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EC number: 268-919-1 | CAS number: 68154-72-3
- 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 corrosion: 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:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC method B.40 tris: In vitro Skin Corrosion: Human Skin Test Method
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, lanolin, lithium salts
- EC Number:
- 268-919-1
- EC Name:
- Fatty acids, lanolin, lithium salts
- Cas Number:
- 68154-72-3
- IUPAC Name:
- Fatty acids, lanolin, lithium salts
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: SOAP 012-2
- Expiration date of the lot/batch: November 01, 2022
- Purity test date: 13 December 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At +10 to +25°C, kept containers tightly closed in a cool, well-ventilated place, kept away from heat, sparks and open flame.
FORM AS APPLIED IN THE TEST (if different from that of starting material) 25 mg of test item were applied to the skin model with a surface area of 0.63 cm2 to uniformly cover the skin surface. The test item is a fine powder.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The test item was applied topically to a three-dimensional human skin model, comprising at least a reconstructed epidermis with a functional stratum corneum. Corrosive materials are identified by their ability to produce a decrease in cell viability (as determined, for example, by using the MTT reduction assay) below defined threshold levels at specified exposure periods. The principle of the human skin model assay is based on the hypothesis that corrosive chemicals are able to penetrate the stratum corneum by diffusion or erosion, and are cytotoxic to the underlying cell layers.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ (EPI-200-SCT)
- Tissue batch number(s): Lot no. 25878
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: At the end of the exposure period, the test item was carefully washed from the skin surface with Dulbecco's phosphate buffered saline (D-PBS)
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg MMT /mL
- Incubation time: 3 h
- Spectrophotometer: Tecan Sunrise Magellan Version 7.2
- Wavelength: 540 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: 1.968 ± 0.147 (acceptance criteria: 1.0-3.0)
- Barrier function: 6.8 h (acceptance criteria:4.77-8.72)
- Contamination: No contamination
NUMBER OF REPLICATE TISSUES: Two replicate tissues for each treatment (exposure periods) were employed
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
The frozen tissues were stored in the freezer (-20 ± 5°C).
The test item was applied to two freeze-killed tissues. In addition, two freeze-killed tissues were left untreated. The entire assay protocol was performed on the frozen tissues in parallel to the assay performed with the live EpiDerm tissues.
- Fresh tissues / killed tissues: Freeze-killed tissues. Due to interacting of the test item with the MTT measurement (reduction of MTT) an additional test with freeze-killed tissues had to be performed.
- N. of replicates : 2
- Method of calculation used:
For the MTT reducing test item, calculations were corrected by values of correspondent additional controls.
True viability = Viability of treated tissue – Interference from test chemical = OD tvt – OD kt
where OD kt = (mean OD tkt – mean OD ukt)
tvt = treated viable tissue kt = killed tissues
tkt = treated killed tissue ukt = untreated killed tissue (NC treated tissue)
If the interference by the test substance is greater than 30% of the negative control value, additional steps must be taken into account or the test substance may be considered incompatible with this test.
PREDICTION MODEL / DECISION CRITERIA
-The criteria of corrosivity associated with the EpiDermTM model are as follows:
- the test item is considered to be corrosive to skin and classified as category 1 (or optional category 1A ), if the viability after 3 minutes exposure is less than 50%;
- the test item is considered to be corrosive to skin and classified as sub-category 1B-and-1C, if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is less than 15%;
- the test item is considered to be non-corrosive to skin, if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg
NEGATIVE CONTROL : sterile deionised water
- Amount(s) applied (volume or weight): 50 µL
POSITIVE CONTROL : 8 N KOH
- Amount(s) applied (volume or weight): 50 µL - Duration of treatment / exposure:
- 1st period: 3 min; 2nd period: 60 min
- Number of replicates:
- Two replicate tissues for each treatment (exposure periods) were employed.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minute ecposure
- Value:
- 98.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour exposure
- Value:
- 95.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean optical density (OD) of the negative control of 2 tissues was 1.456 (3 minute exposure) or 1.552 (1-hour exposure) and therefore well within the acceptable range of ≥ 0.8 to ≤ 2.8
- Acceptance criteria met for positive control: The viability of cells treated with the positive reference item 8 N KOH was 11.2% or 4.4% (3-minute or 1-hour exposure, respectively) of the negative control and, hence well below the 15% cut-off value at the 1-hour exposure
- Acceptance criteria met for variability between replicate measurements: The difference of viability between the two tissue replicates (at 20 - 100% viability) was below the limit of acceptance of 30%.
All acceptance criteria were fulfilled.
Any other information on results incl. tables
Historical data of negative and positive controls
(Most
recent background data from GLP studies of the years 2015 - 2017
(n = 14).
Material |
Average OD (mean% difference ±SD) |
Average viability [%] (mean% difference ±SD) |
Range |
No. of unqualified experi-ments |
|
Viability [%] |
% difference |
||||
Short time incubation – 3‑min |
|||||
Negative control (Non-Corrosive) |
1.624 (2.5±2.4) |
100 (2.5±2.4) |
93.7–106.3 |
0.14–8.6 |
0#1 |
8 N KOH (Corrosive) |
0.126 (8.8±7.4) |
7.6 (8.8±7.4) |
2.0–15.6 |
<0.01–23.7 |
0 |
Long time incubation – 60‑min |
|||||
Negative control (Non-Corrosive) |
1.650 (4.0±5.0) |
100 (4.0±5.0) |
85.6–114.4 |
0.13–18.3 |
0#1 |
8 N KOH (Corrosive) |
0.090 (5.7±9.8) |
5.9 (5.7±9.8) |
2.0–12.6 |
0.30–38.4 |
0#2 |
OD: Optical density. Viability for negative control is set = 100%
SD: Standard deviation
CV: Coefficient of variation
#1 Unqualified results = if the mean OD of the NC tissues is < 0.8 or > 2.8
if difference in viability for duplicate tissues > 30%
#2 Unqualified results = 8 N KOH: viability > 15% (1-hour exposure)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the present test conditions Fatty acids, lanolin, lithium salts tested at two exposure periods of 3 minutes or 1 hour was non-cytotoxic and, hence, predicted to be non-corrosive to skin in an experiment employing an artificial three-dimensional model of human skin.
- Executive summary:
The purpose of this study was to assess the corrosive properties of Fatty acids, lanolin, lithium salts to human skin,in an experiment with an artificial three-dimensional model of human skin. TheEpiDerm™model was employed.
The test item Fatty acids, lanolin, lithium salts, the negative control sterile deionised water or the positive reference item 8 N KOH were applied to the skin model surface at two exposure periods of 3 minutes or 1 hour.
Two tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined byusing the MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue) reduction assayand expressed as relative percentage of viability of the negative control-treated tissues.
In comparison to the negative controls, the mean viability of cells exposed to the test item was 98.1% after a 3-minute exposure period and 95.7% after a 1-hour exposure (corrected viability calculated for MTT reducing test items using freeze-killed control tissues) and hence ,the 3-minute and the1-hour exposure values were above the cut-off percentage cell viability values distinguishing corrosive from non-corrosive test items of ≥50% and ≥15%, respectively.Therefore, the test item was non-corrosive in this skin model and is predicted to be non-corrosive to human skin.
Conducted according to OECD Test Guideline 431 and GLP, the study is considered to be reliable without restriction (Klimisch 1).
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