Amides, from C8-10-fatty acids and tetraethylenepentamine

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

29 mg/m³

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

other: ECETOC

Overall assessment factor (AF):

18

Modified dose descriptor starting point:

NOAEC

Value:

529 mg/m³

Explanation for the modification of the dose descriptor starting point:

An OECD 422 combined 28-day/reproduction screening study resulted in an overall NOAEL of 300 mg/kg/day being the highest dose level tested. The corrected 8 hr inhalation NOAEC for workers is NOAEL(300 mg/kg) * 1.76 mg/m3 = 529 mg/m3. No factor 2 route extrapolation from oral to inhalation. Due to very low vapour pressure, exposure is only possible as aerosol. If any inhalation does occur, this can only be in the form of larger droplets, as the use does not include fine spraying. Droplets will deposit mainly on upper airways, and will be subsequently swallowed following mucociliary transportation to pharynx. This results to no principal difference in absorption compared oral route.

AF for dose response relationship:

1

Justification:

No specific concerns; starting point is NOAEL.

AF for differences in duration of exposure:

6

Justification:

The combination of sub-acute to sub-chronic (AF 3) and su-chronic to chronic (AF 2)

AF for interspecies differences (allometric scaling):

1

Justification:

Already included in NOAEC calculation

AF for other interspecies differences:

1

Justification:

ECETOC reported in 2010 after an extensive review that there is no justification for the suggested additional factor of 2.5; therefore a factor of 1 has been applied.

AF for intraspecies differences:

3

Justification:

ECETOC reported in 2010 after an extensive scientific review that the appropriate factor for intraspecies differences for workers is 3 (Actually considered as sufficient for the combined remaining inter-species and intra-species factors)

AF for the quality of the whole database:

1

Justification:

Available data derived from valid studies showing consistent results within category.

AF for remaining uncertainties:

1

Acute/short term exposure

Hazard assessment conclusion:

low hazard (no threshold derived)

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

hazard unknown (no further information necessary)

Most sensitive endpoint:

irritation (respiratory tract)

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown (no further information necessary)

Most sensitive endpoint:

irritation (respiratory tract)

DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

4.2 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

other: ECETOC

Overall assessment factor (AF):

72

Modified dose descriptor starting point:

NOAEL

Value:

300 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

Extrapolation from oral NOAEL represents a worst case situation, as dermal absorption is considered to be lower compared to oral absorption.

AF for dose response relationship:

1

Justification:

No specific concerns; starting point is NOAEL.

AF for differences in duration of exposure:

6

Justification:

The combination of sub-acute to sub-chronic (AF 3) and su-chronic to chronic (AF 2)

AF for interspecies differences (allometric scaling):

4

Justification:

Default allometric scaling rat to human

AF for other interspecies differences:

1

Justification:

ECETOC reported in 2010 after an extensive review that there is no justification for the suggested additional factor of 2.5; therefore a factor of 1 has been applied.

AF for intraspecies differences:

3

Justification:

ECETOC reported in 2010 after an extensive scientific review that the appropriate factor for intraspecies differences for workers is 3 (Actually considered as sufficient for the combined remaining inter-species and intra-species factors)

AF for the quality of the whole database:

1

Justification:

Available data derived from valid studies showing consistent results within category.

AF for remaining uncertainties:

1

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

Most sensitive endpoint:

skin irritation/corrosion

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

high hazard (no threshold derived)

Most sensitive endpoint:

sensitisation (skin)

Acute/short term exposure

Hazard assessment conclusion:

high hazard (no threshold derived)

Most sensitive endpoint:

sensitisation (skin)

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:

8.7 mg/m³

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

other: ECETOC

Overall assessment factor (AF):

30

Modified dose descriptor starting point:

NOAEC

Value:

261 mg/m³

Explanation for the modification of the dose descriptor starting point:

An OECD 422 combined 28-day/reproduction screening study resulted in an overall NOAEL of 300 mg/kg/day being the highest dose level tested. The corrected 24 hr inhalation NOAEC for general population following route-to-route extrapolation is NOAEL * 1/1.15 mg/m3 = 261 mg/m3. No factor 2 route extrapolation from oral to inhalation. Due to very low vapour pressure, exposure is only possible as aerosol. If any inhalation does occur, this can only be in the form of larger droplets, as the use does not include fine spraying. Droplets will deposit mainly on upper airways, and will be subsequently swallowed following mucociliary transportation to pharynx. This results to no principal difference in absorption compared oral route.

