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EC number: 204-376-9 | CAS number: 120-20-7
- 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
- skin sensitising in LLNA
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
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 50954345T0
- Expiration date of the lot/batch:
- Purity: 99.4 area-% (GC, Rtx-5 Amine capillary), 99.5 area-% (GC, DB-35 MS capillary)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: guaranteed by the sponsor - Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS B.V.,Inc., 5960 AD Horst, The Netherlands
- Age at study initiation: ca. 8 weeks (pretest / main test)
- Weight at study initiation: 17.8 g - 19.2 g (pretest) /16.9 - 22.5 g (main test)
- Housing: singel housing (polycarbonate cages type MII)
- Diet (e.g. ad libitum): Kliba mouse/rat maintenance diet “GLP” supplied by Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, (ad libitum)
- Water (e.g. ad libitum): drinking water (ad libitum)
- Acclimation period: at least 5 days before the first application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- methyl ethyl ketone
- Concentration:
- 10, 25 and 50 %
- No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: A solubility experiment was performed according to the recommendations given by OECD 429. The test-substance preparations at different concentrations were solutions in MEK.
- Irritation:
In order to determine the highest test substance concentration that does not induce local signs of skin irritation and/or systemic toxicity a pretest (experimental conduct in accordance with GLP, but without a GLP status) was performed. Two mice were treated with test substance concentrations of 1%, 10% and 50% each on three consecutive days.
In the pretest, clinical signs were recorded after each application as well as on day 5. Signs of local irritation were recorded on day 1, 2 and 5. Prior to the first application of the test item (day 0), on day 2 and before sacrifice (day 5) the ear thickness was determined by using a micrometer. Furthermore, the ears were punched after sacrifice at the apical area by using a biopsy punch (Ø 0.8 cm) and were immediately pooled per animal and weighed by using an analytical balance. Additionally, the weight of the pooled lymph nodes from both sides was determined for each animal.
No signs of systemic toxicity were observed in the pretest. At the tested concentrations, the animals did not show relevant signs of local irritation as confirmed by determination of the ear weights (compared to current vehicle values). The ear thickness measurements were only increased at the 50% concentration; however, this may be due to moderate or severe compound residues which were noted on the ear skin during the whole observation period.
Therefore, the following dose levels were selected for the main study: 10%, 25% and 50%.
TREATMENT PREPARATION AND ADMINISTRATION:
The test-substance preparation was produced on a weight per weight basis shortly before application by stirring with a magnetic stirrer. After stirring with a magnetic stirrer, the test substance was soluble in the vehicle. MEK was used as vehicle because good solubility of the preparation was achieved.
Analytical investigation of the test substance preparations was done in compliance with the principles of GLP by the test facitliy Pharmacelsus GmbH, 66123 Saarbrücken, Germany (2017BSF015).
nominal analytical
10%w/w: 9.21%w/w
25%w/w: 23.38%w/w
50%w/w: 54.89%w/w - Positive control substance(s):
- other: alpha-Hexylcinnamaldehyde, techn. 85%
- Statistics:
- Mean values and standard deviations of the measured parameters were calculated for the test and control groups from the individual values. The stimulation indices of 3H thymidine incorporation, cell count, lymph node weight and ear weight measurements were calculated as the ratio of the test group mean values for these parameters divided by that of the vehicle control group.
3H thymidine incorporation, cell count, lymph node weight and ear weight: WILCOXON-Test - Positive control results:
- Historical Positive Control Data for alpha-Hexylcinnamaldehylde (techn. 85%) in MEK are performed twice per year using concentrations of 1%, 5%, 15%. The EC3 (estimated concentration that leads to the SI of 3.0) for 3H thymidine incorporation was calculated by semi-logarithmical regression from the results of all concentrations to be 1.4% and 4.5%, respectively. The EC1.5 (estimated concentration that leads to the SI of 1.5) for cell count was calculated to be 1.0% and 2.4%, respectively.
- Key result
- Parameter:
- EC3
- Remarks:
- 3H thymidine incorporation
- Value:
- 5.8
- Parameter:
- other: EC1.5
- Remarks:
- cell count
- Value:
- 4.6
- Parameter:
- SI
- Remarks:
- ³H-thymidine incorporation
- Value:
- 7.78
- Test group / Remarks:
- 10% in MEK
- Parameter:
- SI
- Remarks:
- ³H-thymidine incorporation
- Value:
- 13.54
- Test group / Remarks:
- 25% in MEK
- Parameter:
- SI
- Remarks:
- ³H-thymidine incorporation
- Value:
- 20.76
- Test group / Remarks:
- 50% in MEK
- Cellular proliferation data / Observations:
- EC3 / EC1.5 CALCULATION
The threshold concentration for sensitization induction was <10%. The EC3 (estimated concentration that leads to the SI of 3.0) for 3H thymidine incorporation and the EC1.5 (estimated concentration that leads to the SI of 1.5) for cell count was calculated by semi-logarithmical regression from the results of all concentrations to be 5.8% and 4.6%, respectively. - Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- As the EC3 (3H thymidine incorporation) and the EC1.5 (cell count) were calculated to be above 2%, it is concluded that 3,4-Dimethoxyphenethylamine exhibits a skin sensitizing potential (Skin Sens. Cat. 1B according to CLP) in the Murine Local Lymph Node Assay under the test conditions chosen.
