 

products 
CDR Petition for Certain Food-Use Substances 

40 C.F.R. § 711.15(b)(2)(ii)(E) Criterion Information 

(The availability of comparable processing and use information) 

Processing and use of these substances is well characterized. TSCA-regulated exposures 

associated with these substances are comparable to, or less significant than, the food-use 

exposures associated with these substances which have already been shown to be "safe". More 

specific processing and use information is included in the data summaries at that section of this 

petition that discusses (B) Criterion Information. 
IUR Petition for Certain Food-Use Substances 

40 C.F.R. § 711.15 (b)(2)(ii)(F) Criterion Information 

(Whether the potential risks ofthe chemical substance are adequately managed by EPA or 

another agency or authority) 

CRA is not aware of any information to suggest that these agencies are inadequately managing 

the safe use of fructose. 

The manufacturing and use of these substances primarily fall within the jurisdiction and 

authority of the FDA. However, the EPA, the Occupational Safety and Health Administration 

(OSHA), the National Institute for Occupational Safety and Health (NIOSH), and the Consumer 

Product Safety Commission (CPSC) regulate the manufacture and use of the petitioned 

substances as well. In addition, state environmental protection agencies have authority over 

facilities within their jurisdictions. 

As previously indicated, food uses of the petitioned components far exceed TSCA-regulated 

uses. Activities related to TSCA-regulated processing and use of the petitioned substances will 

also result from food-processing activities. Indeed, the same production equipment, processing 

techniques, and feed stocks may be used. These activities and their resulting environmental 

effects are already controlled adequately under other regulatory regimes. With respect to EPA 

programs specifically, human and environmental exposures are adequately controlled through 

existing regulatory programs such as the Clean Water Act, the Clean Air Act, and the Resource, 

Conservation and Recovery Act, and the Spill Prevention, Control and Countermeasures 

(SPCC) Program. Relevant FDA regulations for the petitioned substances are provided below. 

p e (( 110ne d s u b s t ance CASRN FDA R eg1 ul a: ti on a t 21 C F R .. D-Fructose 57-48-7 101.9- Nutrition labeling offood 

131.111 - Acidified milk 

131.112 - Cultured milk 

131.170 - Eggnog 

131.200 - Yogurt 

131.203 - Lowfat yogurt 

131.206- Nonfat yogurt 

13 3.179 - Pasteurized process cheese 

spread 

146.132- Grapefruitjuice 

155.170 - Canned peas 
C:\Users\price\Desktop\D-fructose EPI Suite.doc 

EP~ Suite Results For CAS 57 -48-7 

HO 

SMILES : 01CC(O)C(O)C(O)C1(0)CO 

CHEM D-Fructose 

MOL FOR: C6 H12 06 

MOL WT : 180.16 

OH 

HO 

---------- - ------------------- EPI SUMMARY (v4.11) --------------------------

Physical Property Inputs: 

Log Kow (octanol-water): 

Boiling Point (deg C) 

Melting Point (deg C) 

Vapor Pressure (mm Hg) 

Water Solubility (mg/L): 

Henry LC (atm-m3/mole) 

KOWWIN Program (v1.68) Results : 

Log Kow(version 1.68 estimate): -1.55 

SMILES : 01CC(O)C(O)C(O)C1(0)CO 

CHEM D-Fructose 

MOL FOR: C6 H12 06 

MOL WT : 180.16 

-------+-----+--------------------------------------------+---------+--------

TYPE I NUM I LOGKOW FRAGMENT DESCRIPTION COEFF VALUE 

-------+-----+--------------------------------------------+---------+--------

Frag 2 I -CH2- [aliphatic carbon] I 0. 4 911 0. 9822 

Frag 3 I -CH [aliphatic carbon] I 0. 3614 1. 0842 

Frag 1 I C [aliphatic carbon- NoH, not tert] I 0.9723 0.9723 

Frag 5 I -OH [hydroxy, aliphatic attach] 1-1.4086 -7.0430 

Frag 1 l -0- [oxygen, aliphatic attach] 1-1.2566 -1.2566 

Factor! 1 l Multi-alcohol correction I 0.4064 0.4064 
C:\Users\price\Desktop\D-fructose EPI Suite.doc 

Factor I 1 

Factor I 3 

Factor I 1 

Const I 

HO-CH-C(-0-)-CH-OH structure correction 

HO-CH-C(-OH)-CH-OH structure correction 

-0-C(-OH)-C-OH structure correction 

Equation Constant 

1.0649 

0.5944 

0.2248 

1.0649 

1.7832 

0.2248 

0.2290 

-------+-----+--------------------------------------------+---------+--------

Log Kow -1.5526 

MPBPVP (vl.43) Program Results: 

Experimental Database Structure Match: 

Name D-TAGATOSE 

CAS Num 000087-81-0 

Exp MP (deg C): 134.5 

Exp BP (deg C): 

Exp VP (mm Hg) : 

SMILES OlCC(O)C(O)C(O)Cl(O)CO 

CHEM D-Fructose 

MOL FOR: C6 Hl2 06 

MOL WT : 180.16 

- ---------- --- --- - - ----- SUMMARY MPBVP vl.43 - ----- ------- - - -----

Boiling Point: 372.50 deg C (Adapted Stein and Brown Method) 

Melting Point: 

Melting Point: 

233.45 deg 

103.84 deg 

168.65 deg 

C (Adapted Joback Method) 

C (Gold and Ogle Method) 

Mean Melt Pt 

Selected MP: 136.24 deg C 

C (Joback; Gold,Ogle Methods) 

(Weighted Value) 

Vapor Pressure Estimations (25 deg C): 

(Using BP: 372.50 deg C (estimated)) 

(Using MP: 134.50 deg C (exp database)) 

VP: 4.68E-009 mm Hg (Antoine Method) 

6.24E-007 Pa (Antoine Method) 

VP: 1.91E-008 mm Hg (Modified Grain Method) 

2.55E-006 Pa (Modified Grain Method) 

VP: 6.38E-006 mm Hg (Mackay Method) 

0.000851 Pa (Mackay Method) 

Selected VP: 1.91E-008 mm Hg (Modified Grain Method) 

2.55E-006 Pa (Modified Grain Method) 

Subcooled liquid VP: 2.4E-007 mm Hg (25 deg C, Mod-Grain method) 

3.2E-005 Pa (25 deg C, Mod-Grain method) 

-------+-----+--------------------+----------+---------

TYPE I NUM I BOIL DESCRIPTION COEFF VALUE 

-------+-----+--------------------+----------+---------

Group 1 -CH2- 24.22 24.22 

Group 1 -CH2- (ring) 26.44 26. 4 4 

Group 3 >CH- (ring) 21.66 64.98 

Group 1 >C< (ring) 11.12 11.12 

Group 1 -0- (ring) 32.98 32.98 

Group 1 -OH (primary) 88.46 88.46 

Group 3 -OH (secondary) 80.63 241.89 

Group 1 -OH (tertiary) 69.32 69.32 

2 
C:\Users\price\Desktop\D-fructose EPI Suite.doc 

* Equation Constant I 198.18 

=============+====================+==========+========= 

RESULT-uncorrl BOILING POINT in deg Kelvin 757.59 

RESULT- carr I BOILING POINT in deg Kelvin 645.66 

I BOILING POINT in deg C 372.50 

-------+-----+--------------------+-------~--+---------

TYPE I NUM I MELT DESCRIPTION COEFF VALUE 

-----~-+-----+--------------------+----------+---------

Group 1 -CH2- 11.27 I 11.27 

Group 1 -CH2- (ring) 7.75 I 7.75 

Group 3 >CH- (ring) 19.88 I 59.64 

Group 1 >C< (ring) 60.15 I 60.15 

Group 1 -0- (ring) 23.05 I 23.05 

Group 1 -OH (primary) 44.45 I 44.45 

Group 3 -OH (secondary) 44.45 I 133.35 

Group 1 -OH (tertiary) 44.45 I 44.45 

* I I Equation Constant I 122.50 

=============+====================+==========+========= 

RESULT MELTING POINT in deg Kelvin 506.61 

I MELTING POINT in deg C I 233.45 

Water Sol from Kow (WSKOW vl.42) Results: 

