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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
52.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
12.5
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
280 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
12.5
Modified dose descriptor starting point:
NOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
52.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
12.5
Dose descriptor:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
280 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
NOAEC

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
60 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
160 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
12.5
Modified dose descriptor starting point:
NOAEL

Local effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
25 % in mixture (weight basis)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
Overall assessment factor (AF):
1
Dose descriptor:
other: NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
25 % in mixture (weight basis)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
Overall assessment factor (AF):
1
Dose descriptor starting point:
other: NOAEL

Workers - Hazard for the eyes

Additional information - workers

Based on the DNELs and considering all the predicted exposure values, are compiled below all the RCR<1

Use Descriptor  Inhalation exposure Dermal exposure Risk Characterization
Process Category [scroll list] Predicted Exposure -     (ppm) - modified Predicted Dermal Exposure (mg/kg/d) - modified  RCR (inhalation) RCR         (dermal) RCR           (all routes)
1 - Use in closed process, no likelihood of exposure 0,01 0,34 0,0 0,0 0,06
2 - Use in closed, continuous process with occasional controlled exposure 0,01 1,37 0,0 0,2 0,19
3 - Use in closed batch process (synthesis or formulation) 0,01 0,34 0,0 0,0 0,06
3 - Use in closed batch process (synthesis or formulation) 0,01 0,34 0,0 0,0 0,06
4 - Use in batch and other process (synthesis) where opportunity for exposure arises 0,5 1,372 0,5 0,2 0,68
8b -Transfer of chemicals from/to vessels/ large containers at dedicated facilities 0,1 1,372 0,1 0,2 0,28
15 - Use of laboratory reagents in small scale laboratories 0,1 0,34 0,1 0,0 0,15
8a -Transfer of chemicals from/to vessels/ large containers at non dedicated facilities 0,5 2,742 0,5 0,4 0,87

Then for workers (in the manufacturing side), based on EFFA table and taking into account that there are no concern in acute toxicity (oral, dermal, inhalation), in eye and skin corrosion, in skin irritation and skin sensitization (up to 25% based on the precautionary principle), in genotoxicity one may conclude that for workers there aren't any hazard once the risk managment mesures are respected.

For any new or innovative exposure level not displayed in the above table, it's not requiered performing any new safety assessment until the predicted value didn't exceed those above.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
25
Dose descriptor:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEC

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
30 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
80 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEL

Local effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
25 % in mixture (weight basis)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
Overall assessment factor (AF):
1
Dose descriptor:
other: NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
25 % in mixture (weight basis)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
Overall assessment factor (AF):
1
Dose descriptor starting point:
other: NOAEL

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Additional information - General Population

Based on the DNELs and considering all the predicted exposure values, are compiled all the RCR from compounding to end-uses.

Compounding:

Use Descriptor  Inhalation exposure Dermal exposure

Risk Characterization

Process Category Predicted Exposure -     (ppm) - modified Predicted Dermal Exposure (mg/kg/d) - modified  RCR (inhalation) RCR         (dermal) RCR           (all routes)
1 - Use in closed process, no likelihood of exposure 0,01 0,34 0,0 0,0 0,06
8a -Transfer of chemicals from/to vessels/ large containers at non dedicated facilities 0,50 2,742 0,5 0,4 0,87
8b -Transfer of chemicals from/to vessels/ large containers at dedicated facilities 0,10 1,372 0,1 0,2 0,28
3 - Use in closed batch process (synthesis or formulation) 0,10 0,34 0,1 0,0 0,15
5 -Mixing or blending in batch processes (multistage and/or significant contact) 0,50 0,01371 0,5 0,0 0,50
8a -Transfer of chemicals from/to vessels/ large containers at non dedicated facilities 0,50 2,742 0,5 0,4 0,87
8b -Transfer of chemicals from/to vessels/ large containers at dedicated facilities 0,10 0,0343 0,1 0,0 0,10
9 -Transfer of chemicals into small containers (dedicated filling line) 0,10 0,0343 0,1 0,0 0,10
15 - Use of laboratory reagents in small scale laboratories 0,10 0,0017 0,1 0,00022667 0,100226667
8a -Transfer of chemicals from/to vessels/ large containers at non dedicated facilities 0,50 0,01371 0,5 0,001828 0,501828