Reference
Test Group |
Treatment |
³H-thymidine incorporation Stimulation Index1 |
Cell count Stimulation Index1 |
Lymph Node Weight Stimulation Index1 |
Ear Weight Stimulation Index1 |
1 |
vehicle MEK |
1.00 |
1.00 |
1.00 |
1.00 |
2 |
10% in MEK |
7.78 ## |
1.91 ## |
1.44 ## |
0.98 |
3 |
25% in MEK |
13.54 ## |
2.71 ## |
2.10 ## |
1.00 |
4 |
50% in MEK |
20.76 ## |
2.87 ## |
2.22 ## |
1.12 # |
1test group x/test group 1 (vehicle control)
The statistical evaluations were performed using the WILCOXON-test (# for p≤0.05, ## for p≤0.01)
Pretest / Irritation Screening:
No signs of systemic toxicity were observed in the pretest. After application of the 1%, 10% and 50% concentrations, the animals did not show relevant signs of local irritation as confirmed by determination of the ear weights (compared to current vehicle values). The ear thickness measurements were only increased at the 50% concentration; however, this may be due to moderate or severe compound residues which were noted on the ear skin during the whole observation period.
Main test:
When applied as 10%, 25% or 50% solution in MEK, the test substance induced a biologically relevant (increase above the cut off Stimulation Index of 3), statistically significant and concentration-dependent increase of3H thymidine incorporation into the cells from the auricular lymph nodes. Concomitantly, all concentrations induced a biologically relevant and statistically significant response (increase to 1.5-fold or above of control value = stimulation index (SI) ≥ 1.5) in the auricular lymph node cell counts.
In addition, statistically significant increases in lymph node weights were noted at all concentrations. The test substance concentrations did not cause increases (SI > 1.25) in ear weight demonstrating the absence of relevant ear skin irritation. However, a statistically significant increase in ear weights was noted at 50%. The expected body weight gain was generally observed during the study. No signs of systemic toxicity were noticed in all animals during general observation. Very slight erythema and/or slight swelling of the ear skin was observed in all animals at the 25% and 50% concentration on study day 2 and/or 5.Depending on the applied concentration slight to severe compound residues were observed on the ear skin in all test-substance treated animals.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The skin sensitizing potential of 3,4-Dimethoxyphenethylamine was assessed by using the radioactive Murine Local Lymph Node Assay (2017, reliability score: 1). Groups of 5 female CBA/CaOlaHsd mice each were treated with 10%, 25% and 50% (w/w) solutions of the test substance in Methyl ethyl ketone (MEK) or with the vehicle alone. The study used 3 test groups and 1 control group. Each test animal was treated with 25 µL per ear of the appropriate test-substance preparation applied to the dorsal surfaces of both ears on three consecutive days. The control group was treated with 25 µL per ear of the vehicle alone. No signs of systemic toxicity were noticed in all animals during general observation. When applied as 10%, 25% or 50% solution in MEK, the test substance induced a biologically relevant (increase above the cut off Stimulation Index of 3), statistically significant and concentration-dependent increase of 3H thymidine incorporation into the cells from the auricular lymph nodes. Concomitantly, all concentrations induced a biologically relevant and statistically significant response (increase to 1.5-fold or above of control value = stimulation index (SI) ≥ 1.5) in the auricular lymph node cell counts. In addition, statistically significant increases in lymph node weights were noted at all concentrations. The test substance concentrations did not cause increases (SI > 1.25) in ear weights demonstrating the absence of relevant ear skin irritation. A statistically significant increase in ear weight was noted at 50%. Very slight erythema and/or slight swelling of the ear skin was observed in all animals at the 25% and 50% concentration on study day 2 and/or 5. Depending on the applied concentration slight to severe compound residues were observed on the ear skin in all test-substance treated animals. Thus, it is concluded that 3,4-Dimethoxyphenethylamine exhibits a skin sensitizing potential in the Murine Local Lymph Node Assay underthe test conditions chosen. The threshold concentration for sensitization induction was <10%. The EC 3 (estimated concentration that leads to the SI of 3.0) for 3H thymidine incorporation and the EC 1.5 (estimated concentration that leads to the SI of 1.5) for cell count was calculated by semi-logarithmical regression from the results of all concentrations to be 5.8% and 4.6%, respectively.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results of the skin sensitization testing, the test item is classified as skin sensitization cat. 1B (H317) according to Regulation (EC) No 1272/2008 (CLP).
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