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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:
22 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):
40
Modified dose descriptor starting point:
NOAEC
Value:
882 mg/m³
Explanation for the modification of the dose descriptor starting point:
The NOAEC long-term, inhalation is based on a NOAEL long-term, oral. A sub-chronic repeated dose oral toxicity study is proposed. Based on available information the NOAEL long-term oral is assumed to be 1000 mg/kg bw/day. See IULCID section 7.5.2 for details on route to route extrapolation.
AF for dose response relationship:
1
Justification:
Default value with NOAEL as starting point.
AF for differences in duration of exposure:
2
Justification:
Extrapolation from sub-chronic to chronic study duration.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value.
AF for other interspecies differences:
1
Justification:
There is no indication of toxicokinetic or toxicodynamic differences between species.
AF for intraspecies differences:
5
Justification:
Default value for workers.
AF for the quality of the whole database:
1
Justification:
Good quality database.
AF for remaining uncertainties:
1
Justification:
No uncertainties remaining.
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:
25 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):
40
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The NOAEC long-term, dermal is based on a NOAEL long-term, oral. A sub-chronic repeated dose oral toxicity study is proposed. Based on available information the NOAEL long-term oral is assumed to be 1000 mg/kg bw/day. See IULCID section 7.5.3 for details on route to route extrapolation.
AF for dose response relationship:
1
Justification:
Default value with NOAEL as starting point.
AF for differences in duration of exposure:
2
Justification:
Extrapolation from sub-chronic to chronic study duration.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value.
AF for other interspecies differences:
1
Justification:
No indication of toxicokinetic or toxicodynamic differences between species.
AF for intraspecies differences:
5
Justification:
Default value for workers.
AF for the quality of the whole database:
1
Justification:
Good quality database.
AF for remaining uncertainties:
1
Justification:
No uncertainties remaining.
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.5 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):
80
Modified dose descriptor starting point:
NOAEC
Value:
438 mg/m³
Explanation for the modification of the dose descriptor starting point:
The NOAEC long-term, inhalation is based on a NOAEL long-term, oral. A sub-chronic repeated dose oral toxicity study is proposed. Based on available information the NOAEL long-term oral is assumed to be 1000 mg/kg bw/day. See IULCID section 7.5.2 for details on route to route extrapolation.
AF for dose response relationship:
1
Justification:
Default value with NOAEL as starting point.
AF for differences in duration of exposure:
2
Justification:
Extrapolation from sub-chronic to chronic study duration
AF for interspecies differences (allometric scaling):
4
Justification:
Default value.
AF for other interspecies differences:
1
Justification:
No indication of toxicokinetic or toxicodynamic differences between species.
AF for intraspecies differences:
10
Justification:
Default value for the general public.
AF for the quality of the whole database:
1
Justification:
Good quality database.
AF for remaining uncertainties:
1
Justification:
No uncertainties remaining.
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:
12.5 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):
80
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The NOAEC long-term, dermal is based on a NOAEL long-term, oral. A sub-chronic repeated dose oral toxicity study is proposed. Based on available information the NOAEL long-term oral is assumed to be 1000 mg/kg bw/day. See IULCID section 7.5.3 for details on route to route extrapolation.
AF for dose response relationship:
1
Justification:
Default value with NOAEL as starting point.
AF for differences in duration of exposure:
2
Justification:
Extrapolation from sub-chronic to chronic study duration.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value.
AF for other interspecies differences:
1
Justification:
No indication of toxicokinetic or toxicodynamic differences between species.
AF for intraspecies differences:
10
Justification:
Default value for the general public.
AF for the quality of the whole database:
1
Justification:
Good quality database.
AF for remaining uncertainties:
1
Justification:
No uncertainties remaining.
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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.5 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):
80
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The NOAEC long-term, inhalation is based on a NOAEL long-term, oral. A sub-chronic repeated dose oral toxicity study is proposed. Based on available information the NOAEL long-term oral is assumed to be 1000 mg/kg bw/day.
AF for dose response relationship:
1
Justification:
Default value with NOAEL as starting point.
AF for differences in duration of exposure:
2
Justification:
Extrapolation from sub-chronic to chronic study duration.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value.
AF for other interspecies differences:
1
Justification:
No indication of toxicokinetic or toxicodynamic differences between species.
AF for intraspecies differences:
10
Justification:
Default value for the general public.
AF for the quality of the whole database:
1
Justification:
Good quality database.
AF for remaining uncertainties:
1
Justification:
No uncertainties remaining.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population