2,6,10-trimethylundec-9-enal

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

23.63 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):

12.5

Dose descriptor starting point:

NOAEL

Value:

335 mg/kg bw/day

Modified dose descriptor starting point:

NOAEC

Value:

295 mg/m³

Explanation for the modification of the dose descriptor starting point:

Exposure via the oral route is considered a more appropriate route of exposure than inhalation as the physical chemical properties such as the physical state (liquid at room temperature and pressure) and vapour pressure indicate that exposure via inhalation is unlikely. Thus, the testing via the oral route was suitable for classification and risk assessment.

AF for dose response relationship:

1

Justification:

the dose-response relationship is deemed reliable

AF for differences in duration of exposure:

1

Justification:

no extrapolation from subchronic to subacute duration

AF for interspecies differences (allometric scaling):

1

Justification:

accounting for differences in metabolic rate per body weight is not applicable for inhalation exposure

AF for other interspecies differences:

2.5

Justification:

accounts for remaining interspecies differences

AF for intraspecies differences:

5

Justification:

accounts for extrapolation to human in the worker environment

AF for the quality of the whole database:

1

Justification:

available data are deemed complete and consistent

AF for remaining uncertainties:

1

Justification:

no remaining uncertainties exist

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

23.63 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):

12.5

Dose descriptor starting point:

NOAEL

Value:

335 mg/kg bw/day

Modified dose descriptor starting point:

NOAEC

Value:

295 mg/m³

Explanation for the modification of the dose descriptor starting point:

Exposure via the oral route is considered a more appropriate route of exposure than inhalation as the physical chemical properties such as the physical state (liquid at room temperature and pressure) and vapour pressure indicate that exposure via inhalation is unlikely. Thus, the testing via the oral route was suitable for classification and risk assessment.

AF for dose response relationship:

1

Justification:

the dose-response relationship is deemed reliable

AF for interspecies differences (allometric scaling):

1

Justification:

accounting for differences in metabolic rate per body weight is not applicable for inhalation exposure

AF for other interspecies differences:

2.5

Justification:

accounts for remaining interspecies differences

AF for intraspecies differences:

5

Justification:

accounts for extrapolation to human in the worker environment

AF for the quality of the whole database:

1

Justification:

available data are deemed complete and consistent

AF for remaining uncertainties:

1

Justification:

no remaining uncertainties exist

Local effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

59.07 mg/m³

Most sensitive endpoint:

repeated dose toxicity

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

5

Dose descriptor:

NOAEC

Value:

295 mg/m³

AF for dose response relationship:

1

Justification:

the dose-response relationship is deemed reliable

AF for differences in duration of exposure:

1

Justification:

no extrapolation from subchronic to subacute duration

AF for interspecies differences (allometric scaling):

1

Justification:

accounting for differences in metabolic rate per body weight is not applicable for inhalation exposure

AF for other interspecies differences:

1

Justification:

accounts for remaining interspecies differences

AF for intraspecies differences:

5

Justification:

accounts for extrapolation to human in the worker environment

AF for the quality of the whole database:

1

Justification:

available data are deemed complete and consistent

AF for remaining uncertainties:

1

Justification:

no remaining uncertainties exist

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

59.07 mg/m³

Most sensitive endpoint:

repeated dose toxicity

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

5

Dose descriptor starting point:

NOAEC

Value:

295 mg/m³

AF for dose response relationship:

1

Justification:

the dose-response relationship is deemed reliable

AF for interspecies differences (allometric scaling):

1

Justification:

accounting for differences in metabolic rate per body weight is not applicable for inhalation exposure

AF for other interspecies differences:

1

Justification:

accounts for remaining interspecies differences

AF for intraspecies differences:

5

Justification:

accounts for extrapolation to human in the worker environment

AF for the quality of the whole database:

1

Justification:

available data are deemed complete and consistent

AF for remaining uncertainties:

1

Justification:

no remaining uncertainties exist

Workers - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

6.7 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):

50

Dose descriptor starting point:

NOAEL

Value:

335 mg/kg bw/day

AF for dose response relationship:

1

Justification:

the dose-response relationship is deemed reliable

AF for differences in duration of exposure:

1

Justification:

no extrapolation from subchronic to subacute duration

AF for interspecies differences (allometric scaling):

4

Justification:

accounts for allometric scaling from rat

AF for other interspecies differences:

2.5

Justification:

accounts for remaining interspecies differences

AF for intraspecies differences:

5

Justification:

accounts for extrapolation to human in the worker environment

AF for the quality of the whole database:

1

Justification:

available data are deemed complete and consistent

AF for remaining uncertainties:

1

Justification:

no remaining uncertainties exist

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

160 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):

50

AF for dose response relationship:

