i OPTIMASI TWEEN 60 DAN SPAN 60 DALAM FORMULASI KRIM M/A EKSTRAK ETANOL PELEPAH PISANG AMBON KUNING (Musa paradisiaca L.) DENGAN SIMPLEX LATTICE DESIGN Skripsi Diajukan untuk Memenuhi Salah Satu Syarat Memperoleh Gelar Sarjana Farmasi (S.Farm) Program Studi Farmasi Diajukan oleh : Robertus Erwin Sarjono NIM : 128114023 FAKULTAS FARMASI UNIVERSITAS SANATA DHARMA YOGYAKARTA 2017 PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
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i
OPTIMASI TWEEN 60 DAN SPAN 60 DALAM FORMULASI KRIM M/A
EKSTRAK ETANOL PELEPAH PISANG AMBON KUNING (Musa
paradisiaca L.) DENGAN SIMPLEX LATTICE DESIGN
Skripsi
Diajukan untuk Memenuhi Salah Satu Syarat
Memperoleh Gelar Sarjana Farmasi (S.Farm)
Program Studi Farmasi
Diajukan oleh :
Robertus Erwin Sarjono
NIM : 128114023
FAKULTAS FARMASI
UNIVERSITAS SANATA DHARMA
YOGYAKARTA
2017
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
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DAFTAR ISI
HALAMAN JUDUL............................................................................................... i
HALAMAN PERSETUJUAN PEMBIMBING …. ……………………………... ii
HALAMAN PENGESAHAN……………………………………………………. iii
HALAMAN PERSEMBAHAN………………………………………………….. iv
PRAKATA………………………………………………………………………... v
PERNYATAAN KEASLIAN KARYA…………………………………………… vii
DAFTAR ISI ……………………………………………………………………... viii
DAFTAR TABEL………………………………………………………………… x
DAFTAR GAMBAR……………………………………………………………... xi
DAFTAR LAMPIRAN…………………………………………………………… xi
INTISARI……………………………………………………………………….... xiii
ABSTRACT………………………………………………………………………. xiv
1. PENDAHULUAN……………………………………………………………... 1
2. METODE PENELITIAN………………………………………………………. 3
2.1. Bahan Penelitian………………………………………………………… 3
2.2. Alat dan Instrumen Penelitian…………………………………………… 3
Dimana, 1+ 2+ 3+⋯+ merupakan respon dari masing-masing
sifat fisik krim. Masing-masing respon diberi bobot dengan jumlah bobot total
= 1. Pada penelitian ini menggunakan 3 respon sebagai parameter utama yaitu
uji daya sebar dengan bobot 0,3; uji pH dengan bobot 0,3; dan uji viskositas
dengan bobot 0,4. Mengingat satuan masing masing respon tidak sama, maka
perlu standarisasi penilaian respon dengan rumus sebagai berikut.N= ..................................................................................(5)
Dimana:
= Nilai standarisasi respon
= Respon yang didapat dari percobaan
= Respon minimal yang diinginkan
= Respon maksimal yang diinginkan (Bolton & Bon, 2004).
Jadi R dapat dihitung dengan mengalikan N dengan bobot yang telah
ditentukan. Sehingga perhitungan respon totalnya menjadi: = ( ×
)+( × viskositas)+( × ) Formula optimum
dipilih dengan melihat nilai tertinggi.
2.11. Analisis statistik
Data utama yang diperoleh adalah data uji viskositas, daya sebar
setelah pembuatan dan profil viskositas tersebut dianalisis menggunakan
software statistik melewati tahap uji tes sebagai berikut : Shapiro-Wilk untuk
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
9
melihat normalitas data yang didapatkan apabila terdistribusi normal
dilanjutkan dengan uji parametrik yaitu Levene test untuk melihat kesamaan
variansi data yang didapatkan, setelah itu dilanjutkan dengan uji anova. Taraf
kepercayaan yang digunakan dalam analisis ini adalah 95%.
