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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | 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
- Study period:
- 2010-11-24 to 2010-11-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
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:
- (23 July 2009)
- 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 (incl. QA statement)
Test material
- Reference substance name:
- 1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C18 unsatd., Me sulfates (salts)
- IUPAC Name:
- 1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C18 unsatd., Me sulfates (salts)
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material: 1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C18 unsatd., Me-sulfates (salts)
Constituent 1
Test animals
- Species:
- other: in vitro test
Test system
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: positive, negative and quality control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µL - Duration of treatment / exposure:
- 60 ± 1 min
- Observation period:
- 42 ± 2 h
- Number of animals:
- triplicates
- Details on study design:
- TEST SYSTEM
EpiDerm EPI-200-SIT (MatTek Corporation, 200 Homer Avenue, Ashland, MA 01721, USA); Lot: 13885
APPLICATION
- test substance was applied topically for 60 min (± 1 min) to the EpiDerm RHE
- after washing: post incubation period of a total of 42 h (± 2 h) at 37°C (± 1°C) and 5% CO2 (± 1%)
- cell viability was determined by using the standard MTT assay
Negative control: 30 µL ultrapure water, 60 ± 1 min
Positive control: 30µL 5% SDS, 60 ± 1 min
Quality control: 30 µL 1% Triton X-100, 2 h ± 15 min
REMOVAL OF TEST SUBSTANCE
- after 60 min rinsing with PBS (15 times)
MTT ASSAY
- at the end of the 42 h (± 2 h) post incubation period, tissues were transferred into 24 well plate prepared for the Standard MTT Assay, each well containing 300 µL MTT medium
- the plates were incubated for 3 h (± 5 min) at 37°C (± 1°C) and 5 % CO2 (± 1 %)
- formazan dye was extracted from the tissues with Isopropanol for 2 h at room temperature while shaking at approx. 120 rpm
- from each tissue 2 x 200 µL aliquots of the blue formazan solution were transferred into a 96 well microtiter plate; OD was determined at 550 nm
DATA ANALYSIS
- viability in % of the treated tissues was calculated in relation to the corresponding negative control
SCORING SYSTEM:
- cell viability measurement (MTT assay, OD at 550 nm)
- mean tissue vialbility > 50% = non-irritant
- mean tissue viability = 50% = irritant (R38 / Category 2)
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: tissue viability
- Value:
- 82.7
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean of triplicates. Time point: 1 h exposure, 42 h post exposure. Reversibility: other: not applicable. (migrated information)
- Other effects / acceptance of results:
- Although residual test substance adhered to the reconstructed epidermis after the rinsing procedure, the overall performance of the study was not affected, because it has been demonstrated that the test substance did not chemically reduce MTT and the cell viability was not decreased below the defined threshold limits.
The positive control (5% SDS) decreased the cell viability to 7.8%. The quality control (1% Triton X-100) experiment resulted in a tissue viability of 95.9% demonstrating intact barrier function of the test system.
Any other information on results incl. tables
No direct MTT reduction capacity of the test substance has been observed.
Viability of epidermal models:
|
Quality control - Skin Barrier 1% Triton X-100 |
Negative control |
Positive control 5% SDS |
Test substance |
60 min exposure; 42 h post exposue |
- |
100.0 (± 1.2) |
7.8 (± 1.3) |
82.7 (± 1.5) |
2 h exposure |
95.5 (± 1.4) |
100.0 (± 4.0) |
- |
- |
result |
valid |
valid |
valid |
Not irritant |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- MDIPA Esterquat 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 according to OECD Guideline 439 (In Vitro Skin Irritation) (22 July 2010) and EU method B.46 (In vitro skin irritation: reconstructed human epidermis model test) (23 July 2009), 30 µL MDIPA Esterquat C18 unsatd. (100% a.i.) was applied in triplicates for 60 min to a three-dimensional human epidermis model (EpiDerm EPI-200-SIT, MatTek Corporation).
After 60 minutes exposure at 37°C, the tissues were rinsed 15 times with phosphate buffered saline to remove residual test substance. Subsequently the skin tissues were incubated for 42 ± 2 h at 37°C.
Cytotoxic (irritancy) was expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.
Positive (5% SDS), negative (ultrapure water) and quality (1% Triton X-100) control gave the appropriate response.
The relative mean tissue viability obtained after 60 minutes treatment with MDIPA Esterquat C18 unsatd. compared to the negative control tissues was 82.7 ± 1.5%. Since the mean relative tissue viability for the test substance was above 50%, MDIPA Esterquat C18 unsatd. is considered to be not irritating.
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