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EC number: 283-815-6 | CAS number: 84731-55-5
- 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
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 1 March 2017 and 01 May 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Lithium isooctadecanoate
- EC Number:
- 283-815-6
- EC Name:
- Lithium isooctadecanoate
- Cas Number:
- 84731-55-5
- Molecular formula:
- C18H35O2.Li
- IUPAC Name:
- Lithium isooctadecanoate
- Reference substance name:
- Isooctadecanoic acid
- EC Number:
- 250-178-0
- EC Name:
- Isooctadecanoic acid
- Cas Number:
- 30399-84-9
- Molecular formula:
- C18H36O2
- IUPAC Name:
- Isooctadecanoic acid
- Reference substance name:
- Lithium laurate
- EC Number:
- 238-663-5
- EC Name:
- Lithium laurate
- Cas Number:
- 14622-13-0
- Molecular formula:
- C12H24O2.Li
- IUPAC Name:
- lithium laurate
- Reference substance name:
- Lithium myristate
- EC Number:
- 243-743-8
- EC Name:
- Lithium myristate
- Cas Number:
- 20336-96-3
- Molecular formula:
- C14H27O2.Li
- IUPAC Name:
- lithium myristate
- Reference substance name:
- Lithium palmitate
- EC Number:
- 243-842-6
- EC Name:
- Lithium palmitate
- Cas Number:
- 20466-33-5
- Molecular formula:
- C16H32O2.Li
- IUPAC Name:
- lithium palmitate
- Reference substance name:
- Lithium nonadecanoate
- Molecular formula:
- C19H37O2Li
- IUPAC Name:
- Lithium nonadecanoate
- Reference substance name:
- Lithium icosanoate
- EC Number:
- 257-088-0
- EC Name:
- Lithium icosanoate
- Cas Number:
- 51250-21-6
- Molecular formula:
- C20H39O2.Li
- IUPAC Name:
- lithium icosanoate
- Test material form:
- solid
- Details on test material:
- - Batch number: A104/99
- Expiration date: 30 November 2018
- Storage condition of test material: At room temperature, protected from light
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
- Specific details on test material used for the study:
- - Stability under test conditions: Stable
- Treatment of test material prior to testing: None
- Preliminary purification step: None
- Final preparation of a solid: Applied neat
In vitro test system
- Test system:
- other: EPISKIN™ Reconstructed Human Epidermis Model
- Source species:
- other: EPISKIN™ Reconstructed Human Epidermis Model
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EPISKIN™ Reconstructed Human Epidermis Model
- Source strain:
- other: EPISKIN™ Reconstructed Human Epidermis Model
- Details on animal used as source of test system:
- The EPISKINTM model is a three-dimensional reconstructed human epidermis model consisting of adult human-derived epidermal keratinocytes seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. A highly differentiated and stratified epidermis model is obtained after a 13-Day culture period comprising of the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
- Justification for test system used:
- This is the test system described in OECD 439. Following a full validation study the EpiSkinTM reconstructed human epidermis model showed evidence of being a reliable and relevant stand-alone test for predicting rabbit skin irritation when the endpoint is measured by MTT reduction and for being used as a replacement for the Draize Skin Irritation Test for the purpose of distinguishing between Irritating and Non-Irritating test items. The procedure followed is based on the recommended EpiSkin™ SOP, Version 1.8 (February 2009), ECVAM Skin Irritation Validation Study.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN™ Reconstructed Human Epidermis Model Kit
- Tissue batch number(s): 17-EKIN-017
- Production date: Not specified
- Shipping date: Not specified
- Delivery date: 25 April 2017
- Date of initiation of testing: 1 March 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
- Temperature of post-treatment incubation (if applicable): 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream of DPBS to gently remove any residual test item
- Observable damage in the tissue due to washing: Not specified
- Modifications to validated SOP: None
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: Labtech LT-4500 microplate reader
- Wavelength: 570 nm
- Filter: None
- Filter bandwidth: Not applicable
- Linear OD range of spectrophotometer: Not specified
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: Not specified
- Barrier function: Not specified
- Morphology: Not specified
- Contamination: Not specified
- Reproducibility: Not specified
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Killed tissues
- Procedure used to prepare the killed tissues: water-killed tissues
- N. of replicates: Not specified
- Method of calculation used: Not specified
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: three
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be an irritant to skin if the relative mean tissue viability after 15-Minute exposure period followed by the 42-Hour post-exposure incubation period is less than 50%.
- The test substance is considered to be non-irritant to skin if the viability after 15-Minute exposure period followed by the 42-Hour post-exposure incubation period is greater than or equal to 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: Appropriately sized discs of the test item were applied
- Concentration: Test material is solid
VEHICLE: Not applicable
NEGATIVE CONTROL
- Amount(s) applied: 10 µL
- Concentration: 0.3 mg/mL in DPBS
POSITIVE CONTROL
- Amount(s) applied: 10 µL
- Concentration: 5% w/v aqueous solution - Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
Test animals
- Species:
- other: reconstituted human epidermis model
- Strain:
- other: reconstituted human epidermis model
- Details on test animals or test system and environmental conditions:
- The plates were kept in the biological safety cabinet at room temperature for 15 minutes. The rinsed tissues were incubated at 37°C, 5% CO2 in air for 42 hours.
Test system
- Type of coverage:
- other: Topical
- Preparation of test site:
- other: Not applicable
- Vehicle:
- other: No vehicle used
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- The test material was applied neat.