Worker Formulation

Use Descriptor  Inhalation exposure Dermal exposure

Risk Characterization

Process Category Predicted Exposure -     (ppm) - modified Predicted Dermal Exposure (mg/kg/d) - modified  RCR (inhalation) RCR         (dermal) RCR           (all routes)
1 - Use in closed process, no likelihood of exposure 0,01 0,34 0,0 0,0 0,06
8a -Transfer of chemicals from/to vessels/ large containers at non dedicated facilities 0,50 2,74 0,5 0,4 0,87
8b -Transfer of chemicals from/to vessels/ large containers at dedicated facilities 0,10 0,03 0,1 0,0 0,10
2 - Use in closed, continuous process with occasional controlled exposure 0,01 1,37 0,0 0,2 0,19
3 - Use in closed batch process (synthesis or formulation) 0,10 0,34 0,1 0,0 0,15
5 -Mixing or blending in batch processes (multistage and/or significant contact) 0,50 0,07 0,5 0,0 0,51
8a -Transfer of chemicals from/to vessels/ large containers at non dedicated facilities 0,50 0,07 0,5 0,0 0,51
8b -Transfer of chemicals from/to vessels/ large containers at dedicated facilities 0,10 0,03 0,1 0,0 0,10
9 -Transfer of chemicals into small containers (dedicated filling line) 0,10 0,03 0,1 0,0 0,10
14 - Production of preparations or articles by tabletting, compression, extrusion, pelletisation 0,10 0,02 0,1 0,0 0,10
15 - Use of laboratory reagents in small scale laboratories 0,10 0,00 0,1 0,0 0,10
8a -Transfer of chemicals from/to vessels/ large containers at non dedicated facilities 0,50 2,74 0,5 0,4 0,87

Industrial - End uses

Use Descriptor  Inhalation exposure Dermal exposure Risk Characterization
Process Category Predicted Exposure -     (ppm) - modified Predicted Dermal Exposure (mg/kg/d) - modified  RCR (inhalation) RCR         (dermal) RCR           (all routes)
1 - Use in closed process, no likelihood of exposure 0,01 0,34 0,0 0,0 0,06
2 - Use in closed, continuous process with occasional controlled exposure 0,01 1,37 0,0 0,2 0,19
4 - Use in batch and other process (synthesis) where opportunity for exposure arises  0,50 0,00 0,5 0,0 0,50
5 -Mixing or blending in batch processes (multistage and/or significant contact) 0,50 0,00 0,5 0,0 0,50
7 -Industrial spraying 0,06 0,01 0,1 0,0 0,06
7 -Industrial spraying 0,06 0,01 0,1 0,0 0,06
8a -Transfer of chemicals from/to vessels/ large containers at non dedicated facilities 0,50 0,00 0,5 0,0 0,50
8b -Transfer of chemicals from/to vessels/ large containers at dedicated facilities 0,10 0,00 0,1 0,0 0,10
10 - Roller application or brushing  0,50 0,01 0,5 0,0 0,50
13 -Treatment of articles by dipping and pouring  0,10 0,00 0,1 0,0 0,10

Instiututional - End uses

Use Descriptor  Inhalation exposure Dermal exposure Risk Characterization
Process Category Predicted Exposure -     (ppm) - modified Predicted Dermal Exposure (mg/kg/d) - modified  RCR (inhalation) RCR         (dermal) RCR           (all routes)
1 - Use in closed process, no likelihood of exposure 0,01 0,34 0,0 0,0 0,06
2 - Use in closed, continuous process with occasional controlled exposure 0,01 0,27 0,0 0,0 0,05
4 - Use in batch and other process (synthesis) where opportunity for exposure arises  0,20 1,37 0,2 0,2 0,38
4 - Use in batch and other process (synthesis) where opportunity for exposure arises  0,20 1,37 0,2 0,2 0,38
11 - Non industrial spraying 0,20 4,29 0,2 0,6 0,77
11 - Non industrial spraying 0,20 4,29 0,2 0,6 0,77
8a -Transfer of chemicals from/to vessels/ large containers at non dedicated facilities 0,50 2,74 0,5 0,4 0,87
8b -Transfer of chemicals from/to vessels/ large containers at dedicated facilities 0,50 1,37 0,5 0,2 0,68
10 - Roller application or brushing  0,50 1,10 0,5 0,1 0,65
10 - Roller application or brushing  0,50 1,10 0,5 0,1 0,65
13 -Treatment of articles by dipping and pouring  0,50 2,74 0,5 0,4 0,87
19 - Hand-mixing with intimate contact (only PPE available 0,01 0,57 0,0 0,1 0,08

