Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.705 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
NOAEL
DNEL value:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
8.82 mg/m³
Explanation for the modification of the dose descriptor starting point:

The relevant dose descriptor selected to derive the inhalation DNEL, was the dermal rat NOAEL of 50 mg/kg bw/day derived from an 2-year NTP study conducted with the read across substance, C8-18 and C18-unsatd. DEA. This dose descriptor which is the starting point was corrected for route-to-route extrapolation:

[i.e., NOAEL dermal rat ÷ SRvrat x (SRvhuman ÷ WSRvhuman) x (ABSdermal-rat/ABSinh-human) x days per week(experimental)/days per week (human population] in accordance with REACH guidance document R.8 (‘Characterization of dose (concentration)-response for human health’) November (2012); where: NOAELdermal rat = 50 mg/kg bw/d; SRvrat = 0.38 m3/kg bw; SRvhuman = 6.7 m3; WSRvhuman = 10 m3; ABSdermal-rat = 10%; ABSinh-human = 100%; days per week(experimental) = 5 days; days per week (human population) = 5 days for workers) = 50 x 1/0.38 x 6.7/10 x 5/5 x 10/100 = 8.82 mg/m3].

AF for dose response relationship:
1
Justification:
starting point is a NOAEL
AF for differences in duration of exposure:
1
Justification:
chronic study
AF for interspecies differences (allometric scaling):
1
Justification:
No assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human) since this is already accounted for when obtaining the corrected NOEC
AF for other interspecies differences:
2.5
Justification:
Assessment factors for remaining non-metabolic differences
AF for intraspecies differences:
5
Justification:
Assessment factors for workers
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No additional factors are required
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:
1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEL
DNEL value:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The relevant dose descriptor selected to derive the dermal DNEL, was the dermal rat NOAEL of 50 mg/kg bw/day derived from an 2-year NTP study conducted with the read across substance, C8-18 and C18-unsatd. DEA. No route-to-route extrapolation is required as starting point is based on a dermal study as well as there is no difference in experimental and the human population exposure conditions.

AF for dose response relationship:
1
Justification:
starting point is a NOAEL
AF for differences in duration of exposure:
1
Justification:
chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
Assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human)
AF for other interspecies differences:
2.5
Justification:
Assessment factor for any remaining non-metabolic differences
AF for intraspecies differences:
5
Justification:
Assessment factor for workers
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No additional assessment factors are required
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:
medium 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:
0.124 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEL
DNEL value:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
3.11 mg/m³
Explanation for the modification of the dose descriptor starting point:

The relevant dose descriptor selected to derive the inhalation DNEL, was the dermal rat NOAEL of 50 mg/kg bw/day derived from an 2-year NTP study conducted with the read across substance, C8-18 and C18-unsatd. DEA. This dose descriptor which is the starting point was corrected for route-to-route extrapolation:

 

[i.e., NOAEL dermal rat ÷ SRvrat x (ABSoral-rat/ABSinh-human)x days per week (experimental)/days per week (human population] in accordance with REACH guidance document R.8 (‘Characterization of dose (concentration)-response for human health’) November (2012); where: NOAELdermal rat = 50 mg/kg bw/d; SRvrat = 1.15 m3/kg bw; ABSdermal-rat = 10%; ABSinh-human = 100%; days per week (experimental) = 5 days; days per week(human population) = 7 days for general population) = 50 x 1/1.15 x 5/7 x 10/100 = 3.11 mg/m3]

AF for dose response relationship:
1
Justification:
starting point is a NOAEL
AF for differences in duration of exposure:
1
Justification:
chronic study
AF for interspecies differences (allometric scaling):
1
Justification:
No assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human) since this is already accounted for when obtaining the corrected NOEC
AF for other interspecies differences:
2.5
Justification:
Assessment factors for remaining non-metabolic differences
AF for intraspecies differences:
10
Justification:
Assessment factors for general population
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No additional factors are required
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:
0.357 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
DNEL value:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
35.71 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The relevant dose descriptor selected to derive the dermal DNEL, was the dermal rat NOAEL of 50 mg/kg bw/day derived from an 2-year NTP study conducted with the read across substance, C8-18 and C18-unsatd. DEA. This dose descriptor which is the starting point was corrected for route-to-route extrapolation:

 

[i.e., NOAEL dermal rat x (ABSdermal-rat/ABSderm-human) x days per week (experimental)/days per week (human population] in accordance with REACH guidance document R.8 (‘Characterization of dose (concentration)-response for human health’) November (2012); where: NOAELdermal rat = 50 mg/kg bw/d; ABSdermal-rat = 10%; ABSderm-human = 10%; days per week (experimental) = 5 days; days per week(human population) = 7 days for general population) = 50 x 10/10 x 5/7 = 35.71 mg/kg bw/day]

AF for dose response relationship:
1
Justification:
starting point is a NOAEL
AF for differences in duration of exposure:
1
Justification:
chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
Assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human)
AF for other interspecies differences:
2.5
Justification:
Assessment factor for any remaining non-metabolic differences
AF for intraspecies differences:
10
Justification:
Assessment factor for general population
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No additional assessment factors are required
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:
0.036 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
DNEL value:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
3.57 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The relevant dose descriptor selected to derive the oral DNEL, was the dermal rat NOAEL of 50 mg/kg bw/day derived from an 2-year NTP study conducted with the read across substance, C8-18 and C18-unsatd. DEA. This dose descriptor which is the starting point was corrected for route-to-route extrapolation:

 

[i.e., NOAEL dermal rat x (ABSdermal-rat/ABSderm-human) x days per week (experimental)/days per week (human population] in accordance with REACH guidance document R.8 (‘Characterization of dose (concentration)-response for human health’) November (2012); where: NOAELdermal rat = 50 mg/kg bw/d; ABSdermal-rat = 10%; ABSoral-human = 100%; days per week (experimental) = 5 days; days per week(human population) = 7 days for general population) = 50 x 10/100 x 5/7 = 3.57 mg/kg bw/day]

AF for dose response relationship:
1
Justification:
starting point is a NOAEL
AF for differences in duration of exposure:
1
Justification:
chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
Assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human)
AF for other interspecies differences:
2.5
Justification:
Assessment factor for any remaining non-metabolic differences
AF for intraspecies differences:
10
Justification:
Assessment factor for general population
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No additional assessment factors are required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population