# KH ® 

## KELL E RA ND HE KMAN LLP
S e n , in g Busi n ess 

### throu g h l. o w e m 

### I Scie nc e®

1001 G Street

, N.W. 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

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This document was delivered electronically. www.khlaw

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## 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 [ EUREAC H 

## HP V Pes tic i d



## Nu m b :r 

### C h e mical Ind ex N ame REA C H R egist r at i o n Li s t 

## e Ex_emptio o LAe i t " 1


### 57-48-7 D-Fructose Anne x 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 (( d 

# s b t



### e 110ne u s ance CASRN FDA R ul 

### ti eg1 

### a: 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: \Us ers\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

Fr ag 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 NU M 

### I Biowin7 FRAGM ENT DESCR I PTION CO E FF VAL U E

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

- --------------- - ------------------- + ---------+---------
F rag 4 Aliphatic alcohol [-OH] 0. 1 328 0.5311

F rag 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

F rag 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 :

S M ILE S : OlCC(O)C(O)C(O)Cl(O)CO
C HEM D-Fructose
M

O

L FOR: C6 H12 06
MO L 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 particula t 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 0.00 00 E-12 cm3/molecule-sec

Addition to Aromatic Rings 0. 0 000 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] 0.0 1 26 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 .53 71 

### ============+============================================+=========+=========
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 0.89 35 L /k g w et -wt)
Estimated Log BAF (upper trophic) -0.049 (BAF 0.893 5 L /k g w e 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/ k g we t

- w t )
Estimated Log BCF (lower trophic) -0.026 (BCF 0. 9 408 L / kg we t

- w t)