Consumer uses -Product categories

AISE Product Category   Dermal exposure Inhalation exposure Oral exposure Total exposure Dermal RCR Inhalation RCR Oral RCR Overall RCR
    mg/kg/day mg/kg/day mg/kg/day mg/kg/day - - - -
LAUNDRY REGULAR (AISE C1, PC35)   7,63410175 - - 7,63410175 0,25447006 - - 0,25447006
LAUNDRY COMPACT (AISE C2, PC35)   7,6331815 - - 7,6331815 0,25443938 - - 0,25443938
FABRIC CONDITIONERS (AISE C3, PC35)   0,487348167 - - 0,48734817 0,01624494 - - 0,01624494
LAUNDRY ADDITIVES (AISE C4, PC35)   7,355105833 - - 7,35510583 0,24517019 - - 0,24517019
HAND DISHWASHING (AISE C5, PC35)   0,104125 - 0,00495 0,109075 0,00347083 - 0,00066 0,01454333
MACHINE DISHWASHING (AISE C6, PC35)   - - 0,00495 0,00495 - - 0,00066 0,00066
SURFACE CLEANERS (AISE C7, PC35)                  
TOILET CLEANERS (AISE C8, PC35)                  
LAUNDRY AIDS (AISE C12, PC35)   0,003333333 0,0002556 - 0,00358893 0,00011111 0,00002556 - 0,00035889
INSECTICIDES AND REPELLANTS (**)                  
REPELLANTS (**)                  
WATER SOFTENERS (AISE C9, PC35) (**)                  
FURNITURE, FLOOR & LEATHER CARE   0,614541667 0,16013793 - 0,7746796 0,02048472 0,01601379 - 0,07746796
WIPES (AISE C15, PC35)   14,29166667 - - 14,2916667 0,47638889 - - 0,47638889
DRAIN PRODUCTS (AISE C13, PC35) (**)                  
AIR FRESHENERS AEROSOL (AISE C17, PC3)   - 1,4893718 - 1,4893718 - 0,14893718 - 0,14893718
AIR FRESHENERS NON-AEROSOL (AISE C18, PC3)   - 0,04938553 - 0,04938553 - 0,00493855 - 0,00493855
OVEN CLEANERS (AISE C10, PC35) (**)                  
CARPET CLEANERS (AISE C11, PC35) (**)                  
DESCALERS (AISE C14, PC35) (**)                  

