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EC number: 279-903-9 | CAS number: 82136-26-3
- 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
Endpoint summary
Administrative data
Description of key information
1) Acute oral toxicity of substance 2-[[3-(dimethylamino)propyl]methylamino]ethanol [equivalent or similar to OECD Guideline 401 (deleted on 17 Dec. 2002)]:
- LD50 in female rat: estimated to be 1537 mg/kg bw;
- LD50 in male rat: estimated to be 1573 mg/kg bw.
2) Acute dermal toxicity of substance 2-[[3-(dimethylamino)propyl]methylamino]ethanol [equivalent or similar to OECD Guideline 402 (before 9 Oct. 2017)]:
- LD50 in male rabbit (abraded skin): estimated to be 1772 mg/kg bw;
- LD50 in male rabbit (intact skin): estimated to be 1808 mg/kg bw.
3) Acute inhalation toxicity of substance 2-[[3-(dimethylamino)propyl]methylamino]ethanol: no study available; study does not need to be conducted because the substance is classified as corrosive to the skin.
4) Conclusion
All of the available studies indicate that the substance 2-[[3-(dimethylamino)propyl]methylamino]ethanol is moderate acute toxic.
Based on the results, the LD50 of the registration substance is considered to be 1537 mg/kg bw via the oral route and 1772 mg/kg bw via the dermal route.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 September 1980 (started); 22 September 1980 (reported)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: study report provides basic data, but some details missing including dose levels
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- The test substance was administered to groups of male and female rats by oral gavage and observed for a period of 14 days.
- GLP compliance:
- no
- Remarks:
- study was conducted before implementation of GLP
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Route of administration:
- oral: unspecified
- Doses:
- 1.59 mL/kg bw, 2.52 mL/kg bw and 4.00 mL/kg bw [not documented; dose volume was calculated as dose level (g/kg) / density (g/mL)]
- No. of animals per sex per dose:
- 3 (not documented)
- Control animals:
- no
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1.7 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- 1.47 - 1.95
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 537 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1.74 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- 1.52 - 1.99
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 573 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- - LD50 (male rat): 1573 mg/kg bw;
- LD50 (female rat): 1537 mg/kg bw - Executive summary:
The test item 2-[[3-(dimethylamino)propyl]methylamino]ethanol was tested in an acute oral toxicity study [equivalent or similar to OECD Guideline 401 (deleted on 17 Dec. 2002), prior to introduction of GLP].
Three female and three male rats per dose level were gavaged once with the test item at dose levels of about 1.6 mL/kg bw, 2.5 mL/kg bw and 4.0 mL/kg bw (number of animals and doses not documented in report).
The acute oral median lethal dose (LD50) of the test material in the rat was estimated to be 1573 mg/kg bw for male and 1537 mg/kg bw for female rat.
Using the EU Globally Harmonised System (GHS), the substance needs to be classified as Acute tox. 4, H302.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 537 mg/kg bw
- Quality of whole database:
- only 1 study available; older study with limited documentation, but considered sufficient for classification and hazard identification
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as corrosive to the skin
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 February 1981 (started); 01 April 1981 (reported)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Remarks:
- study was conducted before implementation of GLP
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Skin of back was shaved and, following application of the test material, was wrapped with occlusive film for 24 hours.
- Duration of exposure:
- 24 hours
- Doses:
- 1.59 mL/kg bw, 2.52 mL/kg bw and 4.00 mL/kg bw [dose volume was calculated as dose level (g/kg) / density (g/mL)]
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1.96 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- 0.81 - 2.73
- Remarks on result:
- other: abraded skin
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 772 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: abraded skin
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- 1.4 - 2.72
- Remarks on result:
- other: intact skin
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 808 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: intact skin
- Mortality:
- 1.59 mL/kg bw: 1/6
2.52 mL/kg bw: 5/6
4.00 mL/kg bw: 6/6 - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- - LD50 (male, abraded skin): 1772 mg/kg bw;
- LD50 (male, intact skin): 1808 mg/kg bw - Executive summary:
The test item 2-[[3-(dimethylamino)propyl]methylamino]ethanol was tested in an acute dermal toxicity study [equivalent or similar to OECD Guideline 402 (before 9 Oct. 2017), prior to introduction of GLP].
The test material was administered to six male New Zealand White rabbits by a single dermal application with 1.59 mL, 2.52 mL and 4.00 mL of the undiluted test material per kg body weight for 24 hours.
Signs of toxicity were usually not observed until the day after the material was applied. Local effects were not reversible within the two-week observation period. Deaths occurred 1 to 4 days post treatment.
The acute dermal median lethal dose (LD50) of the test material in the rabbit was estimated to be 1772 mg/kg bw (abraded skin) and 1808 mg/kg bw (intact skin).
Using the EU Globally Harmonised System (GHS), the substance needs to be classified as Acute tox. 4, H312.
Reference
Signs of toxicity were usually not observed until the day after the material was applied. Local effects were not reversible within the two-week observation period. Deaths occurred 1 to 4 days post treatment.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 772 mg/kg bw
- Quality of whole database:
- only 1 study available; older study with limited documentation, but considered sufficient for classification and hazard identification
Additional information
Justification for classification or non-classification
- Acute toxicity - oral: Acute tox. 4; H302
- Acute toxicity - dermal: Acute tox. 4; H312
- Acute toxicity - inhalation: Acute tox. 4; H332.
On the basis of the available oral and dermal data, the substance 2-[[3-(dimethylamino)propyl]methylamino]ethanol requires classification for lethal effects following a single exposure according to Regulation 1272/2008/EC; considering the significant clinical signs of toxicity observed in the acute toxicity tests, the substance - that is a strong base with a pH of 12 - is also classified for inhalation toxicity:
In addition to classification for inhalation toxicity, the substance needs to be labelled as EUH071: ‘corrosive to the respiratory tract’ as the data available indicate that the mechanism of toxicity is corrosivity.
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