TWINNING PROJECT EG07/AA/EN10

TWINNING PROJECT EG07/AA/EN10
Integrated Waste and Hazardous Substances

Management System
EG07/AA/EN10 ‫ﻣﺸﺮوع اﻟﺘﻮأﻣﺔ‬
‫اﻟﻨﻈــﺎم اﻟﻤﺘﻜــﺎﻣﻞ ﻹدارة اﻟﻤﺨﻠﻔﺎت واﻟﻤﻮاد اﻟﺨﻄﺮة‬
Component 2 / Activity 2.1

Risk Assessment Training Course
C 7.2 Hazard Assessment
- DNELs/DMELs Derivation
Dr. Helmut Fleig
Helmut Fleig
HFC Mannheim
‫ﺗﻘﯿﯿﻢ اﻟﺨﻄﺮ‬
‫ﺧﻄﻮة ‪ =1‬ﺗﻌﺮﯾﻒ اﻟﺨﻄﺮ و‬
‫ﺧﻄﻮة ‪ =2‬ﻋﻼﻗﺔ اﻟﺠﺮﻋﺔ ﺑﺮد اﻟﻔﻌﻞ‬
‫=‬
‫ﺗﻘﯿﯿﻢ اﻻﺧﻄﺎر)‪(HA‬‬
‫‪TWINNING PROJECT EG07/AA/EN10 - Integrated Waste and Hazardous Substances Management System -‬‬
‫ﻣﺸﺮوع اﻟﺘﻮأﻣﺔ‬ ‫اﻟﻨﻈــﺎم اﻟﻤﺘﻜــﺎﻣﻞ ﻹدارة اﻟﻤﺨﻠﻔﺎت واﻟﻤﻮاد اﻟﺨﻄﺮة ‪EG07/AA/EN10‬‬ ‫‪Helmut Fleig‬‬ ‫‪2‬‬
‫ﺗﻘﯿﯿﻢ اﻻﺧﻄﺎر )‪(2‬‬
‫‪ 1.‬ﺗﻌﺮﯾﻒ اﻻﺧﻄﺎر‪:‬‬
‫ﺗﻌﺮﯾﻒ ﻛﻞ اﻻﺛﺎر اﻟﺠﺎﻧﺒﯿﺔ اﻟﻤﺤﺘﻤﻠﺔ‬
‫‪ -‬اﺳﺘﺨﺪام ﻛﻞ اﻟﻤﻌﻠﻮﻣﺎت‪ /‬اﻟﺒﯿﺎﻧﺎت ‪ :‬اﻟﺒﺸﺮﯾﺔ‪ ,‬اﻟﺤﯿﻮاﻧﯿﺔ ﻓﻲ ‪vitro‬‬

‫‪(Q)SAR (=(Quantitative) Structure Activity‬‬
‫)‪Relationship‬‬
‫‪ -‬اﻟﺘﻘﯿﯿﻢ اﻟﺠﻮدي ﻟﻼﺛﺎر اﻟﺘﻲ ﺗﮭﺪد ﺻﺤﺔ اﻻﻧﺴﺎن‬
‫اﻟﻤﺆﺷﺮ اﻟﺠﻮدي ﻟﻠﺠﺮﻋﺔ‬
‫‪TWINNING PROJECT EG07/AA/EN10‬‬ ‫‪- Integrated Waste and Hazardous Substances Management System -‬‬
‫اﻟﻨﻈــﺎم اﻟﻤﺘﻜــﺎﻣﻞ ﻹدارة اﻟﻤﺨﻠﻔﺎت واﻟﻤﻮاد اﻟﺨﻄﺮة‬ ‫ﻣﺸﺮوع اﻟﺘﻮأﻣﺔ ‪EG07/AA/EN10‬‬
‫‪Helmut Fleig‬‬ ‫‪3‬‬
(3) ‫ﺗﻘﯿﯿﻢ اﻻﺧﻄﺎر‬
‫ ﺗﻘﯿﯿﻢ اﻻﺛﺎر‬/‫ ﻋﻼﻗﺔ اﻟﺠﺮﻋﺔ و رد اﻟﻔﻌﻞ‬.2
‫اﻟﺘﻘﯿﯿﻢ اﻟﻜﻤﻲ‬
(Paracelsus) ‫ﺗﻘﺪﯾﺮ اﻟﻌﻼﻗﺔ ﺑﯿﻦ اﻟﺠﺮﻋﺔ و اﻟﺤﺪث و ﺣﺪة اﻻﺛﺎر‬
‫ ﻟﻼﺛﺎر اﻟﻤﺮاﻗﺒﺔ اذا اﻣﻜﻦ‬NOAEL(C)* ‫• ﻧﺴﺐ‬

