Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11.75 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):
75
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
881.58 mg/m³
AF for dose response relationship:
1
Justification:
based on NOAEL
AF for differences in duration of exposure:
6
Justification:
based on RDT study 28 days
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route - already included in route-to-route extrapolation.
AF for other interspecies differences:
1
Justification:
Due to the properties of the substance, a serious dangerous effect is not expected and the AFs used are sufficient.
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
1
Justification:
Reliability 1
AF for remaining uncertainties:
2.5
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:
33.33 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:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
10 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Kow < -2 and Mw >500 (Mw = 1098.94) => 10% absorption

AF for dose response relationship:
1
Justification:
based on NOAEL
AF for differences in duration of exposure:
6
Justification:
based on RDT study 28 days
AF for interspecies differences (allometric scaling):
4
Justification:
based on RDT study on rats
AF for other interspecies differences:
1
Justification:
Due to the properties of the substance, a serious dangerous effect is not expected and the AFs used are sufficient.
AF for intraspecies differences:
1
Justification:
workers
AF for the quality of the whole database:
1
Justification:
Reliability 1
AF for remaining uncertainties:
2.5
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:
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:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
434.78 mg/m³
AF for dose response relationship:
1
Justification:
based on NOAEL
AF for differences in duration of exposure:
6
Justification:
based on RDT study 28 days
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route - already included in route-to-route extrapolation.
AF for other interspecies differences:
1
Justification:
Due to the properties of the substance, a serious dangerous effect is not expected and the AFs used are sufficient.
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
1
Justification:
Reliability 1
AF for remaining uncertainties:
2.5
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:
16.67 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):
600
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
10 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Kow < -2 and Mw >500 (Mw = 1098.94) => 10% absorption

AF for dose response relationship:
1
Justification:
based on NOAEL
AF for differences in duration of exposure:
6
Justification:
based on RDT study 28 days
AF for interspecies differences (allometric scaling):
4
Justification:
based on RDT study on rats
AF for other interspecies differences:
1
Justification:
Due to the properties of the substance, a serious dangerous effect is not expected and the AFs used are sufficient.
AF for intraspecies differences:
10
Justification:
General population
AF for the quality of the whole database:
1
Justification:
Reliability 1
AF for remaining uncertainties:
2.5
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:
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):
600
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
based on NOAEL
AF for differences in duration of exposure:
6
Justification:
based on RDT study 28 days
AF for interspecies differences (allometric scaling):
4
Justification:
based on RDT study on rats
AF for other interspecies differences:
1
Justification:
Due to the properties of the substance, a serious dangerous effect is not expected and the AFs used are sufficient.
AF for intraspecies differences:
10
Justification:
General population
AF for the quality of the whole database:
1
Justification:
Reliability 1
AF for remaining uncertainties:
2.5
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