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

1 Current Velocity (m/sec):

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



### 14Decernis 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 CAS 57-48-7 PAFA 2295
Copyright (c) 2007 DecernisDecernisFDAFoodAdditivesSummaryReportAcuteandOralToxicityOralStudy:1.Effects:NOEFFECTS.HNEL:24000.mg/kgbw/day.Species:swine.Type:SHORTTERM.Duration:28days.PROCSOCEXPBIOLMED150:220-225.Year:1975.OralStudy:10.Effects:HISTOPATHOLOGYOBSERVATION(S)NOTELSEWHERECLASSIFIED-SEECOMMENTS.LEL:40000.mg/kgbw/day.Species:rat.Site:LIVER.Type:SHORTTERM.Comment:Malesonlyotherhistopath=increaseinlivervldl-tri-glyceridesdecreaseinliverapob.Duration:42days.DIABETES27:1215-1229.Year:1978.OralStudy:10.Effects:TISSUEENZVMESDECREASE.LEL:40000.mg/kgbw/day.Species:rat.Site:LIVER.Type:SHORTTERM.Comment:Malesonlyotherhistopath=increaseinlivervldl-tri-glyceridesdecreaseinliverapob.Duration:42days.DIABETES27:1215-1229.Year:1978.OralStudy:11.Effects:HISTOPATHOLOGYOBSERVATION(S)NOTELSEWHERECLASSIFIED-SEECOMMENTS.LEL:68000.mg/kgbw/day.Species:rat.Site:LIVER.Type:REPRODUCTION.Comment:Effectsindamsonlyotherhistopath=increaseinfattyacidsynthesisinliverandadiposetissuefemalesonly.Duration:79days.NUTRMETAB19:73-90,Year:1975.OralStudy:11.Effects:TRIGLYCERIDESINCREASE.LEL:68000.mg/kgbw/day.Species:rat.Site:LIVER.Type:REPRODUCTION.Comment:Effectsindamsonlyotherhistopath=increaseinfattyacidsynthesisinliverandadiposetissuefemalesonly.Duration:79days.NUTRMETAB19:73-90.Year:1975.OralStudy:12.Effects:BODYWEIGHTINCREASE.LEL:16000.mg/kgbw/day.Species:rat.Type:SHORTTERM.Duration:50days.PHYSIOLBEHAV23:881-885.Year:1979.OralStudy:17.Effects:BLOODCHEMISTRYOBSERVATION(S)NOTELSEWHERECLASSIFIED-SEECOMMENTS.LEL:50000.mg/kgbw/day.Species:mouse.Type:SUBCHRONICRODENT.Comment:Malesonly;onedoselevelonly;urinalysisother=decreased"sodium,potassium,chloride,ureaandincreasedoxalate;blood"chemistryother=decreasedd-3-hydroxybutyrate;bloodsamplesoccasionallyhemolysed;controlsfastedanddosedgroupshadfructoseinwaterbeforebloodwasdrawn;nochartsorgraphsprovidedforhistopathology.Duration:147days.FOODCHEMTOXICOL24:389-396.Year:1986.OralStudy:17.Effects:BLOODUREANITROGEN(BUN)DECREASE.LEL:50000.mg/kgbw/day.Species:mouse.Type:SUBCHRONICRODENT.Comment:Malesonly;onedoselevelonly;urinalysisother=decreased"sodium,potassium,chloride,ureaandincreasedoxalate;blood"chemistryother=decreasedd-3-hydroxybutyrate;bloodsamplesoccasionallyhemolysed;controlsfastedanddosedgroupshadfructoseinwaterbeforebloodwasdrawn;nochartsorgraphsprovidedforhistopathology.Duration:147days.FOODCHEMTOXICOL24:389-396.Year:1986.OralStudy:17.Effects:CHOLESTEROLINCREASE.LEL:50000.mg/kgbw/day.Species:mouse.Type:SUBCHRONICRODENT.Comment:Malesonly;onedoselevelonly;urinalysisother=decreased"sodium,potassium,chloride,ureaandincreasedoxalate;blood"chemistryother=decreasedd-3-hydroxybutyrate;bloodsamplesoccasionallyhemolysed;controlsfastedanddosedgroupshadfructoseinwaterbeforebloodwasdrawn;nochartsorgraphsprovidedforhistopathology.Duration:147days.FOODCHEMTOXICOL24:389-396.Year:1986.OralStudy:17.Effects:URINALYSISOBSERVATION(S)NOTELSEWHERECLASSIFIED-SEECOMMENTS.LEL:50000.mg/kgbw/day.Species:mouse.Type:SUBCHRONICRODENT.Comment:Malesonly;onedoselevelonly;urinalysisother=decreased"sodium,potassium,chloride,ureaandincreasedoxalate;blood"Page2Copyright(c)2007DecernisDecernisFDAFoodAdditivesSummaryReportchemistryother=decreasedd-3-hydroxybutyrate;bloodsamplesoccasionallyhemolysed;controlsfastedanddosedgroupshadfructoseinwaterbeforebloodwasdrawn;nochartsorgraphsprovidedforhistopathology.Duration:147days.FOODCHEMTOXICOL24:389-396.Year:1986.OralStudy:2.Effects:HISTOPATHOLOGYOBSERVATION(S)NOTELSEWHERECLASSIFIED-SEECOMMENTS.LEL:60000.mg/kgbw/day.Species:rat.Site:LIVER.Type:SHORTTERM.Comment:Malesonlyotherhistopath=fattyacidsynthesisinliverandadiposetissue.Duration:28days.PROCSOCEXPBIOLMED150:220-225.Year:1975.OralStudy:2.Effects:TRIGLYCERIDESINCREASE.LEL:60000.mg/kgbw/day.Species:rat.Site:LIVER.Type:SHORTTERM.Comment:Malesonlyotherhistopath=fattyacidsynthesisinliverandadiposetissue.Duration:28days.PROCSOCEXPBIOLMED150:220-225.Year:1975.OralStudy:23.Effects:TRIGLYCERIDESINCREASE.LEL:30000.mg/kgbw/day.Species:rat.Type:SHORTTERM.Comment:Onedoselevelonly;malesonly;increasedcapillary"permeabilityofalbumininthethoracicaortaandlungs,effect"uncertain.Duration:14days.AMJHYPERTENS11:563-569.Year:1998.OralStudy:24.Effects:BLOODCHEMISTRYOBSERVATION(S)NOTELSEWHERECLASSIFIED-SEECOMMENTS.LEL:30000.mg/kgbw/day.Species:rat.Site:SKELETALMUSCLE.Type:SHORTTERM.Comment:Onedoselevelonly;malesonly;tissuechemistryobservations=decreasedcapillarypermeabilityofalbuminintheleftquadricepsandskin;clinicalother=increasedsystolicbloodpressure;bloodchemistryother=increasedplasmainsulin;decreasedcapillary"permeabilityofalbumininthethoracicaorta,effectuncertain"siteskeletalmuscle=leftquadriceps.Duration:28days.AMJHYPERTENS11:563-569.Year:1998.OralStudy:24.Effects:BLOODCHEMISTRYOBSERVATION(S)NOTELSEWHERECLASSIFIED-SEECOMMENTS.LEL:30000.mg/kgbw/day.Species:rat.Site:SKIN.Type:SHORTTERM.Comment:Onedoselevelonly;malesonly;tissuechemistryobservations=decreasedcapillarypermeabilityofalbuminintheleftquadricepsandskin;clinicalother=increasedsystolicbloodpressure;bloodchemistryother=increasedplasmainsulin;decreasedcapillary"permeabilityofalbumininthethoracicaorta,effectuncertain"siteskeletalmuscle=leftquadriceps.Duration:28days.AMJHYPERTENS11:563-569.Year:1998.OralStudy:24.Effects:CLINICALOBSERVATION(S)NOTELSEWHERECLASSIFIED-SEECOMMENTS.LEL:30000.mg/kgbw/day.Species:rat.Site:SKELETALMUSCLE.Type:SHORTTERM.Comment:Onedoselevelonly;malesonly;tissuechemistryobservations=decreasedcapillarypermeabilityofalbuminintheleftquadricepsandskin;clinicalother=increasedsystolicbloodpressure;bloodchemistryother=increasedplasmainsulin;decreasedcapillary"permeabilityofalbumininthethoracicaorta,effectuncertain"siteskeletalmuscle=leftquadriceps.Duration:28days.AMJHYPERTENS11:563-569.Year:1998.OralStudy:24.Effects:CLINICALOBSERVATION(S)NOTELSEWHERECLASSIFIED-SEECOMMENTS.LEL:30000.mg/kgbw/day.Species:rat.Site:SKIN.Type:SHORTTERM.Comment:Onedoselevelonly;malesonly;tissuechemistryobservations=decreasedcapillarypermeabilityofalbuminintheleftquadricepsandskin;clinicalother=increasedsystolicbloodpressure;bloodchemistryother=increasedplasmainsulin;decreasedcapillary"permeabilityofalbumininthethoracicaorta,effectuncertain"siteskeletalmuscle=leftquadriceps.Duration:28days.AMJHYPERTENS11:563-569.Year:1998.OralStudy:24.Effects:TISSUECHEMISTRYOBSERVATION.LEL:30000.mg/kgbw/day.Species:rat.Site:SKELETALMUSCLE.Type:SHORTTERM.Comment:Onedoselevelonly;malesonly;tissuechemistryobservations=decreasedcapillarypermeabilityofalbuminintheleftquadricepsandskin;clinicalother=increasedsystolicbloodpressure;bloodchemistryother=increasedplasmainsulin;decreasedcapillary"permeabilityofalbumininthethoracicaorta,effectuncertain"siteskeletalmuscle=leftquadriceps.Duration:28days.AMJHYPERTENS11:563-569.Year:1998.OralStudy:24.Effects:TISSUECHEMISTRYOBSERVATION.LEL:30000.mg/kgbw/day.Species:rat.Site:SKIN.Type:SHORTTERM.Comment:Onedoselevelonly;malesonly;tissuechemistryobservations=decreasedcapillarypermeabilityofalbuminintheleftquadricepsandskin;clinicalother=increasedsystolicbloodPage3Copyright(c)2007DecernisDecernisFDAFoodAdditivesSummaryReportpressure