‫ اذا اﻣﻜﻦ‬DNEL** ‫• ﻧﺴﺐ‬
‫اﻟﺘﻘﯿﯿﻢ اﻟﺸﺒﮫ ﻛﻤﻲ‬
‫ اذا اﻣﻜﻦ‬DMEL*** ‫• ﻧﺴﺐ‬
*NOAEL(C)=No Adverse Effect Level(Concentration) in animal experiments

** DNEL=Derived No Effect Level (Human situation)
***DMEL=Derived Minimal-Effect Level
TWINNING PROJECT EG07/AA/EN10 - Integrated Waste and Hazardous Substances Management System -
‫ﻣﺸﺮوع اﻟﺘﻮأﻣﺔ‬ EG07/AA/EN10 ‫اﻟﻨﻈــﺎم اﻟﻤﺘﻜــﺎﻣﻞ ﻹدارة اﻟﻤﺨﻠﻔﺎت واﻟﻤﻮاد اﻟﺨﻄﺮة‬ Helmut Fleig 4
‫ﺗﻘﯿﯿﻢ اﻻﺧﻄﺎر )‪(4‬‬
‫ﺧﻄﻮة ‪ :1‬ﺗﻘﯿﯿﻢ اﻟﻤﻌﻠﻮﻣﺎت اﻟﻐﯿﺮ ﺑﺸﺮﯾﺔ‬ ‫•‬

‫ﺧﻄﻮة ‪ : 2‬ﺗﻘﯿﯿﻢ اﻟﻤﻌﻠﻮﻣﺎت اﻟﺒﺸﺮﯾﺔ‬ ‫•‬
‫ﺧﻄﻮة ‪ :3‬ﺗﺼﻨﯿﻒ و ﻣﻠﺼﻘﺎت‬ ‫•‬
‫ﺧﻄﻮة ‪ :4‬ﻧﺴﺐ ‪DNELs‬‬ ‫•‬
‫ﺗﻮﺻﯿﻞ اﻻﺧﻄﺎر ﻟﻜﻞ ﻧﻘﻂ اﻟﻨﮭﺎﯾﺔ اﻟﺨﺎﺻﺔ ﺑﺼﺤﺔ اﻻﻧﺴﺎن اﻟﻤﻌﻨﯿﺔ‬
‫اﻟﺘﻘﯿﯿﻢ اﻟﻤﺒﺪأى‬
‫• اﺳﺘﺨﺪام اﻟﻤﻌﻠﻮﻣﺎت اﻟﻤﺘﺎﺣﺔ‬

‫• ﺗﻌﺮﯾﻒ ﻛﺘﻠﺔ اﻟﺘﻌﺮض ‪:‬‬
‫‪ -‬اﻟﻌﺎﻣﻠﯿﻦ‬
‫اﻟﻜﺘﻠﺔ اﻟﻌﺎﻣﺔ‪ :‬اﻟﻤﺴﺘﮭﻠﻜﯿﻦ و اﻟﺒﺸﺮ اﻟﻤﺘﻌﺮﺿﯿﻦ ﻋﻦ ﻃﺮﯾﻖ اﻟﺒﯿﺌﺔ‬
‫• اﺧﺬ ﺳﯿﻨﺎرﯾﻮھﺎت اﻟﺘﻌﺮض‬
‫• اﻟﻘﯿﺎم ﺑﺘﺨﻤﯿﻨﺎت‬
‫• ﺗﺤﺪﯾﺪ ﻣﻨﺎﻃﻖ اﻻھﺘﻤﺎم اﻻﻛﺒﺮ‬
‫• ﺗﺤﻘﯿﻖ ﻣﻨﺎﻃﻖ اﻻھﺘﻤﺎم ﺑﺘﻔﺎﺻﯿﻞ‬
‫اﺳﺘﺨﺪام اﻟﻤﻨﻄﻖ!‬
‫ﺗﻘﯿﯿﻢ اﻟﻤﻌﻠﻮﻣﺎت اﻟﻤﺘﺎﺣﺔ‬
‫• وﺛﺎﻗﺔ اﻟﻌﻼﻗﺔ‬
‫• ﻣﺪي اﻻﻋﺘﻤﺎد‬
Standard Test Guidelines (OECD, EPA a.o.) •
‫ ﻣﺒﺎدئ‬GLP •
‫ أﺛﺎر ﻣﻌﯿﻨﺔ‬/ ‫• أھﻤﯿﺔ ﻣﺮاﻗﺒﺎت‬
DNEL
(REACH) :‫اﻟﺘﻌﺒﯿﺮ اﻟﻜﻤﻲ ﻟﻠﺨﻄﺮ‬
DNEL =Derived No Effect Level (Human situation )
:DNEL ‫ﻧﺴﺐ ﻟﻞ‬