III. Hasil dan Pembahasan
Tujuan dari penelitan ini adalah mengetahui pengaruh komposisi dari Span
60 dan Tween 60 terhadap sifat fisik sediaan krim M/A ekstrak etanol pelepah
pisang Ambon Kuning. Serta mendapatkan formula yang optimal dari sediaan krim
M/A ekstrak etanol pelepah pisang Ambon kuning dengan metode Simplex Lattice
Design.
Penelitian yang pernah dilakukan Hastari pada tahun 2012, mengenai
kandungan zat aktif pada pelepah pisang Ambon yang dapat digunakan sebagai
antibakteri. Penelitian ini dilakukan untuk meningkatkan pemanfaatan pelepah
batang pisang tersebut agar lebih dapat di aplikasikan dalam dunia kefarmasian,
sehingga peneliti memutuskan untuk membuat krim M/A ekstrak etanol pelepah
Pisang Ambon kuning.
Penentuan formula menggunakan metode Simplex Lattice Design, dengan
bantuan program Design Expert® v.10.0.3.1 didapatkan 8 run dikarenakan terdapat
2 faktor komposisi yang digunakan yaitu Tween 60 dan Span 60 sebagai emulgator
krim M/A.
Berdasarkan formula yang telah diperoleh kemudian pembuatan krim
dilakukan, sebanyak 3 kali replikasi untuk setiap formulanya. Formula-formula
tersebut kemudian diuji untuk menunjukan kestabilan fisik maupun kimianya. Uji
tersebut terdiri dari uji organoleptis, uji viskositas, daya sebar, pH yang digunakan
sebagai respon dalam metode Simplex Lattice Design dan ditambahkan uji stabilitas
menggunakan metode freeze-thaw menggunakan 3 siklus untuk melihat stabilitas
sediaan terhadap proses penyimpanan dengan perlakuan suhu.
Pengujian pertama dilakukan setelah pembuatan krim, hal tersebut
dilakukan untuk mengamati perubahan yang mungkin terjadi setelah proses freeze-
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
10
thaw dengan membandingkan hasil setelah pembuatan dan setelah uji. Hasil dari
uji sebelum dilakukan siklus diolah dalam Design Expert® v.10.0.3.1
menggunakan metode Simplex Lattice Design, hal ini dilakukan untuk
mendapatkan profil dari formula yang optimal sebelum dilakukan uji stabilitas dan
dillihat respon yang berpengaruh.
3.1 Uji Organoleptis
Uji organoleptis dilakukan untuk melihat secara fisik apakah terdapat
perubahan bentuk, warna, atau bau dari sediaan yang dibuat. Pengamatan dilakukan
setelah pembuatan hingga siklus terakhir dari freeze-thaw (siklus 3) kemudian hasil
pengamatan dicatat. Ciri fisik dari krim setelah pembuatan semua formula memiliki
warna berwarna hijau dikarenakan efek penambahan ekstrak, bertekstur halus dan
beraroma khas.
Pengamatan secara organoleptis setelah pembuatan terlihat setiap krim
memiliki warna hijau, penambahan ekstrak etanol pelepah Pisang Ambon Kuning
yang berwarna hijau membuat warna krim menjadi hijau yang lebih muda. Untuk
tekstur sendiri hampir setiap formula memiliki tekstur serupa hanya dibedakan
viskositasnya dan daya sebarnya. Kemudian pengamatan dilanjutkan pada saat
siklus terakhir setelah penyimpanan atau siklus 3 untuk melihat apakah terdapat
perubahan fisik krim.
Pada pengamatan setelah siklus 3 tidak nampak perubahan signifikan
terjadi selama proses freeze-thaw pada setiap formula. Warna pada setiap formula
masih serupa dengan awal sediaan dibuat. Secara organoleptis tidak nampak
perubahan yang berarti pada setiap formula.
