# Clinical Research Laboratories, Inc.

Report Status: ReportDate: CRL StudyNumber: Client StudyNumber:
CRLProtocolNumber: StudyDates: Study Title:
TestMaterial: Sponsor:

SponsorRepresentative:

Investigator:



### APPROVAL SIGNATURES:

AnitaLee Cham, M.D. Dermatologist FinalReport December 12,2014 CRL81314-1
FRET 09-0536-01
CL 1.0 2014 October27,2014- December5, 2014 RepeatedInsultPatchTest (RIPT) --Shelanski Method
FRET09-0536-01 (2% inEtOH:DEP(1:3)) International Flavors & FragrancesInc. 800 RoseLane UnionBeach,NJ 07735
Paul Sterchele, PhD SeniorRegulatoryToxicologist Global Regulatory Affairs

AnitaLee Cham, M.D. Dermatologist

Date

371 Hoes Lane, Suite 100 • Piscataway, NJ 08854 • (732) 981-1616 • FAX (732} 981-0520

# Clinical Research Laboratories, Inc.



# ·······•·•·•··
..·.·••·
. G66actiD.icalPractic(! ·.•·.·. ·



# .·· · QualitY**~$~t.r1tll¢~.~~Qft**

# Statement

Clinical StudyNumber: CRL81314-l StartDate: October 27, 2014 Completion Date: December 5, 2014

The clinical study listed above was conducted in accordance with Clinical Research Laboratories, Inc. Standard Operating Procedures, which incorporate the principles of Good Clinical Practice defined by applicable guidelines and regulations established by U.S. RegulatoryAgencies. The conduct ofthe study was monitored for compliance, and the associated records, including source documents or raw data, were reviewed for documentation practices and accuracy by a Project Manager/Study Director and/or a Quality Assurance Representative. Standard Quality Assurance audit procedures for this final reportand studyrelated documents were conducted.
The Project Manager verifies that the clinical study listed above was executed according to the studyprotocol and all documentation contained in the study file accurately reflects the conduct ofthe study.

### /~gill(ture ofProject Manager Date 

### lv-j,,_j 1 '-"

# &~. 12;

# ).cJ/f Date

# Clinical FinalReport Sponsor: llltematimta/Flavors & FragrancesInc. StudyNumber:**CRL813U~J** Page3ofl4 

# Research Laboratories, Inc.

FINALREPORT Repeated InsultPatch Test (RIPD- ShelanskiMethod 1.0 SUMMARY
One hundred twelve subjects participated in evaluating the potential ofFRET 09- 0536-01 (2% in EtOH:DEP(l:3)) to elicit dermal irritation and/or induce sensitization. The test material was applied under an occlusive patch to the upper back ofeach subject and was allowedto remain indirect skin contactfor a period of 24 hours. Patches were applied to the same site on Monday, Wednesday, and Friday for a total of 9 applications during the Induction Period. The sites were graded by a CRL technician for dermal irritation 24 hours after removal ofthe patches by the subjects on Tuesday and Thursday and 48 hours afterremoval ofthe patches on Saturday Following approximately a 2-week rest period, challenge patches were applied to previously untreated test sites on the back. After 24 hours, the patches were removed by a CRL technician and the test sites were evaluated for dermal reactions. The test sites were re-evaluated at 48 and 72 hours. Subjects exhibiting reactions during the Challenge Phase ofthe study may have been asked to return for a 96- ho\lrreading.
One hundred subjects completed the study. The test material identified as FRET 09-0536-01 (2% in EtOH:DEP(l:3)) did not demonstrate a potential for eliciting dermal irritation or sensitization under the following test conditions: 0.2ml ofthe testmaterial applied to a 3.63 cm2 occlusivepatch.
2.0 OBJECTIVE The objective ofthis study was to determine the dermal irritation and sensitization potential ofa testmaterial. 3.0 INVESTIGATOR/INVESTIGATIVE SITE AnitaLee Cham, M.D. Dermatologist Clinical ResearchLaboratories, Inc. 371 Hoes Lane, Suite 100 Piscataway,NewJersey 08854 732-981-1616 

### 4.0 SPONSORREPRESENTATIVE/SPONSOR Paul Sterchele, PHD SeniorRegulatory Toxicologist Global Regulatory Affairs International Flavors & Fragrances Inc. 800 Rose Lane UnionBeach, NJ 07735Filla/Report 

# Clinical SpoiiSor: lntemationalFlavors&: Fragra11ces file. StudyNumber: CRL81314-l 

# Research Laboratories, Inc.

5.0 TESTMATERIAL Page4ofl4

The following test material was provided by International Flavors & Fragrances Inc. and was received byClinical ResearchLaboratories, Inc. on. TestMaterial Test

### Condition PatchType

FRET 09-0536-01 0.2 mlofthe test material was appliedto a 3.63cm 2patch. Thetestmaterial was applied to (2%in the patch as receivedand allowedto evaporate Occlusive* EtOH:DEP(1:3)) for atleast 30 minutes, butno longerthan 90 minutes, priorto patch application. The testmaterial was coded with the following CRL identificationnumber: CRL81314-1 6.0 STUDYDATES This study was initiated on October27, 2014 and was completed onDecember 5, 2014. 7.0 PANEL SELECTION Each subject was assigned a permanent CRL identification number. All subjects signed an Informed Consent Form incompliance with 21 CFRPart 50: "Protection ofHuman Subjects" and a HIPAA Authorization Form in compliance with 45 CFR Parts 160 and 164. All subjects completed a Subject Profile/Medical History Form provided by Clinical Research Laboratories, Inc. prior to the study (Subject Demographics

- Appendix I). Subjects who met the following Inclusion Criteria and none ofthe Exclusion Criteriawere impaneled: 7.1. INCLUSION CRITERIA

a. Subjectis male orfemale between the ages of18 and 70 years; b. Subjects with no visible or known pre-existing skin diseases that might be confused with a skinreaction from the testmaterial, or whichmay bereasonably expected to affect the outcome of the study. This includes subjects with psoriasis oractive eczema, even ifcurrently controlled throughmedication;

c. Subjects who do not report a history ofacute or chronic dermatologic, medical, orphysical conditions that could interfere with dermal scoring; d. Subject agrees to avoid exposure ofthe test sites to the sun and to refrain from visitstotanning salons during the course ofthis study;

e. Subject agrees torefrain from getting patches wet during the course ofthe study; *Occlusive Strip with Flexcon® (Strukmyer LLC, Mesquite,TX or equivalent)

