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EC number: 285-083-3 | CAS number: 85029-58-9
- 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 test substance is not irritating to the skin.
The test substance is not irritating to the eyes.
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:
- 22 Mar 2016 to 03 Aug 2016
- 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)
- Version / remarks:
- 28 July 2015
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 6 July 2012
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No. of test material: 003-142715
- CAS: 85029-58-9
- Purity test date: ca. 98 area-% (LC)
- Content: 98.4 g/100 g (titration)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Storage stability of the test material: The stability under storage conditions over the study period was guaranteed by the sponsor
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
- Homogeneity: The test substance was homogeneous by visual inspection
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:
FORM AS APPLIED IN THE TEST (if different from that of starting material)
- Test substance applied minimally moistened with PBS
OTHER SPECIFICS:
- pH-value: Ca. 5 (undiluted test substance, moistened with de-ionized water; determined in the lab prior to start of the GLP study)
- Physical state / color: Solid / brown - Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: EpiDermTM tissues
- Cell source:
- other: Tissue derived from a single donor
- Source strain:
- other: Epiderm tissue (24 EPI-200 tissues - reconstructed epidermis)
- Details on animal used as source of test system:
- - EpiDermTM tissues: human-derived epidermal keratinocytes which have been cultured to form a multi layered, highly differentiated model of the human epidermis
SOURCE
- All cells used to produce EpiDermTM are purchased or derived from tissue obtained by MatTek Corporation from accredited instructions. In all cases consent was obtained by these institutions from the donor or the donor's legal next of kin, for the use of the tissues or derivatives of the tissue for research purposes.
- Tissue lot number: 23328 - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- SKIN DISC PREPARATION
- Test system: Three dimensional human epidermis model (EpiDermTM)
- Tissue model: EPI-200
- Tissue Lon Number: 23328
- Origin: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
- Procedure used: Test item tested with EpiDermTM using PBS sterile as negative control and 5% (w/v) sodium dodecyl sulfate (SDS) in water as positive control
- Quality control for skin discs: Time of exposure to reduce tissue viability to 50% (ET50; acceptable range: 4.77-8.72 h): ET50 = 5.81 h (Pass)
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: Room temperature (25°C)
- Temperature of post-treatment incubation: 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: The tissues were washed with sterile PBS once (1 hour after start of application)
- Observable damage in the tissue due to washing: No damage observed
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer: SunriseTM Absorbance Reader
- Wavelength: 570 nm
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION:
For skin irritation at least 3 tissue replicates should be sufficient for a test. In case of borderline results, a second test should be performed. In case of discordant results between the first 2 tests, a third test should be performed.
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test-substance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.
- A chemical is considered as "irritant", if the mean relative tissue viability with a test material is ≤ 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- - Amount of test item: 25 µL ( approx. 9 mg)
- Amount of negative control: 30 µL
- Amount of positive control: 30 µL - Duration of treatment / exposure:
- The conditioned, treated tissues were kept under the laminar flow hood at room temperature for 25 minutes overall and for 35 minutes in the incubator.
- Duration of post-treatment incubation (if applicable):
- Tissues were washed 1 h after start of application and then placed into the incubator at 37°C for 24 ± 2 hours. After that tissues were transferred into new 6-well plates pre-filled with 0.9 mL of fresh medium and placed into the incubator for additional 18 ± 2 hours post-incubation period. Afterwards, the assay mediu was replaced by 0.3 mL MTT solution and tissues were incubated in incubator for 3 hours.
- Number of replicates:
- 3 tissue replicates
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 103.4
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 101.1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 100.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- 101.6
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The test substance is not able to reduce MTT directly.
In a pretest it was demonstrated that the color of the test substance did not interfere with the colorimetric test.
