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EC number: 204-101-2 | CAS number: 115-70-8
- 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:
- 58.8 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763.2 mg/m³
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 58.8 mg/m³
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high 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:
- 10.4 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/m³
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 250 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
No DNELs have been derived for the short-term dermal and inhalation exposure of 2 -amino-2 -ethyl-1,3 –propanediol (AEPD) for workers, as it is assumed that the assessment of hazard is sufficiently covered by deriving the respective DNELs for long-term exposure.
No quantitative dose-response data are available for local short-term effects on skin and respiratory tract of AEPD. Therefore, an absolute value for the local effects has been determined. The most sensitive local endpoint is eye corrosion (Parekh, 1982).
The long-term worker DNEL for dermal systemic effects is based on the combined oral repeated dose toxicity and reproduction/developmental screening test (Ishida, 2004) performed according to OECD 422 in rats. In this study, no animals died and no effects with toxicological relevance were observed on body weights, organ weights, haematologic and clinical chemistry parameters, or gross and histopathologic examinations. As no effects were observed up to and including the highest dose level, the NOAEL is ≥ 1000 mg/kg bw/day. This study was chosen as the starting point for deriving the DNEL as there is no dermal repeated dose study. To convert the oral NOAEL [mg/kg bw/day] into a dermal NOAEL [mg/kg bw/day], the differences in absorption between routes as well as differences in dermal absorption between rats and humans have to be accounted for (Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health, European Chemicals Agency, Version 2, December 2010).
For neat AEPD (i.e. basic solution), a dermal absorption of 80% was calculated using QSAR and the available physico-chemical properties. Based on practical experience, the dermal absorption of 80% has to be regarded as a worst case scenario: AEPD is usually used in applications where the pH will be closer to neutral. As a consequence AEPD will predominantly be present in an ionised form which will not easily penetrate the skin. This fact needs to be addressed when performing the exposure assessment.
The long-term worker DNEL for inhalation systemic effects is again based on the combined oral repeated dose toxicity and reproduction/developmental screening test performed according to OECD 422 (Ishida, 2004). This study was chosen as the starting point for deriving the DNEL as there is no inhalation repeated dose study. According to the “Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health” (European Chemicals Agency, Version 2, December 2010), the oral NOAEL should be converted into an inhalatory NAEC: the oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (0.38 m³/kg for 8 h exposure). Additionally, it should be taken into account that during 8 hours light activity at work the respiratory rate becomes higher (10 m³/person) than standard (6.7 m³/person). Considering these differences, the correct starting point is a NAEC of 1763.2 mg/m³. The absorption via the inhalative route is considered to be in the same order as via the oral route.
In general, assessment factors (AF) recommended by ECHA (Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose[concentration]-response for human health. European Chemicals Agency, Version 2, December 2010) were used when applicable to derive the DNELs. Several AFs for which there is additional information were refined. The difference in metabolic rate between humans and the test species has been taken into account, where relevant. The AF for remaining interspecies differences has been set at 1, as the toxicokinetic data indicates that AEPD will not be metabolised. Due to its polarity and size, AEPD will mainly be excreted unmetabolised via the urine (see toxicokinetics). An AF for exposure duration is applied to take into account the difference between experimental exposure duration and the exposure duration for the population. In the combined oral repeated dose toxicity and reproduction/developmental screening test (OECD 422) that is used to derive the long-term exposure DNELs, rats were exposed for at least 42 days. Based on a recent publication (Batke et al., 2011), an AF of 3 has been chosen in this case, as it reflects the exposure duration accurately. The study of Batke et al. (2011) performed an assessment of the time extrapolation factors based on the comparison of NOELs from different duration studies. Batke et al. (2011) concluded that in the majority of cases a factor of 3 is sufficient to convert a subacute exposure duration to chronic exposure duration. As in the present case, the NOAEL corresponds to the highest dose tested with no evidence of treatment related adverse effects, a factor of 3 can be used according to Batke et al. (2011).