;bloodchemistryother=increasedplasmainsulin;decreasedcapillary"permeabilityofalbumininthethoracicaorta,effectuncertain"siteskeletalmuscle=leftquadriceps.Duration:28days.AMJHYPERTENS11:563-569.Year:1998.OralStudy:24.Effects:TRIGLYCERIDESINCREASE.LEL:30000.mg/kgbw/day.Species:rat.Site:SKELETALMUSCLE.Type:SHORTTERM.Comment:Onedoselevelonly;malesonly;tissuechemistryobservations=decreasedcapillarypermeabilityofalbuminintheleftquadricepsandskin;clinicalother=increasedsystolicbloodpressure;bloodchemistryother=increasedplasmainsulin;decreasedcapillary"permeabilityofalbumininthethoracicaorta,effectuncertain"siteskeletalmuscle=left quadriceps.Duration:28days.AMJHYPERTENS11:563-569.Year:1998.OralStudy:24.Effects:TRIGLYCERIDESINCREASE.LEL:30000.mg/kgbw/day.Species:rat.Site:SKIN.Type:SHORTTERM.Comment:Onedoselevelonly;malesonly;tissuechemistryobservations=decreasedcapillarypermeabilityofalbuminintheleftquadricepsandskin;clinicalother=systolicbloodpressure;bloodchemistryother=increasedplasmainsulin;decreasedcapillary"permeabilityofalbumininthethoracicaorta,effectuncertain"siteskeletalmuscle=leftquadriceps.Duration:28days.AMJHYPERTENS11:563-569.Year:1998.OralStudy:25.Effects:BLOODCHEMISTRYOBSERVATION(S)NOTELSEWHERECLASSIFIED-SEECOMMENTS.LEL:30000.mg/kgbw/day.Species:rat.Site:LIVER.Type:SHORTTERM.Comment:Onedoselevelonly;malesonly;tissuechemistryother=decreasedcapillarypermeabilityofalbuminintheleftquadricepsandliver;clinicalother=increasedsystolicbloodpressurebloodchemistryother=increasedplasmainsulinsiteskeletalmuscle=leftquadriceps.Duration:56days.AMJHYPERTENS11:563-569.Year:1998.OralStudy:25.Effects:BLOODCHEMISTRYOBSERVATION(S)NOTELSEWHERECLASSIFIED-SEECOMMENTS.LEL:30000.mg/kgbw/day.Species:rat.Site:SKELETALMUSCLE.Type:SHORTTERM.Comment:Onedoselevelonly;malesonly;tissuechemistryother=decreasedcapillarypermeabilityofalbuminintheleftquadricepsandliver;clinicalother=increasedsystolicbloodpressurebloodchemistryother=increasedplasmainsulinsiteskeletalmuscle=leftquadriceps.Duration:56days.AMJHYPERTENS11:563-569.Year:1998.OralStudy:25.Effects:CLINICALOBSERVATION(S)NOTELSEWHERECLASSIFIED-SEECOMMENTS.LEL:30000.mg/kgbw/day.Species:rat.Site:LIVER.Type:SHORTTERM.Comment:Onedoselevelonly;malesonly;tissuechemistryother=decreasedcapillarypermeabilityofalbuminintheleftquadricepsandliver;clinicalother=increasedsystolicbloodpressurebloodchemistryother=increasedplasmainsulinsiteskeletalmuscle=leftquadriceps.Duration:56days.AMJHYPERTENS11:563-569.Year:1998.OralStudy:25.Effects:CLINICALOBSERVATION(S)NOTELSEWHERECLASSIFIED-SEECOMMENTS.LEL:30000.mg/kgbw/day.Species:rat.Site:SKELETALMUSCLE.Type:SHORTTERM.Comment:Onedoselevelonly;malesonly;tissuechemistryother=decreasedcapillarypermeabilityofalbuminintheleftquadricepsandliver;clinicalother=increasedsystolicbloodpressurebloodchemistryother=increasedplasmainsulinsiteskeletalmuscle=leftquadriceps.Duration:56days.AMJHYPERTENS11:563-569.Year:1998.OralStudy:25.Effects:TISSUECHEMISTRYOBSERVATION.LEL:30000.mg/kgbw/day.Species:rat.Site:LIVER.Type:SHORTTERM.Comment:Onedoselevelonly;malesonly;tissuechemistryother=decreasedcapillarypermeabilityofalbuminintheleftquadricepsandliver;clinicalother=increasedsystolicbloodpressurebloodchemistryother=increasedplasmainsulinsiteskeletalmuscle=leftquadriceps.Duration:56days.AMJHYPERTENS11:563-569.Year:1998.OralStudy:25.Effects:TISSUECHEMISTRYOBSERVATION.LEL:30000.mg/kgbw/day.Species:rat.Site:SKELETALMUSCLE.Type:SHORTTERM.Comment:Onedoselevelonly;malesonly;tissuechemistryother=decreasedcapillarypermeabilityofalbuminintheleftquadricepsandliver;clinicalother=increasedsystolicPage4Copyright(c)2007DecernisDecernis FDA Food Additives Summary Report