Acceptance criteria for negaite control, positive control and variability of the tissues were met. - Interpretation of results:
- GHS criteria not met
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
- Study period:
- 08 Mar 2016 to 03 Aug 2016
- 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:
- 28 July 2015
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- 8 December 2010
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Name of test substance: Orasol Yellow 157
- Test-substance No.: 16/0017-1
- Source and lot/batch No. of test material: 003-142715
- Purity test date: c 98 area-% (LC)
- Content: 98.4 g/100 g
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Homogeneity: The test substance was homogeneous by visual inspection.
- Storage condition of test material: Room temperature
- Solubility and stability of the test substance in the solvent/vehicle: no vehicle
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: no reactivity
OTHER SPECIFICS:
- pH: Ca. 5
- Physical state / color: Solid / brown - Species:
- human
- Strain:
- other: EpiOcularTM model (OCL-200)
- Details on test animals or tissues and environmental conditions:
- - EpiOcularTM model (OCL-200): A three-dimensional non-keratinized tissue construct composed of normal human derived epidermal keratinocytes used to model the human corneal epithelium
- Cell course: All cells used to produce EpiOcularTM are purchased or derived from tissue obtained by MatTek Corporation from accredited institutions.In all cases consent was obtained by these institutions from the donor or the donor's legal next of kin, for the use of the tissues or derivatives of the tissue for research purposes.
- Tissue model: OCL-200
- Tissue Lot Number: 23700 (Certificate of Analysis see appendix)
- Supplier: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- - Amount of test item: 50 µL
- Amount of positive control: 50 µL
- Amount of negative control: 50 µL - Duration of treatment / exposure:
- Total exposure time: 6 h
- Duration of post- treatment incubation (in vitro):
- Postincubation period: 18 h
- Number of animals or in vitro replicates:
- 2 tissue replicates for a single test is sufficient. In case of borderline results a second test is performed. In case of discordant test results between the 2 tests, a third is performed.
- Details on study design:
- MATERIAL AND TECHNICAL EQUIPMENT
- Laminar flow bench: HERAsafe KS 18 (Thermo ELECTRON CORPORATION)
- CO2 incubator: Heraeus BBD 6220
- Incubation conditions: 37°C ± 1°C, 5% ± 1% CO2, 90% ± 5% humidity
- Spectrophotometer: SunriseTM Absorbance Reader
- Wavelength: 570 nm without reference filter
- Assay medium: OCL-200-ASY
- Detection agent: 3-[4.5-dimethylthiazol-2-yl]-2.5-diphenyltetrazolium bromide (MTT)
- Extracting agent: Isopropanol p.a
TISSUE PREPARATION:
Preincubation: On the day of arrival in the laboratory, the tissues were transferred to sterile 6-well plates with 1 mL assay medium and preconditioned in the incubator at 37°C. After 1 h, the preincubation medium was replaced with fresh medium and preconditioning continued in the incubator at standard culture conditions for 16 – 24 h.
Pretreatment: After the pre-incubation, the tissues were pre-treated with 20 μL of PBS in order to wet the tissue surface. The tissues were incubated at standard culture conditions for 30 minutes.
APPLICATION OF THE TEST ITEM:
Using a sharp spoon, approx. 50 μL of the undiluted test material was applied covering the whole tissue surface. Control tissues were applied with 50 μL of negative and of positive control. After application, the tissues were placed into the incubator until the total exposure time of 6 h.
REMOVAL AND POSTINCUBATION PERIOD:
To remove the test item, the tissues were washed with sterile PBS. Tissues were immersed and swiveled three times in each of three beakers filled with PBS. Washed tissues were immediately immersed into 12-well plates and pre-filled with 5 mL/well prewarmed medium (post-soak immersion) in order to remove residual test substance. After 25 minutes of post-soak immersion, each tissue was dried on absorbent paper and transferred to fresh 6-well plates filled with 1 mL/well pre-warmed medium.
The tissues were incubated at standard culture conditions for 18 hours (postincubation period).
