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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 - 21 Jan 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- adopted in 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, C6-18 (branched and linear) alkyl and hydrocarbons, C10-18, n-alkanes, branched alkanes, cycloalkanes, aromatics
- Molecular formula:
- not applicable due to UVCB substance
- IUPAC Name:
- Fatty acids, C6-18 (branched and linear) alkyl and hydrocarbons, C10-18, n-alkanes, branched alkanes, cycloalkanes, aromatics
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- human
- Strain:
- other: EpiOcular™
- Details on test animals or tissues and environmental conditions:
- - Justification of the test method and considerations regarding applicability: The EpiOcular™ EIT was validated by the European Union Reference laboratory for Alternatives to Animal Testing (EURL ECVAM) and Cosmetics Europe between 2008 and 2013. The EpiOcular™ EIT was endorsed as an in vitro test that can be used to identify those chemicals not requiring classification and labelling for eye irritation or serious eye damage in accordance with UN GHS (No Category).
- Description of the cell system used, incl. certificate of authenticity and the mycoplasma status of the cell live: The EpiOcular™ tissue consists of normal, human-derived epidermal keratinocytes which have been cultured to form a stratified squamous epithelium similar to that found in the human cornea. The EpiOcular™ tissue mimics the histological, morphological, biochemical and physiological properties of the human corneal epithelium.
- RhCE tissue or hCE cell construct used, including batch number: MatTek Corporation Protocol: EpiOcular™ Eye Irritation Test (OCL-200-EIT), Model; 02 October 2017, Lot No. 30692 (Assay Medium Lot No.: 011821ISA)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL - Duration of treatment / exposure:
- 30 ± 2 min at 37 °C, 5% CO2 followed by 12 ± 2 min post-exposure immersion
- Duration of post- treatment incubation (in vitro):
- 120 ±15 min at 37 °C, 5% CO2
- Number of animals or in vitro replicates:
- duplicates for each treatment and control group
- Details on study design:
- - Details of the test procedure used: The EpiOcular™ Eye Irritation Test (EIT) consists of a topical exposure of the neat test item to a human reconstructed cornea model followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of MTT [(3-4,5-dimethyl thiazole 2-yl) 2,5-diphenyl-tetrazoliumbromide], present in cell mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The percent reduction of cell viability in comparison of untreated negative controls is used to predict eye irritation potential.
- Indication of controls used for direct MTT-reducers and/or colouring test chemicals: The ability of the test substance to directly reduce MTT and to form a blue/purple reaction product was assessed in a pre-experiment. The test substance was shown to directly reduce MTT in the direct MTT reduction test. Therefore, an additional test with freeze-killed tissues was performed.
- Wavelength and band pass (if applicable) used for quantifying MTT formazan, and linearity range of measuring device (e.g. spectrophotometer): 570 nm, 10 nm filter band pass, linearity plot provided in report
- Description of the method used to quantify MTT formazan: The absorbance (OD570) was measured with a plate reader (Labtech LT-4500 microplate reader).
- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model: The test substance is considered to be not irritating to eye if the tissue viability after 30 min exposure, 12 min post-exposure immersion and 120 min post-exposure incubation is > 60% relative to the negative control treated tissue.
- Acceptable variability between tissue replicates for positive and negative controls : The results are acceptable if the negative control OD is > 0.8 and < 2.5 and if the mean relative viability of the positive control is below 50% of the negative control viability.
- Acceptable variability between tissue replicates for the test chemical: The results are acceptable if the difference of viability between the two relating tissues of a single test item is < 20% in the same run (for positive and negative control tissues and tissues of test items). This applies also to the killed controls (test items and negative killed control) and the colorant controls which are calculated as percent values related to the viability of the relating negative control.
Results and discussion
In vitro
Results
- Irritation parameter:
- percent tissue viability
- Run / experiment:
- 30 min exposure
- Value:
- 89.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Direct-MTT reduction: Since a pre-test for direct MTT reduction was inconclusive due to the intrinsic colour of the test substance, an additional test with freeze-killed was performed. However, the results obtained showed that no interference due to direct reduction of MTT occurred in the main test. It was therefore considered unnecessary to use the results of the freeze-killed tissues for quantitative correction of results.
- Colour interference with MTT: The test substance did not change the colour when mixed with pure isopropanol and thus passed the colour interference pre-test. The use of colour correction tissues was not necessary.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean OD of the tissue replicates treated with the negative control was ≥ 0.8 and ≤ 2.8 for every exposure time (value obtained: 2.220). The negative control acceptance criterion was satisfied.
- Acceptance criteria met for positive control: The mean viability of the tissue replicates treated with the positive control was < 50% compared to the negative control (value obtained: 42.9%). The positive control acceptance criterion was satisfied.
- Acceptance criteria met for variability between replicate measurements: The difference in viability between the two relating tissues in each treatment group was < 20%. This acceptance criterion was satisfied.
Any other information on results incl. tables
Detailed results
Table 1: Mean OD570 Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item |
OD570 of tissues |
Mean OD570 of duplicate tissues |
Individual tissue viability (%) |
Relative mean viability (%) |
Difference in viability (%) |
Negative Control Item |
2.279 |
2.220 |
102.7 |
100* |
5.4 |
2.161 |
97.3 |
||||
Positive Control Item |
0.894 |
0.951 |
40.3 |
42.9 |
5.1 |
1.007 |
45.4 |
||||
Test Item |
1.901 |
1.993 |
85.6 |
89.8 |
8.3 |
2.085 |
93.9 |
OD: Optical Density
*: The mean viability of the negative control tissues is set at 100%
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- Under the conditions of the conducted test, the test substance did not present irritating properties towards human-derived epidermal keratinocytes in the EpiOcular™ model.
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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