1

Justification:

the dose-response relationship is deemed reliable

AF for interspecies differences (allometric scaling):

4

Justification:

accounting for differences in metabolic rate per body weight is not applicable for inhalation exposure

AF for other interspecies differences:

2.5

Justification:

accounts for remaining interspecies differences

AF for intraspecies differences:

5

Justification:

accounts for extrapolation to human in the worker environment

AF for the quality of the whole database:

1

Justification:

available data are deemed complete and consistent

AF for remaining uncertainties:

1

Justification:

no remaining uncertainties exist

Local effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

133 µg/cm²

Most sensitive endpoint:

sensitisation (skin)

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

60

Dose descriptor:

LOAEC

Value:

7 052.63 µg/m³

AF for dose response relationship:

1

Justification:

the dose-response relationship is deemed reliable

AF for differences in duration of exposure:

1

Justification:

no extrapolation needed to account for mapping of adverse outcome pathway

AF for interspecies differences (allometric scaling):

4

Justification:

accounting for differences in metabolic rate per body weight from mice

AF for other interspecies differences:

1

Justification:

no need to account for remaining interspecies differences for local effects

AF for intraspecies differences:

5

Justification:

accounts for extrapolation to human in the worker environment

AF for the quality of the whole database:

3

Justification:

accounts for use of LOAEL as starting point for data deemed complete and consistent

AF for remaining uncertainties:

1

Justification:

no remaining uncertainties exist

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

133.33 µg/cm²

Most sensitive endpoint:

sensitisation (skin)

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

60

Dose descriptor starting point:

LOAEC

Value:

7 052.63 µg/m³

AF for dose response relationship:

1

Justification:

the dose-response relationship is deemed reliable

AF for interspecies differences (allometric scaling):

7

Justification:

accounting for differences in metabolic rate per body weight from mice

AF for other interspecies differences:

1

Justification:

no need to account for remaining interspecies differences for local effects

AF for intraspecies differences:

5

Justification:

accounts for extrapolation to human in the worker environment

AF for the quality of the whole database:

3

Justification:

accounts for use of LOAEL as starting point for data deemed complete and consistent

AF for remaining uncertainties:

1

Justification:

no remaining uncertainties exist

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:

no hazard identified

Additional information - workers

Due to the potential for skin sensitization, workers should wear chemically resistant gloves when handling this material.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

5.83 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

Dose descriptor starting point:

NOAEL

Value:

335 mg/kg bw/day

Modified dose descriptor starting point:

NOAEC

Value:

145.65 mg/m³

Explanation for the modification of the dose descriptor starting point:

Exposure via the oral route is considered a more appropriate route of exposure than inhalation as the physical chemical properties such as the physical state (liquid at room temperature and pressure) and vapour pressure indicate that exposure via inhalation is unlikely. Thus, the testing via the oral route was suitable for classification and risk assessment.

AF for dose response relationship:

1

Justification:

the dose-response relationship is deemed reliable

AF for differences in duration of exposure:

1

Justification:

no extrapolation from subchronic to subacute duration

AF for interspecies differences (allometric scaling):

1

Justification:

accounting for differences in metabolic rate per body weight is not applicable for inhalation exposure

AF for other interspecies differences:

2.5

Justification:

accounts for remaining interspecies differences

AF for intraspecies differences:

10

Justification:

accounts for extrapolation to the human general population

AF for the quality of the whole database:

1

Justification:

available data are deemed complete and consistent

AF for remaining uncertainties:

1

Justification:

no remaining uncertainties exist

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

5.83 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

Dose descriptor starting point:

NOAEL

Value:

335 mg/kg bw/day

Modified dose descriptor starting point:

NOAEC

Value:

145.65 µg/m³

Explanation for the modification of the dose descriptor starting point:

Exposure via the oral route is considered a more appropriate route of exposure than inhalation as the physical chemical properties such as the physical state (liquid at room temperature and pressure) and vapour pressure indicate that exposure via inhalation is unlikely. Thus, the testing via the oral route was suitable for classification and risk assessment.

AF for dose response relationship:

1

Justification:

the dose-response relationship is deemed reliable

AF for interspecies differences (allometric scaling):

1

Justification:

accounting for differences in metabolic rate per body weight is not applicable for inhalation exposure

AF for other interspecies differences:

2.5

Justification:

accounts for remaining interspecies differences

AF for intraspecies differences:

10

Justification:

accounts for extrapolation to the human general population

AF for the quality of the whole database:

1

Justification:

available data are deemed complete and consistent

AF for remaining uncertainties:

1

Justification:

no remaining uncertainties exist

Local effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

14.57 mg/m³

Most sensitive endpoint:

repeated dose toxicity

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

10

Dose descriptor:

NOAEC

Value:

145.65 mg/m³

AF for dose response relationship:

