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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.661 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.661 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEC

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:
0.375 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:
DNEL (Derived No Effect Level)
Value:
0.375 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL

Workers - Hazard for the eyes

Additional information - workers

Acute, subchronic and chronic studies are available for the oral route of exposure, the most relevant

NOAEC is from the chronic study (Hodge 1964) which has the highest NOAEC below the lowest LOAEC.

Only one dermal toxicity study is available (Bullock CH 1971), the study only provides an LD50and lacks

data required to derive a meaningful NOAEL. The dermal DNEL will therefore be derived by route to route

extrapolation from the chronic oral study (Hodge 1964).

One acute inhalation toxicity study is available (Jackson GC 1988), the study only provides an LD50and

lacks data required to derive a meaningful NOAEL. The inhalation DNEL will therefore be derived by route

to route extrapolation from the chronic oral study (Hodge 1964).

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.661 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
600
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.66 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEC

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:
0.375 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:
DNEL (Derived No Effect Level)
Value:
0.375 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.75 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
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.75 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Additional information - General Population

Oral exposure:

Assessment factors for inter and intra species, duration, dose response and quality of data are applied to

the chronic toxicity data.

An assessment factor of 4 is used to correct for differences in metabolic rate per body weight and an

assessment factor of 2.5 (default) for remaining interspecies differences.

A default assessment factor of 10 is applied for intra species differences.

An assessment factor of 1 is applied for exposure duration as no exposure extrapolation is required.

An assessment factor of 3 is applied for the dose response to account for the poor quality of the study from

which the NOAEL is derived

The total assessment factor applied is obtained by multiplication of all the assessment factors giving an

overall assessment factor of 300

Dermal exposure:

The dermal DNEL is derived from the chronic oral study and therefore the same assessment factors apply

with an additional factor of 2 to account for route to route extrapolation.

The total assessment factor applied is therefore 600

Inhalation exposure:

The inhalation DNEL is derived from the chronic oral study and therefore the same assessment factors

apply with an additional factor of 2 to account for route to route extrapolation.

The total assessment factor applied is therefore 600.

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