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EC number: 274-668-9 | CAS number: 70546-25-7
- 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
The following in vitro skin and eye irritation studies showed negative results:
Skin:
assessment of the skin irritancy of the test item Macrolex Fluoreszenzrot G with reconstructed human epidermis (RhE).
Eye:
ocular irritation properties of the test item was performed using the reconstructed human cornea-like epithelium (RhCE) cell model EpiOcularTM.
Evaluation of corrosive/severe irritant properties by using the Bovine Corneal Opacity and Permeability (BCOP) Test Method
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch number: CHA91249
Purity: 97.6 % - Test system:
- artificial membrane barrier model
- Source species:
- human
- Cell type:
- other: reconstructed human epidermis
- Cell source:
- other: reconstructed human epidermis
- Source strain:
- other: reconstructed human epidermis
- Justification for test system used:
- Human full thickness skin models and reconstituted epidermal equivalents are in vitro engineered tissue cultures that provide a three dimensional architecture which is biochemically, morphologically and functionally comparable to human epidermal tissue/skin in vivo. In contrast, organotypic skin explant systems are based on ex vivo skin removed from human or mouse and cultured in toto, afterwards. According to the literature all the models are useful in screening for topically applied irritant, corrosive or photocytotoxic substances.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The model used for this study has a functional stratum corneum with an underlying layer of living cells as recommended by the test guidelines. The barrier function of the stratum corneum is adequate, as has been shown by the supplier.
The viability of the living cells in the model must be sufficiently high to discriminate well between the positive and negative control substances. Cell viability is measured by the amount of MTT reduction, i.e. an OD value, following exposure to the negative control substance or the test item. - Control samples:
- yes, concurrent vehicle
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- Three replicates of the epiCS inserts were exposed to the test item (30 mg), negative or positive control (each 30 µl). For the solid test item 30 µl of 0.9% NaCl were used to moisten and ensure good contact with the epidermis surface. A piece of nylon mesh was used as a spreading aid.
- Duration of treatment / exposure:
- The incubation of the treated epiCS inserts was carried out at RT for 20 min.
- Duration of post-treatment incubation (if applicable):
- After a post treatment incubation period of 42 h of the rinsed tissue in the incubator a MTT assay was performed
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of 3 replicates
- Value:
- 98.81
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Executive summary:
A study was performed for the assessment of the skin irritancy of the test item Macrolex Fluoreszenzrot G with reconstructed human epidermis (RhE). The experiment was carried out in vitro using the commercially available test method epiCS®.
The study was conducted in accordance with OECD TG 439 and EU Test Method B.46.
The test item was applied undiluted topically to the RhE tissue construct in triplicates and incubated for 20 minutes, followed by a 42 hours post-treatment incubation period.
Cell viability was measured in a photometer by the amount of MTT (methylthiazole tetrazolium) reduction. The optical density value obtained for the test item was used to calculate the percentage of viability relative to the negative control, which is set at 100%.
The results of the concurrent negative control (NC, 0.9 % NaCl) and positive control (PC, 5 % SDS) demonstrated the viability (NC) and sensitivity (PC) of the test model.
The following value of cell viability was recorded for the test item: 99 % (rounded).
In conclusion the results of the assay used show no skin irritant properties of the test item Bayscript Magenta BB and thus, the test item requires no classification according to UN GHS.
Reference
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
- 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)
- Version / remarks:
- Adopted 09 Oct 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch number: CHA91249
Purity: 97.6 % - Species:
- human
- Strain:
- other: three-dimensional human cornea model tissue model
- Details on test animals or tissues and environmental conditions:
- - Justification of the test method and considerations regarding applicability:
In principle the EpiOcular™ eye irritation test (EIT) measures the ocular irritation potential of a test item by determination of cytotoxic effects on a reconstructed human cornea epithelium (RhCE) tissue model to discriminate chemicals not requiring classification for eye irritancy (UN GHS No Category) from those requiring classification. The EpiOcular™ EIT is not intended to differentiate between UN GHS Category 1 (serious eye damage) and UN GHS Category 2 (eye irritation). This differentiation would need to be addressed by another tier of a test strategy. As a BCOP has already been conducted and Category 1 can be excluded based on the result, this test can be used to determine, if the substance needs to be classified (Category 2) or not.