blood pressure blood chemistry other= increased plasma insulin site skeletal muscle= left quadriceps. Duration: 56 days. AM J HYPERTENS 11 :563-569. Year: 1998.

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

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

chemistry other= increased plasma insulin site skeletal muscle= left quadriceps. Duration: 56 days. AM J HYPERTENS 11 :563-569. Year: 1998.

Oral Study : 25. Effects: TRIGLYCERIDES INCREASE. LEL: 30000. mg/kg bw/day. Species: rat. Site: SKELETAL MUSCLE. Type: SHORT TERM. Comment: One dose level

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

blood chemistry other= increased plasma i nsulin site skeletal muscle= left quadriceps. Duration : 56 days . AM J HYPERTENS 11:563-569 . Year : 1998 .

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

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

plasma 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 : 29. Effects: CLINICAL OBSERVATION(S) NOT ELSEWHERE CLASSIFIED- SEE COMMENTS. LEL: 33000. mg/kg bw/day. Species: rat. Type: SPECIAL

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

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/day. Species: mouse. Site:

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/day. Species: rat. Type:

SHORT TERM . Comment : One dose level only ; males only; blood chemistry other= increased free fatty acids and insulin. Duration: 14 days. METABOLISM 49:1106-

1110. Year : 2000.

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

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 level only; males only; blood

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: One dose level only; males

only; organ weight increase= increased relative liver and pancreas weights at 66200 mg/kg; decreased " liver copper at 66200 mg/kg, metabolism effect; nutrition 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. Year: 1999.

Oral Study : 32. Effects: ORGAN WEIGHT INCREASE. LEL: 66200. mg/kg bw/day. Species: rat. Site: PANCREAS . Type: SHORT TERM . Comment: One dose level only;

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

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 . Year: 1999.

Oral Study: 33. Effects: BODY WEIGHT INCREASE . LEL: 29000. mg/kg bw/day. Species: rat. Type: CHRONIC RODENT. Comment : One dose level only; sex not stated;

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

pathology other= increased abdominal and epididymal fat content; no charts or graphs provided; reporting incomplete not used for priority ranking. Duration: 330