3.2 Uji Viskositas
Uji viskositas dilakukan untuk mengetahui konsistensi suatu sediaan yang
berpengaruh pada penggunaannya secara topikal. Viskositas merupakan tahanan
dari suatu cairan untuk mengalir, nilai viskositas berbanding lurus dengan
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
11
tahanannya (Sinko,2011). Standar viskositas krim yang ideal yaitu tidak kurang dari
50 dPa-s (Gozali et al., 2009).Viskositas diukur menggunakan Viskometer Rion
seri VT-04 setelah pembuatan krim (siklus 0),diperoleh data sebagai berikut :
Kemudian data tersebut diolah menggunakan Design Expert® v.10 denganmetode SLD, dan mendapatkan persamaan sebagai berikut :Y= 16,079 X1 + 21,682X2 – 14,036 X1.X2 ................................................…..(7)Keterangan :X1 : Komponen Span 60X2 : Komponen Tween 60Y : Respon Daya Sebar
Berikut model plot respon daya sebar :
Gambar 2. Model Plot Respon Daya Sebar
Persamaan (7) memberikan nilai positif pada tiap pengaruh komponen
tunggal span 60 yakni 16,079 poin dan tween 60 sebesar 21,682 poin. Komponen
pengikat air yang bersifat hidrofilik akan memberikan pengaruh yang lebih besar
karena air akan memberikan pengaruh daya sebar yang lebih dari pada fase minyak.
Kemampuan emulgator dalam mengikat fase air secara baik akan berpengaruh
dengan daya sebar sediaan tersebut. Pengaruh pada daya sebar ini secara tidak
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
14
langsung berkaitan dengan nilai viskositasnya. Pada uji freeze-thaw diperoleh hasil
Lampiran 8. Formula dan analisis respon menggunakan Design Expert® v.10.0.3
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
32
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
33
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
34
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
35
Lampiran 9. Optimasi dan Prediksi Formula Optimum Design Expert® v.10.0.3
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
36
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
POLYSORBATE 60
Not available.
C64H126O26
Not available.
WG2934000
9005-67-8
P1178, P1822, PO136
Not available.
SPECTRUM CHEMICAL MFG. CORP.14422 S. SAN PEDRO STREETGARDENA, CA 90248
CALL (310) 516-8000
SPECTRUM CHEMICAL MFG. CORP.14422 S. SAN PEDRO STREETGARDENA, CA 90248
11 0
Material Safety Data SheetNFPA HMIS Personal Protective Equipment
Section 1. Chemical Product and Company Identification
Common Name/Trade Name
CatalogNumber(s).
CAS#
RTECS
CI#
Manufacturer
Synonym
Chemical Name
Chemical Family
IN CASE OF EMERGENCYCHEMTREC (24hr) 800-424-9300
Chemical Formula
Supplier
See Section 15.
Commercial Name(s) TWEEN 60
TSCA T S C A 8 ( b ) i n v e n t o r y :POLYSORBATE 60
110
Health Hazard
Fire Hazard
Reactivity
Page Number: 1
Not applicable.
1) POLYSORBATE 60 9005-67-8 100
Toxicological Dataon Ingredients
Name
Section 2.Composition and Information on Ingredients
Exposure Limits
TWA (mg/m3) STEL (mg/m3) CEIL (mg/m3) % by WeightCAS #
Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation.
CARCINOGENIC EFFECTS: Not available.MUTAGENIC EFFECTS: Not available.TERATOGENIC EFFECTS: Not available.DEVELOPMENTAL TOXICITY: Not available.Repeated or prolonged exposure is not known to aggravate medical condition.
Section 3. Hazards Identification
Potential Acute Health Effects
Potential Chronic HealthEffects
Continued on Next Page
37
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
POLYSORBATE 60 Page Number: 2
Do not induce vomiting. Loosen tight clothing such as a collar, tie, belt or waistband. If the victim is notbreathing, perform mouth-to-mouth resuscitation. Seek immediate medical attention.