Water Sol: le+006 mg/L 

Experimental Water Solubility Database Match: 

Name Fructose 

CAS Num 000057-48-7 

Exp WSol 7.78E+005 mg/L (20 deg C) 

Exp Ref YALKOWSKY,SH & DANNENFELSER,RM (1992) 

SMILES : OlCC(O)C(O)C(O)Cl(O)CO 

CHEM D-Fructose 

MOL FOR: C6 Hl2 06 

MOL WT : 180.16 

---------------------------------- WSKOW vl.42 Results ------------------------

Log Kow (estimated) -1.55 

Log Kow (experimental): not available from database 

Log Kow used by Water solubility estimates: -1.55 

Equation Used to Make Water Sol estimate: 

LogS (mol/L) = 0.796- 0.854 log Kow- 0.00728 MW +Correction 

(used when Melting Point NOT available) 

Correction(s): Value 

No Applicable Correction Factors 

Log Water Solubility (in moles/L) 

Log Water Solubility (in moles/L) 

Water Solubility at 25 deg C (mg / L): 

0.810 

0.744 (Applied Upper Limit) 

le+006 

3 
C:\Users\price\Desktop\D-fructose EPI Suite.doc 

WATERNT Program (v1.01) Results: 

Water Sol (v1.01 est): 1e+006 mg/L 

Experimental Water Solubility Database Match: 

Name Fructose 

CAS Num 000057-48-7 

Exp WSol 7.78E+005 mg/L (20 deg C) 

Exp Ref YALKOWSKY,SH & DANNENFELSER,RM (1992) 

SMILES : 01CC(O)C(O)C(O)C1(0)CO 

CHEM D-Fructose 

MOL FOR: C6 H12 06 

MOL WT : 180.16 

-------+-----+--------------------------------------------+----------+---------

TYPE I NUM I WATER SOLUBILITY FRAGMENT DESCRIPTION COEFF VALUE 

-------+-----+--------------------------------------------+----------+---------

Frag 1 -CH2- [aliphatic carbon] 1-0.5370 -0.5370 

Frag 3 -CH [aliphatic carbon] l-0.5285 -1.5856 

Frag 1 C [aliphatic carbon - No H, not tert] 1-1.0516 -1.0516 

Frag 5 -OH [hydroxy, aliphatic attach] I 1.6012 8.0062 

Frag 1 -o~ [oxygen, aliphatic attach] I 1.2746 1.2746 

Frag 1 -CH2- [aliphatic carbon, cyclic] 1-0.3308 -0.3308 

Canst Equation Constant I 0.2492 

-------+-----+--------------------------------------------+----------+---------

NOTE Maximum Solubility (1,000,000 mg/L) Applied! 

-------+-----+--------------------------------------------+----------+---------

Log Water Sol (moles/L) at 25 dec C 0.7443 

Water Solubility (mg/L) at 25 dec C 1e+006 

ECOSAR Program (v1.11) Results: 

ECOSAR Version 1.11 Results Page 

SMILES 

CHEM 

01CC(O)C(O)C(O)C1(0)CO 

D-Fructose 

CAS Num: 

ChemiD1: 

MOL FOR: C6 H12 06 

MOL WT : 180.16 

Log Kow: -1.553 

Log Kow: 

Log Kow: 

Melt Pt: 

Melt Pt: 134.50 

Wat Sol: 7.346E+005 

Wat Sol: 

Wat Sol: 7.78E+005 

(EPISuite Kowwin v1.68 Estimate) 

(User Entered) 

(PhysProp DB exp value - for comparison only) 

(User Entered for Wat Sol estimate) 

(deg C, PhysProp DB exp value for Wat Sol est) 

(mg/L, EPISuite WSKowwin v1.43 ~stimate) 

(User Entered) 

(mg/L, PhysProp DB exp value) 

4 
C:\Users\price\Desktop\D-fructose EPI Suite.doc 

Values used to Generate ECOSAR Profile 

Log Kow: -1.553 

Wat Sol: 7.78E+005 

(EPISuite Kowwin v1.68 Estimate) 

(mg/L, PhysProp DB exp value) 

ECOSAR vl.ll Class-specific Estimations 

Neutral Organics 

Predicted 

ECOSAR Class Organism 

Neutral 

Neutral 

Neutral 

Neutral 

Neutral 

Neutral 

Neutral 

Neutral 

Neutral 

Neutral 

Neutral 

Organics 

Organics 

Organics 

Organics 

Organics 

Organics 

Organics 

Organics 

Organics 

Organics 

Organics 

Fish 

Daphnid 

Green Algae 

Fish 

Daphnid 

Green Algae 

Fish (SW) 

Mysid 

Fish (SW) 

Mysid (SW) 

Earthworm 

Duration 

====-=-== 96-hr 

48-hr 

96-hr 

96-hr 

96-hr 

14-day 

End Pt mg/L (ppm) 

=-==-== ===:%::==.:::::::= 

LC50 2.3e+005 

LC50 93882.945 

EC50 18016.305 

ChV 15237.300 

ChV 3674.655 

ChV 2272.577 

LC50 2.83e+005 

LC50 2.33e+006 * 

ChV 3508.001 

ChV 5.78e+005 

LC50 731.578 

Note: * = asterisk designates: Chemical may not be soluble enough to 

measure this predicted effect. If the effect level exceeds the 

water solubility by lOX, typically no effects at saturation (NES) 

are reported. 

Class Specific LogKow Cut-Offs 

If the log Kow of the chemical is greater than the endpoint specific cut-offs 

presented below, then no effects at saturation are expected for those endpoints. 

Neutral Organics: 

Maximum LogKow: 

Maximum LogKow: 

Maximum LogKow: 

Maximum LogKow: 

5.0 

6.0 

6.4 

8.0 

(Fish 96-hr LC50; Daphnid LC50, Mysid LC50) 

(Earthworm LC50) 

(Green Algae EC50) 

{ChV) 

HENRYWIN (v3.20) Program Results: 

Bond Est : 9.72E-015 atm-m3/mole (9.85E-010 Pa-m3/mole) 

Group Est: Incomplete 

SMILES 

CHEM 

OlCC(O)C(O)C{O)Cl{O)CO 

D-Fructose 

5 
C:\Users\price\Desktop\D-fructose EPI Suite.doc 

MOL FOR : C6 H12 06 

MOL WT : 180.16 

- - -------- - - --- - - - --- --- --- HENRYWIN v3.20 Results -------------- ---- ----- ---

----------+---------------------------------------------+---------+----------

CLASS BOND CONTRIBUTION DESCRIPTION I COMMENT I VALUE 

----------+---------------------------------------------+---------+----------

HYDROGEN 7 Hydrogen to Carbon (aliphatic) Bonds 1 -0.8377 

HYDROGEN 5 Hydrogen to Oxygen Bonds I 16.1589 

FRAGMENT 5 C-C I 0.5815 

FRAGMENT 7 C-0 I 7.5983 

FACTOR 4 Additional aliphatic alcohol -OH(s) 1-12.0000 

FACTOR * Cyclic mono-ether I .9000 

----------+---------------------------------------------+---------+----------

RESULT BOND ESTIMATION METHOD for LWAPC VALUE TOTAL I 12.401 

----------+---------------------------------------------+---------+----------

HENRYs LAW CONSTANT at 25 deg C = 9.72E-015 atm-m3/mole 

3.97E-013 unitless 

= 9.85E-010 Pa-m3/mole 

--------+----------------- --- --------------------~-----+------------+--------

1 GROUP CONTRIBUTION DESCRIPTION COMMENT VALUE 

--------+-----------------------------------------------+------------+--------

2 CH2 (C) (0) I -0.26 

3 CH (c) (c) ( 0) I 0. 3 6 

5 0-H (C) I 22.25 

1 0 (C) (C) I 2.93 

MISSING Value for: C (0) (0) (C) (C) 