NOAEL(C) ‫ﺗﻌﺮﯾﻒ‬ -
DNEL = NOAEL*/AF**
* NOAEL(C)=No Adverse Effect Level(Concentration) , generally in animal

experiments
**AF= Assessment Factor (Uncertainty factor)
‫ﻋﻮاﻣﻞ اﻟﺘﻘﯿﯿﻢ‬
‫)‪NOAEL(C‬‬ ‫)‪NOAEL(C‬‬
‫= ‪DNEL‬‬ ‫=‬
‫‪AFoverall‬‬ ‫‪AF1 x F2 x F3 ....‬‬
‫‪ :AFoverall‬ﻋﺎﻣﻞ اﻟﺘﻘﯿﯿﻢ ﯾﺄﺧﺬ ﻓﻲ اﻻﻋﺘﺒﺎر اﻟﺘﻨﻮع أو اﻻﻣﻮر اﻟﻤﺸﻜﻮك ﻓﯿﮭﺎ‪.‬‬ ‫•‬
‫ﻋﻨﺪﻣﺎ ﺗﻈﮭﺮ اﻻﻣﻮر اﻟﻤﺸﻜﻮك ﻓﯿﮭﺎ‪ ,‬ﺿﻤﻦ ﻋﻮاﻣﻞ أﺧﺮي‪ ,‬ﻣﻦ اﻟﺘﻨﻮع ﻓﻲ اﻟﻤﻌﻠﻮﻣﺎت اﻟﺘﺠﺮﯾﺒﯿﺔ و ﻣﻦ‬ ‫‪-‬‬
‫اﻟﺘﻨﻮع ﺑﯿﻦ اﻟﻔﺼﺎﺋﻞ‬
‫ﻃﺒﯿﻌﺔ و ﺣﺪة اﻻﺛﺎر‬ ‫‪-‬‬
‫ﺣﺴﺎﺳﯿﺔ اﻟﻜﺘﻠﺔ اﻟﺒﺸﺮﯾﺔ اﻟﺘﻲ ﺗﻨﻄﺒﻖ ﻋﻠﯿﮭﺎ اﻟﻤﻌﻠﻮﻣﺎت اﻟﻜﻤﯿﺔ و اﻟﺠﻮدﯾﺔ ﻋﻦ اﻟﺘﻌﺮض‬ ‫‪-‬‬
‫• ‪: REACH‬اذا ﻟﻢ ﯾﻤﻜﻦ ﺗﻌﺮﯾﻒ ‪ , DNEL‬اذا ﯾﺠﺐ أن ﯾﺼﺮح ﺑﮭﺬا و ﯾﺘﻢ ﺷﺮﺣﮫ‬
‫ﻋﻮاﻣﻞ اﻟﺘﻘﯿﯿﻢ‪ /‬اﻻﺳﺘﻘﺮاء‬
‫• اﺳﺘﻘﺮاء اﻟﺰﻣﻨﻲ‪) e.g. 28 d à :‬ﻣﺰﻣﻦ‪ /‬ﻣﻤﺘﺪ اﻟﻮﻗﺖ(‬

‫• اﺳﺘﻘﺮاء ﺑﯿﻦ اﻟﻔﺼﺎﺋﻞ ) ﻣﺜﻼ اﻟﻔﺄر ‪ -----‬اﻻﻧﺴﺎن(‬
‫• اﺳﺘﻘﺮاء ﺧﺎرج اﻟﻔﺼﺎﺋﻞ ) ﻓﺮوق ﻓﻲ اﻟﺤﺴﺎﺳﯿﺔ(‬
‫• ﺗﻘﯿﯿﻢ اﻻﺛﺎر ) اﻟﺤﺪة‪ ,‬اﻣﻜﺎﻧﯿﺔ اﻟﻌﻼج(‬
‫• اﺳﺘﻘﺮاء اﻟﻄﺮق ) ﻣﺜﻼ اﻻﺳﺘﻨﺸﺎق اﻟﺸﻔﻮى(‬
‫ﻗﺮارات ﺣﺎﻟﺔ ﺑﺤﺎﻟﺔ ﻋﻠﻲ أﺳﺎس اﻟﻤﻌﺎھﺪات‬
‫ﻋﻮاﻣﻞ اﻟﺘﻘﯿﯿﻢ اﻟﻨﻤﻮذﺟﯿﺔ‬
‫ﻋﺎﻣﻞ اﻟﺘﻘﯿﯿﻢ ل‬ ‫اﻟﻘﯿﻤﺔ اﻟﻨﻤﻮذﺟﯿﺔ‬
‫ ﺑﯿﻦ اﻟﻔﺼﺎﺋﻞ‬e.g. rat-human 4

Remaining uncertainty 2.5
‫ داﺧﻞ اﻟﻔﺼﺎﺋﻞ‬-Worker 5
-General population 10
‫ ﻣﺪة اﻟﺘﻌﺮض‬-Subacute to subchronic 3

