Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.8 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
DNEL value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
132.24 mg/m³
Explanation for the modification of the dose descriptor starting point:

For workers: corrected inhalatory N(L)OAEC =oral N(L)OAEL x (1/sRVrat) x (ABS oral -rat/ABS inh -human) x (sRVhuman /wRV)

= N(L)OAEC = 150 mg/kg bw/day x (1/0.38 m3/kg/d) x (50%/100%) x(6.7 m3 / 10 m3) = 132 mg.m3

AF for dose response relationship:
1
Justification:
A clear NOAEL was used to derive the DNEL
AF for differences in duration of exposure:
6
Justification:
Default factor for extrapolating between subacute and chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
None required. Taken into account during correction of starting point
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
5
Justification:
Default factor for workers
AF for the quality of the whole database:
1
Justification:
Sufficient data for the tonnage
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21.12 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):
12.5
Dose descriptor starting point:
NOAEL
DNEL value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
264 mg/m³
Explanation for the modification of the dose descriptor starting point:

For workers: corrected inhalatory N(L)OAEC =oral N(L)OAEL x (1/sRVrat 4 hours) x (ABS oral -rat/ABS inh -human) x (sRVhuman /wRV)

= N(L)OAEC = 150 mg/kg bw/day x (1/0.19 m3/kg/d) x (50%/100%) x(6.7 m3 / 10 m3) = 264 mg.m3

AF for dose response relationship:
1
Justification:
A clear NOAEL was used to derive the DNEL
AF for interspecies differences (allometric scaling):
1
Justification:
None required. Taken into account during correction of starting point
AF for other interspecies differences:
2.5
Justification:
Default for remaining differences
AF for intraspecies differences:
5
Justification:
Default factor for workers
AF for the quality of the whole database:
1
Justification:
database adequate for the tonnage
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties

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:
0.5 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):
300
Dose descriptor starting point:
NOAEL
DNEL value:
150 mg/m³
Modified dose descriptor starting point:
NOAEL
DNEL value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

dermal NOAEL = Oral NOAEL x (oral absorption/dermal absorption) =

150 mg/kg bw/day x (100% / 100%) =150 mg/kg bw/day

AF for dose response relationship:
1
Justification:
A clear NOAEL was used to derive the DNEL
AF for differences in duration of exposure:
6
Justification:
Default factor for extrapolating between subacute and chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor for extrapolating between rat and man
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining differences
AF for intraspecies differences:
5
Justification:
Default factor for workers
AF for the quality of the whole database:
1
Justification:
Sufficient data for the tonnage
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 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):
50
Dose descriptor starting point:
NOAEL
DNEL value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

dermal NOAEL = Oral NOAEL x (oral absorption/dermal absorption) =

150 mg/kg bw/day x (100% / 100%) =150 mg/kg bw/day

AF for dose response relationship:
1
Justification:
A clear NOAEL was used to derive the DNEL
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor for extrapolating between rat and man
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining differences
AF for intraspecies differences:
5
Justification:
Default factor for workers
AF for the quality of the whole database:
1
Justification:
Sufficient data for the tonnage
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

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:
no hazard identified
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:
no hazard identified
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:
no hazard identified
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

As a result of the exposure scenarios derived for the chemical safety assessment, no exposure to the general population is expected.