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EC number: 825-356-1 | CAS number: 2097729-23-0
- 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:
- 1.48 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:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 37 mg/m³
- Explanation for the modification of the dose descriptor starting point:
ECHA guidance recommends that a factor of 2 be applied when doing route to route extrapolation for oral to inhalation exposure; this has been included in this case due to a lack of data or the percentage of oral absorption. Therefore a factor of 2 was applied. Allometric scaling is applied by taking account for the different breathing rates between rats and humans, as described in ECHA technical guidance the oral NOAEL in the rat mg/kg/day *1/0.38 * 6.7/10 = mg/m3 inhalation NOAEC for workers. An additional adjust was made as recommended in ECHA guidance R8.4.3. The oral exposure for the rats was 7 days a week but inhalation exposure of workers is considered to be 5 days a week. This is adjusted by dividing the NOEC by 5/7 or 0.714286.DNELs
- AF for dose response relationship:
- 1
- Justification:
- There was a clear dose response in the study.
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA guidance document Chapter R8, in Appendix R.8-12, indicates that DNELS derived using a NOAEL from a 90 day study are derived using an assessment factor of 2 for extrapolation of the study duration to chronic exposure. As the NOAEL is from a 90 day study the factor of 2 was used.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is already included in the route to route extrapolation from the rat oral NOAEL to the equivalent human inhalation NOAEC.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA guidance recommends an additional factor of 2.5 for other interspecies differences, therefore a factor of 2.5 has been applied.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA guidance recommends a factor of 5 for intraspecies differences for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- While the DNEL is based on a read across substance, the read across substance is considered to be a worst case and will not be less toxic than Ethanol, 2,2’-iminobis-N-tallow alkyl derivatives, N-oxides. Therefore a factor of 1 was used.
- AF for remaining uncertainties:
- 1
- Justification:
- All uncertainties are already included so a factor of 1 is applied.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- 0.3 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:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
ECHA guidance assumes that absorption for dermal exposure is the same as for oral exposure, which is a worst case assumption. So the Oral NOAEL can be used also as the dermal repeat dose NOAEL as the basis for calculating Dermal DNELs.
- AF for dose response relationship:
- 1
- Justification:
- There was a clear dose response in the study.
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA guidance document Chapter R8, in Appendix R.8-12, indicates that DNELS derived using a NOAEL from a 90 day study are derived using an assessment factor of 2 for extrapolation of the study duration to chronic exposure. As the NOAEL is from a 90 day study the factor of 2 was used.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA guidance recommends as factor of 4 for Allometric scaling from effects in the rat to humans, to compensate for the different metabolic rates.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA guidance recommends an additional factor of 2.5 for other interspecies differences, therefore a factor of 2.5 has been applied.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA guidance recommends a factor of 5 for intraspecies differences for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- The DNEL is based on a NOAEL from a conservative read across substance believed to be a worst case for repeat dose toxicity, the study is fully GLP compliant.
- AF for remaining uncertainties:
- 1
- Justification:
- All uncertainties are already included so a factor of 1 is applied.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
Ethanol, 2,2’-iminobis-N-tallow alkyl derivatives, N-oxides is not clasified as irritating to skin but is irritating to eyes. Therefore long term local effects on the skin would be no more than mild irritation. Based on the conditions of use and qualitative risk assessment it is considered not necessary to establish a DNEL for long term local effects from dermal exposure.
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:
- medium hazard (no threshold derived)
Additional information - workers
The information available for Ethanol, 2,2’-iminobis-N-tallow alkyl derivatives, N-oxides and the read across sources 2,2’-(octadec-9-enylimino)diethanol and Ethanol, 2.2’-iminobis,-N-tallow alkyl derivatives are consistent. Adverse effects were mainly seen at local effects in the gastrointestinal tract including irritation to the fore stomach and foamy macrophages. There were no apparent systemic adverse effects, these local effects leading to decreased bodyweight and bodyweight gain in the 150mg/kg bodyweight /day top dose groups assumed to be secondary to the local effects seen in the gastrointestinal tract. The consistency in the effects and the NOAEL values together with the similarities in structure, in particular in their carbon chain distribution are sufficient support for the read across used. Therefore the DNELs calculated based on the read across NOAEL will provide adequate protection for workers from any possibly systemic effects.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.22 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 11.11 mg/m³
- Explanation for the modification of the dose descriptor starting point:
ECHA guidance recommends that a factor of 2 be applied when doing route to route extrapolation for oral to inhalation exposure, recognizing higher absorption via the lungs (oral absorption assumed to default to 50% and inhalation to 100%). Allometric scaling is applied by taking account for the different breathing rates between rats and humans, as described in IUCLID Calculator the oral NOAEL in the rat mg/kg/day *1/1.35 mg/m3 inhalation NOAEC for the general population (based on 60 kg bodyweight rather than 70 kg for workers).
