Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.208 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
DNEL value:
11.79 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
10.394 mg/m³
Explanation for the modification of the dose descriptor starting point:

No available data on inhalatory study; therefore DNEL is derived from oral study route.

Inhalatory N(L)OAEC=oral N(L)OAEL*(1/0.38 m3/kg/d)*0.67*(ABSoral/ABSinh)

ABSoral/ABSinh = 0.5

AF for dose response relationship:
1
Justification:
Starting point NOAEL
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Default
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Workers
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
2
Justification:
Read-across
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:
0.059 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
DNEL value:
11.79 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
11.79 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No available data on dermal study; therefore DNEL is derived from oral study route.

Dermal N(L)OAEC=oral (N(L)OAEL*( ABSoral/ABSdermal)

ABSoral/ABSdermal = 1

AF for dose response relationship:
1
Justification:
Starting point NOAEL
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
2
Justification:
Read-across
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.051 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):
100
Dose descriptor starting point:
NOAEL
DNEL value:
11.79 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
5.126 mg/m³
Explanation for the modification of the dose descriptor starting point:

No available data on inhalatory study; therefore DNEL is derived from oral study route.

Inhalation N(L)OAEC=oral N(L)OAEL*(1/1.15 m3/kg/d)*(ABSoral/ABSinh).

ABSoral/ABSinh = 0.5

AF for dose response relationship:
1
Justification:
Stargint point NOAEL
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Default
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
General population
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
2
Justification:
Read-across
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:
0.029 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):
400
Dose descriptor starting point:
NOAEL
DNEL value:
11.79 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
11.79 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No available data on dermal study; therefore DNEL is derived from oral study route.

Dermal N(L)OAEC=oral (N(L)OAEL*( ABSoral/ABSdermal).

ABSoral/ABSdermal = 1

AF for dose response relationship:
1
Justification:
Stargint point NOAEL
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Rat
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
General population
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
2
Justification:
Read-across
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.029 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):
400
Dose descriptor starting point:
NOAEL
DNEL value:
11.79 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
11.79 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Stargint point NOAEL
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Rats
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
General population
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
2
Justification:
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:
low hazard (no threshold derived)

Additional information - General Population