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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
sensitising, Cat. 1B [based on results of a reliable OECD 429 study (Local Lymph Node Assay) for 2-[[3-(dimethylamino)propyl]methylamino]ethanol where SI values of all three dose groups indicated a positive result (SI: 8.27, 15.25, 15.81)]
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 October 2013 until 26 November 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- Adopted 22 July 2010
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- No. 440/2008
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- On receipt the animals were randomly allocated to cages. The animals were nulliparous and non-pregnant.
After an acclimatization period of at least five days the animals were selected at random and given a number unique within the study by indelible ink marking on the tail and a number written on a cage card.
At the start of the study the animals were in the weight range of 15 to 23 g, and were eight to twelve weeks old.
The animals were group housed in suspended solid floor polypropylene cages furnished with softwood woodflakes.
Free access to mains tap water and food (Teklad Global Rodent diet) was allowed throughout the study.
The temperature and relative humidity were controlled to remain within target ranges of 19 to 25 °C and 30 to 70%, respectively.
The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06.00 to 18.00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study. - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- - Preliminary screening test: test item at concentrations of 50%, 25% and 10% v/v in acetone/olive oil 4:1.
- Main test: test item at concentrations of 10%, 5% or 2.5% v/v in acetone/olive oil 4:1. - No. of animals per dose:
- - Preliminary test: one mouse per test item concentration.
- Main test: four mice per test item concentration. - Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
Please see above in "Details on test animals and environmental conditions".
TREATMENT PREPARATION AND ADMINISTRATION:
For the purpose of the study, the test item was freshly prepared as a solution in acetone/olive oil 4:1. Test concentrations were determined based on the results of the preliminary test (detailed in section "Any other information on results").
The mice were treated by daily application of 25 µL of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test item formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette. A further group of four mice received the vehicle alone in the same manner.
H-Methyl Thymidine Administration:
Five days following the first topical application of the test item or vehicle (Day 6) all mice were injected via the tail vein with 250 µL of phosphate buffered saline (PBS) containing 3H-methyl thymidine (³HTdR: 80 pCi/mL, specific activity 2.0 Ci/mmoL) giving a total of 20 pCi to each mouse.
Observations:
Clinical Observations: All animals were observed twice daily on Days 1, 2 and 3 and on a daily basis on Days 4, 5 and 6. Any signs of toxicity or signs of ill health during the test were recorded.
Body Weights: The body weight of each mouse was recorded on Day 1 (prior to dosing) and Day 6 (prior to termination).
Terminal Procedures:
Termination: Five hours following the administration of ³HTdR all mice were killed by carbon dioxide asphyxiation. The draining auricular lymph nodes from the four mice were excised and pooled for each experimental group. For each group 1 mL of PBS was added to the pooled lymph nodes.
Preparation of Single Cell Suspension:
A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through a 200-mesh stainless steel gauze. The lymph node cells were rinsed through the gauze with 4 mL of PBS into a petri dish labeled with the study number and dose concentration. The lymph node cell suspension was transferred to a centrifuge tube. The petri dish was washed with an additional 5 mL of PBS to remove all remaining lymph node cells, and centrifuged for 10 minutes (1400 rpm). The pellet was resuspended in 10 mL of PBS and re-pelleted. To precipitate out the radioactive material, the pellet was resuspended in 3 mL of 5% Trichloroacetic acid (TCA).
