Fatty acids, tall-oil, reaction products with ethanolamine, ethoxylated

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

98 mg/m³

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

other: ECHA REACH Guidance, ECETOC Technical Report No. 110

Overall assessment factor (AF):

18

Modified dose descriptor starting point:

NOAEC

Value:

1 763.2 mg/m³

Explanation for the modification of the dose descriptor starting point:

Route specific dose descriptor is not available. The recommended approach using oral data and assuming the same absorption for inhalation and oral route is used.

AF for dose response relationship:

1

Justification:

Dose-response (starting point is a NOAEL)

AF for differences in duration of exposure:

6

Justification:

ECHA REACH Guidance

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:

1

Justification:

Any remaining differences are of intraspecies rather than interspecies variability. Based on this, the additional assessment factor of 2.5 for inter species variability will not be used.

AF for intraspecies differences:

3

Justification:

Intraspecies variation (workers). ECETOC proposed in 2010, based on the scientific evidence, that assessment factors of 3 for workers and 5 for the general population are sufficient for covering any intraspecies variability, which includes the remaining differences factor of 2.5.

AF for the quality of the whole database:

1

Justification:

The quality of the whole data base is considered to be sufficient and uncritical.

AF for remaining uncertainties:

1

Justification:

The approach used for DNEL derivation is conservative (e.g., no effects were observed at the limit dose of 1000 mg/kg bw/, which is used as starting point). No further 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:

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:

4.16 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Dermal

DNEL related information

DNEL derivation method:

other: ECHA REACH Guidance, ECETOC Technical Report No. 110

Overall assessment factor (AF):

12

Modified dose descriptor starting point:

NOAEL

Value:

50 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

No route to route extrapolation applied

AF for dose response relationship:

1

Justification:

Dose-response (starting point is a NOAEL )

AF for differences in duration of exposure:

1

Justification:

Exposure duration (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:

1

Justification:

Any remaining differences are of intraspecies rather than interspecies variability. Based on this, the additional assessment factor of 2.5 for inter species variability will not be used.

AF for intraspecies differences:

3

Justification:

Intraspecies variation (workers). ECETOC proposed in 2010, based on the scientific evidence, that assessment factors of 3 for workers and 5 for the general population are sufficient for covering any intraspecies variability, which includes the remaining differences factor of 2.5.

AF for the quality of the whole database:

1

Justification:

Good quality NTP study

AF for remaining uncertainties:

1

Justification:

The approach used for DNEL derivation is conservative. No further 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:

DNEL (Derived No Effect Level)

Value:

31.2 µg/cm²

Most sensitive endpoint:

repeated dose toxicity

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

9

Dose descriptor:

other: corrected LOAEL of 281 µg/cm²

AF for dose response relationship:

3

Justification:

Dose-response (LOAEL to NOAEL)

AF for differences in duration of exposure:

1

Justification:

Exposure duration (chronic study)

AF for interspecies differences (allometric scaling):

1

Justification:

Assessment factor for interspecies difference - allometric (metabolic rate) scaling (rat-to-human) not required since this is already accounted for when obtaining the corrected LOAEL

AF for other interspecies differences:

1

Justification:

Assessment factor for interspecies difference - remaining non-metabolic differences not required

AF for intraspecies differences:

3

Justification:

Intraspecies variation (workers). ECETOC proposed in 2003, based on the scientific evidence, that assessment factors of 3 for workers and 5 for the general population are sufficient for covering any intraspecies variability, which includes the remaining differences factor of 2.5.

AF for the quality of the whole database:

1

Justification:

Good quality NTP conducted study

AF for remaining uncertainties:

1

Justification:

The approach used for DNEL derivation is conservative. No further assessment factors are required.

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:

low hazard (no threshold derived)

General Population - Hazard via inhalation 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:

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:

no hazard identified

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:

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