Immediately flush eyes with running water for at least 15 minutes, keeping eyelids open. Cold water may be used.
After contact with skin, wash immediately with plenty of water. Gently and thoroughly wash the contaminated skinwith running water and non-abrasive soap. Be particularly careful to clean folds, crevices, creases and groin.Cold water may be used. Cover the irritated skin with an emollient. If irritation persists, seek medical attention.Wash contaminated clothing before reusing.
Not available.
Allow the victim to rest in a well ventilated area. Seek immediate medical attention.
Not available.
Not available.
Section 4. First Aid MeasuresEye Contact
Skin Contact
Serious Skin Contact
Inhalation
Serious Inhalation
Ingestion
Serious Ingestion
Not available.
May be combustible at high temperature.
These products are carbon oxides (CO, CO2).
Not available.
Not available.
SMALL FIRE: Use DRY chemical powder.LARGE FIRE: Use water spray, fog or foam. Do not use water jet.
Not available.
Not available.
Risks of explosion of the product in presence of mechanical impact: Not available.Risks of explosion of the product in presence of static discharge: Not available.
Not available.
Section 5. Fire and Explosion Data
Flammability of the Product
Auto-Ignition Temperature
Flash Points
Flammable Limits
Products of Combustion
Fire Hazards in Presence ofVarious Substances
Explosion Hazards in Presenceof Various Substances
Fire Fighting Mediaand Instructions
Special Remarks onFire Hazards
Special Remarks on ExplosionHazards
Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning byspreading water on the contaminated surface and dispose of according to local and regional authorityrequirements.
Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading wateron the contaminated surface and allow to evacuate through the sanitary system.
Section 6. Accidental Release Measures
Small Spill
Large Spill
Continued on Next Page
38
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
POLYSORBATE 60 Page Number: 3
Keep container dry. Keep in a cool place. Ground all equipment containing material. Keep container tightlyclosed. Keep in a cool, well-ventilated place. Combustible materials should be stored away from extreme heatand away from strong oxidizing agents.
Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk, evaporate theresidue under a fume hood. Ground all equipment containing material. Do not breathe dust. Keep away fromincompatibles such as oxidizing agents.
Section 7. Handling and Storage
Precautions
Storage
Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels belowrecommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure toairborne contaminants below the exposure limit.
Safety glasses. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.
Splash goggles. Full suit. Dust respirator. Boots. Gloves. A self contained breathing apparatus should be usedto avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialistBEFORE handling this product.
Not available.
Section 8. Exposure Controls/Personal Protection
Engineering Controls
Personal Protection
Personal Protection in Case ofa Large Spill
Exposure Limits
Not available.
Solid.
Not available.
Not available.
Not available.
1.07 (Water = 1)
Not available.
Not applicable.
Not available.
Not available.
See solubility in water.
Easily soluble in cold water, hot water.
Not available.
Not available.
1131.9 g/mole
Not available.
Not available.
Not available.
Section 9. Physical and Chemical Properties
Physical state and appearance Odor
Taste
ColorMolecular Weight
pH (1% soln/water)
Boiling Point
Melting Point
Critical Temperature
Specific Gravity
Vapor Pressure
Vapor Density
Volatility
Odor Threshold
Water/Oil Dist. Coeff.
Ionicity (in Water)
Dispersion Properties
Solubility
The product is stable.
Non-corrosive in presence of glass.
Reactive with oxidizing agents.
Not available.
Not available.
Section 10. Stability and Reactivity Data
Stability
Instability Temperature
Conditions of Instability
Incompatibility with varioussubstances
Corrosivity
Continued on Next Page
39
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
POLYSORBATE 60 Page Number: 4
Not available.
Not available.Special Remarks onReactivity
Special Remarks onCorrosivity
Polymerization No.
Not available.
LD50: Not available.LC50: Not available.
Slightly hazardous in case of skin contact (irritant), of ingestion, of inhalation.
