Reaction products of N6,N6'-hexane-1,6-diylbis[N2,N4-dibutyl-N2,N4,N6-tris(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4,6-triamine] and allylbromide, subsequently reacted with ethaneperoxoic acid, hydrogenated

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

medium hazard (no threshold derived)

Most sensitive endpoint:

sensitisation (skin)

Acute/short term exposure

Hazard assessment conclusion:

medium hazard (no threshold derived)

Most sensitive endpoint:

sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:

no hazard identified

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

3.8 µg/cm²

Most sensitive endpoint:

sensitisation (skin)

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

200

Dose descriptor:

LOAEC

Value:

750

AF for dose response relationship:

2

Justification:

EC3 value could be derived and additional uncertainties are covered with high interspecies differences assessment factor. While EC3 value can be considered a LOAEC, several publications argued it to be very close to a human NOAEC. Therefore, an assessment factor of 2 was considered adequate.

AF for differences in duration of exposure:

1

Justification:

complete induction timeframe is covered in the LLNA, furthermore differences in exposure conditions are covered in the skin sensitization specific assessment factors

AF for interspecies differences (allometric scaling):

1

Justification:

not required since the effect assessed is a local effect

AF for other interspecies differences:

10

Justification:

default assessment factor according to ECHA Guidance R.8

AF for intraspecies differences:

5

Justification:

default assessment factor according to ECHA Guidance R.8

AF for the quality of the whole database:

1

Justification:

Guideline, GLP study

AF for remaining uncertainties:

2

Justification:

Skin sensitization specific assessment factors:
AF for vehicle or matrix effect: 1 (for justification, please refer to attachment in IUCLID Chapter 13 and CSR)
AF for different exposure conditions: 2 (for justification, please refer to attachment in IUCLID Chapter 13 and CSR)

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

3.8 µg/cm²

Most sensitive endpoint:

sensitisation (skin)

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

200

Dose descriptor starting point:

other: EC3

Value:

750

AF for dose response relationship:

2

Justification:

EC3 value could be derived and additional uncertainties are covered with high interspecies differences assessment factor. While EC3 value can be considered a LOAEC, several publications argued it to be very close to a human NOAEC. Therefore, an assessment factor of 2 was considered adequate.

AF for interspecies differences (allometric scaling):

1

Justification:

not required since the effect assessed is a local effect

AF for other interspecies differences:

10

Justification:

default assessment factor according to ECHA Guidance R.8

AF for intraspecies differences:

5

Justification:

default assessment factor according to ECHA Guidance R.8

AF for the quality of the whole database:

1

Justification:

Guideline, GLP study

AF for remaining uncertainties:

2

Justification:

Skin sensitization specific assessment factors:
AF for vehicle or matrix effect: 1 (for justification, please refer to attachment in IUCLID Chapter 13 and CSR)
AF for different exposure conditions: 2 (for justification, please refer to attachment in IUCLID Chapter 13 and CSR)

General Population - Hazard via oral route

Systemic 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 for the eyes

Local effects

Hazard assessment conclusion:

no hazard identified