PageS Copyright (c) 2007 DecernisDecernisFDAFoodAdditivesSummaryReportdays.ANNNYACADSCI878:716-719.Year:1999.OralStudy:33.Effects:GROSSPATHOLOGYOBSERVATION(S)NOTELSEWHERECLASSIFIED-SEECOMMENTS.LEL:29000.mg/kgbw/day.Species:rat.Type:CHRONICRODENT.Comment:Onedoselevelonly;sexnotstated;studydurationreportedrangedfrom11to17months;bodyweightincrease=averagefinalbodyweight;urineproteinincrease=totalproteinandalbumingrosspathologyother=increasedabdominalandepididymalfatcontent;nochartsorgraphsprovided;reportingincompletenotusedforpriorityranking.Duration:330days.ANNNYACADSCI878:716-719.Year:1999.OralStudy:33.Effects:URINEPROTEININCREASE.LEL:29000.mg/kgbw/day.Species:rat.Type:CHRONICRODENT.Comment:Onedoselevelonly;sexnotstated;studydurationreportedrangedfrom11to17months;bodyweightincrease=averagefinalbodyweight;urineproteinincrease=totalproteinandalbumingrosspathologyother=increasedabdominalandepididymalfatcontent;nochartsorgraphsprovided;reportingincompletenotusedforpriorityranking.Duration:330days.ANNNYACADSCI878:716-719.Year:1999.OralStudy:4.Effects:HISTOPATHOLOGYOBSERVATION(S)NOTELSEWHERECLASSIFIED-SEECOMMENTS.LEL:77000.mg/kgbw/day.Species:rat.Site:LIVER.Type:SHORTTERM.Comment:Otherhistopath=increaseinliverlipids.Duration:30days.TOHOKUJEXPMED115:213-222.Year:1975.OralStudy:4.Effects:TRIGLYCERIDESINCREASE.LEL:77000.mg/kgbw/day.Species:rat.Site:LIVER.Type:SHORTTERM.Comment:Otherhistopath=increaseinliverlipids.Duration:30days.TOHOKUJEXPMED115:213-222.Year:1975.OralStudy:5.Effects:CHOLESTEROLINCREASE.LEL:68000.mg/kgbw/day.Species:rat.Type:SHORTTERM.Comment:Malesonlyincreaseinvldl-triglycerides.Duration:70days.NUTRREPTINT25:161-167.Year:1982.OralStudy:5.Effects:TRIGLYCERIDESINCREASE.LEL:68000.mg/kgbw/day.Species:rat.Type:SHORTTERM.Comment:Malesonlyincreaseinvldl-triglycerides.Duration:70days.NUTRREPTINT25:161-167.Year:1982.OralStudy:6.Effects:BLOODCHEMISTRYOBSERVATION(S)NOTELSEWHERECLASSIFIED-SEECOMMENTS.LEL:68000.mg/kgbw/day.Species:rat.Site:LIVER.Type:SHORTTERM.Comment:Decreaseinadiposetissueenzymesincreaseinliverpyruvatedehydrogenaseotherhistopath=increaseinlivertriglyceridesotherbloodchemistry=increaseinserumphospholipids.Duration:50days.NUTRMETAB16:285-294.Year:1974.OralStudy:6.Effects:CHOLESTEROLINCREASE.LEL:68000.mg/kgbw/day.Species:rat.Site:LIVER.Type:SHORTTERM.Comment:Decreaseinadiposetissueenzymesincreaseinliverpyruvatedehydrogenaseotherhistopath=increaseinlivertriglyceridesotherbloodchemistry=increaseinserumphospholipids.Duration:50days.NUTRMETAB16:285-294.Year:1974.OralStudy:6.Effects:HISTOPATHOLOGYOBSERVATION(S)NOTELSEWHERECLASSIFIED-SEECOMMENTS.LEL:68000.mg/kgbw/day.Species:rat.Site:LIVER.Type:SHORTTERM.Comment:Decreaseinadiposetissueenzymesincreaseinliverpyruvatedehydrogenaseotherhistopath=increaseinlivertriglyceridesotherbloodchemistry=increaseinserumphospholipids.Duration:50days.NUTRMETAB16:285-294.Year:1974.OralStudy:6.Effects:ORGANWEIGHTINCREASE.LEL:68000.mg/kgbw/day.Species:rat.Site:LIVER.Type:SHORTTERM.Comment:Decreaseinadiposetissueenzymesincreaseinliverpyruvatedehydrogenaseotherhistopath=increaseinlivertriglyceridesotherbloodchemistry=increaseinserumphospholipids.Duration:50days.NUTRMETAB16:285-294.Year:1974.OralStudy:6.Effects:TISSUEENZYMESDECREASE.LEL:68000.mg