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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:
7.08 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:
602 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1 061.728 mg/m³
Explanation for the modification of the dose descriptor starting point:

Correction: 602 / (0.380*(10 / 6.7)) = 1061.728 mg/m3

(Transformation from oral to inhalation & Compensation for increased respiratory rate for workers)

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
6
Justification:
ECHA default
AF for interspecies differences (allometric scaling):
1
Justification:
The allometric scaling factor is already applied in the rout to route extrapolation.
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
5
Justification:
ECHA default
AF for the quality of the whole database:
2
Justification:
Based on read-across data
AF for remaining uncertainties:
1
Justification:
No indication that a factor is needed
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.01 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:
602 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 204 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Correction: 602 / (1*(50/100)) = 1204 mg/kg bw

(Compensation for absorption)

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
6
Justification:
ECHA default
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
5
Justification:
ECHA default
AF for the quality of the whole database:
2
Justification:
Based on read-across data
AF for remaining uncertainties:
1
Justification:
No indication that a factor is needed
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
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:
1.74 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):
300
Dose descriptor starting point:
NOAEL
Value:
602 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
523.478 mg/m³
Explanation for the modification of the dose descriptor starting point:

Correction: 602 / (1.150) = 523.478 mg/m3

(Transformation from oral to inhalation)

AF for dose response relationship:
1
Justification:
ECHA/ECETOC default
AF for differences in duration of exposure:
6
Justification:
ECHA/ECETOC default
AF for interspecies differences (allometric scaling):
1
Justification:
The allometric scaling factor is already applied in the rout to route extrapolation.
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
2
Justification:
Based on read-across data
AF for remaining uncertainties:
1
Justification:
No indication that a factor is needed
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 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):
1 200
Dose descriptor starting point:
NOAEL
Value:
602 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 204 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Correction: 602 / (1*(50/100))

(Compensation for absorption)

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
6
Justification:
ECHA/ECETOC default
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
2
Justification:
Based on read-across data
AF for remaining uncertainties:
1
Justification:
No indication that a factor is needed
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
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:
0.5 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):
1 200
Dose descriptor starting point:
NOAEL
Value:
602 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
602 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Correction: 602 / (1) = 602 mg/kg bw

(No compensation for route)

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
6
Justification:
ECHA default
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
2
Justification:
Based on read-across data
AF for remaining uncertainties:
1
Justification:
No indication that a factor is needed
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