Ispra, 20/03/2008

The following four tables summarise the risk characterisation outcome for the Human Health Part of the CARs for Biocides.
It was agreed at TMI08 that these tables should be included in Doc I and in Doc IIC of the CARs.

Note: The following tables are for internal exposure. In case external reference values are set and used in the risk characterisation, these should be mentioned separately.

Table 1: Professional Users – Primary Exposure

Exposure Scenario
(indicate duration) / Estimated Internal Exposure / Relevant NOAEL/
LOAEL
[mg/kg
b.w/day]
Reference Value
e.g: AEL (acute or medium or chronic) / AF
MOEref / MOE / Exposure
/AEL
estimated oral uptake
[mg/kg
b.w/day] / estimated inhalation uptake
[mg/kg
b.w/day] / estimated dermal uptake [mg/kg b.w/day] / estimated total uptake [mg/kg
b.w/day]
Tier 1
(no PPE)
Tier 2
(Refinement, PPE
or other risk
mitigation measures –
Specify)

Table 2: Non Professional Users – Primary Exposure

Exposure Scenario
(indicate duration) / Estimated Internal Exposure / Relevant NOAEL/
LOAEL
[mg/kg
b.w/day]
Reference Value
e.g: AEL (acute or medium or chronic) / AF
MOEref / MOE / Exposure
/AEL
estimated oral uptake
[mg/kg
b.w/day] / estimated inhalation uptake
[mg/kg
b.w/day] / estimated dermal uptake [mg/kg b.w/day] / estimated total uptake [mg/kg
b.w/day]
Tier 1
(no PPE)
Tier 2
Refinement
or other risk
mitigation measures –
Specify)
Exposure Scenario
(indicate duration) / Estimated Internal Exposure / Relevant NOAEL/
LOAEL [mg/kg
b.w/day]
Reference Value
e.g: AEL (acute or medium or chronic) / AF
MOEref / MOE / Exposure
/AEL
estimated inhalation uptake
[mg/kg
b.w/day] / estimated dermal uptake [mg/kg b.w/day] / estimated oral
uptake
[mg/kg b.w/day] / estimated total uptake [mg/kg
b.w/day]
Tier 1 (Worst Case) / Short term Scenario
Exposure Scenario
(indicate duration) / Estimated Internal Exposure / Relevant NOAEL/
LOAEL [mg/kg
b.w/day]
Reference Value
e.g: AEL (acute or medium or chronic) / AF
MOEref / MOE / Exposure
/AEL
estimated inhalation uptake
[mg/kg
b.w/day] / estimated dermal uptake [mg/kg b.w/day] / estimated oral
uptake
[mg/kg b.w/day] / estimated total uptake [mg/kg
b.w/day]
Tier 2 (Refinement - Specify) / Short Term Scenario

Table 3: Indirect Exposure as a result of use – Secondary Exposure

Exposure Scenario
(indicate duration) / Estimated Internal Exposure / Relevant NOAEL/
LOAEL [mg/kg
b.w/day]
Reference Value
e.g: AEL (acute or medium or chronic) / AF
MOEref / MOE / Exposure
/AEL
estimated inhalation uptake
[mg/kg
b.w/day] / estimated dermal uptake [mg/kg b.w/day] / estimated oral
uptake
[mg/kg b.w/day] / estimated total uptake [mg/kg
b.w/day]
Tier 1 (Worst Case) / Chronic Scenario
Exposure Scenario
(indicate duration) / Estimated Internal Exposure / Relevant NOAEL/
LOAEL [mg/kg
b.w/day]
Reference Value
e.g: AEL (acute or medium or chronic) / AF
MOEref / MOE / Exposure
/AEL
estimated inhalation uptake
[mg/kg
b.w/day] / estimated dermal uptake [mg/kg b.w/day] / estimated oral
uptake
[mg/kg b.w/day] / estimated total uptake [mg/kg
b.w/day]
Tier 2 (Refinement- Specify) / Chronic Scenario

Table 4: Indirect Exposure as a result of use – Secondary Exposure

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