Registration Dossier

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.3 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
Modified dose descriptor starting point:
NOAEC
Value:
33 mg/m³
Explanation for the modification of the dose descriptor starting point:

The oral NOAEL of 37 mg/kg bw/d is corrected for breathing rate (1/0.38 *0.67), the extent of oral absorption (50%) and inhalation absorption (100%)

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
no adjustment for allometry required, addresed in the calculation to determine inhalation dose descriptor
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
5
Justification:
default value (worker)
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value
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:
0.37 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
Modified dose descriptor starting point:
NOAEL
Value:
37 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (worst-case) assumptions are made for the extent of oral and dermal absorption; therefore correction of the starting point is not required

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
default value
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
5
Justification:
default value (workers)
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL derivation method:
ECHA REACH Guidance

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

A long-term inhalation systemic DNEL is derived from the NOAEL of 37 mg/kg bw/d identified in a 90 -day rat study and a corrected (inhalation) starting point of 33 mg/m3 derived taking into account breathing rate (1/0.38*0.67), the extent of oral absorption (50%) and inhalation absorption (100%).

A short-term inhalation systemic DNEL is not derived in the absence of any acute hazard.

Local inhalation DNEL values are not derived in the absence of any hazard.

A long-term dermal systemic DNEL is derived from the NOAEL of 37 mg/kg bw/d identified in a 90 -day rat study; correction for the extent of absorption is not reequired as default (worst-case) assumptions are made for oral and dermal absorption (50%).

A short-term dermal systemic DNEL is not derived in the absence of any acute hazard.

Local dermal DNELs are not derived; however the substance is a skin irritant therefore exposure should be minimised through the use of appropriate RMMs and PPE.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.32 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
Modified dose descriptor starting point:
NOAEC
Value:
16 mg/m³
Explanation for the modification of the dose descriptor starting point:

The oral NOAEL of 37 mg/kg bw/d is corrected for breathing rate (/1.15), the extent of oral absorption (50%) and inhalation absorption (100%)

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
no adjustment for allometry required
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
default value (general population)
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value
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:
0.19 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
Modified dose descriptor starting point:
NOAEL
Value:
37 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (worst-case) assumptions are made for the extent of oral and dermal absorption; therefore correction of the starting point is not required

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
default value
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
default value (general population)
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value
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)
Most sensitive endpoint:
skin irritation/corrosion
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:
0.19 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
Modified dose descriptor starting point:
NOAEL
Value:
37 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Not required - subchronic oral study used to define starting dose

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
default value
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
default value (general population)
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value
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

A long-term inhalation systemic DNEL is derived from the NOAEL of 37 mg/kg bw/d identified in a 90 -day rat study and a corrected (inhalation) starting point of 33 mg/m3 derived taking into account breathing rate (1/0.38*0.67), the extent of oral absorption (50%) and inhalation absorption (100%).

A short-term inhalation systemic DNEL is not derived in the absence of any acute hazard.

Local inhalation DNEL values are not derived in the absence of any hazard.

A long-term dermal systemic DNEL is derived from the NOAEL of 37 mg/kg bw/d identified in a 90 -day rat study; correction for the extent of absorption is not required as default (worst-case) assumptions are made for oral and dermal absorption (50%).

A short-term dermal systemic DNEL is not derived in the absence of any acute hazard.

Local dermal DNELs were not derived since the substance is not classified for dermal toxicity.

A long-term oral systemic DNEL is derived from the NOAEL of 37 mg/kg bw/d identified in a 90 -day rat study.

A short-term oral systemic DNEL is not derived in the absence of any acute hazard.

A general hazard was identified for eyes and skin since octanol is classified as a Category 2 skin and eye irritant. For the general population risk management measures are limited since technical controls and PPE use cannot be readily implemented and consequently protection of the general public is reliant on product-integrated measures, which may include dilution of mixtures, use of child resistant fastenings, maximum fill volumes for bottles, product formulation to reduce splash potential, and these are enhanced by labelling and use instructions.