Registration Dossier

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
16.4 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:
1 230 mg/m³
Explanation for the modification of the dose descriptor starting point:

Conversion of an oral rat NOAEL into a corrected inhalatory NOAEC to assess human inhalatory exposure

Corretion factor diffrence in resperatory volumes: 2.63

Corretion factor light activity for workers: 0.67

Correction factor for bioavailability (oral-inhalation worst case): 0.5

Correction factor for difference in human and exposure of worker: 1.4

(ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)

AF for dose response relationship:
1
Justification:
Starting point is NOAEL
AF for differences in duration of exposure:
6
Justification:
subacute (28 Days study) to chronic (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
AF for interspecies differences (allometric scaling):
1
Justification:
allometric scalling during modification of the starting point (resperatory Volumes human/rat) (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
AF for other interspecies differences:
2.5
Justification:
No substance -sepcific data for metabolic rate are available (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
AF for intraspecies differences:
5
Justification:
Standard factor for workers (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
AF for the quality of the whole database:
1
Justification:
good standard quality (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
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:
4.67 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:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 400 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Correction factor for difference in human and exposure of worker: 1.4

AF for dose response relationship:
1
Justification:
Starting point is NOAEL
AF for differences in duration of exposure:
6
Justification:
subacute (28 Days study) to chronic (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
AF for interspecies differences (allometric scaling):
4
Justification:
Standard factor from rat to human (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
AF for other interspecies differences:
2.5
Justification:
No substance -sepcific data for metabolic rate are available (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
AF for intraspecies differences:
5
Justification:
Standard factor for workers (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
AF for the quality of the whole database:
1
Justification:
good stadard quality (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
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:
2.47 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
Value:
370 mg/m³
Explanation for the modification of the dose descriptor starting point:

Conversion of an oral rat NOAEL into a corrected inhalatory NOAEC to assess human inhalatory exposure:

Corretion factor diffrence in resperatory volumes: 0.74

Correction factor for bioavailability (oral-inhalation worst case): 0.5

(ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)

AF for dose response relationship:
1
Justification:
Starting point is NOAEL
AF for differences in duration of exposure:
6
Justification:
subacute (28 Days study) to chronic (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
AF for interspecies differences (allometric scaling):
1
Justification:
standard factor from rat to human (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
AF for other interspecies differences:
2.5
Justification:
No substance -sepcific data for metabolic rate are available (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
AF for intraspecies differences:
10
Justification:
standard factor for difference in population (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
AF for the quality of the whole database:
1
Justification:
good standard quality (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
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:
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
Explanation for the modification of the dose descriptor starting point:

no modifications

AF for dose response relationship:
1
Justification:
NOAEL is starting point
AF for differences in duration of exposure:
6
Justification:
subacute (28 Days study) to chronic (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
AF for interspecies differences (allometric scaling):
4
Justification:
Standard factor from rat to human (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
AF for other interspecies differences:
2.5
Justification:
No substance -sepcific data for metabolic rate are available (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
AF for intraspecies differences:
10
Justification:
standard factor for difference in population (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
AF for the quality of the whole database:
1
Justification:
good standard quality
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
Explanation for the modification of the dose descriptor starting point:

no modifications

AF for dose response relationship:
1
Justification:
NOAEL is starting point
AF for differences in duration of exposure:
6
Justification:
subacute (28 Days study) to chronic (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
AF for interspecies differences (allometric scaling):
4
Justification:
Standard factor from rat to human (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
AF for other interspecies differences:
2.5
Justification:
No substance -sepcific data for metabolic rate are available (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
AF for intraspecies differences:
10
Justification:
standard factor for difference in population (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
AF for the quality of the whole database:
1
Justification:
good standard quality
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