Determination of HTdR Incorporation:
After approximately eighteen hours incubation at approximately 4 °C, the precipitates were recovered by centrifugation at 2100 rpm for ten minutes, re-suspended in 1 mL of TCA and transferred to 10 mL of scintillation fluid. HTdR incorporation was measured by (3-scintillation counting. The samples and scintillation fluid were placed in the sample changer of the scintillator and left for approximately twenty minutes. The purpose of this period of time in darkness was to reduce the risk of luminescence, which has been shown to affect the reliability of the results. After approximately twenty minutes, the vials were shaken vigorously. The number of radioactive disintegrations per minute was then measured using the Beckman LS6500 scintillation system. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Not applicable
- Key result
- Parameter:
- SI
- Value:
- 8.27
- Test group / Remarks:
- 2.5 (% v/v) in acetone/olive oil 4:1
- Remarks on result:
- other: Positive
- Key result
- Parameter:
- SI
- Value:
- 15.25
- Test group / Remarks:
- 5 (% v/v) in acetone/olive oil 4:1
- Remarks on result:
- other: Positive
- Key result
- Parameter:
- SI
- Value:
- 15.81
- Test group / Remarks:
- 10 (% v/v) in acetone/olive oil 4:1
- Remarks on result:
- other: Positive
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION (main test)
Concentration (% v/v) in acetone/olive oil 4:1 dpm dpm/Node Stimulation Index Result
Vehicle 16713.79 2089.22 na na
2.5 138247.10 17280.89 8.27 Positive
5 254853.80 31856.73 15.25 Positive
10 264206.20 33025.78 15.81 Positive
The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group
CLINICAL OBSERVATIONS and SIGNS OF TOXICITY (main test):
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test. Very slight redness on the ears was noted on Day 2 (post dose) in animals treated at a concentration of 10% v/v in acetone/olive oil 4:1.
BODY WEIGHTS (main test):
Body weight change of the test animals between Day 1 and Day 6 was comparable to that observed in the corresponding control group animals over the same period. - Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Remarks:
- The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (disintegrations per minute/node) and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index). The test item is regarded as a sensitizer if at least one concentration of the test item results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test item failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a "non-sensitizer". The results were interpreted according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
- Conclusions:
- The test item was considered to be a sensitizer under the conditions of the test.
- Executive summary:
A study was performed to assess the skin sensitization potential of the test item in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear.
Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 10% v/v, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 µL (25 µL per ear) of the test item as a solution in acetone/olive oil 4:1 at concentrations of 10%, 5% or 2.5% v/v. A further group of four animals was treated with acetone/olive oil 4:1 alone.
The Stimulation Index (SI) expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group. SI values of all three dose groups (2.5, 5, 10 (% v/v) in acetone/olive oil 4:1) indicated a positive result (SI: 8.27, 15.25, 15.81 respectively).
The test item was considered to be a sensitizer under the conditions of the test. Thus, the test item was classified as a skin sensitizer (Category 1B) according to the CLP Regulation (EC) No. 1272/2008 for the Classification, Labelling and Packaging of Substances and Mixtures.
Reference
Results of the preliminary screening test:
Mice treated at concentrations of 50% and 25% v/v in acetone/olive oil 4:1 showed a greater than 25% increase in mean ear thickness on Day 6. Very slight erythema was noted on Days 4 to 6 and on Days 2 to 4 in these mice treated at 50% and 25% respectively.
No signs of systemic toxicity or irritation indicated by an equal to or greater than 25% increase in mean ear thickness were noted at a concentration of 10% v/v in acetone/olive oil 4:1. Very slight erythema was noted on Days 2 and 3.
Based on this information the dose levels selected for the main test were 10%, 5% and 2.5% v/v in acetone/olive oil 4:1.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
A LLNA skin sensitisation study was performed to assess the skin sensitization potential of the test item 2-[[3-(dimethylamino)propyl]methylamino]ethanol in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear.
Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 10% v/v, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 µL (25 µL per ear) of the test item as a solution in acetone/olive oil 4:1 at concentrations of 10%, 5% or 2.5% v/v. A further group of four animals was treated with acetone/olive oil 4:1 alone.
The Stimulation Index (SI) expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group. SI values of all three dose groups [2.5, 5, 10 (% v/v) in acetone/olive oil 4:1] indicated a positive result (SI: 8.27, 15.25, 15.81 respectively).
Based on these data, the substance 2-[[3-(dimethylamino)propyl]methylamino]ethanol is considered to be a skin sensitiser in accordance with the CLP Regulation (sub-category 1B), as it was shown that it could elicit a SI ≥3.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance 2-[[3-(dimethylamino)propyl]methylamino]ethanol requires classification with respect to skin sensitisation.
The classification as Skin. Sensitiser, Cat. 1B (H317) is based on results of a reliable OECD 429 study (Local Lymph Node Assay) on the registration substance itself.
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