# Clinical Research Laboratories, Inc.

7.0 PANEL SELECTION(Continued)
7.1 INCLUSION CRITERIA (CONTINUED) FinalReport Spo11sor: IJtternat/onalFlavors & Fragra11cesInc. Stul(y Number: CRL81314-l PageS ofl4

f. Subject has signed an Informed Consent in conformance with 21CFR Part 50: "Protection ofHuman Subjects;" g. Subject has completed a HIPAA Authorization Form in conformance with 45CFR Parts 160 and 164; h. Subject is in generally good health and has a current Subject Profile/Medical History on file;
1. Subjectis dependable and ableto follow directions as outlined inthe protocol. 7.2. EXCLUSION CRITERIA
a. Subjectispregnant, nursing, or planningtobecome pregnant; b. Subject is currently using any systemic or topical corticosteroids, antiinflammatory drugs, or antihistamines on aregular basis;

c. Subjectreports anergies to cosmetics, toiletries, orpersonal careproducts; d. Subject exhibits any skin disorders, sunburn, scars, excessive tattoos, etc. in the testarea;
e. Subject has scheduled, or is planning to undergo, any medical or surgical procedures duringthe 6week course ofthe study. f. Subjects who have reactedto an IFF testmaterial within the pastyear. 8.0 TESTMETHOD SUMMARY This study was conducted using a modified Shelanski

- Shelanski human patchtest method'. Prior to the application ofthe patch, the test area was wiped with 70% isopropyl alcohol and allowed to dry. The test material, which was prepared as described in the Test Material section ofthe report, was applied to the upper back (between the scapulae) and was aUowed to remain indirect skin contactfor aperiod of24hours. Patches were appliedto the same site onMonday, Wednesday, and Friday for atotal of 9 applications during the Induction Period. This schedule may have been modified to allow for missed visits orholidays. 

### Ifa subject was unable to report on an assigned test date, the test material was applied on 2 consecutive days during the Induction Phase and/or amakeup day was added atthe end oftheInduction Phase.

*H.A. Shelanski and M.V. Shelanski, Proc. Sci. Sect. ToiletGoodsAssoc. 19:46, 1953.

# Clinical FinalReport Sponsor: InternatiomrlFlavors & FragrancesInc. StndyNttmber: CRL81314-I Page6ofl4 

# Research Laboratories, Inc.

8.0 TESTMETHOD SUMMARY (Continued) The sites were graded by a CRL technician for dermal irritation 24 hours after removal ofthe patches by the subjects on Tuesday and Thursday and 48 hours after removal ofthe patches on Saturday, unless the patching schedule was altered as described above. The sites were graded accordingtothe following scoring system: Dermal Scoring Scale 0 No visible skinreaction ± 

### Barelyperceptible erythema 1 + Mild erythema 2+ Well defmed erythema 3+ Severe erythema and edema 4+ Erythema and edema with vesiculation Ifa "2+" reaction or greater occurred, the test material was applied to an adjacent virgin site. Ifa "2+" reaction or greater occurred on the new site, the subject may not have been patched again during the Induction Phase but may have been challenged on the appropriate day of the study. At the discretion of the Study Director, patch sites with scoreslessthan a "2+"mayhave been changed. Following approximately a 2-week rest period, the challenge patches were applied to previously untreated test sites on the back. After 24 hours, the patches were removed by a CRL technician and the test sites were evaluated for dermal reactions. The test sites were re-evaluated at 48 and 72 hours. Subjects exhibiting reactions during the Challenge Phase ofthe study may have been asked to return for a 96- hourreading. 9.0 RESULTS
This study was initiated with 112 subjects. Twelve subjects discontinued study participation for reasons unrelated to the test material. A total of 100 subjects completed the study.
Individual dermal scores recorded during the Induction and Challenge Phases appearinTable I.


### 10.0 ADVERSE EVENTS
No adverse events were reported duringthe study.

# Clinical Research Laboratories, Inc.

11.0 CONCLUSION FinalReport Sponsor: IntemationalFlavors&. Fragrances lttc. StudyNumber: CRL81314-l Page 7ofl4

Based on the test population of 100 subjects and under the conditions ofthis study, the test material identified as FRET 09-0536-01 (2% in EtOH:DEP(l:3)) did not demonstrate a potential for eliciting dermal irritation or sensitization under the following test conditions: 0.2ml ofthe test material applied to a 3.63 cm2 occlusive patch.
12.0 RETENTION
Test materials and all original forms of this study 

### will be retained by Clinical Research Laboratories, Inc. as specified in CRL Standard Operating Procedures 30.6 and 30.6C, unless designated otherwise bythe Sponsor.

# Clinical Research Laboratories, Inc.

TABLE I 

### SummaryofDermal Scores**FiJ~al**Report Sponsor: lnlenzationalFlavors & Fragrancesfire. StudyNumber: CRL8131-t.l Page8ofl4

II .•

## T~tl\{aterial:·l FRET09-0536-01 (2% 

### in EtOH:DEP(l:3)) 

## SulfttL .•.

. 

## ······

.. 

### Challenge Scores 

### ···InductiollScores • · '

..

. .

J

.. ·. 

### 24 48: 7Z



## .:Nuilibt1r. 

## ·r

.. 2

. 3 .·· .

## -.:4

. 

# s .ii 

### . 1. 8 .9

. 

### ••••• }lQur.**HQ~r** }JQur 

### 1 0 0 0 0 0 0 0 0 

### 0 0 0 0 

### 2 0 0 0 0 0 

### 0 0 0 

### 0 0 0 0 

### 3 0 

### 0 0 0 0 

### 0 0 0 0 0 0 0 

### 4 0 0 0 0 

### 0 0 0 0 0 

### 0 0 0 

### 5 0 0 0 0 

### 0 0 0 0 0 

### 0 0 0 

### 6 0 

### 0 0 0 

### 0 0 0 0 0 0 

### 0 0 

### 7 0 0 

### 0 0 0 

### 0 0 0 0 0 0 0 

### 8 0 0 

### 0 0 0 0 0 0 0 0 

### 0 0 

### 9 0 0 

### 0 0 

### 0 0 

### 0 0 

### 0 0 

### 0 0 

### 10 0 0 0 0 0 0 0 0 0 

### 0 0 0 11 0 0 0 0 0 0 

### 0 0 

### 0 0 0 0 12 

### 0 0 

### 0 0 0 

### 0 . 0 0 

### 0 0 

### 0 0 

### 13 0 0 0 0 0 

### 0 0 0 0 

### 0 0 0 

### 14 0 0 0 0 0 0 0 0 0 0 

### 0 0 

### 15 0 

### 0 0 0 0 0 0 0 0 0 

### 0 0 

### 16 0 0 0 0 0 0 0 0 0 0 1+ 

### 0 

### 17 0 0 0 0 0 0 

### 0 0 0 0 0 0 

### 18 0 0 

### 0 0 0 0 0 0 0 

### 0 0 0 

### 19 0 0 

### 0 0 0 0 

### 0 0 0 0 0 0 

### 20 0 0 

### 0 0 0 

### 0 0 0 

### 0 0 0 0 

### 21 

### OHr OHr 0 0 0 0 0 

### 0 0 

### 0 0 

### 0 

### 22 0 0 

### 0 0 0 

### 0 0 

### 0 0 0 

### 0 0 

### 23 0 0 0 0 0 0 0 0 0 0 0 0 

### 24 0 0 0 0 0 0 0 0 0 0 

### 0 0 

### 25 0 0 0 0 0 0 0 0 0 0 0 0 Hr- Hyperp1gmentation

# Clinical Research Laboratories, Inc.

TABLE I (Continued) SummaryofDermal Scores FinalReport Sponsor: InternationalFlaPors & Fragraltces I11c. Study Number: CRL81J14-1 Page9ofl4



### : j:!iStMalerial: 

# I FRET 09-0536-01 

### (2% in EtOH:DEP(1:3))

... .. . ..,.. ··.··· 

### ··• ·•
. .InductionScores ··· .·· ·· Cl!all¢ngeScores ·.Subject ·· . .............•.· 

# . . . 

# ... '·· A 

### :s.:: ............ I 

# f •.•· 

# u ..48 

### 72

**,Nll~bef** •. l. 2 3 .;•.v:
... 

### .s 9

**R9J~r.**

**RoJ~r** Ho.ur

.... 