-Subchronic to chronic 2
-Subacute to chronic 6
‫ ﻃﺮق اﻻﺳﺘﻘﺮاء‬-Differences between human and >=1

animal route
‫ رد ﻓﻌﻞ اﻟﺠﺮﻋﺔ‬Reliability of dose response >=1

(incl.LOAEL/NOAEL extrapolation ) and
severity of effect
‫‪DNELs‬‬
‫• ﺗﻌﺮﯾﻒ اﻻﺛﺎر اﻟﺤﺮﺟﺔ ﻟﻠﻨﺴﺐ اﻟﻲ ‪DENL‬‬
‫• اﻟﻌﻼﻗﺔ ﺑﺴﯿﻨﺎرﯾﻮ اﻟﺘﻌﺮض اﻟﻤﺤﺘﻤﻞ‬
‫• ‪DNEL‬‬
‫‪......... mg/kg bw/day‬‬ ‫– اﻻﺣﺘﻜﺎك اﻟﺸﻔﻮى و اﻟﺠﻠﺪي‬
‫‪......... mg/cm2‬‬ ‫– اﻟﺘﻌﺮض اﻟﺠﻠﺪي اﻟﻤﺤﻠﻲ‬
‫‪......... mg/m3‬‬ ‫– اﻟﺘﻌﺮض ﻋﻦ ﻃﺮﯾﻖ اﻻﺳﺘﻨﺸﺎق‬
(1) ‫ ﻧﻈﺮة ﻋﺎﻣﺔ‬-‫اﺧﻄﺎر اﻟﺼﺤﺔ‬
‫درﺟﺔ اﻟﺨﻄﺮ‬ ‫اﻟﻮﺛﺎﻗﺔ‬ DNEL/ ‫ﻣﻠﺤﻮﻇﺔ‬
DMEL
Deriva-
tion
3.1 ‫اﻟﺴﻤﯿﺔ اﻟﺤﺎدة‬ ‫ اﻟﺤﻮادث‬,‫ااﻻﺣﺪاث اﻟﻤﺼﺎدﻓﺔ ) ﻣﻜﺎن اﻟﻌﻤﻞ‬ ‫ﻋﺎدة ﻻ‬ Not deemed necessary/
(‫اﻟﻜﺒﺮي‬ possible, at least for oral and
dermal exposure not
Use classification for HA
3.2‫ﺗﺄﻛﻞ اﻟﺠﻠﺪ‬ ‫ اﻟﺤﻮادث‬,‫اﻻﺣﺪاث اﻟﻤﺼﺎدﻓﺔ ) ﻣﻜﺎن اﻟﻌﻤﻞ‬ No derivation of non-irritating
(‫اﻟﻜﺒﺮي‬ ‫ﻋﺎدة ﻻ‬ concentrations from standard
skin tests; sometimes
information from humans
NOAELs with respect to local
effects from dermal repeated
dose studies can be used
3.3 ‫ﺿﺮر ﺑﺎﻟﻎ ﻟﻠﻌﯿﻦ‬ ‫ اﻟﺤﻮادث‬,‫اﻻﺣﺪاث اﻟﻤﺼﺎدﻓﺔ ) ﻣﻜﺎن اﻟﻌﻤﻞ‬ ‫ﻋﺎدة ﻻ‬ No derivation of non-irritating
(‫اﻟﻜﺒﺮي‬ concentrations from standard
eye tests
Helmut Fleig
‫اﺧﻄﺎر اﻟﺼﺤﺔ‪ -‬ﻧﻈﺮة ﻋﺎﻣﺔ )‪(2‬‬
‫درﺟﺔ اﻟﺨﻄﺮ‬ ‫اﻟﻮﺛﺎﻗﺔ‬ ‫‪DNEL/‬‬ ‫ﻣﻠﺤﻮﻇﺔ‬

‫‪DMEL‬‬
‫‪Deriva-‬‬
‫‪tion‬‬
‫اﺛﺎرة اﻟﺠﻠﺪ أو اﻟﺘﻨﻔﺲ‬ ‫‪3.4‬‬ ‫اﻟﺘﻌﺮض اﻟﻤﺘﻜﺮر ﻟﻤﻜﺎن اﻟﻌﻤﻞ و اﻟﻤﺴﺘﮭﻠﻚ‬ ‫ﻋﺎدة ﻻ‬ ‫‪Differentiation : Respiratory‬‬
‫‪tract and skin‬‬
‫‪2 Subcategories 1A and 1B‬‬
‫‪potency based‬‬
‫ااﻟﺘﻐﯿﺮ ﻓﻲ اﻟﺨﻼﯾﺎ ‪3.5‬‬ ‫ﻋﺎدة ﻻ‬
‫ااﻟﻤﺴﺮﻃﻨﺎت ‪3.6‬‬ ‫اﻟﺘﻌﺮض اﻟﻤﺘﻜﺮر ﻟﻤﻜﺎن اﻟﻌﻤﻞ و اﻟﻤﺴﺘﮭﻠﻚ‬ ‫‪DMEL:‬‬