- Amount(s) applied (volume or weight with unit): Appropriately sized discs of the test item were applied
- Application method: Prior to the test item being applied 5 µL of sterile distilled water was topically applied to the epidermal surface in order to improve contact between the test item and the epidermis. Appropriately sized discs of the test item were applied to the epidermis surface ensuring uniform covering.
- Concentration: The test material was used as supplied.
VEHICLE: No vehicle used - Duration of treatment / exposure:
- 15 Minutes & 42 hour post exposure incubation
- Observation period:
- Not applicable
- Number of animals:
- Not applicable
- Details on study design:
- TEST SITE
- Area of exposure:Appropriately sized discs of the test item were applied
- % coverage: The test material was applied topically to the corresponding tissues ensuring uniform covering.
- Type of wrap if used: None used
REMOVAL OF TEST SUBSTANCE
- Washing: At the end of the exposure period, each tissue was removed from the well using forceps and rinsed using a wash bottle containing DPBS with Ca++ and Mg++. Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream of PBS to gently remove any residual test material.
- Time after start of exposure: 15 Minutes post exposure
SCORING SYSTEM:
Quantitative MTT Assessment (percentage tissue viability)
For the test material, the relative mean tissue viabilities obtained after the 15 minute treatment followed by the 42 hour post-exposure incubation period were compared to the mean of the negative control treated tissues (n=3). The relative mean viabilities were calculated in the following way:
mean OD570 of test material / mean OD570 of negative control x 100 = Relative mean tissue viability (percentage of negative control)
Classification of irritation potential is based upon relative tissue viability following the 15 minute exposure period followed by the 42 hour post-exposure incubation period according to the following:
Mean tissue viability is =50% : Irritant (I) H315 Category 2
Mean tissue viability is >50% : Non-Irritant (NI) Not classified. Category 3 cannot be determined
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Relative mean viability
- Value:
- 89.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- It was considered unnecessary to perform IL-1a analysis as the results of the MTT test were unequivocal.
The relative mean tissue viability for the positive control treated tissues was 13.8% relative to the negative control treated tissues and the standard deviation value of the viability was 15.4%. The positive control acceptance criteria were therefore satisfied.
The mean OD570 for the negative control treated tissues was 0.666 and the standard deviation value of the viability was 12.6%. The negative control acceptance criteria were therefore satisfied.
Any other information on results incl. tables
RESULTS
Test Material, Positive Control Material and Negative Control Material
The individual and mean OD570 values, standard deviations and tissue viabilities for the test material, negative control material and positive control material are given in Table 1. The mean viabilities and standard deviations of the test material and positive control, relative to the negative control are also given in Table 1.
The relative mean viability of the test material treated tissues was 89.3% after a 15 -minute exposure.
Quality Criteria
The relative mean tissue viability for the positive control treated tissues was =40% relative to the negative control treated tissues and the standard deviation value of the percentage viability was =20%. The positive control acceptance criterion was therefore satisfied.
The mean OD570 for the negative control treated tissues was =0.6 and the SD value of the percentage viability was =20%. The negative control acceptance criterion was therefore satisfied.
Table 1 : Mean OD570 Values and Percentage Viabilities for the Negative Control Material, Positive Control Material and Test Material
Material |
OD570 of tissues |
Mean OD570 of triplicate tissues |
±SD of OD570 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
± SD of Relative mean viability (%) |
Negative Control Material |
0.761 |
0.666 |
0.084 |
114.3 |
100* |
12.6 |
0.636 |
95.5 |
|||||
0.602 |
90.4 |
|||||
Positive Control Material |
0.209 |
0.092 |
0.102 |
31.4 |
13.8 |
15.4 |
0.048 |
7.2 |
|||||
0.019 |
2.9 |
|||||
Test Material |
0.605 |
0.595 |
0.059 |
90.8 |
89.3 |
8.9 |
0.648 |
97.3 |
|||||
0.531 |
79.7 |
OD = Optical density
SD= Standard deviation
*= The mean viability of the negative control tissues is set at 100%
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test material was considered to be Non-Irritant (NI)
- Executive summary:
Introduction:
The purpose of this test was to evaluate the skin irritation potential of the test material using the EPISKINTM reconstituted human epidermis model after a treatment period of 15 minutes followed by a post-exposure incubation period of 42 hours. The principle of the assay was based on the measurement of cytotoxicity in reconstituted human epidermal cultures following topical exposure to the test material by means of the colourimetric MTT reduction assay. Cell viability is measured by enzymatic reduction of the yellow MTT tetrazolium salt (3 -[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a blue formazan salt (within the mitochondria of viable cells) in the test material treated tissues relative to the negative controls.
Methods:
Triplicate tissues were treated with the test material for an exposure period of 15 minutes. At the end of the exposure period each tissue was rinsed before incubating for approximately 42 hours. At the end of the post-exposure incubation period, each tissue was taken for MTT-loading. The maintenance medium from beneath each tissue was transferred to pre-labelled micro tubes and stored in a freezer for possible inflammatory mediator determination. After MTT loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues.
At the end of the formazan extraction period, each tube was mixed thoroughly and duplicate 200 µL samples were transferred to the appropriate wells of a pre-labelled 96-well plate. The optical density was measured at 540 nm. Data are presented in the form of percentage viability (MTT reduction in the test material treated tissues relative to negative control tissues).
Results:
The relative mean viability of the test material treated tissues was 89.3% after a 15-minute exposure.
Quality criteria:
The quality criteria required for acceptance of results in the test were satisfied.
Conclusion: The test material was considered to be Non-Irritant (NI).
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