### 26 0 0 0 0 0 0 0 0 0 0 0 0 

### 27 0 0 0 0 0 0 0 0 0 0 0 0 

### 28 Discontinued 

### 29 0 0 0 0 0 0 0 0 0 0 0 0 

### 30 0 0 0 0 0 0 0 0 0 0 0 0 

### 31 0 0 0 0 0 0 0 Discontinued 

### 32 0 0 0 0 0 0 0 0 0 0 0 0 

### 33 0 0 0 0 0 0 0 0 0 0 0 0 

### 34 0 0 0 0 0 0 0 

### 0 0 0 0 0 

### 35 0 0 0 

### 0 0 0 0 0 0 0 0 

### 0 

### ··36 0 0 

### 0 0

• 0 0 0 0 ... 0 0 0

.. 0



### 37 0 0 0 0 0 0 Discontinued 

### 38 0 0 0 0 0 0 0 0 0 0 0 

### 0 

### 39 0 0 0 

### 0 0 0 

### 0 0 0 0 0 

### 0 

### 40 0 0 0 0 0 

### 0 0 0 0 0 

### 0 0 

### 41 0 0 0 0 0 0 

### 0 0 0 0 0 0 

### 42 0 0 

### 0 0 0 0 0 0 0 0 0 0 

### 43 0 0 0 0 0 0 0 0 0 0 0 0 

### 44 0 0 0 

### 0 0 0 0 

### 0 0 0 0 

### 0 

### 45 0 0 0 0 0 0 Discontinued 

### 46 0 0 0 0 0 0 0 0 0 0 

### 0 0 

### 47 0 0 0 0 0 0 

### 0 0 0 0 0 

### 0 

### 48 0 0 0 0 0 

### 0 0 0 0 0 

### 0 0 

### 49 0 0 0 0 0 0 0 0 0 0 0 0 

### 50 0 0 0 0 0 

### 0 0 0 0 

### 0 0 0''''''''''''''''''' 

# Clinical 

# Research Laboratories, Inc.

TABLE I {Continued) SummaryofDermal Scores FinalReport Sponsor: InternationalFlavors & FragraJJcesl11c. SttufyNumber: CRL81314-1 Page !Oo/14

>

.•·

### TI\Stl\'tat~ri~h

# I FRET 09-0536-01 (2% inEtOH:DEP(1:3)) 

## '**~*J>jt~f**

## '• ': 

### :.**lndntti~JitScores** .....·. ' ' ChallengeScore$.



### Nllmbet- 1 .2 3 4 5 :'I 

# 6 .-10 '8 9· 

### 24. ' 48 7'2 Hout llour lJour 

### 51 0 0 0 0 0 0 0 0 0 0 0 0 

### 52 0 0 0 0 0 0 0 0 0 0 0 0 

### 53 0 0 0 0 0 0 0 0 0 0 0 0 

### 54 0 0 0 0 0 0 0 0 0 0 0 0 

### 55 0 0 0 0 0 0 0 0 0 0 0 0 

### 56 0 0 0 0 

### 0 0 0 0 0 0 0 0 

### 57 0 0 0 0 

### 0 0 0 0 0 0 0 0 

### 58 0 

### 0 0 

### 0 0 0 0 0 0 0 0 0 

### 59 0 0 0 0 

### 0 0 

### 0 0 0 0 0 

### 0 

### 60 0 0 0 

### 0 0 0 

### 0 0 0 0 0 

### 0 

### 61 0 

### 0· 0 

### 0 0 0 0 

### 0

.... I 0 0 0 0 

### 62 0 0 0 0 

### 0 0 0 0 0 0 0 0 

### 63 0 0 

### 0 0 

### 0 0 0 0 0 0 0 0 

### 64 0 0 

### 0 0 0 0 0 0 0 0 0 0 

### 65 0 Discontinued 

### 66 0 0 0 0 0 0 0 0 0 0 0 0 

### 67 0 

### 0 0 0 0 0 0 0 0 0 0 0 

### 68 0 0 0 0 0 0 0 0 0 0 0 0 

### 69 0 0 0 0 

### 0 0 0 

### 0 0 

### 0 0 

### 0 

### 70 0 0 0 0 0 0 0 0 0 0 0 

### 0 71 0 0 0 0 0 0 0 0 0 0 0 0 72 0 0 0 Discontinued 

### 73 0 0 0 0 

### 0 0 0 0 0 0 0 0 

### 74 0 0 0 0 0 0 0 0 0 0 0 0 

### 75 0 0 0 

### 0 0 0 0 0 0 0 0 0.................. 

# Clinical Research Laboratories, Inc.

TABLEI (Continued) SummaryofDermal Scores FinalReport Sponsor: Intemationa/Flavors & FragrancesJuc. StudyNumber: CRLS/314-1 PagellofU

. ·.;
. 

## ·······

.. · .•



### . .• •TestMaterial: FRET09-0536-01 (2% inEtOH:DEP(l:3))

- - - . . 

# . .•.·•···•·····

**:>J:~du¢ti~~;~¢~r~;r.•··.·····•·.·** .·ChallengeScores



### Su~jeci ;

. ;·;



