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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:
0.95 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:
80 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
71 mg/m³
Explanation for the modification of the dose descriptor starting point:

80 x 1/0.38 x 6.7/10 x 0.5

AF for dose response relationship:
1
Justification:
Default factor according to ECHA guidance document
AF for differences in duration of exposure:
4
Justification:
Default factor according to ECHA guidance document
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling should be applied in case of oral-inhalation exposure
AF for other interspecies differences:
2.5
Justification:
Default factor according to ECHA guidance document
AF for intraspecies differences:
5
Justification:
Default factor according to ECHA guidance document
AF for the quality of the whole database:
1
Justification:
Default factor according to ECHA guidance document
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:
0.27 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:
80 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default factor according to ECHA guidance document
AF for differences in duration of exposure:
6
Justification:
Default factor according to ECHA guidance document
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor according to ECHA guidance document
AF for other interspecies differences:
2.5
Justification:
Default factor according to ECHA guidance document
AF for intraspecies differences:
5
Justification:
Default factor according to ECHA guidance document
AF for the quality of the whole database:
1
Justification:
Database is of high quality
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:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.23 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:
80 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
35 mg/m³
Explanation for the modification of the dose descriptor starting point:

80*1/1.15*0.5

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):
1
Justification:
No allometric scaling should be applied in case of oral to inhalation extrapolation
AF for other interspecies differences:
2.5
Justification:
Default value according to ECHA guidance document
AF for intraspecies differences:
10
Justification:
Default value according to ECHA guidance document
AF for the quality of the whole database:
1
Justification:
High quality database
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:
0.13 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:
80 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 documnet
AF for other interspecies differences:
2.5
Justification:
Default value according to ECHA guidance document
AF for intraspecies differences:
10
Justification:
Default value according to ECHA guidance documnet
AF for the quality of the whole database:
1
Justification:
High quality database
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:
0.13 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:
80 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEL based on the results of an OECD 422 screening assay

AF for dose response relationship:
1
Justification:
Defautl factor according to ECHA guidance documnet
AF for differences in duration of exposure:
6
Justification:
Default factor according to ECHA guidance document
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor accordoing to ECHA guidance document
AF for other interspecies differences:
2.5
Justification:
Default factor according to ECHA guidance document
AF for intraspecies differences:
10
Justification:
Default factor according to ECHA guidance document
AF for the quality of the whole database:
1
Justification:
High quality database
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:
low hazard (no threshold derived)

Additional information - General Population