AF for dose response relationship:

1

Justification:

No specific concerns; starting point is NOAEL.

AF for differences in duration of exposure:

6

Justification:

The combination of sub-acute to sub-chronic (AF 3) and sub-chronic to chronic (AF 2)

AF for interspecies differences (allometric scaling):

1

Justification:

Already included in NOAEC calculation

AF for other interspecies differences:

1

Justification:

ECETOC reported in 2010 after an extensive review that there is no justification for the suggested additional factor of 2.5; therefore a factor of 1 has been applied.

AF for intraspecies differences:

5

Justification:

ECETOC reported in 2010 after an extensive scientific review that the appropriate factor for intraspecies differences for consumers/general population is 5 (Actually considered as sufficient for the combined remaining inter-species and intra-species factors)

AF for the quality of the whole database:

1

Justification:

Available data derived from valid studies showing consistent results within category.

AF for remaining uncertainties:

1

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:

2.5 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

other: ECETOC

Overall assessment factor (AF):

120

Modified dose descriptor starting point:

NOAEL

Value:

300 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

Extrapolation from oral NOAEL represents a worst case situation, as dermal absorption is considered to be lower compared to oral absorption.

AF for dose response relationship:

1

Justification:

No specific concerns; starting point is NOAEL.

AF for differences in duration of exposure:

6

Justification:

The combination of sub-acute to sub-chronic (AF 3) and su-chronic to chronic (AF 2)

AF for interspecies differences (allometric scaling):

4

Justification:

Default allometric scaling rat to human

AF for other interspecies differences:

1

Justification:

ECETOC reported in 2010 after an extensive review that there is no justification for the suggested additional factor of 2.5; therefore a factor of 1 has been applied.

AF for intraspecies differences:

5

Justification:

ECETOC reported in 2010 after an extensive scientific review that the appropriate factor for intraspecies differences for consumers/general population is 5 (Actually considered as sufficient for the combined remaining inter-species and intra-species factors)

AF for the quality of the whole database:

1

Justification:

Available data derived from valid studies showing consistent results within category.

AF for remaining uncertainties:

1

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:

DNEL (Derived No Effect Level)

Value:

2.5 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

DNEL related information

DNEL derivation method:

other: ECETOC

Overall assessment factor (AF):

120

Modified dose descriptor starting point:

NOAEL

Value:

300 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

No route-to-route extrapolation needed

AF for dose response relationship:

1

Justification:

No specific concerns; starting point is NOAEL.

AF for differences in duration of exposure:

6

Justification:

The combination of sub-acute to sub-chronic (AF 3) and su-chronic to chronic (AF 2)

AF for interspecies differences (allometric scaling):

4

Justification:

Default allometric scaling for rat to human

AF for other interspecies differences:

1

Justification:

ECETOC reported in 2010 after an extensive review that there is no justification for the suggested additional factor of 2.5; therefore a factor of 1 has been applied.

AF for intraspecies differences:

5

Justification:

ECETOC reported in 2010 after an extensive scientific review that the appropriate factor for intraspecies differences for consumers/general population is 5 (Actually considered as sufficient for the combined remaining inter-species and intra-species factors)

AF for the quality of the whole database:

1

Justification:

Available data derived from valid studies showing consistent results within category.

AF for remaining uncertainties:

1

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

These substances are only applied in professional or industrial settings applying adequate PPE. Consequently, consumers/general population will not be exposed.

However, in order to be able to evaluate possible secondary exposures via environment, the long-term systemic DNELs for general population have been derived.