### ·

**N~m!Jer** •. 3 ••. 

## )<I .....

### :

# ,..,. (.8
..

### ·.· 9 24. 

## 48 72 l 

# z .s ••6

**Jio~n** Hour Hour •••• 

### . ·

## .. 76 0 0 0 0 0 0 0 0 0 0 0 0 

### 77 0 0 0 0 0 0 0 0 0 0 0 0 

### 78 0 Discontinued 

### 79 0 0 0 0 0 0 0 0 0 0 0 0 

### 80 0 0 0 0 0 0 0 0 0 0 0 0 

### 81 0 0 0 0 0 0 0 0 0 0 0 0 

### 82 0 0 0 

### 0 0 0 0 0 0 0 0 0 

### 83 0 0 0 

### 0 0 0 0 0 0 

### 0 0 0 

### 84 0 0 0 0 0 Discontinued 

### 85 0 0 0 0 0 0 0 0 0 0 

### X 0* 

### 86

. . ... . . . · · Discontinued 

### 87 0 0 0 0 0 0 0 0 0 0 0 0 

### 88 0 0 0 0 0 0 0 0 0 0 0 0 

### 89 0 0 0 0 0 0 0 0 0 0 0 0 

### 90 0 0 0 0 0 Discontinued 

### 91 0 0 0 0 0 0 0 0 0 0 0 0 92 0 0 0 0 0 

### 0 0 0 0 

### 0 0 0 

### 93 0 0 0 0 

### 0 0 0 0 0 0 

### 0 0 

### 94 0 0 0 0 0 

### 0 0 Discontinued 

### 95 0 0 0 0 0 0 0 0 0 0 0 0 

### 96 0 0 0 0 0 0 0 0 

### X Discontinued 

### 97 0 0 0 0 0 0 0 0 0 0 0 0 

### 98 0 0 0 0 0 0 0 0 0 0 0 0 

### 99 0 0 0 0 0 0 0 0 0 0 0 0 

### 100 0 0 0 0 0 0 0 0 

### 0 0 0 0 X- SubjectAbsent *No reaction was observed atthe 96 hourevaluation'''''''''' 

# Clinical Research Laboratories, Inc.

TABLE I (Continued) SummaryofDermal Scores FinalReport Sponsor: ltltemationalFlavors & FragrancesInc. StudyNumber: CRL813U-1 Pagel1ofl4

TestMaterial! 

# IFRET 09-0536-0I (2% inEtOH:DEP(l:3))

' .' '
.. ' : ' ..... 

### Induction

## Scor¢$ 

# <·

---**ChallengeS:co~**

### --_ 

### Subject'

. ............ ----------- -.

### :Nilillb~r 

## 3 ...... 

# :t·•_.:**-~-** ··_ ._.· 

### ····,··· _24: ' :-48 72 1 2 

## 'A: : 

### 8 9 --7> 

## Hour Hour Hour 101 0 0 0 0 0 0 0 0 0 0 0 0 102 0 0 0 0 0 0 0 0 0 0 0 0 103 0 0 0 0 0 0 0 0 0 0 0 0 104 0 0 0 0 0 0 0 0 0 0 0 0 105 0 0 0 0 0 0 0 0 0 0 0 0 106 0 0 0 0 0 0 0 0 0 0 0 0 107 0 0 0 0 0 0 0 0 0 0 0 0 108 0 0 0 0 0 0 0 0 0 0 0 0 109 0 0 0 0 0 0 0 0 0 0 0 0 110 0 0 0 0 0 0 0 0 0 0 0 0 

### Ill 0 0 0 0 0 0 0 0 

## o- 0 0 0 112 0 0 0 0 0 0 0 0 0 0 0 0 '· Subj¢ct. 

# .Number 1 2 3 4 5 6 7 8 9 

### 10 11 

### 12

... 13 

### 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 

# Clinical Research Laboratories, Inc.

Appendix I SubjectDemographics

Subject


### . cJU.,<

**'.Ag~ s~x**  •Iliifutls 

# . mil-· Sub feet

**Nliinl>~~r** 

### DN 33175 34 

### F 29 

### MC 02025 33 

### F 30 

### BW 17003 64 

### F 31 JB 

### 14759 63 

### F 32 JD 

### 11122 53 

### F 33 

### MS 13309 35 

### F 34 

### DB 32989 56 

### F 35 

### KT 31548 64 

### F 36 

### ER 30633 56 

### F 37 

### RV 08103 37 

### F 38 

### BS 28576 61 

### F 39 

### KW 30192 64 

### F 40 

### SL 18114 38 

### F 41 

### DL 25050 43 

### F 42 TL 

### 33407 42 

### F 43 RP 

### 31532 63 

### M 44 

### FP 24056 59 

### F 45 

### GK 18831 29 

### M 46 

### AE 29803 31 

### M 47 

### MC 28585 38 

### F 48 JG 

### 27625 63 

### F 49 MB 

### 18220 67 

### F 

## so DG 01828 56 

### F 51 

### AG 32545 57 

### F 52 WB 

### 30469 64 

### M 53 

## ss 27553 57 

### F 54 AA 

### 32652 60 

### M 55 

### RT 31341 51 

### F 56 FinalReport Sponsor: lntemationalFlavors & Fragra11cesInc. StudyNumber: CRL813U-I Pagel3ofl4



### Subject· 

## ·cRt Age Sex Initials <iD# 

### BB 01668 51 

### F TA 33389 46 

### F JB 25556 38 

### M PR 05291 52 

### F CM 00741 69 

### F JG 

### 24987 54 

### M JA 05348 65 

### F ED 20237 55 

### F DM 15909 59 

### F DM 27962 57 

### F DT 32525 66 

### F CR 29212 46 

### F JS 30187 53 

### F AB 23147 49 

### F NI 33422 20 

### F DL 09278 54 

### F MO 33415 55 

### F IN 

### 03306 69 

### F DR 31032 52 

### F AC 33413 22 

### F CN 27549 52 

### F BW 27548 67 

### F DP 32402 63 

### F CA 33435 55 M MR 

### 31934 18 M 

### MV 02437 68 

### F 

## uw 33434 50 

### F CM 19646 56 

### F$ubject Number 

### 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 

### 73 74 75 76 77 78 79 80 81 82 83 84 

# Clinical Research Laboratories, Inc.

·Subject 

## cRt· fuitia]s


### . ID#.

GK 

### 03981 NC 

### 10624 MT 

### 30825 FT 

### 28815 AD 

### 32492 NC 

### 33362 NP 

### 30154 ER 

### 33363 SH 

### 33411 AS 

### 33436 LR 

### 33408 AM 

### 32178 CB 

### 33196 AC 

### 19727 PT 

### 31460 CR 

### 09622 JR 

### 29685 CB 

### 24697 GF 

### 23083 JB 

### 29335 

## ss 06517 WM 

### 33214 HG 

### 33133 JH 

### 19225 TC 

### 29284 SK 

### 18539 LJ 

### 33022 LN 

### 24351 AppendixI SubjectDemographics (Continued)



### Age 

# sex S!!b'ect L 

## .Nl!mber

. 

### 63 F 

### 85 36 F 

### 86 24 F 

### 87 45 F 

### 88 54 F 

### 89 51 F 

### 90 28 M 

### 91 44 M 

### 92 41 F 

### 93 18 M 

### 94 34 F 

### 95 38 F 

### 96 54 F 

### 97 29 F 

### 98 54 F 

### 99 56 F 

### 100 67 F 

### 101 62 F 

### 102 51 F 

### 103 58 F 

### 104 59 F 

### 105 37 M 

### 106 56 M 

### 107 50 M 

### 108 34 F 

### 109 62 F 

### 110 34 M 

### 111 48 F 

### 112 FinalReport Sponsor: lntemationatFlavors & FragratiCesInc. StudyNumber: CR£81314-I Page l4ofl4

**>s~~ject** . CRL 

# ... ··Age Sex 

### •. Ibitials

. 

