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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEC
Value:
50 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
25 mg/m³
Explanation for the modification of the dose descriptor starting point:

The following correction was made to the NOAEC (inhalation): Correction for experimental exposure duration (6 h/d to 8 h/d), Correction for respiratory volume (worker): 6.7 m3/10 m3. Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 50*(6 h/ 8 h) *(6.7 m3/10 m3) = 25 mg/m3.

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
2
Justification:
ECHA default (subchronic to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA default (inhalation rat to inhalation human)
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:
1
Justification:
ECHA default
AF for remaining uncertainties:
1
Justification:
ECHA default
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:
0.14 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEC
Value:
50 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
14.3 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The following correction was made to the NOAEC (inhaled): Correction respiratory volume rat (8 hour) = 0.38 m3/kg bw. Correction for exposure duration: 6 h/8 h (6 hours exposure in rats to 8 hours exposure in workers). Therefore, the corrected NOAEL for repeat-dose systemic effects via the dermal route is: 50*(6/8)*0.38 = 14.3 mg/kg bw/day.

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
2
Justification:
ECHA default (subchronic to chronic)
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:
1
Justification:
ECHA default
AF for remaining uncertainties:
1
Justification:
ECHA default
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:
0.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEC
Value:
50 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
12.5 mg/m³
Explanation for the modification of the dose descriptor starting point:

The following correction was made to the NOAEC (inhalation): Correction for exposure duration (6 h/d to 24 h/d). Therefore the corrected NOAEC for infrequent use repeated-dose systemic effects via the inhalation route is: 50*(6 h/ 24 h) = 12.5 mg/m3

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
1
Justification:
ECHA default for infrequent use DNEL
AF for interspecies differences (allometric scaling):
1
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:
1
Justification:
ECHA default
AF for remaining uncertainties:
1
Justification:
ECHA default
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:
0.14 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEC
Value:
50 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
14.38 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The following correction was made to the NOAEC (inhaled): Correction respiratory volume rat (24 hour) = 1.15 m3/kg bw. Correction for exposure duration: 6 h/24 h (6 hours exposure in rats to 24 hours exposure in general population).  Therefore the corrected NOAEL for repeat-dose systemic effects via the dermal route is: 50*(6/24)*1.15 = 14.38 mg/kg bw/day

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
1
Justification:
ECHA default for infrequent use DNEL
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:
1
Justification:
ECHA default
AF for remaining uncertainties:
1
Justification:
ECHA default
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:
0.14 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEC
Value:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
14.38 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The following correction was made to the NOAEC (inhaled): Correction respiratory volume rat (24 hour) = 1.15 m3/kg bw. Correction for exposure duration: 6 h/24 h (6 hours exposure in rats to 24 hours exposure in general population).  Correction for dosing frequency: 5 days/7 days. Therefore the corrected NOAEL for repeat-dose systemic effects via the oral route is: 50*(6/24)*1.15 = 14.38 mg/kg/day

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
1
Justification:
ECHA default for infrequent use DNEL
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:
1
Justification:
ECHA default
AF for remaining uncertainties:
1
Justification:
ECHA default
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