1

Justification:

the dose-response relationship is deemed reliable

AF for differences in duration of exposure:

1

Justification:

no extrapolation needed from subchronic to subacute

AF for interspecies differences (allometric scaling):

1

Justification:

accounting for differences in metabolic rate per body weight is not applicable for inhalation exposure

AF for other interspecies differences:

1

Justification:

accounts for remaining interspecies differences

AF for intraspecies differences:

10

Justification:

accounts for extrapolation to the human general population

AF for the quality of the whole database:

1

Justification:

available data are deemed complete and consistent

AF for remaining uncertainties:

1

Justification:

no remaining uncertainties exist

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

14.57 mg/m³

Most sensitive endpoint:

repeated dose toxicity

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

25

Dose descriptor starting point:

NOAEC

Value:

145.65 mg/m³

AF for dose response relationship:

1

Justification:

the dose-response relationship is deemed reliable

AF for interspecies differences (allometric scaling):

1

Justification:

accounting for differences in metabolic rate per body weight is not applicable for inhalation exposure

AF for other interspecies differences:

1

Justification:

accounts for remaining interspecies differences

AF for intraspecies differences:

10

Justification:

accounts for extrapolation to the general human population

AF for the quality of the whole database:

1

Justification:

available data are deemed complete and consistent

AF for remaining uncertainties:

1

Justification:

no remaining uncertainties exist

General Population - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

3.35 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

Dose descriptor starting point:

NOAEL

Value:

335 mg/kg bw/day

AF for dose response relationship:

1

Justification:

the dose-response relationship is deemed reliable

AF for differences in duration of exposure:

1

Justification:

no extrapolation needed from subchronic to subacute duration

AF for interspecies differences (allometric scaling):

4

Justification:

accounts for allometric scaling from rat

AF for other interspecies differences:

2.5

Justification:

accounts for remaining interspecies differences

AF for intraspecies differences:

10

Justification:

accounts for extrapolation to the general human population

AF for the quality of the whole database:

1

Justification:

available data are deemed complete and consistent

AF for remaining uncertainties:

1

Justification:

no remaining uncertainties exist

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:

38.1 µg/cm²

Most sensitive endpoint:

sensitisation (skin)

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

210

Dose descriptor:

LOAEC

Value:

3 478.26 µg/m³

AF for dose response relationship:

1

Justification:

the dose-response relationship is deemed reliable

AF for differences in duration of exposure:

1

Justification:

no extrapolation needed from subchronic to subacute duration

AF for interspecies differences (allometric scaling):

7

Justification:

accounting for differences in metabolic rate per body weight from mice

AF for other interspecies differences:

1

Justification:

no need to account for remaining interspecies differences for local effects

AF for intraspecies differences:

10

Justification:

accounts for extrapolation to the general human population

AF for the quality of the whole database:

1

Justification:

available data are deemed complete and consistent

AF for remaining uncertainties:

3

Justification:

accounts for use of LOAEL as starting point for data deemed complete and consistent

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

38.1 µg/cm²

Most sensitive endpoint:

sensitisation (skin)

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

210

Dose descriptor starting point:

LOAEC

Value:

3 478.26 µg/m³

AF for dose response relationship:

1

Justification:

the dose-response relationship is deemed reliable

AF for interspecies differences (allometric scaling):

7

Justification:

accounting for differences in metabolic rate per body weight from mice

AF for other interspecies differences:

1

Justification:

no need to account for remaining interspecies differences for local effects

AF for intraspecies differences:

10

Justification:

accounts for extrapolation to the general human population

AF for the quality of the whole database:

1

Justification:

available data are deemed complete and consistent

AF for remaining uncertainties:

3

Justification:

accounts for use of LOAEL as starting point for data deemed complete and consistent

General Population - Hazard via oral route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

3.35 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

Dose descriptor starting point:

NOAEL

Value:

335 mg/kg bw/day

AF for dose response relationship:

1

Justification:

the dose-response relationship is deemed reliable

AF for differences in duration of exposure:

1

Justification:

no extrapolation needed from subchronic to subacute duration

AF for interspecies differences (allometric scaling):

4

Justification:

accounts for allometric scaling from rat

AF for other interspecies differences:

2.5

Justification:

accounts for remaining interspecies differences

AF for intraspecies differences:

10

Justification:

accounts for extrapolation to the human general population

AF for the quality of the whole database:

1

Justification:

available data are deemed complete and consistent

AF for remaining uncertainties:

1

Justification:

no remaining uncertainties exist

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

While use of this material in final product preparations, to which the general population would be exposed, would be below the threshold for induction of skin sensitization, use may exceed the threshold for elicitation of skin sensitization and therefore pre-sensitized individuals may experience adverse reaction.