- Description of the cell system used, incl. certificate of authenticity and the mycoplasma status of the cell live:
The experiment was carried out on the EpiOcular™ RhCE tissue construct (about 0.6 cm² in size; MatTek Corporation, Slovakia).
The RhCE tissue equivalents were shipped in 24 well cell culture plates on semi solid agar’s medium (Part#: OCL-200, OCL -212; Lot No.: 23755; Testing date: 06 Dec 2016). - 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 µg - Duration of treatment / exposure:
- 6h
- Duration of post- treatment incubation (in vitro):
- 18h
- Number of animals or in vitro replicates:
- each 2 tissues for the test item, positive and negative controls
- Details on study design:
- - RhCE tissue construct used, including batch number: The EpiOcular™ RhCE tissue construct consists of 3 viable layers of cells and a non-keratinized surface as recommended by the test guidelines. The cell viability and barrier function as well as sterility of each batch of the RhCE tissue construct used is adequate, as has been demonstrated by the supplier.
RhCE tissue viability in EpiOcular™ EIT is measured by enzymatic conversion of the vital dye MTT by the viable cells of the tissue into a blue MTT formazan salt that is quantitatively measured after extraction from tissues.
- Doses of test chemical and control substances used: 50 µg of the neat test item, 50 µL negative control (deionized water) and positive control (neat methyl acetate), respectively, were applied to the EpiOcular™ tissue surface in duplicate.
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods (where applicable): 37 ± 2°C; 6h exposure, 25 min. post-soak immersion, 18h post-treatment incubation
- Indication of controls used for direct MTT-reducers and/or colouring test chemicals (if applicable): Killed control and colour control not required.
- Number of tissue replicates used per test chemical and controls (positive control, negative control, NSMTT, NSCliving and NSCkilled, if applicable): each 2 tissues for the test item, positive and negative controls
- Wavelength and band pass (if applicable) used for quantifying MTT formazan, and linearity range of measuring device (e.g. spectrophotometer): The concentration of formazan was measured by determination of the OD of the isopropanol-extracts in duplicate at 570 nm in an automatic reader of a spectrophotometer (EL808, Bio-Tek; 96 well format, 200 µL).
- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model: For interpretation of cell viability results the cut-off value distinguishing classified (irritant) from non-classified substances as given in OECD TG 492 was used:
- The test chemical is identified as not irritant and not requiring classification according to UN GHS (No Category) if the mean percent tissue viability after exposure and post-exposure incubation is more than (>) 60%.
- The test chemical is identified as irritant and potentially requiring classification according to UN GHS (Category 2 or Category 1) if the mean percent tissue viability after exposure and post exposure incubation is less than or equal (≤) to 60%.
- Positive and negative control means and acceptance ranges based on historical data: The following acceptance criteria determine the validity of an assay:
- mean OD 570 nm negative control (NC) is > 0.8 and < 2.5
- mean relative viability of the positive control (PC) is < 50 % (relative to negative control)
- the difference of viability between the two replicates is < 20 %. - Irritation parameter:
- other: mean percent tissue viability
- Value:
- 95.5
- Vehicle controls validity:
- not examined
- Remarks:
- no vehicle used
- Negative controls validity:
- valid
- Remarks:
- 100 % final cell viability
- Positive controls validity:
- valid
- Remarks:
- 24.1 % final cell viability
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes - Interpretation of results:
- GHS criteria not met
- Remarks:
- not irritant
- Conclusions:
- The study was conducted under GLP according to OECD guideline 439 on the registered substance itself. The method is to be considered scientifically reasonable with no deficiencies in documentation or any deviations, the validity criteria are fulfilled, positive and negative controls gave the appropriate response. Hence, the results can be considered as reliable to assess the irritation potential of the test item to the eye in vitro.