Consumer uses - Product subcategories

AISE Product Category AISE Product Subcategory Dermal exposure Inhalation exposure Oral exposure Total exposure Dermal RCR Inhalation RCR Oral RCR Overall RCR
    mg/kg/day mg/kg/day mg/kg/day mg/kg/day - - - -
LAUNDRY REGULAR (AISE C1, PC35) LAUNDRY REGULAR                
  Powder  5,19288192 - - 5,19288192 0,17309606 - - 0,17309606
  Liquid  7,63410175 - - 7,63410175 0,25447006 - - 0,25447006
LAUNDRY COMPACT (AISE C2, PC35) LAUNDRY COMPACT                
  Powder 5,330795 - - 5,330795 0,17769317 - - 0,17769317
  Liquid/gel 7,6331815 - - 7,6331815 0,25443938 - - 0,25443938
  Tablet 0,48729704 - - 0,48729704 0,01624323 - - 0,01624323
FABRIC CONDITIONERS (AISE C3, PC35) FABRIC CONDITIONERS                
  Liquid Regular 0,48734817 - - 0,48734817 0,01624494 - - 0,01624494
  Liquid Concentrate 0,48683692 - - 0,48683692 0,0162279 - - 0,0162279
LAUNDRY ADDITIVES (AISE C4, PC35) LAUNDRY ADDITIVES                
  Powder Bleach 0,20896575 - - 0,20896575 0,00696553 - - 0,00696553
  Liquid Bleach (ml) 7,35510583 - - 7,35510583 0,24517019 - - 0,24517019
  Tablet 0,20855675 - - 0,20855675 0,00695189 - - 0,00695189
HAND DISHWASHING (AISE C5, PC35) HAND DISHWASHING                
  Liquid Regular (a) 0,104125 - 0,00495 0,109075 0,00347083 - 0,00066 0,01454333
  Liquid Concentrate (a) 0,104125 - 0,00495 0,109075 0,00347083 - 0,00066 0,01454333
MACHINE DISHWASHING (AISE C6, PC35) MACHINE DISHWASHING                
  Powder - - 0,00495 0,00495 - - 0,00066 0,00066
  Liquid - - 0,00495 0,00495 - - 0,00066 0,00066
  Tablet - - 0,00495 0,00495 - - 0,00066 0,00066
SURFACE CLEANERS (AISE C7, PC35) SURFACE CLEANERS                
  Liquid (a) 0,15720833 - - 0,15720833 0,00524028 - - 0,00524028
  Powder (a) 0,05716667 - - 0,05716667 0,00190556 - - 0,00190556
  Gel (neat) 7,14583333 - - 7,14583333 0,23819444 - - 0,23819444
  Spray (neat) 1,42916667 0,12024 - 1,54940667 0,04763889 0,012024 - 0,15494067
TOILET CLEANERS (AISE C8, PC35) TOILET CLEANERS                
  Powder                
  Liquid (ml)                
  Gel                
  Tablet                
LAUNDRY AIDS (AISE C12, PC35) LAUNDRY AIDS                
  Ironing Aids - Spray  0,00333333 0,0002556 - 0,00358893 0,00011111 0,00002556 - 0,00035889
INSECTICIDES AND REPELLANTS (**) INSECTICIDES                
(AISE C19, PC8) Liquid Electric                
  Spray (air neat)                
  REPELLANTS                
  Liquid                
  Spray (aerosol and pump spray)                
WATER SOFTENERS (AISE C9, PC35) (**) WATER SOFTENERS                
  Powder (a)                
  Liquids (ml)                
  Tabs(tab)                
FURNITURE, FLOOR & LEATHER CARE MAINTENANCE PRODUCTS                
(AISE C20, PC31) Spray 0,61454167 0,16013793 - 0,7746796 0,02048472 0,01601379 - 0,07746796
WIPES (AISE C15, PC35) WIPES                
  Bathroom 14,2916667 - - 14,2916667 0,47638889 - - 0,47638889
  Kitchen 7,14583333 - - 7,14583333 0,23819444 - - 0,23819444
  Floor 4,2875 - - 4,2875 0,14291667 - - 0,14291667
DRAIN PRODUCTS (AISE C13, PC35) (**) DRAIN PRODUCTS                
AIR FRESHENERS AEROSOL (AISE C17, PC3) AIR FRESHENERS                
  Aerosol i) aqueous                                - 1,4893718 - 1,4893718 - 0,14893718 - 0,14893718
  Aerosol ii) non-Aqueous - 0,9574533 - 0,9574533 - 0,09574533 - 0,09574533
AIR FRESHENERS (AISE C18, PC3) AIR FRESHENERS                
  Perfume in/on solid substrate - 0,04678937 - 0,04678937 - 0,00467894 - 0,00467894
  Diffusers (heated+ electrical) - 0,04938553 - 0,04938553 - 0,00493855 - 0,00493855
OVEN CLEANERS (AISE C10, PC35) (**) OVEN CLEANER                
  Liquid                
  Spray                
CARPET CLEANERS (AISE C11, PC35) (**) CARPET CLEANER                
  Liquid                 
  Spray                
DESCALERS (AISE C14, PC35) (**) DESCALERS                

In any cases, the resulting exposure to D-menthol on the skin, by inhalation and in oral from the use descriptors are reported in the tables aboves.

For each case of use descriptor declared the RCR (all routes) <1

Therefore for any unrevealed or undeclared use descriptor coming up later, resulting in exposures levels lower than those above are considered as safe.