‫‪Generally‬‬
‫‪possible‬‬
‫‪Helmut Fleig‬‬
Health Hazard (HH) – Overview (3)
‫درﺟﺔ اﻟﺨﻄﺮ‬ ‫اﻟﻮﺛﺎﻗﺔ‬ DNEL-/ ‫ﻣﻠﺤﻮﻇﺔ‬

DMEL-
Derivation
3.7 ‫ﺳﻤﯿﺔ اﻋﺎدة اﻻﻧﺘﺎج‬ ‫ﻣﻜﺎن اﻟﻌﻤﻞ‬ DNEL: Generally Subdivision: Fertility and adverse
‫اﻟﻤﺴﺘﮭﻠﻚ‬ possible effects on development
Additional category for lactation
Specific Target Organ 3.8 ‫ﻣﻜﺎن اﻟﻌﻤﻞ‬ DNEL: Generally 2 Categories for serious non-lethal
Toxicity ‫اﻟﻤﺴﺘﮭﻠﻚ‬ not for Cats 1 and effects: cf. Acute toxicity
– Single Exposure 2 Category 3 for transient effects
(STOT-SE) Possible for Cat 3 (Respiratory Tract Iirritation;
in certain cases Narcotic Effects)
DNEL derivation on available valid
human and experimental data
Specific Target Organ 3.9 ‫ﻣﻜﺎن اﻟﻌﻤﻞ‬ DNEL: Generally Most relevant application of the
Toxicity ‫اﻟﻤﺴﺘﮭﻠﻚ‬ required and DNEL concept
– Repeated Exposure possible
(STOT-RE)
3.10 ‫ﺧﻄﺮ اﻻﺳﺘﻨﺸﺎق‬ ‫اﻟﻤﺴﺘﮭﻠﻚ‬ ‫ﻋﺎدة ﻻ‬ In REACH under Acute toxicity

Helmut Fleig
‫اﺳﺘﺨﺪام اﻟﻤﻌﻠﻮﻣﺎت اﻻﺧﺮي‬
:‫ﺗﻌﺮض اﻻﺳﺘﻨﺸﺎق‬
(OELs)‫ﺗﻄﺒﯿﻖ ﻣﺴﺘﻮﯾﺎت اﻟﺘﻌﺮض اﻟﻤﮭﻨﻲ‬
( ca. (‫ ﻣﺎدة‬100 ‫) ﺗﻘﺮﯾﺒﺎ‬OELs ‫ ارﺷﺎدات اﻻﺗﺤﺎد اﻻوروﺑﻲ‬-

