Kelompok 9: Riski Amanda Rina Mediana Ulfah Nurhidayah Verika Astriana Yosiepin Mulyadi Yuriani
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1. Uji Draize
Uji standar untuk mengevaluasi potensi iritasi dari suatu campuran pada hewan dipubilkasikan oleh Draize et al. pada tahun 1944. Waktu kontak yang lama pada kulit kelinci yang sangat permeabel menghasilkan suatu uji yang dapat mengidentifikasi banyak bahan yang juga mengiritasi kulit manusia. Iritasi primer kulit diukur dengan teknik patch tes pada kulit kelinci albino bebas rambut yang
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Tabel 5. Nilai Nilai untuk Reaksi Reaksi Kulit pada pada Kelinci Albino setelah Aplikasi Pertama dari Iritan Primer Potensial Iritasi Kulit
Nilai
Eritema Tidak ada eritema
0
Eritema sangat ringan (dapat
1
diterima) Eritema cukup
2
Eritema sedang hingga berat
3
Eritema berat
4
Edema Tidak ada edema
0
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2. Variabel Uji
Abrasi: efek maksimum dari iritan diharapkan dapat diamati pada kulit yang mengelupas, karena absorpsi perkutan dapat menjadi faktor pembatas. Draize mencatat bahwa stratum korneum harus digores tanpa mengeluarkan darah, tetapi tidak menspesifikasi prosedur. prosedur. Formulator kosmetik harus memilih antara banyak komponen dari basis dalam formulasi dari keamanan dan toksisitas. t oksisitas. pengetahuan tentang potensi iritasi relativ dari masing-
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Tabel 6. Nilai untuk Uji Kulit Kulit oleh National Institute Institute for Occupational Safety and Health Interpretation Nilai
Kulit utuh
0-0,9
Interpretasi
Noniritan; mungkin aman untuk kontak kont ak dengan kulit manusia utuh
1-1,9
Iritan ringan; mungkin aman digunakan, tetapi pengukuran proteksii yang cocok dianjurkan proteks selama kontak
2-4
Terlalu mengirita mengiritasi si untu kontak dengan kulit manusia; hindari kontak
Kulit mengelupas
0-0,9
Nontoksik untuk komponen seluler dari kulit yang mengelupas; mungkin aman untuk kontak dengan kulit manusia
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Kulit utuh
0-0,9
Kulit mengelupas
0-0,9
Reaksi campuran
Aman untuk kontak dengan kulit manusia
1-1,9
Aman untuk kontak dengan kulit manusia utuh;mungkin aman untuk kontak dengan kulit yang mengelupas jika diproteksi
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Aplikasi berulang: karena rendahnya sensitivitas dari kulit manusia terhadap iritan, pengujian pada manusia biasanya dilakukan dengan patch aplikasi berulang seperti
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Uji Kulit pada Manusia 1.
Preventif Uji kulit yang dilakukan untuk mencegah terjadinya efek samping terhadap kulit. Konsumen yang akan menggunakan kosmetika atau akan menggunakan kosmetika baru, dapat dilakukan uji pakai
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2. Diagnostik Uji kulit yang dilakukan pada kosmetika
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Uji Eliminasi dan Uji Pakai (Usage Test ) Penderita yang menunjukkan gejala efek samping dianjurkan untuk segera menghentikan pemakaian seluruh kosmetika.
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Uji Tempel (Patch Test)
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Uji Terbuka (Open Test)
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1.Draize Test
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•
•
Pra-induksi •
• •
•
Pemberian konsentrasi iritan pembuka (30, 10, 3, 3%) pada kulit panggul sebelah kiri masing-masing konsentrasi 0,25 ml Reaksi kulit dilihat setelah 24 jam, konsentrasi iritan minimal dan konsentrasi noniritan maksimal ditentukan dengan kriteria all or none
0,1 ml dari senyawa yang tidak diencerkan atau dengan pengenceran bertingkat pada kulit panggul 6-8 babi guinea per grup konsentrasi (grup 1-6) Pemberian dilakukan setiap hari 3 minggu atau 5 kali setiap minggu Baca reaksi 24 jam setelah pemberian atau di akhir tiap minggu, konsentrasi iritan minimal dan konsentrasi noniritan maksimal ditentukan dengan kriteria all or none Apabila terjadi reaksi kulit yang kuat, tempat pemberian diganti
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Kecak et.al membandingkan 32 bahn parfum yang dideskripsikan sebagai alergen, berikut hasilnya: Open Epicutaneous Test
Draize Drai ze Test
Positif (OET dan intradermal test)
18
18
7
15
17
Hanya OET
4
4
0
0
0
Total senyawa senya wa
Intradermal test Max Test
Freund’s
Complete Adjunant Test
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Klecak melakukan perbandingan uji hewan dengan 21 parfum dengan komposisi konsentrasi yang tinggi, pada kosmetik, sediaan farmasi, dan produk rumah tangga
Total senyawa senya wa
Positif (OET dan intradermal test)
Open Epicutaneous Test
1
1a
Intradermal test Draize Drai ze Test
Max Test
Freund’s
Complete Adjunant Test 1
1
1
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7.Kadar logam Tidak bisa digunakan babi guinea metode
mudah m udah dilakukan dan sensitif, sensitif, dipertimbangkan faktor-faktor yang berpengaruh dalam pemilihan metode uji
Hasil
dipengaruhi pula oleh pengalaman peneliti
kadar
logam berbeda bergantung dosisi (tetap atau bertingkat), rute kontak kulit (topikal, intradermal, atau keduanya)
Kelebihan Tiap Metode Draize test, paling sedikit membedakan, dapat dibuat lebih sensitif dengan peningkatan dosis dan banyaknya injeksi Metode
Buhler, memiliki rekam data yang bagus sebgai skrining untuk formulasi
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Variasi Uji Manusia
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Semua uji yang dilakukan pada manusia adalah modifikasi dari model babi guinea Landsteiner dan Chase
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Perbedaan maximization test dengan draize test Jumlah objek percobaan. draize test 10 objek pencobaan
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Jumlah subjek percobaan draize test 200 subjek Maximization test 25 subjek.
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Perbandingan sensitivitas Marzulli dan Maibach terbatasnya informasi yang tersedia pada sensitivitas. ditemukan kesamaan pada kedua metode tetapi berbeda pada keadaan sesungguhnya. Kesimpulan
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