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EC number: 308-121-3 | CAS number: 97862-72-1
- 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:
- 17 August 2017 to 22 September 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
- Report date:
- 2017
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:
- Fatty acids, lanolin, esters with cholesterol-low lanolin alcs.
- EC Number:
- 295-374-7
- EC Name:
- Fatty acids, lanolin, esters with cholesterol-low lanolin alcs.
- Cas Number:
- 92044-94-5
- IUPAC Name:
- Fatty acids, lanolin, esters with cholesterol-low lanolin alcs.
- Test material form:
- solid - liquid: suspension
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: Reconstructed Human Epidermis
- Cell source:
- other: MatTek kit
- Justification for test system used:
- Description EpiDermTM (EPI-200) Reconstructed Human Epidermis
Lot Number 25842
Date of Receipt 19th Sep 2017
Morphology EPI-200 LOT#: 25842
Histological examination demonstrates human epidermis-like structure: including multiple layers (at least 4) of viable epithelial cells (basal layer, stratum spinosum, stratum granulosum) which are present under multilayered stratum corneum: 9 layers--> - PASS
Tissue thickness: 95.5 µm --> Acceptance range: >70 µm and <130 µm) - PASS
Tissue Viability: Optical Density (O.D.) values: 1.39 ± 0.046 (mean and SD of MTT value of 3 tissues exposed to H2O) -->Acceptance range: [1.0 - 3.0]- PASS
Skin Barrier Function: ET 50% of tissues exposed to 100 µL Triton X-100 1% (n=3): 7.12 h -->Acceptance range: [4.77h- 8.72h] - PASS
Sterility: No evidence of contamination during long term antibiotic and antimycotic free culture: No contamination reported --> - PASS - Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: MatTek
- Tissue batch number(s): 25842
- Delivery date: 19 September 2017
- Date of initiation of testing: 25 September
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 31 minutes at room temperature and 34 minutes at 37°C, 5% CO2, ≥95% RH
- Temperature of post-treatment incubation: 42 ± 4h post-treatment incubation
REMOVAL OF TEST MATERIAL AND CONTROLS: rinsing (no details)
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: no data
- Incubation time:no data
- Spectrophotometer: BMG LabTech FluoStar Optima (calibrated on 24 July 2017)
- Wavelength: 570 nm
- Linear OD range of spectrophotometer: not indicated
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA: based on blanks obtained during 66 historical runs (no data provided)
NUMBER OF REPLICATE TISSUES: 3/treatment
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
•A test item is considered to be an irritant (I) to skin in accordance with UN GHS Category 2 or EU R38 if the skin model viability after exposure and post-treatment incubation is ≤50%.
•A test item may be considered as a non-irritant (NI) if the skin model viability after exposure and post-treatment incubation is >50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mgTEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg neat
NEGATIVE CONTROL:Sterile Dulbecco’s Phosphate Buffered Saline (DPBS) neat
POSITIVE CONTROL: 5% Sodium dodecyl sulphate (SDS)
- Concentration (if solution): 5% in water - Duration of treatment / exposure:
- 31 minutes at room temperature and 34 minutes at 37°C, 5% CO2, ≥95% RH
- Duration of post-treatment incubation (if applicable):
- 42 ± 4h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 97.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Prior to the study, the required compatibility checks confirmed that the test item did not interfere with MTT and no water colouration was observed.
Acceptance criterion 1 The mean OD570 of the negative control (treated with DPBS) tissues must be ≥ 0.8 and ≤ 2.8 1.514 PASS
Acceptance criterion 2 The mean of the positive control relative percentage viability must be ≤ 20% of the mean of the negative controls. 5.097 PASS
Acceptance criterion 3 The standard deviation of viability percentages for triplicate skin models in each experimental condition must be < 18% NC: 5.243; PC: 1.176; TA2: 12.886 PASS
Acceptance criterion 4 The mean OD of the 6 wells containing extraction solvent alone (blanks) must be ≤ 0.1. 0.162 FAIL
blank controls:
Optical Density (OD) values obtained with blanks were higher than 0.1 (0.162) causing a deviation from the acceptance criteria. However, the spectrophotometer was fully validated and had passed all required tests. The OD values for blanks observed in this study are consistent with historical data using this spectrophotometer in the XCellR8 laboratory and meet our current internal acceptance criteria of blank OD values <0.194 (mean of XCellR8 historical data, based on blanks obtained during 66 historical runs), therefore this is not considered to be an issue in the interpretation of this study data.
Any other information on results incl. tables
Viability measurements after 65 min of application and 42h (± 4h) post-incubation of test and reference items and controls.
Condition |
Tissue # |
Raw data |
Blank corrected data |
Mean OD |
% of Viability |
||
Aliquot 1 |
Aliquot 2 |
Aliquot 1 |
Aliquot 2 |
||||
NC |
Tissue 1 |
1.781 |
1.753 |
1.619 |
1.591 |
1.605 |
106.022 |
Tissue 2 |
1.657 |
1.587 |
1.495 |
1.425 |
1.460 |
96.444 |
|
Tissue 3 |
1.663 |
1.614 |
1.501 |
1.452 |
1.477 |
97.534 |
|
PC |
Tissue 1 |
0.268 |
0.251 |
0.106 |
0.089 |
0.098 |
6.451 |
Tissue 2 |
0.224 |
0.231 |
0.062 |
0.069 |
0.066 |
4.337 |
|
Tissue 3 |
0.226 |
0.234 |
0.064 |
0.072 |
0.068 |
4.502 |
|
TA2 |
Tissue 1 |
1.481 |
1.453 |
1.319 |
1.291 |
1.305 |
86.207 |
Tissue 2 |
1.657 |
1.552 |
1.495 |
1.390 |
1.443 |
95.288 |
|
Tissue 3 |
1.859 |
1.845 |
1.697 |
1.683 |
1.690 |
111.636 |
NC: negative control (DPBS), PC: Positive control (SDS 5%), TA2: test substance
Code |
Mean of OD |
SD of OD |
Mean of viability (%) |
SD of viability (%) |
CV % |
Classification |
NC |
1.514 |
0.079 |
100.000 |
5.243 |
5.243 |
Non-Irritant |
PC |
0.077 |
0.018 |
5.097 |
1.176 |
23.064 |
Irritant |
TA2 |
1.479 |
0.195 |
97.710 |
12.886 |
13.188 |
Non-Irritant |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the outcome of the study the substance is considered not irritating to the skin.
- Executive summary:
The skin irritation potential of the substance was assessed in vitro according to OECD Test Guideline 439.After a 65 minute exposure on the surface of the EpiDermTM reconstructed human epidermis and a 42 ± 4h post-exposure incubation time, viability of the tissues was assessed and compared to the negative control. The percentage of viability obtained was 97.710 % and therefore the substance is considered as non-irritant to the skin
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