--------+-----------------------------------------------+------------+--------

RESULT I GROUP ESTIMATION METHOD for LOG GAMMA VALUE I INCOMPLETE I 25.28 

--------+-----------------------------------------------+------------+--------

For Henry LC Comparison Purposes: 

Exper Database: none available 

User-Entered Henry LC: not entered 

Henrys LC [via VP/WSol estimate using User-Entered or Estimated values]: 

HLC: 4.528E-015 atm-m3/mole (4.588E-010 Pa-m3/mole) 

VP: 1.91E-008 mm Hg (source: MPBPVP) 

WS: 1E+006 mg/L (source: WSKOWWIN) 

Log Octanol-Air (KOAWIN v1.10) Results: 

Log Koa: 10.851 

SMILES : 01CC(O)C(O)C(O)C1(0)CO 

CHEM D-Fructose 

MOL FOR: C6 H12 06 

MOL WT : 18 0 . 16 

------------------- - ------- KOAWIN v1.10 Results ------------------------- -

Log Koa (octanol/air) estimate: 10.851 

Koa (octanol/air) estimate: 7.092e+010 

Using: 

Log Kow: -1.55 (KowWin est) 

6 
C:\Users\price\Desktop\D-fructose EPI Suite.doc 

HenryLC: 

Log Kaw: 

LogKow 

LogKow 

Henry LC: 

Henry LC: 

9.72e-015 

-12.401 

atm-m3/mo1e (HenryWin est) 

(air/water part.coef.) 

(exp database) 

-1.55 (KowWin estimate) 

--- atm-m3/mole(exp database) 

9.72e-015 atm-m3/mole (HenryWin bond estimate) 

Log Koa (octanol/air) estimate: 10.851 (from KowWin/HenryWin) 

BIOWIN (v4.10) Program Results: 

SMILES : 01CC(O)C(O)C(O)C1(0)CO 

CHEM D-Fructose 

MOL FOR: C6 H12 06 

MOL WT : 180.16 

------------------- -------- BIOWIN v4.10 Results - - ---------------- ----------

Biowin1 (Linear Model Prediction) Biodegrades Fast 

Biowin2 (Non-Linear Model Prediction) : Does Not Biodegrade Fast 

Biowin3 (Ultimate Biodegradation Timeframe) : Weeks 

Biowin4 (Primary Biodegradation Timeframe): Days 

Biowin5 (MITI Linear Model Prediction) Biodegrades Fast 

Biowin6 (MITI Non-Linear Model Prediction) : Biodegrades Fast 

Biowin7 (Anaerobic Model Prediction) : Biodegrades Fast 

Ready Biodegradability Prediction: YES 

------+-----+--------------------------------------------+---------+---------

TYPE I NUM I Biowin1 FRAGMENT DESCRIPTION COEFF VALUE 

------+-----+--------------------------------------------+---------+---------

Frag 4 Aliphatic alcohol [-OH] 0.1587 0.6349 

Frag 1 1 Carbon with 4 single bonds & no hydrogens -0.1839 -0.1839 

Frag I 1 Aliphatic ether [C-0-C] -0.3474 -0.3474 

MolWtl * Molecular Weight Parameter -0.0858 

Constl * Equation Constant 0.7475 

============+============================================+=========+========= 

RESULT Biowin1 (Linear Biodeg Probability) 0.7654 

============+============================================+=========+========= 

------+-----+--------------------------------------------+---------+---------

TYPE I NUM I Biowin2 FRAGMENT DESCRIPTION COEFF VALUE 

------+-----+--------------------------------------------+---------+---------

Frag 4 Aliphatic alcohol [-OH] 1.1178 4.4712 

Frag I 1 Carbon with 4 single bonds & no hydrogens -1.7232 -1.7232 

Frag I 1 Aliphatic ether [C-0-C] -3.4294 -3.4294 

MolWtl * Molecular Weight Parameter -2.5583 

============+============================================+=========+========= 

RESULT Biowin2 (Non-Linear Biodeg Probability) 0.4425 

============+============================================+=========+========= 

A Probability Greater Than or Equal to 0.5 indicates --> Biodegrades Fast 

A Probability Less Than 0.5 indicates --> Does NOT Biodegrade Fast 

------+-----+--------------------------------------------+---------+---------

TYPE I NUM I Biowin3 FRAGMENT DESCRIPTION COEFF VALUE 

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-----+-----+-----------------------------------------+--------

Frag 4 Aliphatic alcohol [-OH] 0.1600 

Frag I 1 Carbon with 4 single bonds & no hydrogens -0.2121 

Frag I 1 Aliphatic ether [C-0-C] -0.0087 

MolWtl * Molecular Weight Parameter 

Constl * Equation Constant 

0.6399 

-0.2121 

-0.0087 

-0.3981 

3.1992 

============+============= ·====·===================+=========+========= 

RESULT Biowin3 (Survey Model - Ultimate Biodeg) 3.2201 

============+ +=========+========= 

------+-----+-------------------------·-------------------+---------+---------

TYPE I NUM I Biowin4 FRAGMENT DESCRIPTION COEFF VALUE 

------+-----+----------------------------- ---------------+---------+---------

Frag 4 I Aliphatic alcohol [-OH] 0.1294 0.5178 

Frag 1 1 I Carbon with 4 single bonds & no hydrogens -0.1534 -0.1534 

Frag I 1 I Aliphatic ether [C-0-C] -0.0097 -0.0097 

MolWtl * I Molecular Weight Parameter -0.2599 

Constl * I Equation Constant 3.8477 

============+=============--===========,===================+=========+========= 

RESULT Biowin4 (Survey Model - Primary Biodeg) 3.9424 

============+============================================+=========+========= 

Result Classification: 

(Primary & Ultimate) 

5.00 -> hours 

2.00 ->months 

4.00 ->days 

1.00 -> longer 

3.00 ->weeks 

------+-----+-------------------------·----------------+---------+---------

TYPE I NUM I Biowin5 FRAGMENT DESCRIPTION COEFF VALUE 

------+-----+--------------------------------------------+---------+---------

Frag 4 Aliphatic alcohol [-OH] 0.1611 0.6446 

Frag 1 Carbon with 4 single bonds & no hydrogens 0.0676 0.0676 

Frag 1 Aliphatic ether [C-0-C] 0.0015 0.0015 

Frag 1 -CH2- [linear] 0.0494 0.0494 

Frag 1 -CH2- [cyclic] 0.0197 0.0197 

Frag 3 -CH - [cyclic] 0.0124 0.0373 

MolWtl * Molecular Weight Parameter -0.5360 

Constl * Equation Constant 0.7121 

============+======,-- +=========+========= 

RESULT Biowin5 (MITI Linear Biodeg Probability) 0.9963 

============+ +=========+========= 

------+-----+-------------------------------------------+---------+---------

TYPE I NUM I Biowin6 FRAGMENT DESCRIPTION COEFF VALUE 

------+-----+--------------------------------------------+---------+---------

Frag 4 Aliphatic alcohol [-OH] 1 . 0041 4.0166 

Frag 1 Carbon with 4 single bonds & no hydrogens 0.3990 0.3990 

Frag 1 Aliphatic ether [C-0-C] -0 . 1071 -0.1071 

Fra.g 1 -CH2- [linear] 0 . 4295 0.4295 

Frag 1 -CH2- [cyclic] 0 . 2365 0.2365 

Frag 3 -CH - [cyclic] -0 .1295 -0.3884 

MolWtl * Molecular Weight Parameter -5.2010 

============+============================================+=========+========= 

RESULT IBiowin6 (MITI Non-Linear Biodeg Probability) I 0.8711 

============+============================================+=========+========= 

A Probability Greater Than or Equal to 0.5 indicates --> Readily Degradable 

A Probability Less Than 0.5 indicates --> NOT Readily Degradable 

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------+-----+------------- - ------------------- -----------+--- ------+---------