Not available.
Not available.
Not available.
Not available.
Section 11. Toxicological Information
Routes of Entry
Toxicity to Animals
Chronic Effects on Humans
Other Toxic Effects onHumans
Special Remarks onToxicity to Animals
Special Remarks onChronic Effects on Humans
Special Remarks on otherToxic Effects on Humans
Not available.
Not available.
Possibly hazardous short term degradation products are not likely. However, long term degradation products mayarise.
The products of degradation are more toxic.
Not available.
Section 12. Ecological Information
Ecotoxicity
BOD5 and COD
Products of Biodegradation
Toxicity of the Productsof Biodegradation
Special Remarks on theProducts of Biodegradation
Section 13. Disposal Considerations
Waste Disposal
DOT Classification Not a DOT controlled material (United States).
Not applicable.
Not applicable.
Section 14. Transport Information
Identification
DOT (Pictograms)
Special Provisions forTransport
Continued on Next Page
40
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
POLYSORBATE 60 Page Number: 5
Not available..
01
1
110E
Not controlled under WHMIS (Canada).
This product is not classified accordingto the EU regulations.
Section 15. Other Regulatory Information and Pictograms
Other Regulations
Other Classifications WHMIS (Canada)
DSCL (EEC)
HMIS (U.S.A.) Health Hazard
Fire Hazard
Reactivity
National Fire ProtectionAssociation (U.S.A.)
Personal Protection
Health
Flammability
Reactivity
Specific hazard
WHMIS (Canada)(Pictograms)
DSCL (Europe)(Pictograms)
TDG (Canada)(Pictograms)
ADR (Europe)(Pictograms)
Protective Equipment
Dust respirator. Be sure to use anapproved/certified respirator orequivalent.
Lab coat.
Safety glasses.
Gloves.
Federal and StateRegulations
TSCA 8(b) inventory: POLYSORBATE 60
CaliforniaProposition 65Warnings
California prop. 65: This product contains the following ingredients for which the State of California has foundto cause cancer which would require a warning under the statute: No products were found.California prop. 65: This product contains the following ingredients for which the State of California has foundto cause birth defects which would require a warning under the statute: No products were found.
Continued on Next Page
41
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
POLYSORBATE 60 Page Number: 6
Not available.
Not available.
CALL (310) 516-8000
All chemicals may pose unknown hazards and should be used with caution. This Material Safety Data Sheet (MSDS) applies only to the material as packaged. If this product iscombined with other materials, deteriorates, or becomes contaminated, it may pose hazards not mentioned in this MSDS. It shall be the user's responsibility to develop propermethods of handling and personal protection based on the actual conditions of use. While this MSDS is based on technical data judged to be reliable, Spectrum Quality Products,Inc. assumes no responsibility for the completeness or accuracy of the information contained herein.
Notice to Reader
Verified by Sonia Owen.
Printed 9/13/2006.
Validated by Sonia Owen on 8/11/2006.
Other SpecialConsiderations
References
Section 16. Other Information
MSDS Code P4006
42
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
Sorbitan monostearate
Not available.
Sorbitan Monostearate
C24H46O6
Not available.
WG2933500
1338-41-6
S 1 3 1 8 , X X 7 7 8 , S P A 6 0 ,SPA63
Not available.
SPECTRUM LABORATORY PRODUCTS INC.14422 S. SAN PEDRO STREETGARDENA, CA 90248
CALL (310) 516-8000
SPECTRUM LABORATORY PRODUCTS INC.14422 S. SAN PEDRO STREETGARDENA, CA 90248
12 0
Material Safety Data SheetNFPA HMIS Personal Protective Equipment
Section 1. Chemical Product and Company Identification
Section 2.Composition and Information on Ingredients
Exposure Limits
TWA (mg/m3) STEL (mg/m3) CEIL (mg/m3) % by WeightCAS #
Hazardous in case of eye contact (irritant), of inhalation. Slightly hazardous in case of skin contact (irritant), ofingestion.
