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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.77 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):
150
Modified dose descriptor starting point:
NOAEC
Value:
265 mg/m³
Explanation for the modification of the dose descriptor starting point:
Convert oral NOAEL to Inhaltion NOAEC: 300 mg/kg/day x [1/0.38 x rat oral absorption (50%) / human inhalation absorption (100%) x (6.7/10)] = 265 mg/m3
AF for dose response relationship:
1
Justification:
Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
AF for differences in duration of exposure:
6
Justification:
Extrapolation from subacute study to chronic exposure value in line with Table R.8-5 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
AF for interspecies differences (allometric scaling):
1
Justification:
Differences in species addressed in calculation of dose descriptor starting point.
AF for other interspecies differences:
2.5
Justification:
Differences in species addressed in calculation of dose descriptor starting point.
AF for intraspecies differences:
5
Justification:
Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
AF for the quality of the whole database:
2
Justification:
Limited information on chronic, reproductive and developmental toxicity. (OECD 422 study only)
AF for remaining uncertainties:
1
Justification:
Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.3 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA guidance states that a multiplying factor of between 1 and 5 may be used to derive an acute DNEL from a long-term DNEL. The median value of 3 is used here.
DNEL extrapolated from long term DNEL

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:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Value:
600 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Convert oral NOAEL to dermal NOAEL: 300 mg/kg/day x (50 [oral absorption rat]/25 [dermal absorption human]) = 600 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
AF for differences in duration of exposure:
6
Justification:
Extrapolation from subacute study to chronic exposure value in line with Table R.8-5 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value in line with Table R.8-3 and Appendix R. 8-2, part 2, example B5 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
AF for other interspecies differences:
2.5
Justification:
Differences in species addressed in calculation of dose descriptor starting point.
AF for intraspecies differences:
5
Justification:
Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
AF for the quality of the whole database:
2
Justification:
Limited information on chronic, reproductive and developmental toxicity. (OECD 422 study only)
AF for remaining uncertainties:
1
Justification:
Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA guidance states that a multiplying factor of between 1 and 5 may be used to derive an acute DNEL from a long-term DNEL. The median value of 3 is used here.
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

There are no data regarding the substance's sub-chronic toxicological effects and the data regarding long term exposure is limited to a single OECD 422 study. Systemic effects with regards to the repeated dose exposure to the substance were seen in this study and as the oral NOAEL is considered suitable to be used in extrapolating both the dermal and inhalation DNELs for this material the results of this study have been used as the starting point of the derivations. An additional safety factor of 2 has been applied in order to account for the limited information on chronic reproductive and chronic toxicity and that only one species has been examined. The value of 2 rather than a higher figure reflects the non-specific nature of the toxicity observed. Similarly data on reproductive toxicology is limited to the same OECD 422 study, although effects were considered to be limited to maternal toxicity and related to lower bodyweight gains in the top dose group. No effects specifically related to reproductive health of the animals were seen.

The substance is considered not to be harmful following acute administration by the oral route and furthermore read across to data on the two structural fragments (Tall oil and ethanolamine) suggests that the substance would not be harmful by dermal exposure either. The substance has a high log Pow and low water solubility and is therefore considered unlikely to fully penetrate the epidermis making dermal absorption unlikely. The substance exists in the form of a highly viscous gel or paste and has a low vapour pressure which suggests that inhalation exposure is unlikely.

No irritant or sensitising effects were seen in the applicable studies on analogous substances that have used to support the registration of this substance and it is concluded that the same would be true for the substance itself. The limited data available on the substance itself support this conclusion. No local effects are expected following exposure to the substance. Hence, derivation of DNELs for local effects (Either short or long term) is not considered necessary.

Based on the available studies used to support the registration, the substance would not be considered to exhibit any genotoxic potential.

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

Additional information - General Population

Exposure to the general population is not expected based on the substance use pattern. Tall oil, compounds with ethanolamine is intended for use within industrial and professional use sectors only and no uses by the general population are anticipated. As such it is considered justified not to derive a DNEL for this type of exposure.