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Diss Factsheets
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EC number: 941-174-6 | CAS number: -
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- 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:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- (20 July 2012)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- (22 July 2010)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C16-18 (even numbered) and C18 unsatd., Me sulfates (salts)
- EC Number:
- 941-174-6
- IUPAC Name:
- 1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C16-18 (even numbered) and C18 unsatd., Me sulfates (salts)
- Test material form:
- other: white solid wax
- Details on test material:
- - Name of test material: MDIPA-Esterquat C16-18 and C18 unsatd.
- Physical state: waxy solid
- Analytical purity: 100%
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: MDIPA-Esterquat C16-18 and C18 unsatd.
- Physical state: solid
- Analytical purity: 100%
Test animals
- Species:
- other: three-dimensional human epidermis model (EPISKIN-SM)
Test system
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: negative control, positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
To reach optimal contact with the tissue without causing mechanical damage, the test substance was applied using a cotton swab. The exact amount of test substance applied could not be determined using this method. Since optimal contact was obtained using this method this deviation has no impact on the study integrity.
- skin was moistened with 5 μL Milli-Q water to ensure close contact - Duration of treatment / exposure:
- 15 min
- Observation period:
- 42 h
- Number of animals:
- triplicates
- Details on study design:
- TEST SYSTEM
- EPISKIN Small Model (EPISKIN-SM, 0.38 cm², Batch no.: 12-EKIN-039)
Three-dimensional human epidermis model, which consists of adult human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days, which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
APPLICATION
-the test substance was heated to approximately 50°C to soften the waxy substance
- the test substance was applied with a cotton swab directly on top of the moistened skin tissue and spread to match the size of the tissue
- incubation with test substance for 15 min at room temperature
- after washing: post incubation period of a total of 42 h at 37°C
- cell viability was determined by using the standard MTT assay
Negative control (3 tissues): 25 µL PBS
Positive control (3 tissues): 25 µL 5% SDS
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the tissues were washed with phosphate buffered saline, pre-warmed to approximately 50°C, removal was performed with a spatula (this has no impact on the study integrity)
- Time after start of exposure: 15 min
MTT ASSAY
After incubation, cell culture inserts were dried carefully to remove excess medium and were transferred into a 12-wells plate prefilled with 2 mL MTT-medium (0.3 mg/mL). The tissues were incubated for 3 h at 37°C. After incubation the tissues were placed on blotting paper to dry the tissues. Total biopsy was made by using a biopsy punch. Epidermis was separated from the collagen matrix and both parts were placed in prelabeled microtubes and extracted with 500 μl isopropanol (Merck, Darmstadt, Germany). Tubes were stored refrigerated and protected from light for 70 hours. The amount of extracted formazan was determined spectrophotometrically at 570 nm.
DATA ANALYSIS
Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues. Skin irritation potential of the test substance was classified according to remaining cell viability following exposure of the test substance.
SCORING SYSTEM:
- mean tissue vialbility > 50% = non-irritant
- mean tissue viability = 50% = irritant (R38 / Category 2)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 114
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 100
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The relative mean tissue viability obtained after 15 minutes treatment with the test item compared to the negative control tissues was 114%. Since the mean relative tissue viability was above 50%, the test item is considered to be non-irritant.
The positive control had a mean cell viability after 15 minutes exposure of 9%. The absolute mean OD570 of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 14%, indicating that the test system functioned properly.
No direct MTT reduction capacity of the test substance has been observed.
Any other information on results incl. tables
Viability of epidermal models:
|
Mean tissue viability (% of control)
|
Negative control (PBS) |
100 |
Positive control (5% SDS) |
9 |
Test item |
114 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- MDIPA-Esterquat C16-18 and C18 unsatd. is not irritating in the in vitro skin irritation test under the experimental conditions described in this report.
- Executive summary:
In a dermal irritation study performed in accordance with OECD Guideline 439 (In Vitro Skin Irritation) (22 July 2010) and EU method B.46 (In vitro skin irritation: reconstructed human epidermis model test) (20 July 2012), MDIPA-Esterquat C16-18 and C18 unsatd. (100% a. i.) was applied to the three-dimensional human epidermis model tissue (EPISKIN Small Model (EPISKIN-SM, 0.38 cm², Batch no.: 12-EKIN-039) for an exposure period of 15 minutes. The number of replicate tissues was three). The test substance was heated in advance to approximately 50°C to soften the waxy substance. To achieve optimal contact with the tissue without causing mechanical damage, the test substance was applied using a cotton swab. The exact amount of test substance applied to cover the entire skin surface could not be determined using this method. Since optimal contact was obtained using this method this deviation has no impact on the study integrity. After 15 minutes exposure at room temperature, the tissues were washed with phosphate buffered saline pre-warmed to approximately 50°C, and residual test substance was carefully removed using a spatula. Subsequently the tissue constructs were incubated for 42 h at 37°C. Cytotoxicity (irritancy) was expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.
The positive (5% SDS) and negative (PBS) control gave responses that were within the acceptance criteria and as such demonstrated the validity of the study.
The relative mean tissue viability obtained after 15 minutes treatment with MDIPA-Esterquat C16-18 and C18 unsatd. compared to the negative control tissues was 114%. Since the mean relative tissue viability for the test substance was above 50%, MDIPA-Esterquat C16-18 and C18 unsatd. is identified to be not irritating.
Data generated by fully validatedin vitromethods can be used for REACH purposes provided that the information for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment. Based on the result of thein vitroskin irritation study, MDIPA-Esterquat C16-18 and C18 unsatd. as neat substance would be Not Classified (NC) for skin irritation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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