CARCINOGENIC EFFECTS: Not available.MUTAGENIC EFFECTS: Not available.TERATOGENIC EFFECTS: Not available.DEVELOPMENTAL TOXICITY: Not available.Repeated or prolonged exposure is not known to aggravate medical condition.
Section 3. Hazards Identification
Potential Acute Health Effects
Potential Chronic HealthEffects
Continued on Next Page
43
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
Sorbitan monostearate Page Number: 2
Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to anunconscious person. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention ifsymptoms appear.
Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for atleast 15 minutes. Get medical attention.
Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops.
Not available.
If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Getmedical attention.
Not available.
Not available.
Section 4. First Aid MeasuresEye Contact
Skin Contact
Serious Skin Contact
Inhalation
Serious Inhalation
Ingestion
Serious Ingestion
Not available.
May be combustible at high temperature.
These products are carbon oxides (CO, CO2).
CLOSED CUP: >110°C (230°F).
Not available.
SMALL FIRE: Use DRY chemical powder.LARGE FIRE: Use water spray, fog or foam. Do not use water jet.
Slightly flammable to flammable in presence of heat.Non-flammable in presence of shocks.
Not available.
Risks of explosion of the product in presence of mechanical impact: Not available.Risks of explosion of the product in presence of static discharge: Not available.
Not available.
Section 5. Fire and Explosion Data
Flammability of the Product
Auto-Ignition Temperature
Flash Points
Flammable Limits
Products of Combustion
Fire Hazards in Presence ofVarious Substances
Explosion Hazards in Presenceof Various Substances
Fire Fighting Mediaand Instructions
Special Remarks onFire Hazards
Special Remarks on ExplosionHazards
Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning byspreading water on the contaminated surface and dispose of according to local and regional authorityrequirements.
Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading wateron the contaminated surface and allow to evacuate through the sanitary system.
Section 6. Accidental Release Measures
Small Spill
Large Spill
Continued on Next Page
44
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
Sorbitan monostearate Page Number: 3
Keep container tightly closed. Keep container in a cool, well-ventilated area. Do not store above 24°C (75.2°F).
Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk, evaporate theresidue under a fume hood. Ground all equipment containing material. Do not ingest. Do not breathe dust.Avoid contact with eyes. Wear suitable protective clothing. In case of insufficient ventilation, wear suitablerespiratory equipment. If ingested, seek medical advice immediately and show the container or the label.
Section 7. Handling and Storage
Precautions
Storage
Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels belowrecommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure toairborne contaminants below the exposure limit.
Splash goggles. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent.Gloves.
Splash goggles. Full suit. Dust respirator. Boots. Gloves. A self contained breathing apparatus should be usedto avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialistBEFORE handling this product.
Not available.
Section 8. Exposure Controls/Personal Protection
Engineering Controls
Personal Protection
Personal Protection in Case ofa Large Spill
Exposure Limits
Not available.
Solid. (Waxy solid.)
Not available.
Not applicable.
57°C (134.6°F)
1 (Water = 1)
Not available.
Not applicable.
Not available.
Not available.
Not available.
Insoluble in cold water.Soluble in ethanol, isopropanol, mineral oil, and vegetable oil.Insoluble in propylene glycol.
Not available.
Not available.
43.6 g/mole
Slight.
Bland
White to Tan.
Section 9. Physical and Chemical Properties
Physical state and appearance Odor
Taste
ColorMolecular Weight
pH (1% soln/water)
Boiling Point
Melting Point
Critical Temperature
Specific Gravity
Vapor Pressure
Vapor Density
Volatility
Odor Threshold
Water/Oil Dist. Coeff.
Ionicity (in Water)
Dispersion Properties
Solubility
The product is stable.
Reactive with oxidizing agents.
Not available.