MTT INCUBATION:
After the post-incubation period, the assay medium was replaced by 0.3 mL MTT solution and the tissues were incubated in the incubator for 3 hours. After incubation, the tissues were washed with PBS to stop the MTT-incubation. The formazan that was metabolically produced by the tissues was extracted by incubation of the tissues in isopropanol at room temperature overnight or for at least 2 hours on a plate shaker. The optical density at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically. Blank values were established of 4 microtiter wells filled with isopropanol for each microtiter plate.
EVALUATION CRITERIA:
A chemical is considered as "irritant", if the mean relative tissue viability with a test material is ≤ 60%.
However a borderline range is statistically determined. Therefore, mean percent tissue viability equal to ± 5% of the cut-off value is considered to be discordant. - Irritation parameter:
- other: tissue viability (%)
- Run / experiment:
- 1
- Value:
- 115.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: tissue viability (%)
- Run / experiment:
- 2
- Value:
- 100.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: tissue viability (%)
- Run / experiment:
- mean
- Value:
- 108.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: Yellowish discoloration of the test substance-treated tissues was observed after the washing procedure.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes - Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
In an in-vitro skin irritation study (BASF, 2016) performed according to the OECD guideline No. 439, the EpiDermTM test method was employed. Human skin cells derived from reconstructed human epidermis tissue containing normal human keratinocytes were used for the test system. Sterile PBS was used a negative control and 5% (w/v) sodium dodecyl sulfate (SDS) in water was used as a positive control. Tissues were washed 1 h after start of application and then placed into the incubator at 37°C for 24 ± 2 hours. After that tissues were transferred into new 6-well plates pre-filled with 0.9 mL of fresh medium and placed into the incubator for additional 18 ± 2 hours post-incubation period. The test methods was performed in at least 3 tissue replicates. In case of equivocal results a second or a third test should be performed. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test-substance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability. Based on the available information, the test item is not determined to cause irritation to skin
In a primary dermal irritation study (BASF, 1974) according to BASF internal standard, two male Vienna White rabbits were dermally exposed to 1 g of a 50% aqueous test substance preparation. The test substance was applied in a single dose to the clipped skin of the back of an experimental animal (2.5 x 2.5 cm, occlusive) for 20 hours and was not washed off. Untreated skin areas served as control. The degree of irritation was observed after 24 hours and 8 days. For the evaluation of the results, the scheme was converted to the OECD Draize scheme. Due to test substance coloring, skin reddening was not visible after 24 hours and 8 days. No abnormalities were noted. Based on the available information the test item is not considered to be irritating to the skin.
Eye irritation:
In an in-vitro eye irritation testing method (BASF, 2016) performed according to the OECD guideline No. 492, the EpiOcularTM test method was employed. The ocular irritation potential was assessed by a single topical application of ca. 50μL bulk volume (about 12 mg) of the undiluted test substance to a reconstructed three dimensional human cornea model. 2 EpiOcular™ tissues were incubated with the test substance for 6 h followed by an 18-h post- incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test-substance treated epidermal tissues is compared to that of negative control tissues. The ratio of the values indicates the relative tissue viability. A chemical is considered as "irritant", if the mean relative tissue viability with a test material is ≤ 60%. Based on the available information, the test item is not considered to be irritating to the eye.
In a primary irritation study (BASF ,1974) according to BASF-internal standard, 50 mg of the test substance without a vehicle was instilled into the conjunctival sac of the right eye of two Vienna White rabbits. The left eye was treated with talcum powder and served as control. The test substance was not washed out. The animals were observed after 24 hours and 8 days. For the evaluation of the results, the BASF scheme was converted to the OECD Draize scheme. After 24 hours the mean conjunctiva score was 1. No other abnormalities were noted. Effects were fully reversible after 8 days. Based on the available information the test substance is not considered to be irritating to the eye.
Justification for classification or non-classification
Based on the available information classification for skin and eye irritation is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.
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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