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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11.9 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:
70 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.7 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:
10 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Oral DNEL:

The relevant endpoint is the NOAEL of 1000 mg/kg bw/d from the repeat dose oral rat study; no treatment-related adverse effects were seen.

The following assessment factors were used:

-       Intraspecies: 4 (rat) and 2.5 (remaining differences).

-       Interspecies: 5

-       Exposure duration: no additional factor was used for short-term exposure but 6 was used for extrapolation from a sub-acute study to chronic exposure for the long term exposure.

-       Dose-response: 1 was used due to low toxicity and no relevant effects seen in the repeat dose study.

-       Quality of the data base: 2 was used due to the absence of sufficient data on reproductive or developmental toxicity.

The overall assessment factor of for short-term effects is 100 and for long-term effects is 600.

 

Dermal DNEL

It is assumed that Dermal absorption = Oral absorption and therefore Dermal DNEL = Oral DNEL.

 

Inhalation DNEL

Using the Oral DNEL, extrapolation to Inhalation by taking into consideration 70 kg bw and 10 m3/person was carried out.

 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.8 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
1 200
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.8 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
1 200
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.8 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
1 200
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Oral DNEL:

The relevant endpoint is the NOAEL of 1000 mg/kg bw/d from the repeat dose oral rat study; no treatment-related adverse effects were seen.

The following assessment factors were used:

-       Intraspecies: 4 (rat) and 2.5 (remaining differences).

-       Interspecies: 10

-       Exposure duration: no additional factor was used for short-term exposure but 6 was used for extrapolation from a sub-acute study to chronic exposure for the long term exposure.

-       Dose-response: 1 was used due to low toxicity and no relevant effects seen in the repeat dose study.

-       Quality of the data base: 2 was used due to the absence of sufficient data on reproductive or developmental toxicity.

The overall assessment factor of for short-term effects is 200 and for long-term effects is 1200.

 

·        Dermal DNEL

It is assumed that Dermal absorption = Oral absorption and therefore Dermal DNEL = Oral DNEL.

 

·        Inhalation DNEL

Using the Oral DNEL, extrapolation to Inhalation by taking into consideration 70 kg bw and 20 m3/person was carried out.

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