### ···lD# PN 

### 03277 57 F ER 

### 33438 22 M LJ 

### 28423 45 F DC 

### 20624 61 F RC 

### 31248 21 M JL 

### 31000 49 F PS 

### 31629 56 F MP 

### 33431 20 F 

## cw 16399 54 F JW 

### 32123 39 F KH 

### 33439 25 M BT 

### 33424 42 M JP 

### 22148 39 F 

### RE 

### 26689 42 M AA 

### 29940 20 F DW 

### 20399 54 F RJ 

### 26063 52 F NF 

### 14449 58 F BC 

### 30844 23 F AS 

### 02343 65 F TM 

### 30142 46 F JG 

### 16720 29 F JN 

### 30414 32 F JS 

### 24960 53 F ST 

### 27390 56 F KB 

### 32105 41 F DL 

### 27410 53 F AM 

### 13130 48 FHRIPT FRET 09-0536

TEST SAMPLE Samplepreparation: R&D (Gary Mertz) Request date: September 17,2014 Test Chemical: FRET 09-0536

TestArticle FRET09-0536-01, 2% w/w inEthanol:DEP [25:75]


### 8 98 294 400 g g g g FRET 09-0536 Ethanol Diethyl Phthalate (043615) Total
Final FRET08-0338 Concentration= 8/400 (2% w/w)

Test Article FRET09-0536-02, 2% w/w 

### inEthanol:DEP [25:751
8 98 294 400 

### g g g g Distilled water Ethanol Diethyl Phthalate (043615) Total
Final DistilledWaterConcentration= 8/400(2%w/w)



### PFS

# Clinical Research Laboratories, Inc.

Report Status: ReportDate: CRLStudy Number: Client StudyNumber: CRLProtocol Number: StudyDates: StudyTitle:
TestMaterial: Sponsor:

SponsorRepresentative:

Investigator:

APPROVAL SIGNATURES:

AhitaLee Cham, M.D. Dermatologist FinalReport December 12, 2014 CRL81314-2
FRET09-0536-02 CL 1.0 2014 October27,2014- December5, 2014 Repeated Insult PatchTest (RIPT) -Shelanski Method
FRET 09-0536-02 (2% inEtOH:DEP(1:3)) International Flavors & FragrancesInc. 800Rose Lane Union Beach,

### NJ 07735
Paul Sterchele,PhD SeniorRegulatory Toxicologist GlobalRegulatoryAffairs

AnitaLee Cham, M.D. Dermatologist

Date

371 Hoes Lane, Suite 100• Piscataway, NJ 08854 • (732) 981-1616 • FAX (732) 981-0520

# Clinical Research Laboratories, Inc.



# ····•· Go.od**€iinic~I\Praetice·•·•··**



# ..·

...Quai · •**~$sltt~;c~**

# A:ijdit**St~t~lllent** 

# ··

Clinical StudyNumber: CRL81314-2 StartDate: October27, 2014 Completion Date: December 5, 2014

The clinical study listed above was conducted in accordance with Clinical Research Laboratories, Inc. Standard Operating Procedures, which incorporate the principles of Good Clinical Practice defined by applicable guidelines and regulations established by U.S. RegulatoryAgencies. The conduct ofthe study was monitored for compliance, and the associated records, including source documents or raw data, were reviewed for documentation practices and accuracy by a Project Manager/Study Director and/or a Quality Assurance Representative. Standard Quality Assurance audit procedures forthis ---fmal report and study related documentswere conducted.

The ProjectManager verifies that the clinical study listed above was executed according to the studyprotocol and all documentation contained inthe study file accurately reflects the conduct ofthe study.



### 1>--fi>---/t'/ "'Signature ofProjectManager Date 

# J)a_

.1 

## J, 2 tf( Date

# Clinical FinalReport Sponsor: IntematiotlalFlavors & Fragra11ces Inc. StudyNumber: CRL81314-2 Page3ofl4 

# Research Laboratories, Inc.

FINAL REPORT 

### Repeated InsultPatch Test (RIPD
- Shelanski Method 1.0 SUMMARY
One hundred twelve subjects participated in evaluating the potential ofFRET 09- 0536-02 (2% in EtOH:DEP(I :3)) to elicit dermal irritation and/or induce sensitization. The test material was applied under an occlusive patch to the upper back ofeach subjectand was allowedto remain in direct skin contactfor aperiod of 24 hours. Patches were applied to the same site on Monday, Wednesday, and Friday for a total of9 applications during the Induction Period. The sites were graded by a CRL technician for dermal irritation·24 hours after removal of the patches by the subjects onTuesday·and Thursday and 48 hours after removal ofthe patches on Saturday Following approximately a 2-week rest period, challenge patches were applied to previously untreated test sites on the back. After 24 hours, the patches were removed by a CRL technician and the test sites were evaluated for dermal reactions. The test sites were re-evaluated at 48 and 72 hours. Subjects exhibiting reactions during the Challenge Phase ofthe study may have been asked to retum for a 96- hmrrreading.
One hundred subjects completed the study. The test material identified as FRET 09-0536-02 (2% in EtOH:DEP(l:3)) did not demonstrate a potential for eliciting dermal irritation or sensitization under the following test conditions: 0.2ml ofthe test material appliedto a 3.63 cm2 occlusive patch.
2.0 OBJECTIVE The objective ofthis study was to determine the dermal irritation and sensitization potential ofatestmaterial. 3.0 INVESTIGATOR/INVESTIGATIVE SITE AnitaLee Cham, M.D. Dermatologist Clinical Research Laboratories, Inc. 3

71 Hoes Lane, Suite 1 00 Piscataway, NewJersey 08854 732-981-1616 4.0 SPONSOR REPRESENTATIVE/SPONSOR Paul Sterchele, PHD Senior Regulatory Toxicologist Global Regulatory Affairs International Flavors & Fragrances Inc. 800 Rose Lane Union Beach, NJ 07735Fi11a/Report 

# Clinical Sponsur: IntemationalFlavors & Fragram:esInc. StudyNumber: CRLS/314-2 

# Research Laboratories, Inc.

5.0 TESTMATERIAL Page4of/4

Thefollowingtestmaterial was providedbyInternational Flavors & Fragrances Inc. andwasreceivedby ClinicalResearch Laboratories, Inc. onOctober 13, 2014.
TestMaterial TestCondition Patch Type

FRET 09-0536-02 0.2 ml ofthe testmaterial was appliedto a 3.63cm 2patch. Thetestmaterial was appliedto (2%in the patch asreceived and allowedto evaporate Occlusive* EtOH:DEP(1:3)) for at least 30 minutes, butno longerthan 90 minutes, priorto patchapplication. Thetest material wascodedwiththefollowing CRLidentificationnumber: CRL81314-2 

### 6.0 STUDYDATES This studywasinitiatedon October 27, 2014andwas completed onDecember 5, 2014. 

### 7.0 PANEL SELECTION Each subject was assigned a permanent CRL identification number. All subjects signed an Informed ConsentForm in compliance with 21 CFRPart 50: "Protection ofHuman Subjects" and a IDP AAAuthorization Form in compliance with 45 CFR Parts 160 and 164. All subjects completed a SubjectProfile/Medical History Form provided by Clinical Research Laboratories, Inc. prior to the study (Subject Demographics