Batke et al., 2011, Evaluation of time extrapolation factors based on the database RepDose. Toxicol Lett, 205(2):122 -129
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 29.4 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):
- 60
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763.2 mg/m³
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 29.4 mg/m³
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high 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:
- 5.2 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):
- 240
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 250 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.17 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):
- 240
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 4
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - General Population
The general population is not exposed to 2-amino-2-ethyl-1,3–propanediol (AEPD), based on its identified uses. However, the long-term consumer DNELs for oral, dermal and inhalation systemic effects have been derived. No DNELs have been derived for the short-term dermal, inhalation and oral exposure of AEPD for the general population, as it is assumed that the assessment of hazard is sufficiently covered by deriving the respective DNELs for long-term exposure. No quantitative dose-response data are available for local short-term effects on skin and respiratory tract of AEPD. Therefore, an absolute value for local effects has been determined. The most sensitive local endpoint is eye corrosion (Parekh, 1982).
The long-term DNEL for the general population, dermal systemic effects is based on the combined oral repeated dose toxicity and reproduction/developmental screening test (Ishida, 2004) performed according to OECD 422 in rats. In this study, no animals died and no effects with toxicoloical relevance were observed on body weights, organ weights, haematologic and clinical chemistry parameters, or gross and histopathologic examinations. As no effects were observed up to and including the highest dose level, the NOAEL is ≥ 1000 mg/kg bw/day. This study was chosen as the starting point for deriving the DNEL as there is no dermal repeated dose study. To convert the oral NOAEL [mg/kg bw/day] into a dermal NOAEL [mg/kg bw/day], the differences in absorption between routes as well as differences in dermal absorption between rats and humans have to be accounted for (Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health. European Chemicals Agency, Version 2, December 2010).
For neat AEPD (i.e. basic solution), a dermal absorption of 80% was calculated using QSAR and the available physico-chemical properties. Based on practical experience, the dermal absorption of 80% has to be regarded as a worst case scenario: AEPD is usually used in applications where the pH will be closer to neutral. As a consequence AEPD will predominantly be present in an ionised form which will not easily penetrate the skin. This fact needs to be addressed when performing the exposure assessment.
The long-term DNEL for the general population, inhalation systemic effects is again based on the combined oral repeated dose toxicity and reproduction/developmental screening test performed according to OECD 422 (Ishida, 2004). This study was chosen as the starting point for deriving the DNEL as there is no inhalation repeated dose study. According to the Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose[concentration]-response for human health (European Chemicals Agency, Version 2, December 2010), the oral NOAEL should be converted into an inhalatory NAEC: the oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m³/kg for 24 h exposure). Therefore, the corrected starting point is a NAEC of 869.6 mg/ m³. The absorption via the inhalative route is considered to be in the same order of magnitude as via the oral route. The long-term DNEL for the general population, oral systemic effects is also based on the combined oral repeated dose toxicity and reproduction/ developmental screening test (Ishida, 2004) performed according to OECD 422 in rats. In this study, no animals died and no treatment-related effects were observed on body weights, organ weights, haematologic and clinical chemistry parameters, or gross and histopathologic examinations. As no effects were observed up to and including the highest dose level, the NOAEL is ≥ 1000 mg/kg bw/d. The study was performed via the oral route and the value can be used directly to derive the oral DNEL.
In general, assessment factors (AF) recommended by ECHA (Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose[concentration]-response for human health. European Chemicals Agency, Version 2, December 2010) were used when applicable to derive the DNELs. Several AFs for which there is additional information were refined. The difference in metabolic rate between humans and the test species has been taken into account, where relevant. The AF for remaining interspecies differences has been set at 1, as the toxicokinetic data indicates that AEPD will not be metabolised. Due to its polarity and size, AEPD will mainly be excreted unmetabolised via the urine (see toxicokinetics). An AF for exposure duration is applied to take into account the difference between experimental exposure duration and the exposure duration for the general population. In the combined oral repeated dose toxicity and reproduction/developmental screening test (OECD 422) that is used to derive the long-term exposure DNELs, rats were exposed for at least 42 days. Based on a recent publication (Batke et al., 2011), an AF of 3 has been chosen in this case, as it reflects the exposure duration accurately. The study of Batke et al. (2011) performed an assessment of the time extrapolation factors based on the comparison of NOELs from different duration studies. Batke et al. (2011) concluded that in the majority of cases a factor of 3 is sufficient to convert a subacute exposure duration to chronic exposure duration. As in the present case, the NOAEL corresponds to the highest dose tested with no evidence of treatment related adverse effects, a factor of 3 can be used according to Batke et al. (2011).
Batke et al., 2011, Evaluation of time extrapolation factors based on the database RepDose. Toxicol Lett, 205(2):122 -129.
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