TYPE I NUM I Biowin7 FRAGMENT DESCRI PTION COEFF VALUE 

------+-----+--------- ---------------- -------------------+---------+---------

Frag 4 Aliphatic alcohol [-OH] 0. 1328 0.5311 

Frag 1 Carbon with 4 single bonds & no hydrogens -0.3342 -0.3342 

Frag 1 Aliphatic ether [C-0-C] -0 . 2573 -0.2573 

Frag 1 -CH2- [linear] 0.0260 0.0260 

Frag 1 -CH2- [cyclic] -0.1200 -0.1200 

Frag 3 -CH - [cyclic] 0.0395 0.1184 

Const l * Equation Constant 0.8361 

============+============================================+=========+========= 

RESULT Biowin7 (Anaerobic Linear Biodeg Prob) 0.8000 

============+============================================+=========+========= 

A Probability Greater Than or Equal to 0.5 indicates -~>Biodegrades Fast 

A Probability Less Than 0.5 indicates --> Does NOT Biodegrade Fast 

Ready Biodegradability Prediction: (YES or NO) 

Criteria for the YES or NO prediction: If the Biowin3 (ultimate survey 

model) result is "weeks" or faster (i.e. "days", "days to weeks", or 

"weeks'' AND the Biowin5 (MITI linear model) probability is >= 0.5, then 

the prediction is YES (readily biodegradable). If this condition is not 

satisfied, the prediction is NO (not readily biodegradable) . This method 

is based on application of Bayesian analysis to ready biodegradation data 

(see Help). Biowin5 and 6 also predict ready biodegradability, but for 

degradation in the OECD301C test only; using data from the Chemicals 

Evaluation and Research Institute Japan (CERIJ) database. 

BioHCwin (vl.Ol) Program Results : 

SMILES : OlCC(O)C(O)C(O)Cl(O)CO 

CHEM D-Fructose 

MOL FOR: C6 H12 06 

MOL WT : 180.16 

-------------- - ------- ---- BioHCwin vl.Ol Results ---------------------------

NO Estimate Possible . . . Structure NOT a Hydrocarbon 

(Contains atoms other than C, H or S (-S-)) 

AEROWIN Program (vl.OO) Results: 

Sorption to aerosols (25 Dec C) [AEROWIN v1.00]: 

Vapor pressure (liquid/subcooled): 3.2E-005 Pa (2.4E-007 mm Hg) 

Log Koa (Koawin est ) : 10.851 

Kp (particle/gas partition coef. (m3/ug)): 

Mackay model 0.0938 

Octanol/air (Koa) model: 0.0174 

Fraction sorbed to airborne particulat es (phi): 

Junge-Pankow model 0.772 

Mackay model 0.882 

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Octanol/air (Koa) model: 0.582 

AOP Program (v1.92) Results: 

SMILES : 01CC(O)C(O)C(O)C1(0)CO 

CHEM D-Fructose 

MOL FOR : C6 H12 06 

MOL WT : 180.16 

------------------- SUMMARY (AOP vl.92): HYDROXYL RADICALS 

Hydrogen Abstraction 68.2254 E-12 cm3/molecule-sec 

Reaction with N, s and -OH 0.7000 E-12 cm3/molecule-sec 

Addition to Triple Bonds 0 .0000 E-12 cm3/molecule-sec 

Addition to Olefinic Bonds 0.0000 E-12 cm3/molecule-sec 

Addition to Aromatic Rings 0. 0000 E-12 cm3/molecule-sec 

Addition to Fused Rings 0.0000 E-12 cm3/molecule-sec 

OVERALL OH Rate Constant 68.9254 E-12 cm3/molecule-sec 

HALF-LIFE= 0.155 Days (12-hr day; 1.5E6 OH/cm3) 

HALF-LIFE= 1.862 Hrs 

(25 deg C) ------

------------- ------SUMMARY (AOP v1.91): OZONE REACTION (25 deg C) -----------

****** NO OZONE REACTION ESTIMATION ****** 

(ONLY Olefins and Acetylenes are Estimated) 

Experimental Database: NO Structure Matches 

Fraction sorbed to airborne particulates (phi): 

0.827 (Junge-Pankow, Mackay avg) 

0.582 (Koa method) 

Note: the sorbed fraction may be resistant to atmospheric oxidation 

KOCWIN Program (v2.00) Results : 

SMILES : 01CC(O)C(O)C(O)C1(0)CO 

CHEM D-Fructose 

MOL FOR: C6 H12 06 

MOL WT : 180.16 

----------- - - ------------ -- KOCWIN v2.00 Results ------------- - -------------

Koc Estimate from MCI : 

First Order Molecular Connectivity Index .. . .... . .. . 

Non-Corrected Log Koc (0.5213 MCI + 0.60) 

Fragment Correction(s): 

2 Aliphatic Alcohol ( -C-OH) . . . . . . . . . . . : -2 . 6358 

1 Ether, aliphatic ( -C-0-C-) . .. .. .. .. . : -0 . 8 716 

Corrected Log Koc .... . .. . . . . .. ... . .. ... . .. . ....... . 

Over Correction Adjustment to Lower Limit Log Koc . . . : 

Estimated Koc: 10 L/kg <=========== 

Koc Estimate from Log Kow: 

Log Kow (Kowwin estimate) 

5.510 

3.4721 

-0.0353 

1.0000 

-1.55 

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Non-Corrected Log Koc (0.55313 logKow + 0 . 9251) 0.0677 

Fragment Correction(s) : 

2 Aliphatic Alcohol (-C-OH) . . . . . . . . . . . : -0.8229 

1 Ether, aliphatic (-C-0-C..,-) .. .. .. .. .. : -0.0906 

Corrected Log Koc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -0.8457 

Estimated Koc: 0.1426 L/kg <=========== 

HYDROWIN Program (v2.00) Results: 

====== ===~========== ==== 

SMILES : 01CC(O)C(O)C(O)C1(0)CO 

CHEM D-Fructose 

MOL FOR: C6 H12 06 

MOL WT : 180.16 

------------- ------ - ------- HYDROWIN v2.00 Results - --------------------------

Currently, this program can NOT estimate a hydrolysis rate constant for 

the type of chemical structure entered!! 

ONLY Esters, Carbamates, Epoxides, Halomethanes (containing 1-3 halogens), 

Specific Alkyl Halides & Phosphorus Esters can be estimated!! 

When present, various hydrolyzable compound-types will be identified. 

For more information, (Click OVERVIEW in Help or see the User's Guide) 

***** CALCULATION NOT PERFORMED 

BCFBAF Program (v3.01) Results : 

SMILES : 01CC(O)C(O)C(O)C1(0)CO 

CHEM D-Fructose 

MOL FOR: C6 H12 06 

MOL WT : 180.16 

***** 

------ - -------------------------- BCFBAF v3.01 - - - - -------------------- - -------

Summary Results: 

Log BCF (regression-based estimate) : 

Biotransformation Half-Life (days) : 

Log BAF (Ar.not-Gobas upper trophic): 

0.50 (BCF = 3.16 L/kg wet-wt) 

0.0013 (normalized to 10 g fish) 

-0.05 (BAF = 0.894 L/kg wet-wt) 

Log Kow (experimental): not available from database 

Log Kow used by BCF estimates: -1.55 

Equation Used to Make BCF estimate: 

Log BCF = 0.50 

Correction(s): Value 

Correction Factors Not Used for Log Kow < 1 

Estimated Log BCF = 0 . 500 (BCF = 3.162 L/kg wet-wt) 

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Whole Body Primary Biotransformation Rate Estimate for Fish: 

