Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.93 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
Modified dose descriptor starting point:
NOAEC
Value:
220 ng/m³
Explanation for the modification of the dose descriptor starting point:

250 mg/kg bw/day x (1/0.38) x (50% oral abs / 100% inhalation abs) x (6.7/10)

AF for dose response relationship:
1
Justification:
No adverse effects observed in repeat dose, genotoxic or reproductive studies
AF for differences in duration of exposure:
6
Justification:
Default factor for subacute to chronic study extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
Already taken into account during the correction of starting dose
AF for other interspecies differences:
2.5
Justification:
Default factor for workers
AF for intraspecies differences:
5
Justification:
Default factors for workers
AF for the quality of the whole database:
1
Justification:
Database appropriate for tonnage
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
0.83 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:
250 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default valie in ECHA guidance document
AF for differences in duration of exposure:
6
Justification:
Default value in ECHA guidance document
AF for interspecies differences (allometric scaling):
4
Justification:
Default value for rat to human according to ECHA guidance document
AF for other interspecies differences:
2.5
Justification:
Default, no substance and route specific information on toxicokinetic and toxicodynamics is available for animals and human
AF for intraspecies differences:
5
Justification:
Default factors for workers as per ECHA guidance document
AF for the quality of the whole database:
1
Justification:
Database is of high quality (GLP guideline study)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
0.73 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
109 mg/m³
Explanation for the modification of the dose descriptor starting point:

250*1/1.15*0.5 = 109 mg/m3

AF for dose response relationship:
1
Justification:
Deafulat value according to ECHA guidance document
AF for differences in duration of exposure:
6
Justification:
Default value according to ECHA guidance document
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling should be applied in case of oral to inhalation exposure
AF for other interspecies differences:
2.5
Justification:
Default value according to ECHA guidance document. No substance and route specific information on toxicokinetic and toxicodynamic is available for animals and human
AF for intraspecies differences:
10
Justification:
Default value in ECHA guidance document for general population
AF for the quality of the whole database:
1
Justification:
Data base is of high quality (GLP guideline study)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
0.42 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:
250 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default value according to ECHA guidance documnet
AF for differences in duration of exposure:
6
Justification:
Default value according to ECHA guidance document
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor according to ECHA guideance document for exprapolation from rat to human
AF for other interspecies differences:
2.5
Justification:
Default factor: No substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
AF for intraspecies differences:
10
Justification:
Default factor according to ECHA guidance document for general population
AF for the quality of the whole database:
1
Justification:
Database is of high quality (GLP guideline study)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
0.42 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:
250 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default value according to ECHA guidance document
AF for differences in duration of exposure:
6
Justification:
Default value according to ECHA guidance document
AF for interspecies differences (allometric scaling):
4
Justification:
Default value according to ECHA guidance document for extrpolation from rats to human
AF for other interspecies differences:
2.5
Justification:
Default value according to ECHA guidance documents: No substance and route specific information on toxicokinetic and toxicodynamic is available
AF for intraspecies differences:
10
Justification:
Default value according to ECHA guidance document for general population
AF for the quality of the whole database:
1
Justification:
Database is of high quality (GLP guideline study)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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