; p-Xylene OEL 50 ppm ‫ﻣﺜﻼ‬
(STELs)‫ ﻣﺴﺘﻮﯾﺎت اﻟﺘﻌﺮض اﻟﻘﺼﯿﺮ اﻟﻤﺪي‬-

p-Xylene: EU STEL 100 ppm ‫ﻣﺜﻼ‬
National OELs (in EU; e.g. MAC): ca. 600
Establishment of OELs on a valid data base using same methodology as for DNEL- derivation
Acrylic Acid (AA) ‫ﻣﺜﺎل‬
:‫ﻧﻤﻮذج اﻟﺘﻌﺮض‬
:‫• ﻣﻜﺎن اﻟﻌﻤﻞ‬
‫اﻟﺘﺼﻨﯿﻊ‬ -
‫ اﻻﺳﺘﻨﺸﺎق‬:‫ﻃﺮق اﻟﺘﻌﺮض‬ -
‫• ﻗﻄﺎع اﻻﺳﺘﮭﻼك‬
(Superabsorber; ) ‫ ﻓﻮط اﻻﻃﻔﺎل‬:‫ اﺳﺘﺨﺪام‬-
residual monomeric AA in Polyacrylate )
‫ ﺟﻠﺪي‬:‫ ﻃﺮق اﻟﺘﻌﺮض‬-
‫ﺗﻌﺮﯾﻒ اﻟﺨﻄﺮ و رد ﻓﻌﻞ اﻟﺠﺮﻋﺔ)‪(1‬‬
‫ﻣﻜﺎن اﻟﻌﻤﻞ‪:‬‬
‫‪ -‬ﻗﺎﻋﺪة اﻟﺒﯿﺎﻧﺎت‪ 90 :‬ﯾﻮم دراﺳﺔ اﺳﺘﻨﺸﺎق ﻋﻠﻲ اﻟﻔﺌﺮان‬
‫) دراﺳﺎت ﻣﺘﻌﺪدة(‬
‫أﺛﺎر‪Impairment of olfactory epithelium; irritation :‬‬ ‫‪-‬‬
‫‪- NOAEC: 15 mg/m3‬‬
‫ﺗﻌﺮﯾﻒ اﻟﺨﻄﺮ و رد ﻓﻌﻞ اﻟﺠﺮﻋﺔ )‪(2‬‬
‫اﻟﻤﺴﺘﮭﻠﻚ‪:‬‬
‫ﻗﺎﻋﺪة اﻟﺒﯿﺎﻧﺎت‪ 18 :‬ﺷﮭﺮ دراﺳﺔ ﻣﯿﺎه اﻟﺸﺮب‬ ‫•‬
‫أﺛﺎر‪ :‬اﺿﻄﺮاﺑﺎت ﻟﻠﺠﮭﺎز اﻟﮭﻀﻤﻲ‬ ‫‪-‬‬
‫‪- NOAEL: 40 mg/kg bodyweight‬‬
‫اﻓﺘﺮاض‪ NOAEL :‬ﻟﻠﺘﻌﺮض اﻟﺠﻠﺪي اﻟﻤﻤﺎﺛﻞ‬ ‫‪-‬‬
DNELs of AA
‫اﻟﺘﻌﺮض‬ ‫ = ﻃﺮق‬SF1xSF2xSF3xSF4
• AS total ‫ اﻟﻤﺪة‬NOAEL
= AFoverall DNEL
(‫ﻃﻮﯾﻞ اﻟﻤﺪي اﻻﺳﺘﻨﺸﺎق) اﻟﻌﺎﻣﻞ‬ 15 mg/m3 5 3 mg/m3
(‫ﻃﻮﯾﻞ اﻟﻤﺪي ﺟﻠﺪي ) ﻣﺴﺘﮭﻠﻚ‬ 40 mg/kg 10 4 mg/kg

bw*/d bw/d
‫ﻋﻮاﻣﻞ اﻟﺘﻘﯿﯿﻢ اﻟﻌﺎﻣﺔ‬
AFoverall = AF1xAF2xAF3xAF4
AF1 = 1‫ ﺟﻮدة اﻟﺪراﺳﺔ‬-

AF2 = 1‫ اﻟﺸﻜﻮك ﺑﺎﻟﻨﺴﺒﺔ ﻟﺘﻌﺪد اﻟﻘﯿﻢ‬-
AF3 = 5‫ ﻧﻮع و ﺣﺪة اﻻﺛﺎر‬-
‫ ﻣﻜﺎن اﻟﻌﻤﻞ‬- AF4 = 1
AF4 = 2‫ اﻟﺤﺴﺎﺳﯿﺔ اﻟﺨﺎﺻﺔ ﻟﻠﻤﺴﺘﮭﻠﻜﯿﻦ‬-
Modified DNEL- derivation on basis of the MOS (Margin

of Safety) given in the report
Source: Risk Assessment Report Acrylic acid, 2002; Rapporteur Germany
‫اﻟﻤﺴﺮﻃﻨﺎت‬
‫اﻟﺘﻘﯿﯿﻢ‪:‬‬
‫• ﻣﻦ ﺣﯿﺚ اﻟﺠﻮدة‬
‫اﻟﺘﺼﻨﯿﻒ ﻣﺒﻨﻲ ﻋﻠﻲ دراﺳﺎت ﺣﯿﻮاﻧﯿﺔ ﻣﻼﺋﻤﺔ و ﻣﻌﻠﻮﻣﺎت ‪.‬‬
‫‪- Carc Cat 1 and 2; R45/49 ; Carc Cat 3; R40‬‬
‫• ﻣﻦ ﺣﯿﺚ اﻟﻜﻤﯿﺔ‪:‬‬
‫ﻟﻠﻤﺴﺮﻃﻨﺎت اﻟﺴﺎﻣﺔ ﻋﻠﻲ اﻟﺠﯿﻨﻼ ﻟﯿﺲ ھﻨﺎك ﻣﺴﺘﻮي ﻣﻌﯿﻦ ‪ ,‬ﻟﮭﺬا ﻟﯿﺲ ھﻨﺎك ﻧﺴﺐ‬
‫‪NOAEL‬أو ‪DNEL‬‬
‫• ﺳﺒﮫ ﻛﻤﻲ‪:‬‬
‫‪DMEL*:‬‬
‫ﯾﻨﻄﺒﻖ ﻋﻠﻲ اﻟﻤﺨﺎﻃﺮة اﻟﻨﻈﺮﯾﺔ اﻟﻤﻨﺨﻔﻀﺔ ﻟﺘﻘﯿﯿﻢ ﺗﺠﻨﺐ اﻻﺛﺎر‬
‫‪* DMEL=Derived Minimal Effect Level‬‬
‫ﺷﺮح اﻟﺠﺮﻋﺎت‬
T 25-Concept (Norway/Netherlands; 1997):
‫ اﺳﺘﺨﺪام ﺗﺼﻨﯿﻒ‬.%25 ‫اﺳﺘﯿﻔﺎء ﻃﻮﻟﻲ ﻟﺒﯿﺎﻧﺎت اﻟﺴﺮﻃﺎن ﻟﺤﻮادث اﻻورام اﻟﻲ‬ •