- Appendix I). Subjects who met the following Inclusion Criteria and none oftheExclusion Criteriawere impaneled: 7.1. INCLUSION CRITERIA

a. Subject ismale orfemale betweenthe ages of18 and70years; b. Subjects with no visible or known pre-existing skin diseases that might be confused with a skinreaction from thetestmaterial, orwhichmay bereasonably expected to affect the outcome of the study. This includes subjects with psoriasis oractive eczema, even ifcurrently controlledthroughmedication;

c. Subjects who do not report a history ofacute or chronic dermatologic, medical, orphysical conditionsthat could interfere withdermal scoring; d. Subject agrees to avoid exposure ofthe test sites to the sun and to refrain from visitsto tanning salons during the course ofthis study;

e. Subject agrees torefrain from gettingpatcheswet during the course ofthe study;
*Occlusive Strip with Flexcon® (Strukmyer LLC, Mesquite,TX or equivalent)

# Clinical Research Laboratories, Inc.

7.0 PANEL SELECTION (Continued) 7.1 INCLUSION CRITERIA(CONTINUED) F1nalReport Sponsor: InternationalFlavors & Fragr01tcesInc. StudyNumber: CRLS/3/4-2 Page5of14

f. Subject has signed an Informed Consent in conformance with 21CFR Part 50: "ProtectionofHuman Subjects;" g. Subjecthas completed a HIPAA Authorization Form in conformance with 45CFR Parts 160and 164; h. Subject is in generally good health and has a current Subject Profile/Medical Historyonfile; 

### i. Subjectis dependable and able to follow directions as outlinedinthe protocol. 7.2. EXCLUSION CRITERIA

a. Subject ispregnant, nursing, orplanningto becomepregnant; b. Subject is currently using any systemic or topical corticosteroids, antiinflammatory drugs, orantihistamines onaregularbasis;

c. Subjectreports allergies to cosmetics, toiletries, orpersonal care products; d. Subject exhibits any skin disorders, sunburn, scars, excessive tattoos, etc. in the testarea;
e. Subject has scheduled, or is planning to undergo, any medical or surgical procedures duringthe 6week course ofthe study. f. Subjects who have reactedto anIFF test material withinthe past year. 

### 8.0 TESTMETHOD SUMMARY This study was conductedusing a modified Shelanski

- Shelanski human patch test method*. Prior to the application ofthe patch, the test area was wiped with 70% isopropyl alcohol and allowed to dry. The test material, which was prepared as described in the Test Material section ofthe report, was. applied to the upper back (betweenthe scapulae) and was allowed to remain in direct skin contact for a period of24hours. Patches were appliedto the same site onMonday, Wednesday, and Friday for atotal of 9 applications during the Induction Period. This schedule may have been modified to allow for missed visits or holidays. 

### Ifa subject was unable to report on an assigned test date, the test material was applied on 2 consecutive days during the Induction Phase and/or amakeup day was added atthe end ofthe InductionPhase.

*H.A. Shelanski and M.V. Shelanski, Proc. Sci. Sect. Toilet Goods Assoc. 19:46, 1953.

# Clinical FinalReport Sponsor: InternationalFlavors & FragrallcesInc. StudyNumber: CRL81314-2 Poge6 of/4 

# Research Laboratories, Inc.

8.0 TESTMETHOD SUMMARY (Continued) The sites were graded by a CRL technician for dermal irritation 24 hours after removal ofthe patches by the subjects on Tuesday and Thursday and 48 hours after removal ofthe patches on Saturday, unless the patching schedule was altered as described above. The sites were graded according to the following scoring system: Dermal ScoringScale 0 No visible skinreaction ± Barelyperceptible erythema 1 + Mild erythema 2+ Well defined erythema 3+ Severe erythemaand edema 4+ Erythema and edemawith vesiculation Ifa "2+" reaction or greater occurred, the test material was applied to an adjacent virgin site. 

### Ifa "2+" reaction or greater occurred onthe new site, the subject may not have been patched again during the Induction Phase but may have been challenged on the appropriate day of the study. At the discretion of the Study Director, patch siteswithscoreslessthan a "2+'' mayhave beenchanged. Following approximately a 2-week rest period, the challenge patches were applied to previously untreated test sites on the back. After 24 hours, the patches were removed by a CRLtechnician and the test sites were evaluatedfor dermal reactions. The test sites were re-evaluated at 48 and 72 hours. Subjects exhibiting reactions during the Challenge Phase ofthe study may have been asked to return for a 96- hourreading. 

### 9.0 RESULTS
This study was initiated with 112 subjects. Twelve subjects discontinued study participation for reasons unrelated to the test material. A total of 100 subjects completed the study.
Individual dermal scores recorded during the Induction and Challenge Phases appear in Table I.
10.0 ADVERSE EVENTS
No adverse events were reported during the study.

# Clinical Research Laboratories, Inc.

11.0 CONCLUSION Fi1ralReport Sponsor: lntemationalFlavors&. FragrtmcesInc. ShtdyNumber:**CRLB/314~2** Page 7ofl4

Based on the test population of 100 subjects and under the conditions ofthis study, the test material identified as FRET 09-0536-02 (2% in EtOH:DEP(l:3)) did not demonstrate a potential for eliciting dermal irritation or sensitization under the following test conditions: 0.2ml ofthe test material applied to a 3.63 cm 2 occlusive patch.
12.0 RETENTION
Test materials and all original forms of this study will be retained by Clinical Research Laboratories, Inc. as specified 

### in CRL Standard Operating Procedures 30.6 and 30.6C, unless designated otherwise bythe Sponsor.

# Clinical Research Laboratories, Inc.

TABLE I SummaryofDermal Scores FinalReport Sponsor: InternationalFlavors & FragrmJcesInc. StudyNumber:

**CRL81314~2** PageS of/4



### ·.,· ·•·•····· j



## '['~t.Ma.terialt 

# IFRET 09-0536-02 (2% 

### in EtOH:DEP(1:3))



# .

**s~~j;cf** 

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.. 2. ·. 5 .

... 7. 9 

### Ii:oui Ii:o)lr Hour 1:

......... 

