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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:
4.7 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
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:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
705.26 mg/m³
Explanation for the modification of the dose descriptor starting point:

= NOAEL *6.7/10/0.38 (see REACH guidance chapter R.8)

AF for dose response relationship:
1
Justification:
see REACH guidance R.8
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
see REACH guidance R.8
Justification:
see REACH guidance R.8; included in modified dose descriptor
AF for other interspecies differences:
2.5
Justification:
see REACH guidance R.8
AF for intraspecies differences:
5
Justification:
see REACH guidance R.8
AF for the quality of the whole database:
2
Justification:
Study from Read-Across
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
18.81 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor:
NOAEC
Value:
2 821.04 mg/m³
AF for dose response relationship:
1
Justification:
see REACH guidance R.8
AF for differences in duration of exposure:
6
Justification:
subacute to chronic; see REACH guidance R.8
AF for interspecies differences (allometric scaling):
1
Justification:
see REACH guidance R.8
AF for other interspecies differences:
2.5
Justification:
see REACH guidance R.8
AF for intraspecies differences:
5
Justification:
see REACH guidance R.8
AF for the quality of the whole database:
2
Justification:
Study from Read-Across
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:
0.67 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
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:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

= NOAEL (rat) / 4 (allometric scaling); see REACH guidance R.8

AF for dose response relationship:
1
Justification:
see REACH guidance R.8
AF for differences in duration of exposure:
6
Justification:
subacute to chronic; see REACH guidance R.8
Justification:
included in modified NOAEL (human) (see above); see REACH guidance R.8
AF for other interspecies differences:
2.5
Justification:
see REACH guidance R.8
AF for intraspecies differences:
5
Justification:
see REACH guidance R.8
AF for the quality of the whole database:
2
Justification:
Study from Read-Across
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.67 mg/cm²
Most sensitive endpoint:
developmental toxicity / teratogenicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor:
NOAEC
Value:
400 mg/m³
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
subacute to chronic; see REACH guidance R.8
AF for interspecies differences (allometric scaling):
1
Justification:
see REACH guidance R.8
AF for other interspecies differences:
2.5
Justification:
see REACH guidance R.8
AF for intraspecies differences:
5
Justification:
see REACH guidance R.8
AF for the quality of the whole database:
2
Justification:
Study from Read-Across
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:
1.16 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
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:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
347.83 mg/m³
Explanation for the modification of the dose descriptor starting point:

= NOAEL / 1.15; see REACH guidance R.8

AF for dose response relationship:
1
Justification:
see REACH guidance R.8
AF for differences in duration of exposure:
6
Justification:
subacute to chronic; see REACH guidance R.8
AF for interspecies differences (allometric scaling):
1
Justification:
already included in modified NOAEC; see REACH guidance R.8
AF for other interspecies differences:
2.5
Justification:
see REACH guidance R.8
AF for intraspecies differences:
10
Justification:
see REACH guidance R.8
AF for the quality of the whole database:
2
Justification:
Study from Read-Across
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.64 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor:
NOAEC
Value:
347.83 mg/m³
AF for dose response relationship:
1
Justification:
see REACH guidance R.8
AF for differences in duration of exposure:
6
Justification:
see REACH guidance R.8
AF for interspecies differences (allometric scaling):
1
Justification:
see REACH guidance R.8
AF for other interspecies differences:
2.5
Justification:
see REACH guidance R.8
AF for intraspecies differences:
10
Justification:
see REACH guidance R.8
AF for the quality of the whole database:
2
Justification:
Study from Read-Across
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:
0.33 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
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:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

= NOAEL / 4 (allometric scaling); see REACH guidance R.8

AF for dose response relationship:
1
Justification:
see REACH guidance R.8
AF for differences in duration of exposure:
6
Justification:
subacute to chronic; see REACH guidance R.8
Justification:
already included in modified NOAEL
AF for other interspecies differences:
2.5
Justification:
see REACH guidance R.8
AF for intraspecies differences:
10
Justification:
see REACH guidance R.8
AF for the quality of the whole database:
2
Justification:
Study from Read-Across
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.33 mg/cm²
Most sensitive endpoint:
developmental toxicity / teratogenicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Dose descriptor:
NOAEC
Value:
400 mg/m³
AF for dose response relationship:
1
Justification:
see REACH guidance R.8
AF for differences in duration of exposure:
6
Justification:
see REACH guidance R.8
AF for interspecies differences (allometric scaling):
1
Justification:
see REACH guidance R.8
AF for other interspecies differences:
2.5
Justification:
see REACH guidance R.8
AF for intraspecies differences:
10
Justification:
see REACH guidance R.8
AF for the quality of the whole database:
2
Justification:
Study from Read-Across
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:
0.33 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 200
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
AF for dose response relationship:
1
Justification:
see REACH guidance R.8
AF for differences in duration of exposure:
6
Justification:
subactute to chronic; see REACH guidance R.8
AF for interspecies differences (allometric scaling):
4
Justification:
see REACH guidance R.8
AF for other interspecies differences:
2.5
Justification:
see REACH guidance R.8
AF for intraspecies differences:
10
Justification:
see REACH guidance R.8
AF for the quality of the whole database:
2
Justification:
Study from Read-Across
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