‫ﻓﺌﺎت اﻟﺠﺮﻋﺎت و اﻟﻤﺨﺎﻟﯿﻂ‬
- - High: T 25 < 1mg/kg/day •
- - Low : T 25 > 100 mg/kg/day
- Derivation of a DMEL
‫اﻟﻨﺴﺐ ل ‪DMEL‬‬
‫• ﻗﺎﻋﺪة اﻟﺒﯿﺎﻧﺎت‪:‬‬
‫• دراﺳﺔ اﻟﻤﺴﺮﻃﻨﺎت ﻋﻦ اﻟﻄﺮﯾﻖ اﻟﺸﻔﻮي‬
‫‪T25: 10 mg/kg/d‬‬
‫• اﺳﺘﺨﺪام ﻟﻌﻮاﻣﻞ اﻟﺸﻚ‪:‬‬

‫‪ :Linearised‬ﺟﺮﻋﺎت ﻋﺎﻟﯿﺔ و ﻣﻨﺨﻔﻀﺔ ﻟﻼﺳﺘﻘﺮاء‪1/100,000‬‬
‫‪à DMEL= 0.01ug/kg/day‬‬
‫” ﻧﮭﺞ ﻋﺎﻣﻞ اﻟﺘﻘﯿﯿﻢ اﻟﻜﺒﯿﺮ“ ‪(several factors): 1/25,000‬‬
‫‪àDMEL=0.4ug/kg/day‬‬

TWINNING PROJECT EG07/AA/EN10 - Integrated Waste and Hazardous Substances Management System

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TWINNING PROJECT EG07/AA/EN10 - Integrated Waste and Hazardous Substances Management System

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Integrated Waste and Hazardous Substances

Component 2 / Activity 2.1

‫ﺧﻄﻮة ‪ =1‬ﺗﻌﺮﯾﻒ اﻟﺨﻄﺮ و‬

‫ﺧﻄﻮة ‪ =2‬ﻋﻼﻗﺔ اﻟﺠﺮﻋﺔ ﺑﺮد اﻟﻔﻌﻞ‬

‫‪ -‬اﺳﺘﺨﺪام ﻛﻞ اﻟﻤﻌﻠﻮﻣﺎت‪ /‬اﻟﺒﯿﺎﻧﺎت ‪ :‬اﻟﺒﺸﺮﯾﺔ‪ ,‬اﻟﺤﯿﻮاﻧﯿﺔ ﻓﻲ ‪vitro‬‬

‫ ﻟﻼﺛﺎر اﻟﻤﺮاﻗﺒﺔ اذا اﻣﻜﻦ‬NOAEL(C)* ‫• ﻧﺴﺐ‬

*NOAEL(C)=No Adverse Effect Level(Concentration) in animal experiments

‫ﺧﻄﻮة ‪ :1‬ﺗﻘﯿﯿﻢ اﻟﻤﻌﻠﻮﻣﺎت اﻟﻐﯿﺮ ﺑﺸﺮﯾﺔ‬ ‫•‬

‫ﺗﻮﺻﯿﻞ اﻻﺧﻄﺎر ﻟﻜﻞ ﻧﻘﻂ اﻟﻨﮭﺎﯾﺔ اﻟﺨﺎﺻﺔ ﺑﺼﺤﺔ اﻻﻧﺴﺎن اﻟﻤﻌﻨﯿﺔ‬

‫• اﺳﺘﺨﺪام اﻟﻤﻌﻠﻮﻣﺎت اﻟﻤﺘﺎﺣﺔ‬

Standard Test Guidelines (OECD, EPA a.o.) •

‫ أﺛﺎر ﻣﻌﯿﻨﺔ‬/ ‫• أھﻤﯿﺔ ﻣﺮاﻗﺒﺎت‬

(REACH) :‫اﻟﺘﻌﺒﯿﺮ اﻟﻜﻤﻲ ﻟﻠﺨﻄﺮ‬

DNEL =Derived No Effect Level (Human situation )

