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EC number: 242-332-0 | CAS number: 18448-65-2
- 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 vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of keratinocytes
Test material
- Reference substance name:
- Bis(hydroxyethyl)methyloleylammonium chloride
- EC Number:
- 242-332-0
- EC Name:
- Bis(hydroxyethyl)methyloleylammonium chloride
- Cas Number:
- 18448-65-2
- Molecular formula:
- C23H48NO2.Cl
- IUPAC Name:
- bis(2-hydroxyethyl)(methyl)[(9Z)-octadec-9-en-1-yl]azanium chloride
Constituent 1
Results and discussion
- Positive control results:
- Positive Control (Cinnamic aldehyde) induction >1.5-fold at concentration 16-128µM and EC1.5 was calculated as 8.113 µM.
In vitro / in chemico
Results
- Key result
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
In this study, Bis(hydroxyethyl)methyloleylammonium chloride was classified as Negative using the KeratinoSens prediction model.
The test item did not induce statistically significant luciferase induction >1.5 in repetitions 2 and 3 but did induce significant luciferase induction in repetition 1. The respective EC1.5 value in rep 1 was calculated as 0.869 µM, however the viability was less than 70% at the inducing concentration and therefore rep 1 was also considered negative.
Sensitisation Potential of the Test Item: Repetition 1
Rep 1 |
Test item concentration (µM) |
|||||||||||
|
0.977 |
1.953 |
3.906 |
7.813 |
15.625 |
31.250 |
62.500 |
125.000 |
250.000 |
500.000 |
1000.000 |
2000.000 |
Mean fold induction |
1.687 |
1.795 |
0.694 |
0.025 |
0.001 |
0.002 |
0.004 |
0.006 |
0.012 |
0.035 |
0.073 |
0.006 |
Viability % |
56.329 |
19.937 |
-1.582 |
-6.962 |
-7.278 |
-5.063 |
0.000 |
-2.848 |
-3.797 |
-0.949 |
2.215 |
6.329 |
T-test |
4.61E-06 |
4.08E-07 |
3.42E-02 |
2.44E-09 |
1.27E-09 |
1.28E-09 |
1.37E-09 |
1.43E-09 |
1.69E-09 |
3.22E-09 |
9.37E-09 |
1.46E-09 |
SD |
0.078 |
0.220 |
0.156 |
0.019 |
0.000 |
0.000 |
0.001 |
0.001 |
0.003 |
0.008 |
0.021 |
0.002 |
IMAX |
1.795 at 1.953 µM |
|||||||||||
EC1.5 |
0.869 µM |
|||||||||||
IC30 |
0.610 µM |
|||||||||||
IC50 |
1.147 µM |
Sensitisation Potential of the Test Item: Repetition 2
Rep 2 |
Test item concentration (µM) |
|||||||||||
|
0.977 |
1.953 |
3.906 |
7.813 |
15.625 |
31.250 |
62.500 |
125.000 |
250.000 |
500.000 |
1000.000 |
2000.000 |
Mean fold induction |
1.020 |
1.374 |
1.409 |
0.409 |
0.004 |
0.004 |
0.006 |
0.006 |
0.011 |
0.043 |
0.122 |
0.012 |
Viability % |
83.740 |
56.325 |
22.708 |
8.848 |
-6.163 |
-5.071 |
-0.527 |
-1.368 |
-0.176 |
1.443 |
3.665 |
4.268 |
T-test |
8.47E-01 |
1.17E-02 |
4.28E-03 |
8.39E-05 |
1.37E-09 |
1.37E-09 |
1.43E-09 |
1.44E-09 |
1.65E-09 |
4.02E-09 |
3.75E-08 |
1.73E-09 |
SD |
0.275 |
0.380 |
0.229 |
0.143 |
0.001 |
0.000 |
0.001 |
0.001 |
0.002 |
0.014 |
0.051 |
0.005 |
IMAX |
1.409 at 3.906 µM |
|||||||||||
EC1.5 |
N/A - threshold of induction not crossed at any test item concentration |
|||||||||||
IC30 |
1.466 µM |
|||||||||||
IC50 |
2.320 µM |
Sensitisation Potential of the Test Item: Repetition 3
Rep 3 |
Test item concentration (µM) |
|||||||||||
|
0.977 |
1.953 |
3.906 |
7.813 |
15.625 |
31.250 |
62.500 |
125.000 |
250.000 |
500.000 |
1000.000 |
2000.000 |
Mean fold induction |
0.644 |
0.698 |
0.483 |
0.040 |
0.002 |
0.002 |
0.003 |
0.005 |
0.010 |
0.033 |
0.057 |
0.005 |
Viability % |
75.116 |
37.728 |
8.435 |
-6.187 |
-5.544 |
-4.961 |
1.779 |
