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EC number: 629-704-1 | CAS number: 226995-92-2
- 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
Skin sensitisation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- November 2000
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Poly(oxy-1,2-ethanediyl), alpha-[2-[bis(2-aminoethyl)methylammonion)ethyl]-, omega-hydroxy, N,N'-di-Limnanthes alba seed oil acyl derivatives, methyl sulfates (salts)
- EC Number:
- 629-704-1
- Cas Number:
- 226995-92-2
- Molecular formula:
- The substance is a UVCB - no specific molecular weight or formula is available.
- IUPAC Name:
- Poly(oxy-1,2-ethanediyl), alpha-[2-[bis(2-aminoethyl)methylammonion)ethyl]-, omega-hydroxy, N,N'-di-Limnanthes alba seed oil acyl derivatives, methyl sulfates (salts)
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Batch number: CW-4896
Storage conditions: at room temperature
Purity: 85.9% actives
Expiry date: 2 years
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- Nulliparous and non-pregnant.
On the first day of treatment animals were approximately 9 weeks old and had a mean body weight of 20.5 ± 1.0g.
Acclimitisation: 5 days
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Preliminary test: 5, 10, 25 and 50% concentration.
Main test - first experiment: 0, 1, 2.5 and 5%.
Main test - second experiment: 0, 0.1, 0.5 and 1%. - No. of animals per dose:
- Preliminary test: 4 animals
Main test: 4 animals/dose - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- In the positive control group given HCA at the concentration of 25%, a moderate increase in cellularity and a stimulation index exceeding the threshold value of 3 (First experiment: SI = 4.62; Second experiment: SI = 6.97) was noted. The study was therefore considered to be valid.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 17.36
- Test group / Remarks:
- 1%
- Key result
- Parameter:
- SI
- Value:
- 47.89
- Test group / Remarks:
- 2.5%
- Key result
- Parameter:
- SI
- Value:
- 6.43
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- SI
- Value:
- 2.03
- Test group / Remarks:
- 0.1%
- Key result
- Parameter:
- SI
- Value:
- 6.98
- Test group / Remarks:
- 0.5%
- Key result
- Parameter:
- SI
- Value:
- 14.58
- Test group / Remarks:
- 1%
- Cellular proliferation data / Observations:
- Preliminary test:
The substance was an irritant at all concentrations tested.
Main test:
No clinical signs and no mortality was observed during the study.
The body weight gain of the treated animals was similar to that of the controls.
A slight to moderate erythema (grades 1-3) was noted in all animals given the concentrations of 2.5% and 5%. Dryness of the skin was recorded at the concentrations 1, 2.5 and 5% and crusts at the concentration of 5%. These skin reactions were associated with increase in ear thickness at the concentrations of 5, 2.5, 1 and 0.5%.
No cutaneous reactions and no increase in ear thickness were observed in the animals given the concentration of 0.1%.
A significant lymphoproliferation was noted in the treated groups given the concentration of 5, 2.5, 1 and 0.5%. However, as this lymphoproliferation was not dose-dependent and as it could be due to the sole irritant effect observed at these same concentrations, it was not attributed to delayed contact hypersensitivity. No lymphoproliferation was noted at the concentration of 0.1%.
Any other information on results incl. tables
Study results - First Experiment
Concentration (%) | 0 | 1 | 2.5 | 5 |
Viability (%) | 91.67 | 89.89 | 80.32 | 91.03 |
Cellularity index | - | 9.09 | 5.66 | 9.68 |
Stimulation Index | - | 17.36 | 47.89 | 6.43 |
Increase in ear thickness (% between day 1 -6) | 0 | 23.3 | 68.63 | 83.5 |
Study results: Second Experiment
Concentration (%) | 0 | 0.1 | 0.5 | 1 |
Viability (%) | 95.93 | 95.14 | 95.14 | 96.98 |
Cellularity index | - | 1.07 | 2.85 | 4.67 |
Stimulation Index | - | 2.03 | 6.98 | 14.58 |
Increase in ear thickness (% between day 1 -6) | 3.06 | 7.14 | 23.71 | 42.27 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance induces a lymphoproliferation which is most probably not attributable to delayed contact hypersensitivity in the murine LLNA.
- Executive summary:
This study was undertaken to evaluate the potential of the substance to induce delayed contact hypersensitivity using the murine LLNA. Evaluation of irritation was also conducted in parallel by measurement of ear thickness. A preliminary test was conducted in order to define the concentration of the substance to be usedin the main test. There were two experiments conducted in the main test. The first experiment employed substance concentrations of 1, 2.5 and 5% and the second experiment employed 0.1, 0.5 and 1%. The second experiment was included becuase irritation occurred at all concentrations in the first experiment. In both experiments a negative group that received the vehicle only and a positive group that received alph hexyl cinnamaldehyde (HCA) only was also included. Four females of CBA/J strain mice were included per dose group. During the induction phase the substance was applied over the ears (25 µL/ear) for three consecutive days. After 2 days of resting, the proliferation of lymphocytes in the lymph node draining the application site was measured by incoporation of tritiated methyl thymidine (day 6). The obtained values were used to calclulate the Stimulation Index (SI). The substance was an irritant at all concentrations tested in the preliminary test. In the main test there were no clinical signs and no mortality observed.
The body weight gain of the treated animals was similar to that of the controls. A slight to moderate erythema (grades 1-3) was noted in all animals given the concentrations of 2.5% and 5%. Dryness of the skin was recorded at the concentrations 1, 2.5 and 5% and crusts at the concentration of 5%. These skin reactions were associated with increase in ear thickness at the concentrations of 5, 2.5, 1 and 0.5%. No cutaneous reactions and no increase in ear thickness were observed in the animals given the concentration of 0.1%. A significant lymphoproliferation was noted in the treated groups given the concentration of 5, 2.5, 1 and 0.5%. However, as this lymphoproliferation was not dose-dependent and as it could be due to the sole irritant effect observed at these same concentrations, it was not attributed to delayed contact hypersensitivity. No lymphoproliferation was noted at the concentration of 0.1%. In conclusion, the substance induces a lymphoproliferation which is most probably not attributable to delayed contact hypersensitivity in the murine LLNA.
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