:DNEL ‫ﻧﺴﺐ ﻟﻞ‬

* NOAEL(C)=No Adverse Effect Level(Concentration) , generally in animal

**AF= Assessment Factor (Uncertainty factor)

‫• ‪: REACH‬اذا ﻟﻢ ﯾﻤﻜﻦ ﺗﻌﺮﯾﻒ ‪ , DNEL‬اذا ﯾﺠﺐ أن ﯾﺼﺮح ﺑﮭﺬا و ﯾﺘﻢ ﺷﺮﺣﮫ‬

‫• اﺳﺘﻘﺮاء اﻟﺰﻣﻨﻲ‪) e.g. 28 d à :‬ﻣﺰﻣﻦ‪ /‬ﻣﻤﺘﺪ اﻟﻮﻗﺖ(‬

‫ﻗﺮارات ﺣﺎﻟﺔ ﺑﺤﺎﻟﺔ ﻋﻠﻲ أﺳﺎس اﻟﻤﻌﺎھﺪات‬

‫ ﺑﯿﻦ اﻟﻔﺼﺎﺋﻞ‬e.g. rat-human 4

‫ ﻣﺪة اﻟﺘﻌﺮض‬-Subacute to subchronic 3

‫ ﻃﺮق اﻻﺳﺘﻘﺮاء‬-Differences between human and >=1

‫ رد ﻓﻌﻞ اﻟﺠﺮﻋﺔ‬Reliability of dose response >=1

‫• اﻟﻌﻼﻗﺔ ﺑﺴﯿﻨﺎرﯾﻮ اﻟﺘﻌﺮض اﻟﻤﺤﺘﻤﻞ‬

‫درﺟﺔ اﻟﺨﻄﺮ‬ ‫اﻟﻮﺛﺎﻗﺔ‬ ‫‪DNEL/‬‬ ‫ﻣﻠﺤﻮﻇﺔ‬

‫ااﻟﻤﺴﺮﻃﻨﺎت ‪3.6‬‬ ‫اﻟﺘﻌﺮض اﻟﻤﺘﻜﺮر ﻟﻤﻜﺎن اﻟﻌﻤﻞ و اﻟﻤﺴﺘﮭﻠﻚ‬ ‫‪DMEL:‬‬

‫درﺟﺔ اﻟﺨﻄﺮ‬ ‫اﻟﻮﺛﺎﻗﺔ‬ DNEL-/ ‫ﻣﻠﺤﻮﻇﺔ‬

3.10 ‫ﺧﻄﺮ اﻻﺳﺘﻨﺸﺎق‬ ‫اﻟﻤﺴﺘﮭﻠﻚ‬ ‫ﻋﺎدة ﻻ‬ In REACH under Acute toxicity

( ca. (‫ ﻣﺎدة‬100 ‫) ﺗﻘﺮﯾﺒﺎ‬OELs ‫ ارﺷﺎدات اﻻﺗﺤﺎد اﻻوروﺑﻲ‬-

(STELs)‫ ﻣﺴﺘﻮﯾﺎت اﻟﺘﻌﺮض اﻟﻘﺼﯿﺮ اﻟﻤﺪي‬-

‫أﺛﺎر‪Impairment of olfactory epithelium; irritation :‬‬ ‫‪-‬‬

‫‪- NOAEC: 15 mg/m3‬‬

‫أﺛﺎر‪ :‬اﺿﻄﺮاﺑﺎت ﻟﻠﺠﮭﺎز اﻟﮭﻀﻤﻲ‬ ‫‪-‬‬

‫‪- NOAEL: 40 mg/kg bodyweight‬‬

‫اﻓﺘﺮاض‪ NOAEL :‬ﻟﻠﺘﻌﺮض اﻟﺠﻠﺪي اﻟﻤﻤﺎﺛﻞ‬ ‫‪-‬‬

(‫ﻃﻮﯾﻞ اﻟﻤﺪي اﻻﺳﺘﻨﺸﺎق) اﻟﻌﺎﻣﻞ‬ 15 mg/m3 5 3 mg/m3

(‫ﻃﻮﯾﻞ اﻟﻤﺪي ﺟﻠﺪي ) ﻣﺴﺘﮭﻠﻚ‬ 40 mg/kg 10 4 mg/kg

AF1 = 1‫ ﺟﻮدة اﻟﺪراﺳﺔ‬-

Modified DNEL- derivation on basis of the MOS (Margin

Source: Risk Assessment Report Acrylic acid, 2002; Rapporteur Germany

‫ اﺳﺘﺨﺪام ﺗﺼﻨﯿﻒ‬.%25 ‫اﺳﺘﯿﻔﺎء ﻃﻮﻟﻲ ﻟﺒﯿﺎﻧﺎت اﻟﺴﺮﻃﺎن ﻟﺤﻮادث اﻻورام اﻟﻲ‬ •

‫• اﺳﺘﺨﺪام ﻟﻌﻮاﻣﻞ اﻟﺸﻚ‪:‬‬

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