------+-----+--------------------------------------------+---------+---------

TYPE I NUM I LOG BIOTRANSFORMATION FRAGMENT DESCRIPTION I COEFF VALUE 

------+-----+--------------------------------------------+---------+---------

Frag 4 Aliphatic alcohol [ -OH] - 0.0616 - 0 . 24 62 

Frag 1 Carbon with 4 single bonds & no hydrogens - 0.2984 -0.2984 

Frag 1 Aliphatic ether [C-0-C] - 0.02 32 -0.0232 

Frag 1 -CH2- [linear] 0 . 02 42 0.0242 

Frag 1 -CH2- [cyclic] 0.0963 0.0963 

Frag 3 -CH - [cyclic] 0.0126 0.0378 

L Kowl * Log Kow = -1.55 (KowWin estimate) 0.3 073 -0.4772 

MolWtl * Molecular Weight Parameter -0.4620 

Constl * Equation Constant -1 .5371 

============+============================================+=========+========= 

RESULT LOG Bio Half-Life (days) I -2.8859 

RESULT Bio Half-Life (days) I 0. 001301 

NOTE Bio Half-Life Normalized to 10 g fish at 15 deg C I 

============+============================================+=========+========= 

Biotransformation Rate Constant: 

kM (Rate Constant): 125 /day (10 gram fish) ** 

kM (Rate Constant): 70.29 /day (100 gram fish) ** 

kM (Rate Constant): 39.53 /day (1 kg fish) ** 

kM (Rate Constant): 22.23 /day (10 kg fish) ** 

** Predicted value exceeds theoretical whole body maximum value. 

kM (Rate Constant) of 125 /day is recommended/applied for 10 g fish 

Arnot-Gobas BCF & BAF Methods (including biotransformation rate estimates): 

Estimated Log BCF (upper trophic) -0.049 (BCF 0.8935 L/kg wet-wt) 

Estimated Log BAF (upper trophic) -0.049 (BAF 0.8935 L/kg we t-wt) 

Estimated Log BCF (mid trophic) -0.031 (BCF 0.9321 L/kg wet- wt) 

Estimated Log BAF (mid trophic) -0.031 (BAF 0.9321 L/ kg we t - wt ) 

Estimated Log BCF (lower trophic) -0.026 (BCF 0. 9408 L/ kg we t - wt) 

Estimated Log BAF (lower trophic) -0.026 (BAF 0.9408 L/kg wet - wt ) 

Arnot-Gobas BCF & BAF Methods (assuming a biotransformation rate of zero) : 

Estimated Log BCF (upper trophic) -0.048 (BCF 0.896 L/kg wet-wt) 

Estimated Log BAF (upper trophic) = -0.048 (BAF = 0.896 L/kg wet-wt) 

Volatilization From Water 

Chemical Name: D-Fructose 

Molecular Weight 

Water Solubility 

Vapor Pressure 

180.16 g/mole 

Henry's Law Constant: 9.72E-015 atm-m3/mole (estimated by Bond SAR Method) 

RIVER LAKE 

Water Depth (meters): 1 1 

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Wind Velocity (m/sec) : 5 

Current Velocity (m/sec): 1 

HALF-LIFE (hours) 

HALF-LIFE (days ) 

HALF-LIFE (years) 

8.085E+010 

3.369E+009 

9.223E+006 

0 .5 

0 . 05 

8. 82E+Oll 

3.675E+010 

1.006E+008 

STP Fugacity Model: Predicted Fate in a Wastewater Treatment Facility 

=====:::::::=.=:::1:1=== 

(using 10000 hr Bio P,A,S) 

PROPERTIES OF: D-Fructose 

Molecular weight (g/mol) 

Aqueous solubility (mg/1) 

Vapour pressure (Pa) 

(atm) 

(mm Hg) 

0 

0 

Henry 's law constant (Atm-m3/mol) 

Air-water partition coefficient 

Octanol-water partition coefficient (Kow) 

Log Kow 

Biomass to water partition coefficient 

Temperature [deg C] 

1 80 .16 

0 

0 

9.72E-015 

3. 97519E-013 

0.0281838 

-1.55 

0.805637 

25 

Biodeg rate constants (hA-1),half life 

-Primary tank 0.04 16.09 

in biomass (h) and in 2000 mg/L MLSS (h) : 

10000.00 

-Aeration tank 0.04 16.09 10000.00 

-Settling tank 0.04 16.09 10000.00 

STP Overall Chemical Mass Balance : 

g/h mol/h percent 

Influent 1.00E+001 5.6E-002 100.00 

Primary sludge 2.50E-002 1.4E-004 0.25 

Waste sludge 1.50E-001 8.4E-004 1. 50 

Primary volatilization 5.30E-012 2.9E-014 0.00 

Settling volatilization 1.44E-011 8.0E-014 0.00 

Aeration off gas 3. 56E-011 2. OE-013 0.00 

Primary biodegradation 1. 7 6E-003 9.8E-006 0.02 

Settling biodegradation 5.27E-004 2.9E-006 0.01 

Aeration biodegradation 6.93E-003 3.8E-005 0.07 

Final water effluent 9.82E+OOO 5.4E-002 98.15 

Total removal 1.85E-001 1.0E-003 1. 85 

Total biodegradation 9.22E-003 5.1E-005 0.09 

Level III Fugacity Model (Full-Output): 

Chern Name D-Fructose 

Molecular Wt : 180.16 

Henry's LC 9.72e-015 atm-m3/mole (Henrywin program) 

Vapor Press : 1.91e-008 mm Hg (Mpbpwin program) 

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Liquid VP 

Melting Pt 

Log Kow 

Soil Koc 

2.41e-007 mm Hg (super-cooled) 

136 deg C (Mpbpwin program) 

-1.55 (Kowwin program) 

10 (KOCWIN MCI method) 

Mass Amount Half-Life Emissions 

(percent) (hr) (kg/hr) 

Air 9.82e-007 3.72 

Water 30.6 360 

Soil 69.4 720 

Sediment 0.0688 3.24e+003 

Fugacity Reaction Advection 

(atm) (kg/hr) (kg/hr) 

Air 5.4e-018 0.00351 

Water 1.58e-019 1.13e+003 

Soil 7.4e-018 1.28e+003 

Sediment 1.44e-019 0.283 

Persistence Time: 640 hr 

Reaction Time: 

Advection Time: 

Percent Reacted: 

Percent Advected: 

796 hr 

3.27e+003 hr 

80.4 

19.6 

1000 

1000 

1000 

0 

Reaction 

(percent) 

0.000189 

587 

0 

0.0264 

Advection 

(percent) 

0.000117 

37.7 

42.8 

0.00942 

Half-Lives (hr), (based upon Biowin (Ultimate) and Aopwin): 

Air: 3. 725 

Water: 360 

Soil: 720 

Sediment: 3240 

Biowin estimate: 3.220 (weeks 

Advection Times (hr): 

Air: 100 

Water: 1000 

Sediment: 5e+004 

4811-7724-0089, Y. 

6.29e-006 

19.6 

0 

0.000881 

14 
Decernis FDA Food Additives Summary Report 

Administrative and Chemical Profile 

• 21CFR101 .9 

21 CFR 131.111 

21 CFR 131.112 

21 CFR 131.170 

21 CFR 131.200 

21 CFR 131.203 

21 CFR 131.206 

21 CFR 133.179 

21 CFR 146.132 

21 CFR 155.170 

No Function Available 

Note= Studies 1-12 from sugar task force report. [ASP] 

Technical Effects 

FDA Supplemental Information 

levulose 

• Flavor enhancer. Structure = (A09) simple and complex carbohydrates [i.e. mono-, oligo-, and polysaccharides). 

Flavoring agent or adjuvant. Structure= (A09) simple and complex carbohydrates [i.e. mono-, oligo-, and polysaccharides). 

Formulation aid. Structure= (A09) simple and complex carbohydrates [i.e. mono-, oligo-, and polysaccharides). 

Nutritive sweetener. Structure= (A09) simple and complex carbohydrates [i.e. mono-, oligo-, and polysaccharides). 

Processing aid. Structure= (A09) simple and complex carbohydrates [i.e. mono-, oligo-, and polysaccharides). 

Solvent or vehicle. Structure = (A09) simple and complex carbohydrates [i.e. mono-, oligo-, and polysaccharides). 

Stabilizer or thickener. Structure= (A09) simple and complex carbohydrates [i.e. mono-, oligo-, and polysaccharides). 

