Registration Dossier
Registration Dossier
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EC number: 405-370-0 | CAS number: 6334-25-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 23.51 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 225
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Acute toxicity
This substance is not classified for acute toxicity hazards, for this reason no acute DNELs need to be calculated.
Local effects
Since no local effects were described, the DNELs are based on the systemic effects only.
LONG -TERM DNEL
The long-term DNEL is based on a NOAEL of 1000 mg/kg.
long-term DNEL for the inhalation route (systemic effects, route to-route extrapolation) =
1000 * (1/ sRV(a) * 0.67 (b) )
--------------------------------------------------------------------------------------------------------------------------- =
75 (c)
1000* (1/ 0.38) * 0.67
-------------------------------------------------------- = 23.51 mg/m3
75
(a) Standard respiratory volume (sRV) rat:0.38 m3/kg
(b) correction for worker respiratory volume (conservative default for route to route)
(c)interspecies (without allometric scaling) * intraspecies * correction for duration: (2.5 * 5 * 6 )
long-term DNEL for the dermal route (systemic effects, route to-route extrapolation)
1000 *1 (a) / 4*2.5*5 (b) *6 (c) = 3.3 mg/kg bw/day
(a) route to route extrapolation oral to dermal
(b) assessment factors (interspecies * intraspecies (4*2.5) * 5)
(c) Correction for duration from subacute to chronic (6)
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Acute toxicity
This substance is not supposed to be used by the general population.
Local effects
This substance is not supposed to be used by the general population.
LONG -TERM DNEL
The long-term DNEL is based on a NOAEL of 1000 mg/kg.
long-term DNEL for the inhalation route (systemic effects, route to-route extrapolation) =
1000 * (1/ sRV(a))
--------------------------------------------------------------------------------------------------------------------------- =
2.5*10*6 (b)
1000* (1/ 1.15)
-------------------------------------------------------- = 5.8 mg /m3
150
(a) Standard respiratory volume (sRV) rat for general public (24h):1.15 m3/kg
(b) Interspecies (without allometric scaling) * intraspecies * correction for duration: (2.5 * 10 * 6 )
long-term DNEL for the dermal route (systemic effects, route to-route extrapolation)
1000 *1 (a) / 4*2.5*10 (b) *6 (c) = 1.67 mg/kg bw/day
(a) route to route extrapolation oral to dermal
(b) assessment factors (interspecies * intraspecies (4*2.5) * 10)
(c) Correction for duration from subacute to chronic (6)
long-term DNEL for the oral route (systemic effects)
1000 / 4*2.5*10 (a) *6(b) = 1.67 mg/kg bw/day
(a) assessment factors (interspecies * intraspecies (4*2.5) * 10)
(b) Correction for duration from subacute to chronic (6)
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