/kgbw/day.Species:rat.Site:LIVER.Type:SHORTTERM.Comment:Decreaseinadiposetissueenzymesincreaseinliverpyruvatedehydrogenaseotherhistopath=increaseinlivertriglyceridesotherbloodchemistry=increaseinserumphospholipids.Duration:PageSCopyright(c)2007DecernisDecernisFDAFoodAdditivesSummaryReport50days.NUTRMETAB16:285-294.Year:1974.OralStudy:6.Effects:TISSUEENZYMESINCREASE.LEL:68000.mg/kgbw/day.Species:rat.Site:LIVER.Type:SHORTTERM.Comment:Decreaseinadiposetissueenzymesincreaseinliverpyruvatedehydrogenaseotherhistopath=increaseinlivertriglyceridesotherbloodchemistry=increaseinserumphospholipids.Duration:50days.NUTRMETAB16:285-294.Year:1974.OralStudy:7.Effects:BLOODCHEMISTRYOBSERVATION(S)NOTELSEWHERECLASSIFIED-SEECOMMENTS.LEL:68000.mg/kgbw/day.Species:rat.Site:LIVER.Type:SHORTTERM.Comment:Malesonlyincreaseinfattyacidsynthesisinadiposetissueotherhistopath=increaseinliverfattyacids"otherbloodchemistry=increaseinfreefattyacids,insulin"andcorticosterone.Duration:30days.HORMMETABRES6:99-106.Year:1974.OralStudy:7.Effects:HISTOPATHOLOGYOBSERVATION(S)NOTELSEWHERECLASSIFIED-SEECOMMENTS.LEL:68000.mg/kgbw/day.Species:rat.Site:LIVER.Type:SHORTTERM.Comment:Malesonlyincreaseinfattyacidsynthesisinadiposetissueotherhistopath=increaseinliverfattyacids"otherbloodchemistry=increaseinfreefattyacids,insulin"andcorticosterone.Duration:30days.HORMMETABRES6:99-106.Year:1974.OralStudy:7.Effects:ORGANWEIGHTINCREASE.LEL:68000.mg/kgbw/day.Species:rat.Site:LIVER.Type:SHORTTERM.Comment:Malesonlyincreaseinfattyacidsynthesisinadiposetissueotherhistopath=increaseinliverfattyacids"otherbloodchemistry=increaseinfreefattyacids,insulin"andcorticosterone.Duration:30days.HORMMETABRES6:99-106.Year:1974.OralStudy:7.Effects:TRIGLYCERIDESINCREASE.LEL:68000.mg/kgbw/day.Species:rat.Site:LIVER.Type:SHORTTERM.Comment:Malesonlyincreaseinfattyacidsynthesisinadiposetissueotherhistopath=increaseinliverfattyacids"otherbloodchemistry=increaseinfreefattyacids,insulin"andcorticosterone.Duration:30days.HORMMETABRES6:99-106.Year:1974.OralStudy:8.Effects:HISTOPATHOLOGYOBSERVATION(S)NOTELSEWHERECLASSIFIED-SEECOMMENTS.LEL:69000.mg/kgbw/day.Species:rat.Site:LIVER.Type:SHORTTERM.Comment:Otherhistopath=increaseinliverlipidsincreaseinliverg6pdandmeenzymesanimalsfedfor3hr/day.JNUTRYear:1977.OralStudy:8.Effects:ORGANWEIGHTINCREASE.LEL:69000.mg/kgbw/day.Species:rat.Site:LIVER.Type:SHORTTERM.Comment:Otherhistopath=increaseinliverlipidsincreaseinliverg6pdandmeenzymesanimalsfedfor3hr/day.JNUTR107:534-538.Year:1977.OralStudy:8.Effects:TISSUEENZYMESINCREASE.LEL:69000.mg/kgbw/day.Species:rat.Site:LIVER.Type:SHORTTERM.Comment:Otherhistopath=increaseinliverlipidsincreaseinliverg6pdandmeenzymesanimalsfedfor3hr/day.JNUTR107:534-538.Year:1977.Genotoxicity•Study:13.Effects:Cytotoxic(ld50islessthan5millimolar)Species:MIDGE.Type:CYTOTOXICITY.Duration:48.CHROMOSOMA41:297-326.Year:1973.Comment:Treated4thinstarlarvae..LEL:10.mg/ml.OtherPage7Copyright(c)2007DecernisDecernis 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-Objection Letters" is an

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

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

unclear , users are advised to contact FDA directly for clarification . Page 8 Copyright ( c) 2 0 07 Decemis