### 1 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 3 0 0 0 0 0 0 0 0 0 0 0 0 4 0 0 0 0 0 0 0 0 0 0 0 0 5 0 0 0 0 0 0 0 0 0 0 0 0 6 0 0 0 0 0 0 0 0 0 0 0 0 7 0 0 0 0 0 0 0 0 0 0 0 0 8 0 0 0 0 0 0 0 0 0 0 0 0 9 0 0 0 0 0 0 0 0 0 0 0 0 10 0 0 0 0 0 0 0 0 0 0 0 0 

### 11 0 0 0 0 0 0 0 0 0 0 0 0 12 0 0 0 I·· 0 

### 0 0 0 0 

### 0 0 0 0 13 0 0 0 0 0 0 0 0 0 0 0 0 14 0 0 0 0 0 0 0 0 0 0 0 0 15 0 0 0 0 0 0 0 0 0 0 0 0 16 0 0 0 0 0 0 0 0 0 0 0 0 17 0 

### 0 0 0 0 0 0 0 0 0 0 0 18 0 0 0 0 0 0 0 0 0 0 0 0 19 0 0 0 0 0 

### 0 0 0 0 0 0 0 20 0 0 0 0 0 0 0 0 0 0 0 0 21 0 0 0 0 0 0 0 0 0 0 

### 0 0 22 0 0 

### 0 0 0 0 0 0 0 0 0 0 23 0 0 0 0 0 0 0 0 0 0 0 0 24 0 0 0 0 0 0 0 0 0 0 0 0 25 0 0 0 0 0 0 0 0 0 0 0 0... 

# Clinical Research Laboratories, Inc.

TABLEI (Continued) Summary ofDermal Scores FinalReport Sponsor: JnternatiollalFlavors & Fragrances Im:. StudyNumber: CRL81314-2 Page 9of/4



### ····•.···• ••• T!\SfMatelia.i: 

# IFRET09-0536-02 (2% in EtOH:DEP(l :3)) 

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### H:ilur. Hour :Hour .. 26 0 0 0 0 0 0 0 0 0 0 0 0 27 0 0 0 0 0 0 0 0 0 0 0 

### 0 28 Discontinued 29 0 0 0 0 0 0 

### 0 0 0 0 0 0 30 0 0 0 0 0 0 0 0 0 0 0 0 31 0 0 0 

### 0 0 0 0 Discontinued 32 0 0 0 0 0 0 0 

### 0 0 0 0 0 33 0 0 0 0 0 0 0 0 0 0 0 0 34 0 0 0 0 0 0 0 0 0 0 

### 0 0 35 0 0 0 0 0 0 

### 0 0 0 0 0 0 36 0 0 0 0 0 0 0 0 0 0 0 

### 0 37 0 0 0 0 0 0 Discontinued 38 0 0 0 

### 0 0 0 0 0 0 0 0 0 39 0 0 0 0 0 0 0 0 0 0 0 0 40 0 0 0 

### 0 0 0 0 0 0 0 0 0 41 0 0 0 0 0 0 0 0 0 0 0 0 42 0 0 0 0 0 0 0 0 0 0 0 0 43 0 0 0 0 0 0 0 0 0 0 0 0 44 0 0 0 0 0 0 0 0 0 0 

### 0 0 45 0 0 0 0 0 0 Discontinued 46 0 0 0 0 0 0 0 0 0 0 0 0 47 0 0 0 

### 0 0 0 0 0 0 0 0 0 48 0 0 0 0 0 0 0 0 0 0 0 0 49 0 0 0 0 0 0 0 0 

### OHr 0 0 0 50 0 0 0 0 0 0 0 0 0 0 0 0 Hr- Hyperpigmentation

# Clinical Research Laboratories, Inc.

TABLEI (Continued) SummaryofDermal Scores Fi1Ja/Report Sponsor: lntemationalFlavors & FragraJtcesInc. StudyNumber: CRLB/314·2 Poge/Oof/4



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### 0 0 0 0 0 0 0 55 0 0 0 0 0 0 0 0 0 0 0 

### 0 56 0 0 0 0 0 0 0 0 0 0 0 0 57 0 0 0 0 0 0 0 0 0 0 0 0 58 0 

### 0 0 0 0 0 

### 0 0 0 

### 0 0 0 59 0 0 0 0 0 0 0 0 0 0 0 0 60 0 0 0 0 0 0 0 0 0 0 0 0 61 0 0 0 0 0 

### 0 0 0 0 0 0 0 62 0 0 0 0 0 0 0 0 0 0 0 0 63 0 0 0 0 0 0 0 0 0 0 0 

### 0 64 0 0 0 0 0 0 0 0 0 0 0 0 65 0 Discontinued 66 0 0 

### 0 0 0 0 0 0 0 0 0 0 67 0 0 0 0 0 0 0 0 0 0 0 0 68 0 0 0 0 

### 0 0 0 0 0 0 0 0 69 0 0 0 0 0 0 0 0 0 0 0 0 70 0 0 0 0 0 0 0 0 0 0 0 0 71 0 0 0 0 0 0 0 0 0 0 0 0 72 0 0 0 Discontinued 73 0 0 0 

### 0 0 0 0 0 

### 0 0 0 0 74 0 0 0 0 0 0 

### 0 0 

### 0 0 

### 0 0 75 0 0 0 0 0 

### 0 0 0 

### 0 0 0 0

# Clinical Research Laboratories, Inc.

TABLE I (Continued) SummaryofDermal Scores Fi11afReport Sponsor: InternationalFlavors & Fragra1Jces /1Jc. StudyN11mber: CRL81314-2 Page 11 af/4



## ··•·•·r
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### 76 0 0 0 0 0 0 0 0 0 0 0 0 

### 77 0 0 0 0 0 0 0 0 0 0 0 0 

### 78 0 Discontinued 

### 79 0 0 0 0 0 0 0 0 

### 0 0 0 0 

### 80 0 0 0 0 0 0 0 0 0 0 0 0 

### 81 0 0 0 0 0 0 0 0 0 0 0 0 

### 82 0 0 0 0 0 0 0 0 0 0 0 0 

### 83 0 0 0 0 0 0 0 0 0 0 0 0 

### 84 0 

### 0 0 0 0 Discontinued 

### 85 0 0 0 0 0 0 

## I 0 0 

## I 0 

### II 0 X 

## I 0* 

### 86 Discontinued ' 

### 87 0 0 0 0 0 0 0 0 0 0 0 0 

### 88 0 0 0 0 0 0 0 0 0 0 0 0 

### 89 0 

### 0 0 0 0 0 0 0 0 0 0 0 

### 90 0 0 0 0 0 Discontinued 

### 91 0 0 0 0 0 0 

### 0 0 0 0 0 0 

### 92 0 0 0 0 0 0 0 0 0 0 0 0 

### 93 0 0 0 0 0 0 0 0 0 0 0 0 

### 94 0 0 0 0 0 0 0 Discontinued 

### 95 0 0 0 0 0 0 0 0 0 0 0 0 

### 96 0 0 0 0 0 0 0 0 X Discontinued 

### 97 0 0 0 0 0 0 0 0 0 0 0 0 

### 98 0 0 0 0 0 0 0 0 0 0 0 0 

### 99 0 0 0 0 0 0 0 0 0 0 0 0 

### 100 0 0 0 0 0 0 0 0 0 0 ± ±

**X~** Subject Absent *No reactionwas observed atthe96 hourevaluation

# Clinical Research Laboratories, Inc.

TABLEI (Continued) 

### Summary ofDermal Scores FinalReport Sponsor: lntemationalFlavors & FragrancesInc. St11dyN11mber: CRL81314-2 Page/2of/4



### .

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### 101 0 0 0 0 0 

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### 0 0 0 0 0 W3 0 0 0 0 0 0 0 

