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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.47 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
75
Dose descriptor starting point:
NOAEL
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.7 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
300
Dose descriptor starting point:
NOAEL
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The long-term DNEL is based on a NOAEL of 150 mg/kg based on 42 repeated dose toxicity.

Long-term DNEL for dermal route calculation (systemic effects, route to-route extrapolation) = 150 *1 (a) / 4*2.5*5 (b) *6 (c)* 1,4(d) = 0.7 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)

(d) correction factor between human workers and experimental exposure condition

Long-term DNEL for the inhalation route (systemic effects, route to-route extrapolation) = 150 * (1/ sRV(a)) * 0.67 (b) /75 (c)*1.4 (d) *0.5 (e ) = 2.47  mg/m3

(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 )

(d) Correction for differences between human and experimental exposure conditions (1.4)

(e) Corrction for bioavailability (0.5)

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.435 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
150
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.25 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
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.25 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
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The long-term DNEL is based on a NOAEL for repeated dose toxixity of 150 mg/kg.

Long-term DNEL for dermal route calculation (systemic effects, route to-route extrapolation) = 150 *1 (a) / 4*2.5*10 (b) *6 (c) = 0.25 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 inhalation route (systemic effects, route to-route extrapolation) = 150 * (1/ sRV(a)* 0.5 (b) 150 (c)) = 0.435 mg/m3

(a) Standard respiratory volume (sRV) rat 24 h: 1.15 m3/kg

(b) Corrction for bioavailability (0.5)

(c)interspecies (without allometric scaling) * intraspecies * correction for duration: (2.5 * 10 * 6 )

Long-term DNEL for oral route calculation (systemic effects, route to-route extrapolation) = 150 / 4*2.5*10 (b) *6 (c) = 0.25 mg/kg bw/day

(b) assessment factors (interspecies * intraspecies (4*2.5) * 10)

(c) Correction for duration from subacute to chronic (6)