As the final test item-treated tissue viability was > 60% (76.2%) relative to negative control, the test item can be characterized as NOT having eye irritating properties. - Executive summary:
The model used is standardized and commercially available.
The EpiOcularTM Eye Irritation Test (EIT) was conducted in accordance with OECD 492.
The solid test item was applied topically to the RhCE tissue surface in duplicate for 6 hours, followed by an 18 hour post-treatment incubation period.
Cell viability was measured in a spectrophotometer by assessing the extent of MTT (methylthiazole tetrazolium) reduction. The optical density value obtained for the test item was used to calculate the percentage of viability relative to the negative control, which was set at 100 %.
The results of the concurrent negative control (NC, deionized water) and positive control (PC, neat methyl acetate) demonstrated the viability (NC) and sensitivity (PC) of the tissue model.
The final mean percent tissue viability recorded for the test item is 96 % (rounded).
According to the results of this study the test item was identified as not requiring classification for eye irritation according to UN GHS (No Category).
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 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 i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch number: CHA91249
Purity: 97.6 % - Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Test system: isolated cornea from eyes of slaughtered cattle
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- 750 µl of the test material formulations were applied to the corneas.
- Duration of treatment / exposure:
- 4 hours
- Duration of post- treatment incubation (in vitro):
- 90 min
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- In this test method, eye damaging properties of a test item is assessed by quantitative measurements of changes in corneal opacity and permeability with an opacitometer and a visible light spectrophotometer, respectively. Both measurements are used to calculate an IVIS, which is used to assign an in vitro irritancy hazard classification
category for prediction of the in vivo ocular irritation potential of a test item.
The BCOP test method uses isolated corneas from the eyes of freshly slaughtered cattle. Corneal opacity is measured quantitatively as the amount of light transmission through the cornea. Permeability is measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea, as detected in the medium in the posterior chamber of the corneal holder. Test items are applied to the epithelial surface ofthe cornea by addition to the anterior chamber of the corneal holder. - Irritation parameter:
- cornea opacity score
- Run / experiment:
- Mean
- Value:
- 13.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- fluorescein leakage
- Run / experiment:
- Mean
- Value:
- -0.002
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: IVIS (in vitro irritation score)
- Run / experiment:
- Mean
- Value:
- 13.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Based on OECD TG 437 and the experimental conditions reported the test item is classified as not seriously damaging the eye
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Based on the experimental conditions reported in an OECD TG 437 study the test item is classified as not seriously damaging the eye (no Category 1).
Referenceopen allclose all
Tabular In vitro irritancy score
Cornea No. | Opacity per cornea | Permeability per cornea | IVIS per cornea | IVIS per group; mean (SD) | |
Negative control isotonic saline solution | 1 2 3 |
4.0 1.1 1.1 |
0.008 0.010 0.011 |
4.1 1.3 1.3 0.5 |
2.2 (1.6) |
Positive Control 20% Imidazole | 4 5 6 |
85.7 55.1 79.6 |
0.667 0.624 0.448 |
95.7 64.4 86.3 |
82.1 (16.0) |
Test item 20 % Bayscript Magenta BB |
10 11 12 |
30.5 1.9 8.2 |
-0.001 -0.002 -0.002 |
30.5 1.9 8.2 |
13.5 (15.0) |
IVIS < 55: classification as Category 1 is not warranted
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
No classification is warranted because the following in vitro skin and eye irritation studies showed negative results:
Skin:
assessment of the skin irritancy of the test item Macrolex Fluoreszenzrot G with reconstructed human epidermis (RhE).
Eye:
ocular irritation properties of the test item was performed using the reconstructed human cornea-like epithelium (RhCE) cell model EpiOcularTM.
Evaluation of corrosive/severe irritant properties by using the Bovine Corneal Opacity and Permeability (BCOP) Test Method
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.