Amides, coco, N,N-bis(hydroxyethyl); C10-12 and C18-unsatd. DEA

Toxicological Summary

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

Value:

50 mg/kg bw/day

Modified dose descriptor starting point:

NOAEC

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

Value:

50 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

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)

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

Value:

50 mg/kg bw/day

Modified dose descriptor starting point:

NOAEC

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

Value:

50 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

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

Value:

50 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

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)