Texturizer. Structure= (A09) simple and complex carbohydrates [i.e. mono-, oligo-, and polysaccharides). 

Page 1 
Decernis FDA Food Additives Summary Report 

Acute and Oral Toxicity 

Oral Study: 1. Effects: NO EFFECTS. HNEL: 24000. mg/kg bw/day. Species: swine. Type: SHORT TERM. Duration: 28 days. PROC SOC EXP 

Year: 1975. 

Oral Study: 10. Effects: HISTOPATHOLOGY OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 40000. mg/kg bw/d

Type: SHORT TERM. Comment: Males only other histopath= increase in liver vldl-tri-glycerides decrease in liver apob. Duration: 42 days. D

Year: 1978. 

Oral Study: 10. Effects: TISSUE ENZVMES DECREASE. LEL: 40000. mg/kg bw/day. Species: rat. Site: LIVER. Type: SHORT TERM. Commen

histopath= increase in liver vldl-tri-glycerides decrease in liver apob. Duration: 42 days. DIABETES 27:1215-1229. Year: 1978. 

Oral Study: 11. Effects: HISTOPATHOLOGY OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 68000. mg/kg bw/d

Type: REPRODUCTION. Comment: Effects in dams only other histopath= increase in fatty acid synthesis in liver and adipose tissue female

NUTR METAB 19:73-90, Year: 1975. 

Oral Study: 11. Effects: TRIGL YCERIDES INCREASE. LEL: 68000. mg/kg bw/day. Species: rat. Site: LIVER. Type: REPRODUCTION. Comme

other histopath= increase in fatty acid synthesis in liver and adipose tissue females only. Duration: 79 days. NUTR METAB 19:73-90. Year: 

Oral Study: 12. Effects: BODY WEIGHT INCREASE. LEL: 16000. mg/kg bw/day. Species: rat. Type: SHORT TERM. Duration: 50 days. PHYSI

1979. 

Oral Study: 17. Effects: BLOOD CHEMISTRY OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 50000. mg/kg bw/d

SUBCHRONIC RODENT. Comment: Males only; one dose level only; urinalysis other= decreased" sodium, potassium, chloride, urea and 

chemistry other= decreased d-3-hydroxybutyrate; blood samples occasionally hemolysed; controls fasted and dosed groups had fructose 

drawn; no charts or graphs provided for histopathology. Duration: 147 days. FOOD CHEM TOXICOL 24:389-396. Year: 1986. 

Oral Study: 17. Effects: BLOOD UREA NITROGEN (BUN) DECREASE. LEL: 50000. mg/kg bw/day. Species: mouse. Type: SUBCHRONIC RO

one dose level only; urinalysis other= decreased "sodium, potassium, chloride, urea and increased oxalate; blood " chemistry other= de

blood samples occasionally hemolysed; controls fasted and dosed groups had fructose in water before blood was drawn; no charts or grahistopathology. Duration: 147 days. FOOD CHEM TOXICOL 24:389-396. Year: 1986. 

Oral Study: 17. Effects: CHOLESTEROL INCREASE. LEL: 50000. mg/kg bw/day. Species: mouse. Type: SUBCHRONIC RODENT. Comment: 

only; urinalysis other= decreased " sodium, potassium, chloride, urea and increased oxalate; blood " chemistry other= decreased d-3-hy

samples occasionally hemolysed; controls fasted and dosed groups had fructose in water before blood was drawn; no charts or graphs pr

Duration: 147 days. FOOD CHEM TOXICOL 24:389-396. Year: 1986. 

Oral Study: 17. Effects: URINALYSIS OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 50000. mg/kg bw/day. Spe

SUBCHRONIC RODENT. Comment: Males only; one dose level only; urinalysis other= decreased" sodium, potassium, chloride, urea and 

Page2 
Decernis FDA Food Additives Summary Report 

chemistry other= decreased d-3-hydroxybutyrate; blood samples occasionally hemolysed; controls fasted and dosed groups had fructose 

drawn; no charts or graphs provided for histopathology. Duration: 147 days. FOOD CHEM TOXICOL 24:389-396. Year: 1986. 

Oral Study: 2. Effects: HISTOPATHOLOGY OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 60000. mg/kg bw/da

Type: SHORT TERM. Comment: Males only other histopath= fatty acid synthesis in liver and adipose tissue. Duration: 28 days. PROC SOC 

Year: 1975. 

Oral Study: 2. Effects: TRIGLYCERIDES INCREASE. LEL: 60000. mg/kg bw/day. Species: rat. Site: LIVER. Type: SHORT TERM. Comment: M

fatty acid synthesis in liver and adipose tissue. Duration: 28 days. PROC SOC EXP BIOL MED 150:220-225. Year: 1975. 

Oral Study: 23. Effects: TRIGL YCERIDES INCREASE. LEL: 30000. mg/kg bw/day. Species: rat. Type: SHORT TERM. Comment: One dose le

increased capillary " permeability of albumin in the thoracic aorta and lungs, effect" uncertain. Duration: 14 days. AM J HYPERTENS 11 :5

Oral Study: 24. Effects: BLOOD CHEMISTRY OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 30000. mg/kg bw/d

SKELETAL MUSCLE. Type: SHORT TERM. Comment: One dose level only; males only; tissue chemistry observations= decreased capillar

the left quadriceps and skin; clinical other= increased systolic blood pressure; blood chemistry other= increased plasma insulin; decreas

albumin in the thoracic aorta, effect uncertain " site skeletal muscle= left quadriceps. Duration: 28 days. AM J HYPERTENS 11:563-569. Y

Oral Study: 24. Effects: BLOOD CHEMISTRY OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 30000. mg/kg bw/d

Type: SHORT TERM. Comment: One dose level only; males only; tissue chemistry observations =decreased capillary permeability of albu

skin; clinical other= increased systolic blood pressure; blood chemistry other= increased plasma insulin; decreased capillary " permeabi

aorta, effect uncertain " site skeletal muscle= left quadriceps. Duration: 28 days. AM J HYPERTENS 11 :563-569. Year: 1998. 

Oral Study: 24. Effects: CLINICAL OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 30000. mg/kg bw/day. Specie

MUSCLE. Type: SHORT TERM. Comment: One dose level only; males only; tissue chemistry observations = decreased capillary permeabi

quadriceps and skin; clinical other= increased systolic blood pressure; blood chemistry other= increased plasma insulin; decreased capalbumin in the thoracic aorta, effect uncertain" site skeletal muscle = left quadriceps. Duration: 28 days. AM J HYPERTENS 11 :563-569. Y

Oral Study: 24. Effects: CLINICAL OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 30000. mg/kg bw/day. Specie

SHORT TERM. Comment: One dose level only; males only; tissue chemistry observations = decreased capillary permeability of albumin in 

clinical other= increased systolic blood pressure; blood chemistry other= increased plasma insulin; decreased capillary " permeability of 

aorta, effect uncertain " site skeletal muscle= left quadriceps. Duration: 28 days. AM J HYPERTENS 11 :563-569. Year: 1998. 

Oral Study: 24. Effects: TISSUE CHEMISTRY OBSERVATION. LEL: 30000. mg/kg bw/day. Species: rat. Site: SKELETAL MUSCLE. Type: SH

dose level only; males only; tissue chemistry observations= decreased capillary permeability of albumin in the left quadriceps and skin; c

systolic blood pressure; blood chemistry other= increased plasma insulin; decreased capillary " permeability of albumin in the thoracic a

skeletal muscle = left quadriceps. Duration: 28 days. AM J HYPERTENS 11 :563-569. Year: 1998. 

Oral Study: 24. Effects: TISSUE CHEMISTRY OBSERVATION. LEL: 30000. mg/kg bw/day. Species: rat. Site: SKIN. Type: SHORT TERM. Com

males only; tissue chemistry observations = decreased capillary permeability of albumin in the left quadriceps and skin; clinical other= in

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Decernis FDA Food Additives Summary Report 

pressure; blood chemistry other= increased plasma insulin; decreased capillary" permeability of albumin in the thoracic aorta, effect unc

=left quadriceps. Duration: 28 days. AM J HYPERTENS 11:563-569. Year: 1998. 

