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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.234 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):
25
Dose descriptor starting point:
NOAEL
Value:
25 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
30.855 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point: NOAEL (oral route, subchronic) = 25 mg/kg bw/day
Correction factor for differences in respiratory volume (rat/workers): 1/0.38
Correction factor for light activity at work: 6.7/10
Correction factor for difference between human and experimental exposure conditions: 7/5 (In the study, animals were exposed 7 days per week, and workers work 5 days per week).
Absorptions by inhalation and oral route are not known; therefore, it was considered that oral absorption in the rat was 50% less effective than the human absorption by inhalation in accordance with ECHA Guidance.
NOAEC = NOAEL x (1/0.38) x (6.7/10) x 0.5 x 7/5 = 25 x (1/0.38) x (6.7/10) x 0.5 x 7/5 = 30.85526316 mg/m3

AF for dose response relationship:
1
Justification:
ECHA REACH Guidance
AF for differences in duration of exposure:
2
Justification:
Subchronic exposure to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance
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:
0.35 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):
100
Dose descriptor starting point:
NOAEL
Value:
25 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
35 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point: NOAEL (oral route, subchronic) = 25 mg/kg bw/day
Correction factor for difference between human and experimental exposure conditions: 7/5 (In the study, animals were exposed 7 days per week, and workers work 5 days per week).
Absorptions by dermal and oral routes are not known; therefore, it was considered that oral absorption in the rat was equivalent to human absorption via the dermal route in accordance with ECHA Guidance.
NOAEL = NOAEL x 1 x 7/5 = 25 x 1 x 7/5 = 35 mg/kg bw/d

AF for dose response relationship:
1
Justification:
ECHA REACH Guidance
AF for differences in duration of exposure:
2
Justification:
Subchronic exposure to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Rats to Humans
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance
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:
0.217 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):
50
Dose descriptor starting point:
NOAEL
Value:
25 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
10.87 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point: NOAEL (oral route, subchronic) = 25 mg/kg bw/day
Correction factor for differences in respiratory volume (rat/general population): 1/1.15
Absorptions by inhalation and oral route are not known, therefore it was considered that oral absorption in the rat was 50% less effective than the human absorption by inhalation in accordance with ECHA Guidance.
NOAEC = NOAEL x (1/1.15) x 0.5 = 25 x (1/1.15) x 0.5 = 10.86956522 mg/m3

AF for dose response relationship:
1
Justification:
ECHA REACH Guidance
AF for differences in duration of exposure:
2
Justification:
Subchronic exposure to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance
AF for intraspecies differences:
10
Justification:
ECHA REACH Guidance
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance
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:
0.125 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):
200
Dose descriptor starting point:
NOAEL
Value:
25 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
25 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point: NOAEL (oral route, subchronic) = 25 mg/kg bw/day
Absorptions by dermal and oral routes are not known, therefore it was considered that oral absorption in the rat was equivalent to human absorption via the dermal route in accordance with ECHA Guidance.
NOAEL = NOAEL x 1 = 25 x 1 = 25 mg/kg bw/day

AF for dose response relationship:
1
Justification:
ECHA REACH Guidance
AF for differences in duration of exposure:
2
Justification:
Subchronic exposure to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Rats to Humans
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance
AF for intraspecies differences:
10
Justification:
ECHA REACH Guidance
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance
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:
0.125 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):
200
Dose descriptor starting point:
NOAEL
Value:
25 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:


No modification of the dose descriptor starting point is required.



AF for dose response relationship:
1
Justification:
ECHA REACH Guidance
AF for differences in duration of exposure:
2
Justification:
Subchronic exposure to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Rats to Humans
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance
AF for intraspecies differences:
10
Justification:
ECHA REACH Guidance
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance
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

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