Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11.76 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:
882 mg/m³
Explanation for the modification of the dose descriptor starting point:

1000 (mg/kg)*1/0.38*6.7/10*0.5 = 882 mg/m3

AF for dose response relationship:
1
Justification:
Standard AF acccording to ECHA guidance document
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic, standard AF according to ECHA guidance document
Justification:
Already taken into consideration during allometric scaling
AF for intraspecies differences:
5
Justification:
Standard AF acccording to ECHA guidance document
AF for the quality of the whole database:
1
Justification:
Standard AF acccording to ECHA guidance document
AF for remaining uncertainties:
2.5
Justification:
Standard AF acccording to ECHA guidance document
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:
3.33 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
AF for dose response relationship:
1
Justification:
Standard value according to ECHA Guidance Document
AF for differences in duration of exposure:
6
Justification:
Standard value according to ECHA Guidance Document
AF for interspecies differences (allometric scaling):
4
Justification:
Standard value according to ECHA Guidance Document
AF for other interspecies differences:
1
Justification:
Standard value according to ECHA Guidance Document
AF for intraspecies differences:
5
Justification:
Standard value according to ECHA Guidance Document
AF for the quality of the whole database:
1
Justification:
Standard value according to ECHA Guidance Document
AF for remaining uncertainties:
2.5
Justification:
Standard value according to ECHA Guidance Document
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

Not classified as a hazard for the eyes

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:
other:
Overall assessment factor (AF):
150
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
435 mg/m³
Explanation for the modification of the dose descriptor starting point:

1000 * 1/1.15*0.5 = 435 mg/m3

AF for dose response relationship:
1
Justification:
Standard value according to ECHA Guidance Document
AF for differences in duration of exposure:
6
Justification:
Standard value according to ECHA Guidance Document
AF for interspecies differences (allometric scaling):
1
Justification:
Already taken into consideration during allometric scaling
AF for other interspecies differences:
1
Justification:
Standard value according to ECHA Guidance Document
AF for intraspecies differences:
10
Justification:
Standard value according to ECHA Guidance Document
AF for the quality of the whole database:
1
Justification:
Standard value according to ECHA Guidance Document
AF for remaining uncertainties:
2.5
Justification:
Standard value according to ECHA Guidance Document
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:
1.6 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
AF for dose response relationship:
1
Justification:
Standard value according to ECHA Guidance Document
AF for differences in duration of exposure:
6
Justification:
Standard value according to ECHA Guidance Document
AF for interspecies differences (allometric scaling):
4
Justification:
Standard value according to ECHA Guidance Document
AF for other interspecies differences:
1
Justification:
Standard value according to ECHA Guidance Document
AF for intraspecies differences:
10
Justification:
Standard value according to ECHA Guidance Document
AF for the quality of the whole database:
1
Justification:
Standard value according to ECHA Guidance Document
AF for remaining uncertainties:
2.5
Justification:
Standard value according to ECHA Guidance Document
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:
1.6 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
AF for dose response relationship:
1
Justification:
Standard value according to ECHA Guidance Document
AF for differences in duration of exposure:
6
Justification:
Standard value according to ECHA Guidance Document
AF for interspecies differences (allometric scaling):
4
Justification:
Standard value according to ECHA Guidance Document
AF for other interspecies differences:
1
Justification:
Standard value according to ECHA Guidance Document
AF for intraspecies differences:
10
Justification:
Standard value according to ECHA Guidance Document
AF for the quality of the whole database:
1
Justification:
Standard value according to ECHA Guidance Document
AF for remaining uncertainties:
2.5
Justification:
Standard value according to ECHA Guidance Document
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

Not classified as a hazard to the eye.