Oral Study: 24. Effects: TRIGLYCERIDES INCREASE. LEL: 30000. mg/kg bw/day. Species: rat. Site: SKELETAL MUSCLE. Type: SHORT TER

only; males only; tissue chemistry observations= decreased capillary permeability of albumin in the left quadriceps and skin; clinical othe

pressure; blood chemistry other= increased plasma insulin; decreased capillary " permeability of albumin in the thoracic aorta, effect unce

= left quadriceps. Duration: 28 days. AM J HYPERTENS 11 :563-569. Year: 1998. 

Oral Study: 24. Effects: TRIGL YCERIDES INCREASE. LEL: 30000. mg/kg bw/day. Species: rat. Site: SKIN. Type: SHORT TERM. Comment: O

only; tissue chemistry observations = decreased capillary permeability of albumin in the left quadriceps and skin; clinical other= 

blood chemistry other= increased plasma insulin; decreased capillary" permeability of albumin in the thoracic aorta, effect uncertain" sit

quadriceps. Duration: 28 days. AM J HYPERTENS 11 :563-569. Year: 1998. 

Oral Study: 25. Effects: BLOOD CHEMISTRY OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 30000. mg/kg bw/d

Type: SHORT TERM. Comment: One dose level only; males only; tissue chemistry other= decreased capillary permeability of albumin in th

clinical other= increased systolic blood pressure blood chemistry other= increased plasma insulin site skeletal muscle = left quadriceps. 

HYPERTENS 11 :563-569. Year: 1998. 

Oral Study: 25. Effects: BLOOD CHEMISTRY OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 30000. mg/kg bw/d

SKELETAL MUSCLE. Type: SHORT TERM. Comment: One dose level only; males only; tissue chemistry other= decreased capillary perme

quadriceps and liver; clinical other= increased systolic blood pressure blood chemistry other= increased plasma insulin site skeletal mus

Duration: 56 days. AM J HYPERTENS 11:563-569. Year: 1998. 

Oral Study: 25. Effects: CLINICAL OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 30000. mg/kg bw/day. Specie

SHORT TERM. Comment: One dose level only; males only; tissue chemistry other= decreased capillary permeability of albumin in the left 

other= increased systolic blood pressure blood chemistry other= increased plasma insulin site skeletal muscle= left quadriceps. Duratio

11 :563-569. Year: 1998. 

Oral Study: 25. Effects: CLINICAL OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 30000. mg/kg bw/day. Specie

MUSCLE. Type: SHORT TERM. Comment: One dose level only; males only; tissue chemistry other= decreased capillary permeability of alb

and liver; clinical other= increased systolic blood pressure blood chemistry other= increased plasma insulin site skeletal muscle= left qu

AM J HYPERTENS 11:563-569. Year: 1998. 

Oral Study: 25. Effects: TISSUE CHEMISTRY OBSERVATION. LEL: 30000. mg/kg bw/day. Species: rat. Site: LIVER. Type: SHORT TERM. Co

males only; tissue chemistry other= decreased capillary permeability of albumin in the left quadriceps and liver; clinical other= increased 

blood chemistry other= increased plasma insulin site skeletal muscle= left quadriceps. Duration: 56 days. AM J HYPERTENS 11 :563-569. 

Oral Study: 25. Effects: TISSUE CHEMISTRY OBSERVATION. LEL: 30000. mg/kg bw/day. Species: rat. Site: SKELETAL MUSCLE. Type: SH

dose level only; males only; tissue chemistry other= decreased capillary permeability of albumin in the left quadriceps and liver; clinical o

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Decernis FDA Food Additives Summary Report 

blood pressure blood chemistry other= increased plasma insulin site skeletal muscle= left quadriceps. Duration: 56 days. AM J HYPERTE

Oral Study: 25. Effects: TRIGL YCERIDES INCREASE. LEL: 30000. mg/kg bw/day. Species: rat. Site: LIVER. Type: SHORT TERM. Comment: 

only; tissue chemistry other= decreased capillary permeability of albumin in the left quadriceps and liver; clinical other= increased systol

chemistry other= increased plasma insulin site skeletal muscle= left quadriceps. Duration: 56 days. AM J HYPERTENS 11 :563-569. Year: 

Oral Study : 25. Effects: TRIGLYCERIDES INCREASE. LEL: 30000. mg/kg bw/day. Species: rat. Site: SKELETAL MUSCLE. Type: SHORT TER

only; males only; tissue chemistry other= decreased capillary permeability of albumin in the left quadriceps and liver; clinical other= incre

blood chemistry other= increased plasma insulin site skeletal muscle= left quadriceps. Duration: 56 days. AM J HYPERTENS 11:563-569. 

Oral Study: 29. Effects: BLOOD CHEMISTRY OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 33000. mg/kg bw/d

SPECIAL TOXICOLOGICAL STUDY. Comment: One dose level only; males only; clinical other= increased systolic blood pressure; blood c

plasma insulin; emphasis of this study was on blood pressure and insulin levels. Duration: 56 days. EUR J PHARMACOL 373:R1-R4. Year: 

Oral Study: 29. Effects: CLINICAL OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 33000. mg/kg bw/day. Specie

TOXICOLOGICAL STUDY. Comment: One dose level only; males only; clinical other= increased systolic blood pressure; blood chemistry 

insulin; emphasis of this study was on blood pressure and insulin levels. Duration: 56 days. EUR J PHARMACOL 373:R1-R4. Year: 1999. 

Oral Study: 3. Effects: HISTOPATHOLOGY OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 105000. mg/kg bw/d

LIVER. Type: SHORT TERM. Comment: Other histopath= increase in fatty acid synthesis. Duration: 14 days. NUTR RES 1 :73-82. Year: 1981

Oral Study: 30. Effects: BLOOD CHEMISTRY OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 60000. mg/kg bw/

SHORT TERM. Comment: One dose level only; males only; blood chemistry other= increased free fatty acids and insulin. Duration: 14 day

1110. Year: 2000. 

Oral Study: 30. Effects: BODY WEIGHT DECREASE. LEL: 60000. mg/kg bw/day. Species: rat. Type: SHORT TERM. Comment: One dose lev

chemistry other= increased free fatty acids and insulin. Duration: 14 days. METABOLISM 49:1106-1110. Year: 2000. 

Oral Study: 30. Effects: TRIGL YCERIDES INCREASE. LEL: 60000. mg/kg bw/day. Species: rat. Type: SHORT TERM. Comment: One dose le

chemistry other= increased free fatty acids and insulin. Duration: 14 days. METABOLISM 49:1106-1110. Year: 2000. 

Oral Study: 32. Effects: ORGAN WEIGHT INCREASE. LEL: 66200. mg/kg bw/day. Species: rat. Site: LIVER. Type: SHORT TERM. Comment: 

only; organ weight increase= increased relative liver and pancreas weights at 66200 mg/kg; decreased " liver copper at 66200 mg/kg, met

""the data reported here are on the low fat, copper adequate diet" groups 1 and 3. Duration: 28 days. JAM COLL NUTR 18:83-87. Year: 1

Oral Study: 32. Effects: ORGAN WEIGHT INCREASE. LEL: 66200. mg/kg bw/day. Species: rat. Site: PANCREAS. Type: SHORT TERM. Com

males only; organ weight increase =increased relative liver and pancreas weights at 66200 mg/kg; decreased" liver copper at 66200 mg/k

study"" the data reported here are on the low fat, copper adequate diet" groups 1 and 3. Duration: 28 days. JAM COLL NUTR 18:83-87. Y

Oral Study: 33. Effects: BODY WEIGHT INCREASE. LEL: 29000. mg/kg bw/day. Species: rat. Type: CHRONIC RODENT. Comment: One dos

study duration reported ranged from 11 to 17 months; body weight increase= average final body weight; urine protein increase =total pro

pathology other= increased abdominal and epididymal fat content; no charts or graphs provided; reporting incomplete not used for priori

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Decernis FDA Food Additives Summary Report 

days. ANN NY ACAD SCI 878:716-719. Year: 1999. 

