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Diss Factsheets
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EC number: 943-242-0 | 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 23 - 26 Oct 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: other guideline: ECVAM international validation study on in vitro tests for acute skin irritation: Report on the validity of the EPISKIN and EpiDerm assays and on the Skin Integrity Function Test (Altern Lab Anim. 2007 Dec.; 35 (6): 559-601)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Protocol for: IN VITRO EpiDerm™ SKIN IRRITATION TEST (EPI-200-SIT), Rev. 3/23/2009, MatTek Corporation, Ashland, USA
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany
Test material
- Reference substance name:
- 2,2-dimethyl-1,3-propanediyl dioleate
- EC Number:
- 255-713-1
- EC Name:
- 2,2-dimethyl-1,3-propanediyl dioleate
- Cas Number:
- 42222-50-4
- IUPAC Name:
- 2,2-dimethylpropane-1,3-diyl bisoctadec-9-enoate
- Details on test material:
- - Name of test material (as cited in study report): 2,2-dimethyl-1,3-propanediyl dioleate
- Physical state: yellowish liquid
- Analytical purity: 100%
- Lot/batch No.: OE 10124A
- Expiration date of the lot/batch: 2013-01-24
- Storage condition of test material: in a closed vessel at room temperature (20 ± 5 °C)
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: EpiDermTM; reconstructed three-dimensional human epidermis (EPI-200)
- Details on test animals or test system and environmental conditions:
- TEST SKIN MODEL
- Source: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
TEST METHOD
The EpiDermTM model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organised basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. Irritant materials are identified by their ability to penetrate the stratum corneum and to damage the underlaying cell layers which is determined through a decrease in cell viability as determined by MTT reduction assay.
ADAPTATION TO CELL CULTURE CONDITIONS
Prior to treatment, tissue inserts were transferred into 6-well plates containing 900 µL assay medium per well. The plates were pre-incubated in an incubator for 1 h (37 °C, 5% CO2) before use. After pre-incubation, tissue-free wells were filled with 0.9 mL fresh assay medium and the tissues were inserted into the respective wells. Afterwards, tissues were incubated at 37 °C and 5% CO2 for a period of 18 h.
INCUBATION CONDITIONS (INCUBATOR)
- Temperature (°C): 37
- CO2 gas concentration (%): 5
Test system
- Type of coverage:
- other: open (in vitro system)
- Preparation of test site:
- other: intact reconstructed human epidermis
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: concurrent control tissues treated with DPBS served as negative controls, positive controls were exposed to 5% SDS
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 30 µL
NEGATIVE CONTROL SUBSTANCE:
- Negative control substance: Dulbecco’s phosphate buffered saline (DPBS without CaCl2 and MgCl2)
- Amount(s) applied: 30 µL
POSITIVE CONTROL SUBSTANCE:
- Positive control substance: SDS, 5% (v/v) in deionised water
- Amount(s) applied: 30 µL - Duration of treatment / exposure:
- 1 h
- Observation period:
- not applicable, post-treatment incubation period: 42 h
- Number of animals:
- not applicable, the test was performed in triplicates for each treatment and control group
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the tissues were rinsed with DPBS to remove residual test substance
- Time after start of exposure: 1 h
- Post-treatment incubation period: 42 h
CELL VIABILITY MEASUREMENTS
For determining alterations in cell viability, MTT reduction assays were performed 42 h after the incubation period. Therefore, tissues were incubated in 0.3 mL MTT solution (1 mg/mL in medium) for 3 h at 37 °C and 5% CO2. After aspiration of the MTT solution, tissues were washed with DPBS for several times and subsequently thoroughly dried. For the extraction of the formazan product, each tissue insert was placed into an empty pre-warmed 24-well plate and 2 mL of isopropanol was pipetted onto each insert. After shaking the plate for 2 h at room temperature, the optical density was measured at 570 nm in a 96-well plate using a plate spectral photometer.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 100
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean value of negative controls (DPBS). Time point: 1 h . Reversibility: other: reversibility: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 7.8
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean value of positive controls (5% SDS). Time point: 1 h. Reversibility: other: reversibility: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 100.3
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean value of tissues treated with the test item (100%). Time point: 1 h. Reversibility: other: reversibility: not applicable. (migrated information)
In vivo
- Irritant / corrosive response data:
- No irritating potential of the test substance was observed, since the mean relative cell viability of tissues was ≥ 50% compared to the negative control. The positive and negative controls showed the expected results and therefore validated the study.
- Other effects:
- No further effects were observed.
Any other information on results incl. tables
RESULTS OF THE PRE-TESTS
After 1 h incubation, a mixture of the test substance with 0.3 mL water did not result in colour formation, which might interfere with the measurement of optical density in the main study. No direct MTT reduction was caused by the test substance as shown by the observation that the MTT solution did not change its colour after 1 h incubation with the test substance. No reaction with the nylon mesh was observed after 1 h incubation with the test substance.
Table 3. Results of MTT assay after 1 h exposure
|
Negative control |
Test item |
Positive control |
||||||
Tissue sample |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
OD570 |
2.132 2.151 |
2.044 2.084 |
2.028 2.044 |
2.227 2.225 |
2.074 2.066 |
1.958 1.971 |
0.214 0.211 |
0.215 0.216 |
0.222 0.225 |
OD570(mean) |
2.081 |
2.003 |
1.975 |
2.165 |
2.009 |
1.904 |
0.152 |
0.155 |
0.163 |
OD570(mean values of replicates ± %RSD) |
2.020 ± 2.7 |
2.026 ± 6.5 |
0.157 ± 3.6 |
||||||
Viability (%) |
100 |
100.3 |
7.8 |
OD = optical density; RSD = relative standard deviation
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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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