-0.089 |
0.030 |
1.398 |
4.843 |
9.132 |
T-test |
1.52E-02 |
4.03E-02 |
4.82E-04 |
3.73E-09 |
1.29E-09 |
1.30E-09 |
1.33E-09 |
1.40E-09 |
1.60E-09 |
3.02E-09 |
5.88E-09 |
1.40E-09 |
SD |
0.218 |
0.256 |
0.140 |
0.020 |
0.000 |
0.001 |
0.001 |
0.002 |
0.003 |
0.011 |
0.011 |
0.002 |
IMAX |
0.698 at 1.953 µM |
|||||||||||
EC1.5 |
N/A - threshold of induction not crossed at any test item concentration |
|||||||||||
IC30 |
1.111 µM |
|||||||||||
IC50 |
1.633 µM |
Determination criteria for the skin sensitisation potential ofthe test item |
|||
|
REP1 |
REP2 |
REP3 |
Does at least one concentration of Test Item induce luciferase activity >1.5-fold: |
Yes |
No |
No |
Does the first concentration inducing luciferase activity above 1.5, have a viability above 70%: |
No |
N/A |
N/A |
Is p value < 0.05 for at least one concentration that yielded >1.5-fold induction with viability above 70% |
Yes |
N/A |
N/A |
Does EC1.5value occur at a concentration <1000µM (or <200µg/ml) |
Yes |
N/A |
N/A |
Does the test item induce the luciferase in a dose-dependent manner |
No |
N/A |
N/A |
Classification |
Negative |
Negative |
Negative |
All of the formal acceptance criteria of the tests were met,except for the average induction of the positive control (cinnamic aldehyde) at 32 µM, which was not within the historical range (1.6 and 3).However, as all other acceptance criteria were met, and there was a dose-dependent increase of induction with the positive control, results are considered to be valid.
Assay Acceptance Criteria (Mean of 3 repetitions)
Criteria |
Result |
PASS or FAIL |
|
1 |
Positive Control (PC) (Cinnamic aldehyde) induction>1.5-fold in at least one concentration |
16-128µM |
PASS |
2 |
Average induction of PC at 32µM is [1.6-3.0] |
4.773 |
FAIL |
3 |
EC1.5value is [6-39µM] |
8.113 |
PASS |
4 |
CV% of blank values < 20% |
17.0218 |
PASS |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a study conducted according to OECD Test Guideline 442D, Bis(hydroxyethyl)methyloleylammonium chloride was found to be not sensitising to the skin.
- Executive summary:
The human skin sensitisation potential of Bis(hydroxyethyl)methyloleylammonium chloride was assessed using the validated in vitro method, the KeratinoSens assay, in accordance with the current OECD Test Guideline 442D. This study was assigned a reliability score of 1 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).
All of the formal acceptance criteria of the tests were met, with the exception of the average induction of the positive control (cinnamic aldehyde) at 32 µM, which was not within the historical range (1.6 and 3). However, as all other acceptance criteria were met, and there was a dose-dependent increase of induction with the positive control, the results of this study are considered to be valid.
The results from this study found that Bis(hydroxyethyl)methyloleylammonium chloride did not induce statistically significant luciferase induction (>1.5) in repetitions 2 or 3. Significant luciferase induction was induced in repetition 1 and the respective EC1.5 value was calculated as 0.869 µM, however, the cellular viability was less than 70% at the inducing concentration and therefore rep 1 was also considered negative. Bis(hydroxyethyl)methyloleylammonium chloride is therefore classified as Negative according to the KeratinoSens prediction model.
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