### 0 0 0 0 0 104 0 0 0 0 0 0 0 

### 0 0 0 0 0**1~** 

### 0 0 0 0 0 0 0 

### 0 0 0 0 0 106 0 0 0 0 0 0 0 0 0 

### 0 0 0 107 0 

### 0 0 0 0 0 0 

### 0 0 0 0 0 108 0 

### 0 0 0 0 0 0 

### 0 0 0 0 0 109 0 

### 0 0 0 0 0 0 

### 0 0 0 0 0 110 0 0 0 

### 0 0 0 0 0 0 0 0 0 

### 111 0 0· 

### 0 0 

### 0 0 0 

### 0 0 0 0 0 112 0 0 0 0 

### 0 0 0 0 0 0 0 0**Sullj~\!t** 

## Nwnb.er 1 

### 2 3 4 5 6 7 8 9 10 11 

### 12 13 

### 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 

# Clinical Research Laboratories, Inc.

AppendixI SubjectDemographics 

## •subject· 

# ·cro,.



# ·····~~~···· **·$¢~·** 

### • Iuitillls · 

## J»tf **swJ~:iit.** 

## Nlil#J)e.f· DN 33175 34 F 

### 29 

### MC 02025 33 F 

### 30 

### BW 17003 64 F 

### 31 JB 

### 14759 63 F 

### 32 JD 

### 11122 53 F 

### 33 

### MS 13309 35 F 

### 34 

### DB 32989 56 F 

### 35 

### KT 31548 64 F 

### 36 

### ER 30633 56 F 

### 37 

### RV 08103 37 F 

### 38 

### BS 28576 61 F 

### 39 

### KW 30192 64 

### F 40 

### SL 18114 38 

### F 41 

### DL 25050 43 F 

### 42 

### TL 33407 42 

### F 43 RP 

### 31532 63 

### M 44 

### FP 24056 59 

### F 45 

### GK 18831 29 

### M 46 

### AE 29803 31 

### M 47 

### MC 28585 38 

### F 48 JG 

### 27625 63 F 

### 49 

### MB 18220 67 F 

### 50 

### DG 01828 56 F 

### 51 

### AG 32545 57 F 

### 52 WB 

### 30469 64 

### M 53 

## ss 27553 57 F 

### 54 AA 

### 32652 60 

### M 55 

### RT 31341 51 F 

### 56 FiltalRepot1 Spo11sor: llrtemationalFlavors & FragraiJCesInc. StudyNumber:

**CRL81314~2** Page13ofU

**$u'I:J]~~t** 

### CRb 

# .Ag¢• Sex

**~D.!tj~~** 

### ·• 

## Iri#

BB 01668 51 

### F TA 33389 46 F 

### JB 25556 38 

### M PR 05291 52 F 

### CM 00741 69 F JG 

### 24987 54 

### M JA 05348 65 F 

### ED 20237 55 F 

### DM 15909 59 F 

### DM 27962 57 F 

### DT 32525 66 F 

### CR 29212 46 F I 

### JS 30187 53 F 

### AB 23147 49 F Nl 

### 33422 20 F 

### DL 09278 54 

### F MO 33415 55 

### F IN 

### 03306 69 

### F DR 31032 52 

### F AC 33413 22 F 

### CN 27549 52 F 

### BW 27548 67 F 

### DP 32402 63 F 

### CA 33435 55 

### M MR 

### 31934 18 

### M MV 02437 68 F 

# uw 33434 50 F 

### CM 19646 56 F**:SJI~j¢~tH**

### :Nii&:b~r 

### 57 58 59 60 61 62 63 64 65 66

................... 

### 67 68 69 70 71 72 

### 73 74 75 76 77 78 79 80 81 82 83 84 

# Clinical Research Laboratories, Inc.

{S*bj¢¢tT 

### dRI.:. WtiiilS .•.• ·lD#



### GK 03981 

### NC 10624 

### MT 30825 

### FT 28815 AD 

### 32492 

### NC 33362 NP 

### 30154 

### ER 33363 

### SH 33411 

### AS 33436 

### LR 33408 

### AM 32178 

### CB 33196 

### AC 19727 

### PT 31460 

### CR 09622 JR 

### 29685 

### CB 24697 

### GF 23083 JB 

### 29335 

## ss 06517 

### WM 33214 

### HG 33133 JH 

### 19225 

### TC 29284 

### SK 18539 LJ 

### 33022 

### LN 24351 AppendixI SubjectDemographics (Continued)



## I Age 

## Sei



# ........... 

# • IJ.Sill>'ect·**···.:.~'\.':''** 63 

### F 85 36 

### F 86 24 

### F 87 45 

### F 88 54 

### F 89 51 

### F 90 28 

### M 91 44 

### M 92 41 

### F 93 18 

### M 94 34 

### F. 95 38 

### F 96 54 

### F 97 29 

### F 98 54 

### F 99 56 F 

### 100 67 F 

### 101 62 F 

### 102 51 F 

### 103 58 F 

### 104 59 F 

### 105 37 

### M 106 56 

### M 107 50 

### M 108 34 F 

### 109 62 F 

### 110 34 

### M 111 48 

### F 112 FinalReport Sponsor: InternationalFlavors & FragrancesI11c. StudyNumber: CRL81314v2 Page 14ofl4

### ~ii~J¢1\t 

## .dRI..< 

## tnitiau lD#·· 

### Age. Sex 

### PN 03277 57 F 

### ER 33438 22 

### M LJ 28423 45 

### F DC 20624 61 F 

### RC 31248 21 

### M JL 31000 49 F 

### PS 31629 56 

### F MP 

### 33431 20 F 

## cw 16399 54 F 

### JW 32123 39 

### F KH 

### 33439 25 

### M BT 33424 42 

### M JP 22148 39 

### F RE 

### 26689 42 

### M AA 

### 29940 20 

### F DW 20399 54 F RJ 

### 26063 52 

### F NF 

### 14449 58 

### F BC 30844 23 

### F AS 02343 65 

### F TM 

### 30142 46 

### F JG 

### 16720 29 

### F JN 

### 30414 32 F 

### JS 24960 53 F 

### ST 27390 56 

### F KB 32105 41 

### F DL 27410 53 

### F AM 

### 13130 48 

### FHRIPT FRET 09-0536

TEST SAMPLE Samplepreparation: R&D (Gary Mertz) Request date: September 17, 2014 Test Chemical: FRET 09-0536

TestArticle FRET 09-0536-01, 2% w/w inEthanol:DEP [25:75]


### 8 98 294 400 g g g g FRET09-0536 Ethanol Diethyl Phthalate (043615) Total
Final FRET 08-0338 Concentration= 8/400 (2% w/w)

Test Article FRET09-0536-02, 2% w/w inEthanol:DEP [25:751
8 98 294 400 g g g g Distilledwater Ethanol Diethyl Phthalate (043615) Total

··· ·· Final DistilledWater Concentration= 8/400 (2% w/w) ····································



### PFS