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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11.6 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
76
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
882 mg/m³
Explanation for the modification of the dose descriptor starting point:

The starting NOAEL is based on the 28-day oral study, therefore, there no additional correction for differences between human & experimental exposure conditions required.

AF for dose response relationship:
1
Justification:
Substance has low toxicity and dose-response curve is not steep
AF for differences in duration of exposure:
6
Justification:
Default AF for subacute study to chronic assessment
AF for interspecies differences (allometric scaling):
1
Justification:
Not required when converting animal oral exposure to human inhalation exposure.
AF for other interspecies differences:
2.5
Justification:
No data available to justify alterations to standard factor
AF for intraspecies differences:
5
Justification:
No data available to justify alterations to standard factor for workers
AF for the quality of the whole database:
1
Justification:
There are sufficient studies available to indicate data from this study are representative.
AF for remaining uncertainties:
1
Justification:
No data indicating there should be additional concerns.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

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:
1.67 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The starting NOAEL is based on the 28-day oral study, therefore, there no additional correction for differences between human & experimental exposure conditions required.

AF for dose response relationship:
1
Justification:
Substance has low toxicity and dose-response curve is not steep
AF for differences in duration of exposure:
6
Justification:
Default AF for subacute study to chronic assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF for allometric scaling for rat to human
AF for other interspecies differences:
2.5
Justification:
No data available to justify alterations to standard factor
AF for intraspecies differences:
5
Justification:
No data available to justify alterations to standard factor for workers
AF for the quality of the whole database:
1
Justification:
There are sufficient studies available to indicate data from this study are representative.
AF for remaining uncertainties:
1
Justification:
No data indicating there should be additional concerns.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.9 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
435 mg/m³
Explanation for the modification of the dose descriptor starting point:

The starting NOAEL is based on the 28-day oral study, therefore, there no additional correction for differences between human & experimental exposure conditions required.

AF for dose response relationship:
1
Justification:
Substance has low toxicity and dose-response curve is not steep
AF for differences in duration of exposure:
6
Justification:
Default AF for subacute study to chronic assessment
AF for interspecies differences (allometric scaling):
1
Justification:
Not required when converting animal oral exposure to human inhalation exposure.
AF for other interspecies differences:
2.5
Justification:
No data available to justify alterations to standard factor
AF for intraspecies differences:
10
Justification:
No data available to justify alterations to standard factor for general population
AF for the quality of the whole database:
1
Justification:
There are sufficient studies available to indicate data from this study are representative.
AF for remaining uncertainties:
1
Justification:
No data indicating there should be additional concerns.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

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:
0.833 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The starting NOAEL is based on the 28-day oral study, therefore, there no additional correction for differences between human & experimental exposure conditions required.

AF for dose response relationship:
1
Justification:
Substance has low toxicity and dose-response curve is not steep
AF for differences in duration of exposure:
6
Justification:
Default AF for subacute study to chronic assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF for allometric scaling for rat to human
AF for other interspecies differences:
2.5
Justification:
No data available to justify alterations to standard factor
AF for intraspecies differences:
10
Justification:
No data available to justify alterations to standard factor for general population
AF for the quality of the whole database:
1
Justification:
There are sufficient studies available to indicate data from this study are representative.
AF for remaining uncertainties:
1
Justification:
No data indicating there should be additional concerns.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.833 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The starting NOAEL is based on the 28-day oral study, therefore, there no additional correction for differences between human & experimental exposure conditions required.

AF for dose response relationship:
1
Justification:
Substance has low toxicity and dose-response curve is not steep
AF for differences in duration of exposure:
6
Justification:
Default AF for subacute study to chronic assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF for allometric scaling for rat to human
AF for other interspecies differences:
2.5
Justification:
No data available to justify alterations to standard factor
AF for intraspecies differences:
10
Justification:
No data available to justify alterations to standard factor for general population
AF for the quality of the whole database:
1
Justification:
There are sufficient studies available to indicate data from this study are representative.
AF for remaining uncertainties:
1
Justification:
No data indicating there should be additional concerns.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

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