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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
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- Nanomaterial pour density
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- Endpoint summary
- Stability
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- 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 / corrosion
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12-14 February 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Modern guideline study performed in a GLP certified laboratory
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
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
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Batch number: RW 2013-10-22
Form: Powder
Color: Orange
Storage conditions: Room temperature
Expiring date: 22. 10. 2018
Constituent 1
Test system
- Controls:
- other: SDS (5% aq.) and PBS treated epidermis were used as positive and negative controls respectively (three units / control).
- Amount / concentration applied:
- 10 mg test item was applied evenly to each disks of EPISKIN (three units)
- Duration of treatment / exposure:
- 15 minutes
- Observation period:
- 2 days
- Number of animals:
- 3 replicates
- Details on study design:
- Disks of EPISKIN (three units) were treated with test item and incubated for 15 minutes at room temperature. Exposure of test material was terminated by rinsing with PBS 1x solution. Epidermis units were then incubated at 37 °C for 42 hours in an incubator with 5% CO2. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37°C in 5% CO2 protected from light. The precipitated formazan was then extracted using acidified isopropanol and quantified spectrophotometrically.
The test item has an intrinsic colour (orange), one additional chemical-treated tissue was used for the non-specific OD evaluation.
SDS (5% aq.) and PBS treated epidermis were used as positive and negative controls respectively (three units / control). For each treated tissue viability was expressed as a percentage relative to negative control.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: mean tissue viabilityin-vitro
- Basis:
- mean
- Remarks:
- %
- Time point:
- other: day 2
- Score:
- 67
- Max. score:
- 77
- Reversibility:
- no data
- Remarks:
- not applicable
- Irritant / corrosive response data:
- All obtained test item viability results (mean OD: 0.550) were above 50 % when compared to the viability values obtained from the negative control, therefore the test item was considered to be non-irritant to skin
Any other information on results incl. tables
The results of the optical density (OD) measured at 570 nm of each replicate and the calculated % viability of the cells is presented below:
OD values and viability percentages of the controls
Controls | Optical Density (OD) | Viability (%) | |
Negative Control: | 1 | 0.764 | 93 |
2 | 0.860 | 105 | |
3 | 0.833 | 102 | |
mean | 0.819 | 100 | |
standard deviation (SD) | 6.02 | ||
Positive Control: | 1 | 0.067 | 8 |
2 | 0.045 | 6 | |
3 | 0.037 | 5 | |
mean | 0.050 | 6 | |
standard deviation (SD) | 1.91 |
OD values and viability percentages of the test item
Test Item | Optical Density (OD) | Viability (%) | |
YELLOW LF 6881 | 1 | 0.593 | 72 |
2 | 0.629 | 77 | |
3 | 0.428 | 52 | |
mean | 0.550 | 67 | |
standard deviation (SD) | 13.07 |
OD values and NSC % of additional control
Additional colour control | Optical Density (OD) | Non Specific Colour %(NSC %) | |
YELLOW LF 6881 | 1 | 0.024 | 3.0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In this in vitro skin irritation test in the EPISKIN model with test item YELLOW LF 6881 the results indicated that the test item is Non Irritant (NI) [UN GHS: No Category].
- Executive summary:
Disks of EPISKIN (three units) were treated with test item and incubated for 15 minutes at room temperature. Exposure of test material was terminated by rinsing with PBS 1x solution. Epidermis units were then incubated at 37 °C for 42 hours in an incubator with 5% CO2. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37°C in 5% CO2protected from light. The precipitated formazan was then extracted using acidified isopropanol and quantified spectrophotometrically.
The test item has an intrinsic colour (orange), one additional chemical-treated tissue was used for the non-specific OD evaluation.
SDS (5% aq.) and PBS treated epidermis were used as positive and negative controls respectively (three units / control). For each treated tissue viability was expressed as a percentage relative to negative control.
The test item is considered to be irritant to skin, if the mean relative viability after 15 minutes exposure and 42 hours post incubation is less or equal (≤) to 50% of the negative control.
The test item showed reduced cell viability in comparison to the negative control (mean value: 67 %). However all obtained test item viability results were above 50 % when compared to the viability values obtained from the negative control, therefore the test item was considered to be non-irritant to skin.
Positive and negative controls showed the expected cell viability values within acceptable limits.The experiment was considered to be valid.
In this in vitro skin irritation test in the EPISKIN model withtest itemYELLOW LF 6881the results indicated that the test itemis Non Irritant (NI) [UN GHS: No Category].
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