- AF for dose response relationship:
- 1
- Justification:
- There was a clear dose response in the study.
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA guidance document Chapter R8, in Appendix R.8-12, indicates that DNELS derived using a NOAEL from a 90 day study are derived using an assessment factor of 2 for extrapolation of the study duration to chronic exposure. As the NOAEL is from a 90 day study the factor of 2 was used.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is already included in the route to route extrapolation from the rat oral NOAEL to the equivalent human inhalation NOAEC.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA guidance recommends an additional factor of 2.5 for other interspecies differences, therefore a factor of 2.5 has been applied.
- AF for intraspecies differences:
- 10
- Justification:
- ECHA guidance recommends a factor of 10 for intraspecies differences for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- While the DNEL is based on a read across substance, the read across substance is considered to be a worst case and will not be less toxic than Ethanol, 2,2’-iminobis-N-tallow alkyl derivatives, N-oxides. Therefore a factor of 1 was used.
- AF for remaining uncertainties:
- 1
- Justification:
- All uncertainties are already included so a factor of 1 is applied.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- 0.15 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
ECHA guidance assumes that absorption for dermal exposure is the same as for oral exposure, which is a worst case assumption. So the Oral NOAEL can be used also as the dermal repeat dose NOAEL as the basis for calculating Dermal DNELs.
- AF for dose response relationship:
- 1
- Justification:
- There is a clear dose response so a factor of 1 is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA guidance document Chapter R8, in Appendix R.8-12, indicates that DNELS derived using a NOAEL from a 90 day study are derived using an assessment factor of 2 for extrapolation of the study duration to chronic exposure. As the NOAEL is from a 90 day study the factor of 2 was used.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA guidance recommends as factor of 4 for Allometric scaling from effects in the rat to humans, to compensate for the different metabolic rates.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA guidance recommends an additional factor of 2.5 for other interspecies differences, therefore a factor of 2.5 has been applied.
- AF for intraspecies differences:
- 10
- Justification:
- ECHA guidance recommends a factor of 10 for intraspecies differences for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- While the DNEL is based on a read across substance, the read across substance is considered to be a worst case and will not be less toxic than Ethanol, 2,2’-iminobis-N-tallow alkyl derivatives, N-oxides. Therefore a factor of 1 was used.
- AF for remaining uncertainties:
- 1
- Justification:
- All uncertainties are already included so a factor of 1 is applied.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- 0.15 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There is no route to route extrapolation as the NOAEL is from an oral study in rats and ECHA assumes equal absorption via the oral and dermal routes so no modification of the dose descriptor. This is a conservative approach
- AF for dose response relationship:
- 1
- Justification:
- There was a clear dose response so a factor of 1 is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA guidance document Chapter R8, in Appendix R.8-12, indicates that DNELS derived using a NOAEL from a 90 day study are derived using an assessment factor of 2 for extrapolation of the study duration to chronic exposure. As the NOAEL is from a 90 day study the factor of 2 was used.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA guidance recommends as factor of 4 for Allometric scaling from effects in the rat to humans, to compensate for the different metabolic rates.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA guidance recommends an additional factor of 2.5 for other interspecies differences, therefore a factor of 2.5 has been applied.
- AF for intraspecies differences:
- 10
- Justification:
- ECHA guidance recommends a factor of 10 for intraspecies differences for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- While the DNEL is based on a read across substance, the read across substance is considered to be a worst case and will not be less toxic than Ethanol, 2,2’-iminobis-N-tallow alkyl derivatives, N-oxides. Therefore a factor of 1 was used.
- AF for remaining uncertainties:
- 1
- Justification:
- All uncertainties are already included so a factor of 1 is applied.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
The information available for Ethanol, 2,2’-iminobis-N-tallow alkyl derivatives, N-oxides and the read across sources 2,2’-(octadec-9-enylimino)diethanol and Ethanol, 2.2’-iminobis,-N-tallow alkyl derivatives are consistent. Adverse effects were mainly seen at local effects in the gastrointestinal tract including irritation to the fore stomach and foamy macrophages. There were no apparent systemic adverse effects, these local effects leading to decreased bodyweight and bodyweight gain in the 150mg/kg bodyweight /day top dose groups assumed to be secondary to the local effects seen in the gastrointestinal tract. The consistency in the effects and the NOAEL values together with the similarities in structure, in particular in their carbon chain distribution are sufficient support for the read across used. Therefore the DNELs calculated based on the read across NOAEL will provide adequate protection for the general population from any possibly systemic effects.
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.
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