Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 940-448-2 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-10-09 to 2013-10-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in accordance with GLP regulations and OECD/EU guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 26 July 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 06 July 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- tris(9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-9H-xanthen-9-ylium) 6-[(3-sulfonatonaphthalen-2-yl)methyl]-3-[(6-sulfonatonaphthalen-2-yl)methyl]naphthalene-2-sulfonate
- EC Number:
- 940-448-2
- Molecular formula:
- Not applicable (UVCB)
- IUPAC Name:
- tris(9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-9H-xanthen-9-ylium) 6-[(3-sulfonatonaphthalen-2-yl)methyl]-3-[(6-sulfonatonaphthalen-2-yl)methyl]naphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- other: EpiSkinSM
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- TEST SYSTEM
EpiSkinSM, EPISKIN SNC Lyon, France, is a three-dimensional human epidermis model. Adult human-derived epidermal keratinocytes are 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 the main basal, supra basal, spinous and granular layers and a functional stratum corneum. Its use for skin irritation testing involves topical application of test materials to the surface of the epidermis, and the subsequent assessment of their effects on cell viability.
- Supplier: SKINETHIC Laboratories; 4, rue Alexandre Fleming, 69007 – LYON, France.
- Batch No.: 13-EKIN-035
- Expiry date: 14 October 2013
Test system
- Type of coverage:
- other: EpiSkin model
- Preparation of test site:
- other: EpiSkin model
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not applicable
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 10 mg of the test item - Duration of treatment / exposure:
- 15 min
- Observation period:
- 42 hours
- Number of animals:
- 3 replicates per test item
3 replicates negative controls
3 replicates positive controls
3 replicates of additional control for coloured test item (i.e. for non-specific OD evaluation) - Details on study design:
- TEST SITE
- Area of exposure: the whole surface of the EpiSkin model
REMOVAL OF TEST SUBSTANCE
- Washing: PBS 1x solution
- Time after start of exposure: 15 minutes
SCORING SYSTEM: Viability of the test item treated EpiSkin model in comparison to negative control.
The test substance is considered to be a skin irritant (R38), if the mean relative viability after 15 minutes exposure and 42 hours post incubation is less or equal (≤) to 50 % of the negative control.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: Viability [% control]
- Value:
- 87
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 42 h. Max. score: 100.0. Remarks: Test item. (migrated information)
- Irritation / corrosion parameter:
- other: other: Viability [% control]
- Value:
- 26
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 42 h. Max. score: 100.0. Remarks: Positive control (SDS 5% aq.). (migrated information)
In vivo
- Irritant / corrosive response data:
- - Cell viability
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. - Other effects:
- - Validity of the test
The mean OD value of the three negative control tissues was 0.862. The mean OD value obtained for the positive control was 0.224 and this result corresponds to 26 % viability when compared to the results obtained from the negative controls. Each calculated standard deviation value (SD) for the % viability was below 18. All validity criteria were within acceptable limits and therefore the study can be considered as valid.
- Indicator for potential false viability
Possible direct MTT reduction with test substance:
No colour change was observed after three hours of incubation. The test material did not interact with the MTT, therefore additional controls and data calculations were not necessary. A false estimation of viability can be precluded.
Colouring potential of test substances:
As the test item has an intrinsic colour (red), three additional chemical-treated tissues were used for the non-specific OD evaluation. Mean OD (measured at 570 nm) of these tissues were determined as 0.025. The Non Specific Colour% (NSC %) was calculated as 2.9 %. Therefore additional data calculation was not necessary. A false estimation of viability can be precluded.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results obtained from this in vitro skin irritation test, using the EPISKIN model, indicated that the test item reveals no skin irritation potential under the utilised testing conditions. According to the current OECD Guideline No. 439, DOCU Red 116 is considered as non-irritant to skin and is therefore not classified.
- Executive summary:
The purpose of the study was to determine the skin irritation potential of the test item DOCU Red 116 on reconstituted human epidermis in the EPISKIN model in vitro.
Disks of epidermal units (three units / chemical) were treated with the test item and incubated for 15 minutes at room temperature. Exposure of the test material was terminated by rinsing the epidermal units 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 and protected from light. The resulting formazan chrystals were extracted with acidified isopropanol and quantified with the optical densities (OD) recorded spectrophotometrically.
SDS 5 % aq. and 1 x PBS treated epidermis units were used as positive and negative controls, respectively. For each treated tissue, viability was expressed as a percentage relative to negative control.
The test item is considered to be a skin irritant, if the mean relative viability after 15 minutes exposure and 42 hours post incubation is less than or equal to (≤) 50% when compared to the viability values obtained from the negative control.
In this in vitro skin irritation test using the EPISKIN model, the test item DOCU Red 116 did not show significantly reduced cell viability in comparison to the negative control. 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.
The results obtained from this in vitro skin irritation test, using the EPISKIN model, indicated that the test item reveals no skin irritation potential under the utilised testing conditions. According to the current OECD Guideline No. 439, DOCU Red 116 is considered as non-irritant to skin and is therefore not classified.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.