Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 268-452-3 | CAS number: 68092-28-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.98 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC Technical Report No. 110
- Overall assessment factor (AF):
- 18
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 17.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- (20 × 1/0.38 × 6.7/10 × 0.5 [50% oral abs rat / 100% inhalation abs hum]
- 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:
- 2
- 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 ECETOC Technical Report No. 110.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Differences in species addressed in calculation of dose descriptor starting point
- AF for other interspecies differences:
- 1
- Justification:
- Differences in species addressed in calculation of dose descriptor starting point
- AF for intraspecies differences:
- 3
- Justification:
- Default value in ECETOC Technical Report No. 110.
- AF for the quality of the whole database:
- 3
- Justification:
- Very recent OECD 408 study on highly similar read across substance.
- AF for remaining uncertainties:
- 1
- Justification:
- Default value in ECETOC Technical Report No. 110.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.55 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):
- 72
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 20 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- (20 × 2 [oral absorption rat 50%/dermal absorption human 25%]
- AF for dose response relationship:
- 3
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and ECETOC Technical Report No. 110.
- AF for differences in duration of exposure:
- 2
- 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 default value in ECETOC Technical Report No. 110.
- 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 default value in ECETOC Technical Report No. 110.
- AF for other interspecies differences:
- 1
- Justification:
- Differences in species addressed in calculation of dose descriptor starting point
- AF for intraspecies differences:
- 3
- Justification:
- Default value in ECETOC Technical Report No. 110.
- AF for the quality of the whole database:
- 1
- Justification:
- Very recent OECD 408 study on highly similar read across substance
- AF for remaining uncertainties:
- 1
- Justification:
- Default value in ECETOC Technical Report No. 110.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Tall oil, compound with diethanolamine is not acutely toxic after oral administration, as the LD50 values are higher than 2000 mg/kg bw. The substance did show irritating properties to both skin and eye when tested in vivo, but there is no dose response data.Based on results of GPMTs with component substances (diethanolamine and distilled tall oil) the compound is not considered to be a sensitiser. Therefore acute DNELs for systemic effects or acute and long-term DNELs for local effects are not possible to define.
Results of in vitro studieswith the component substances showed tall oil, compound with diethanolamineis considered not to possess any genotoxic potential.
A oral repeat-dose 90 day toxicity study in rats on the read across substance Diethanolamine was available. As this was the most recent study and was conducted on the closest structural analogue it was used as the starting point for DNELs setting. An additional oral repeat-dose combined reproductive/developmental toxicity study on the read across substance tall oil and further repeat dose studies both oral and dermal on the component substances are also available to help support the read across and address this end point.
All assessment factors were the default values taken from ECETOC Technical Report No. 110, Guidance on Assessment Factors to Derive a DNEL. To prepare this publication, ECETOC conducted an extensive and documented review of the scientific literature. Therefore, the AF supplied in the ECETOC document are considered valid and scientifically justifiable.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.29 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):
- 30
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 8.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- (20 × 1/1.15 × × 0.5 [50% oral abs rat / 100% inhalation abs hum]
- AF for dose response relationship:
- 3
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and default value in ECETOC Technical Report No. 110.
- AF for differences in duration of exposure:
- 2
- 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 default value in ECETOC Technical Report No. 110.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Differences in species addressed in calculation of dose descriptor starting point
- AF for other interspecies differences:
- 1
- Justification:
- Differences in species addressed in calculation of dose descriptor starting point
- AF for intraspecies differences:
- 5
- Justification:
- Default value in ECETOC Technical Report No. 110.
- AF for the quality of the whole database:
- 1
- Justification:
- Very recent OECD 408 study on highly similar read across substance.
- AF for remaining uncertainties:
- 1
- Justification:
- Default value in ECETOC Technical Report No. 110.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.33 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):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 20 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- NOAEL = 20 mg/kg/day (20 × 2 [oral absorption rat 50%/dermal absorption human 25%]
- AF for dose response relationship:
- 3
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and default value in ECETOC Technical Report No. 110.
- AF for differences in duration of exposure:
- 2
- 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 default value in ECETOC Technical Report No. 110.
- 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 default value in ECETOC Technical Report No. 110.
- AF for other interspecies differences:
- 1
- 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:
- 1
- Justification:
- Very recent OECD 408 study on highly similar read across substance
- AF for remaining uncertainties:
- 1
- Justification:
- default value in ECETOC Technical Report No. 110.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.17 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):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 20 mg/kg bw/day
- AF for dose response relationship:
- 3
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and default value in ECETOC Technical Report No. 110.
- AF for differences in duration of exposure:
- 2
- 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 anddefault value in ECETOC Technical Report No. 110.
- 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 default value in ECETOC Technical Report No. 110.
- AF for other interspecies differences:
- 1
- Justification:
- Default value in ECETOC Technical Report No. 110.
- AF for intraspecies differences:
- 5
- Justification:
- default value in ECETOC Technical Report No. 110.
- AF for the quality of the whole database:
- 1
- Justification:
- Very recent OECD 408 study on highly similar read across substance
- AF for remaining uncertainties:
- 1
- Justification:
- default value in ECETOC Technical Report No. 110.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
Tall oil, compound with diethanolamine is not acutely toxic after oral administration, as the LD50 values are higher than 2000 mg/kg bw. The substance did show irritating properties to both skin and eye when tested in vivo, but there is no dose response data. Based on results of GPMTs with component substances (diethanolamine and distilled tall oil) the compound is not considered to be a sensitiser. Therefore acute DNELs for systemic effects or acute and long-term DNELs for local effects are not possible to define.
Results of in vitro studies with the component substances showed tall oil, compound with diethanolamine is considered not to possess any genotoxic potential.
A oral repeat-dose 90 day study in rats on the read across diethanolamine was available, performed in rats. As this was the most recent study and was conducted on the closest structural analogue it was used as the starting point for DNELs setting. An additional oral repeat-dose combined reproductive/developmental toxicity study on the read across substance tall oil and further repeat dose studies both oral and dermal on the component substances are also available to help support the read across and address this end point.
All assessment factors were the default values taken from ECETOC Technical Report No. 110, Guidance on Assessment Factors to Derive a DNEL. To prepare this publication, ECETOC conducted an extensive and documented review of the scientific literature. Therefore, the AF supplied in the ECETOC document are considered valid and scientifically justifiable.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