Oral Study: 33. Effects: GROSS PATHOLOGY OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 29000. mg/kg bw/

CHRONIC RODENT. Comment: One dose level only; sex not stated; study duration reported ranged from 11 to 17 months; body weight inc

weight; urine protein increase= total protein and albumin gross pathology other= increased abdominal and epididymal fat content; no cha

reporting incomplete not used for priority ranking. Duration: 330 days. ANN NY ACAD SCI878:716-719. Year: 1999. 

Oral Study: 33. Effects: URINE PROTEIN INCREASE. LEL: 29000. mg/kg bw/day. Species: rat. Type: CHRONIC RODENT. Comment: One dos

study duration reported ranged from 11 to 17 months; body weight increase = average final body weight; urine protein increase = total prot

pathology other= increased abdominal and epididymal fat content; no charts or graphs provided; reporting incomplete not used for priorit

days. ANN NY ACAD SCI 878:716-719. Year: 1999. 

Oral Study: 4. Effects: HISTOPATHOLOGY OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 77000. mg/kg bw/day

Type: SHORT TERM. Comment: Other histopath= increase in liver lipids. Duration: 30 days. TOHOKU J EXP MED 115:213-222. Year: 1975. 

Oral Study: 4. Effects: TRIGL YCERIDES INCREASE. LEL: 77000. mg/kg bw/day. Species: rat. Site: LIVER. Type: SHORT TERM. Comment: O

liver lipids. Duration: 30 days. TOHOKU J EXP MED 115:213-222. Year: 1975. 

Oral Study: 5. Effects: CHOLESTEROL INCREASE. LEL: 68000. mg/kg bw/day. Species: rat. Type: SHORT TERM. Comment: Males only incr

Duration: 70 days. NUTR REPT INT 25:161-167. Year: 1982. 

Oral Study: 5. Effects: TRIGL YCERIDES INCREASE. LEL: 68000. mg/kg bw/day. Species: rat. Type: SHORT TERM. Comment: Males only inc

Duration: 70 days. NUTR REPT INT 25:161-167. Year: 1982. 

Oral Study: 6. Effects: BLOOD CHEMISTRY OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 68000. mg/kg bw/da

Type: SHORT TERM. Comment: Decrease in adipose tissue enzymes increase in liver pyruvate dehydrogenase other histopath= increase i

blood chemistry= increase in serum phospholipids. Duration: 50 days. NUTR METAB 16:285-294. Year: 1974. 

Oral Study: 6. Effects: CHOLESTEROL INCREASE. LEL: 68000. mg/kg bw/day. Species: rat. Site: LIVER. Type: SHORT TERM. Comment: De

enzymes increase in liver pyruvate dehydrogenase other histopath= increase in liver triglycerides other blood chemistry= increase in serum 

50 days. NUTR METAB 16:285-294. Year: 1974. 

Oral Study: 6. Effects: HISTOPATHOLOGY OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 68000. mg/kg bw/da

Type: SHORT TERM. Comment: Decrease in adipose tissue enzymes increase in liver pyruvate dehydrogenase other histopath= increase i

blood chemistry= increase in serum phospholipids. Duration: 50 days. NUTR METAB 16:285-294. Year: 1974. 

Oral Study: 6. Effects: ORGAN WEIGHT INCREASE. LEL: 68000. mg/kg bw/day. Species: rat. Site: LIVER. Type: SHORT TERM. Comment: D

enzymes increase in liver pyruvate dehydrogenase other histopath= increase in liver triglycerides other blood chemistry= increase in seru

50 days. NUTR METAB 16:285-294. Year: 1974. 

Oral Study: 6. Effects: TISSUE ENZYMES DECREASE. LEL: 68000. mg/kg bw/day. Species: rat. Site: LIVER. Type: SHORT TERM. Comment

enzymes increase in liver pyruvate dehydrogenase other histopath= increase in liver triglycerides other blood chemistry= increase in seru

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Decernis FDA Food Additives Summary Report 

50 days. NUTR METAB 16:285-294. Year: 1974. 

Oral Study: 6. Effects: TISSUE ENZYMES INCREASE. LEL: 68000. mg/kg bw/day. Species: rat. Site: LIVER. Type: SHORT TERM. Comment: 

enzymes increase in liver pyruvate dehydrogenase other histopath= increase in liver triglycerides other blood chemistry= increase in seru

50 days. NUTR METAB 16:285-294. Year: 1974. 

Oral Study: 7. Effects: BLOOD CHEMISTRY OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 68000. mg/kg bw/da

Type: SHORT TERM. Comment: Males only increase in fatty acid synthesis in adipose tissue other histopath= increase in liver fatty acids " 

increase in free fatty acids, insulin" and corticosterone. Duration: 30 days. HORM METAB RES 6:99-106. Year: 1974. 

Oral Study: 7. Effects: HISTOPATHOLOGY OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 68000. mg/kg bw/da

Type: SHORT TERM. Comment: Males only increase in fatty acid synthesis in adipose tissue other histopath= increase in liver fatty acids" 

increase in free fatty acids, insulin" and corticosterone. Duration: 30 days. HORM METAB RES 6:99-106. Year: 1974. 

Oral Study: 7. Effects: ORGAN WEIGHT INCREASE. LEL: 68000. mg/kg bw/day. Species: rat. Site: LIVER. Type: SHORT TERM. Comment: M

acid synthesis in adipose tissue other histopath= increase in liver fatty acids " other blood chemistry= increase in free fatty acids, insulin " 

Duration: 30 days. HORM METAB RES 6:99-106. Year: 1974. 

Oral Study: 7. Effects: TRIGLYCERIDES INCREASE. LEL: 68000. mg/kg bw/day. Species: rat. Site: LIVER. Type: SHORT TERM. Comment: M

acid synthesis in adipose tissue other histopath= increase in liver fatty acids" other blood chemistry= increase in free fatty acids, insulin 

Duration: 30 days. HORM METAB RES 6:99-106. Year: 1974. 

Oral Study: 8. Effects: HISTOPATHOLOGY OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 69000. mg/kg bw/da

Type: SHORT TERM. Comment: Other histopath= increase in liver lipids increase in liver g6pd and me enzymes animals fed for 3hr/day. J 

1977. 

Oral Study: 8. Effects: ORGAN WEIGHT INCREASE. LEL: 69000. mg/kg bw/day. Species: rat. Site: LIVER. Type: SHORT TERM. Comment: O

liver lipids increase in liver g6pd and me enzymes animals fed for 3hr/day. J NUTR 107:534-538. Year: 1977. 

Oral Study: 8. Effects: TISSUE ENZYMES INCREASE. LEL: 69000. mg/kg bw/day. Species: rat. Site: LIVER. Type: SHORT TERM. Comment: 

liver lipids increase in liver g6pd and me enzymes animals fed for 3hr/day. J NUTR 107:534-538. Year: 1977. 

Genotoxicity 

• Study: 13. Effects: Cytotoxic (ld50 is less than 5 millimolar) Species: MIDGE. Type: CYTOTOXICITY. Duration: 48. CHROMOSOMA 41:297-3

Treated 4th instar larvae .. LEL: 10. mg/ml. 

Other 

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Decernis FDA Food Additives Summary Report 

. 

Market Survey: SRI1996. Human Consumption: 192.8949833 mg/kg/da. Market Disappearance: 250000000 lbs/yr. 

Disclaimer Regarding Source FDA Information 

The information in the database regarding effective Food Contact Notifications, Threshold of Regulation Exemptions, and so-called "No-Objec

abstraction of relevant information in FDA's administrative files. In all cases, the actual record of FDA's decision takes precedence over summ

particular, information on so-called "No-Objection" letters should be narrowly construed. In cases where applicability of the summary inform

unclear, users are advised to contact FDA directly for clarification. 

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