Excess heat, incompatible materials
Section 10. Stability and Reactivity Data
Stability
Instability Temperature
Conditions of Instability
Incompatibility with varioussubstances
Continued on Next Page
45
PLAGIAT MERUPAKAN TINDAKAN TIDAK TERPUJI
Sorbitan monostearate Page Number: 4
Non-corrosive in presence of glass.
Not available.
Not available.
Corrosivity
Special Remarks onReactivity
Special Remarks onCorrosivity
Polymerization Will not occur.
Inhalation. Ingestion.
Acute oral toxicity (LD50): 31000 mg/kg [Rat].
Hazardous in case of inhalation.Slightly hazardous in case of skin contact (irritant), of ingestion.
Not available.
Not available.
Acute Potential Health Effects:Skin: May cause skin irritation.Eyes: May cause eye irritation.Inhalation: May cause respiratory tract irritation.Ingestion: May cause digestive tract irritation.The toxicological properties of this substance have not been fully investigated.
May cause adverse reproductive effects based on animal data.
Section 11. Toxicological Information
Routes of Entry
Toxicity to Animals
Chronic Effects on Humans
Other Toxic Effects onHumans
Special Remarks onToxicity to Animals
Special Remarks onChronic Effects on Humans
Special Remarks on otherToxic Effects on Humans
Not available.
Not available.
Possibly hazardous short term degradation products are not likely. However, long term degradation products mayarise.
The product itself and its products of degradation are not toxic.
Not available.
Section 12. Ecological Information
Ecotoxicity
BOD5 and COD
Products of Biodegradation
Toxicity of the Productsof Biodegradation
Special Remarks on theProducts of Biodegradation
Section 13. Disposal Considerations
Waste Disposal Waste must be disposed of in accordance with federal, state and local environmentalcontrol regulations.
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Sorbitan monostearate Page Number: 5
DOT Classification Not a DOT controlled material (United States).
Not applicable.
Not applicable.
Section 14. Transport Information
Identification
DOT (Pictograms)
Special Provisions forTransport
EINECS: This product is on the European Inventory of Existing Commercial Chemical Substances.
01
2
210E
Not controlled under WHMIS (Canada).
R36- Irritating to eyes.
Section 15. Other Regulatory Information and Pictograms
Other Regulations
Other Classifications WHMIS (Canada)
DSCL (EEC)
HMIS (U.S.A.) Health Hazard
Fire Hazard
Reactivity
National Fire ProtectionAssociation (U.S.A.)
Personal Protection
Health
Flammability
Reactivity
Specific hazard
WHMIS (Canada)(Pictograms)
DSCL (Europe)(Pictograms)
TDG (Canada)(Pictograms)
ADR (Europe)(Pictograms)
Protective Equipment
Federal and StateRegulations
TSCA 8(b) inventory: Sorbitan monostearate
CaliforniaProposition 65Warnings
S2- Keep out of the reach of children.S46- If swallowed, seek medical adviceimmediately and show this container or label.
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Dust respirator. Be sure to use anapproved/certified respirator orequivalent.
Lab coat.
Splash goggles.
Gloves.
Not available.
Not available.
CALL (310) 516-8000
All chemicals may pose unknown hazards and should be used with caution. This Material Safety Data Sheet (MSDS) applies only to the material as packaged. If this product iscombined with other materials, deteriorates, or becomes contaminated, it may pose hazards not mentioned in this MSDS. It shall be the user's responsibility to develop propermethods of handling and personal protection based on the actual conditions of use. While this MSDS is based on technical data judged to be reliable, Spectrum Quality Products,Inc. assumes no responsibility for the completeness or accuracy of the information contained herein.
Notice to Reader
Verified by Sonia Owen.
Printed 9/14/2006.
Validated by Sonia Owen on 8/24/2006.
Other SpecialConsiderations
References
Section 16. Other Information
MSDS Code S4623
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Lampiran 12. Surat Determinasi Tanaman Pisang Ambon