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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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16/05/2017-18/06/2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Qualifier:
- according to guideline
- Guideline:
- other: Council regulation 440/2008, Method B.40 BIS:"In vitro skin Corrision:Human skin model Test", May 30, 2008
- Qualifier:
- according to guideline
- Guideline:
- other: MatTek Corporation protocol for: In Vitro EpiDerm TM Skin Corrosion Test (EPI-200-SCT) For Use with MatTek Corporation's reconstructed Human Epidermal Model EpiDerm; Version 07/11/2014.
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch No.of test material: 78-242-15
- Expiration date of the batch: 01/02/2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, protected from light
- Stability under test conditions: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item was applied undiluted. 50 µL of the test item was dispensed directly atop the EpiDerm TM tissue. The test item was spread to match size of the tissue. A nylon mesh was used as spreading aid.
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from multiple donors
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- after 3 minutes
- Value:
- >= 50
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- not specified
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- after 60 minutes
- Value:
- >= 15
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- not specified
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no corrosive effects. the test item is classified as "non-corrosive".
- Executive summary:
In the present study the skin corrosivity potential of the test item was analysed. Since corrosive chemicals are cytotoxic after a short time exposure to the stratum corneum of the epidermis the cytotoxic effects of the test item on EpiDermÔ, a reconstituted three-dimensional human epidermis model, were determined. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 3 min and 60 min exposure period and compared to those of the concurrent negative controls.
The test item showed no non-specific MTT-reducing potential but it showed colouring after mixture with isopropanol. Therefore, NSClivingwas determined. No correction of results was necessary because NSClivingwas below 5% (3 min treatment: 0.3%; 60 min treatment: 0.6%).
The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was³ 50% (104.7%) after 3 min treatment and³ 15% (93.8%) after 60 min treatment.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22/11/2017-15/12/2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Qualifier:
- according to guideline
- Guideline:
- other: MatTek Corporation Protocol for: In Vitro EpiDermTM Skin Irritation Test (EPI-200-SIT) For use with MatTek Corporation’s Reconstructed Human Epidermal Model EpiDerm (EPI-200-SIT); Version 07-Nov-2014
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from multiple donors
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- after 60 minutes treatment and 42 h post-incubation
- Value:
- > 50
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- not specified
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no irritant effects. The relative mean tissue viability after 60 min of exposure and 42 h post-incubation was > 50%. The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category”.
Referenceopen allclose all
The test item showed no non-specific MTT-reducing potential but it showed colouring after mixture with isopropanol. Therefore, NSClivingwas determined. No correction of results was necessary because NSClivingwas below 5% (3 min treatment: 0.3%; 60 min treatment: 0.6%).
The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was³ 50% (104.7%) after 3 min treatment and³ 15% (93.8%) after 60 min treatment.
The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 50% (104.2%) after 60 min treatment and 42 h post-incubation.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21/06/2017-21/06/2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: Bovine
- Strain:
- not specified
- Vehicle:
- physiological saline
- Amount / concentration applied:
- TEST MATERIAL
It was not possible to get a 20% concentration of solution/suspension with the test item in physiological saline 0.9% NaCl. Therefore the test item was administered directly and moistened with physiological saline 0.9% NaCl.
VEHICLE
Physiological saline 0.9% NaCl (AlleMan Pharma, lot no. 609709, expiry date: 21/06/2017) - Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- cornea opacity score
- Value:
- 13.09
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- No prediction can be made regarding the classification of the test substance YELLOW 2747 according to the evaluation criteria. Further testing in another suitable method is required.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11/12/2017-13/12/2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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)
- Qualifier:
- according to guideline
- Guideline:
- other: EURL ECVAM DB-ALM Method Summary No. 164: EpiOcular™ Eye Irritation Test - Summary, 22 July 2015
- Qualifier:
- according to guideline
- Guideline:
- other: EpiOcular™ Eye Irritation Test (OCL-200-EIT) For the prediction of acute ocular irritation of chemicals For use with MatTek Corporation’s Reconstructed Human EpiOcular™ Model, 29 June 2015
- GLP compliance:
- yes (incl. QA statement)
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- The mean relative tissue viability
- Value:
- <= 60
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In this study under the given conditions the test item showed irritant effects.
Referenceopen allclose all
The controls confirmed the validity of the study. The mean absolute OD570of the two negative control tissues was > 0.8 and < 2.5 (1.661). The mean relative tissue viability (% negative control) of the positive control was < 50% (18.6%). The inter tissue difference of replicate tissues of all dose groups was < 20% (18.6%).
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for classification or non-classification
Skin irritation
The In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) test and the In Vitro Skin Irritation: Reconstructed Human Epidermis Test has been performed.
The test item showed no corrosive or irritant effects.
Eye irritation
The eye irritancy potential of YELLOW 2747 was investigated in the bovine corneal opacity and permeability assay.
The result ( Mean in vitro irritation score) has been 13.09 .
The IVIS cut-off values for identifying test substances as inducing serious eye damage (UN GHS Category 1) and test substances not requiring classification for eye irritation or serious eye damage (UN GHS No Category) are:
IVIS |
UN GHS |
≤ 3 |
No Category |
> 3; ≤ 55 |
No prediction can be made |
> 55 |
Category 1 |
The substance does not require classification for serious eye damage (UN GHS No Category), but no prediction can be made and further testing is required.
The In vitro Eye Irritation: Ocular Irritation Assay using the EpiOcularTMHuman Tissue Model has been performed.
In this study under the given conditions the test item showed irritant effects. The test item is classified as “irritant“ in accordance with UN GHS “Category 2”.
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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