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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 263-606-6 | CAS number: 62570-50-7
- 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
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- Additional procedure for test items that induce both colour interference and reduction of MTT was not performed. Procedure is designed to avoid possible double correction, without correction the test item is clearly negative. Does not affect study outcome
- GLP compliance:
- yes
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EPISKIN Small Model (0.38 cm² reconstructed epidermis of normal human keratinocyes grown on a collegen matrix for 13 days.)
- Vehicle:
- other: Milli-Q water
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 11.0-13.8 mg of test item was added to the appropriate tissue samples
- Duration of treatment / exposure:
- Exposure period of 15 ± 0.5 minutes, following this the tissues were washed with phosphate buffered saline to remove residual test item
- Duration of post-treatment incubation (if applicable):
- Tissues were incubated for 48 hours at 37 °C
- Number of replicates:
- 15 test tissued used, consiting of 5 replicatex of 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 15 ± 0.5 minutes
- Value:
- ca. 98
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Skin irritation is expressed as the remaining cell viability after exposure to the test item. The relative man tissue validity obtained after 15 ± 0.5 minutes treatment with Disperse Blue 359 compared to the negative control tissues was 98 %. Since the mean relative tissue viability for Disperse Blue 359 was above 50 % after 15 ± 0.5 minutes treatment Disperse Blue 359 is considered to be a non-irritant.
The positive control had a mean cell viability of 6.2 % after 15 ± 0.5 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissue was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 10 %, indicating that the test system function properly.
Finally, it is concluded that this test is valid and that Disperse Blue 359 is a non-irritant in the in vitro skin irritation test under the experimental conditions described. - Executive summary:
Batch 135214 of Disperse Blue 359 was a dark blue powder with a purity of 99%. Skin tissue was moistened with 5µL of Milli-Q water and at least 10 mg of Disperse Blue 359 was applied directly on top of the tissue for 15 ± 0.5 minutes. After a 42-hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.
Disperse Blue 359 did interact with 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT). In addition to the normal procedure, three killed tissues treated with test item and three killed untreated tissues were used for the cytotoxicity evaluation with MTT. The non-specific reduction of MTT by Disperse Blue 359 was 4.4 % of the negative control tissues. The net OD of the treated killed tissues was subtracted from the ODs of the test item treated viable tissues.
Furthermore, Disperse Blue 359 showed colour interference in aqueous solutions. In addition to the normal procedure, three tissue were treated with test item. Instead of MTT solution this tissue was incubated with assay medium. The non-specific colour by Disperse Blue 359 was 4.9 % of the negative control tissues. The OD of the tissue incubated with assay medium was subtracted from the ODs of the test item treated tissues incubated with MTT medium.
Skin irritation is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue validity obtained after 15 ± 0.5 minutes treatment with Disperse Blue 359 compared to the negative control tissues was 98 %. Since the mean relative tissue viability for Disperse Blue 359 was above 50 % after 15 ± 0.5 minutes treatment Disperse Blue 359 is considered to be a non-irritant.
The positive control had a mean cell viability of 6.2 % after 15 ± 0.5 minutes exposure. The absolute mean OD570(optical density at 570 nm) of the negative control tissue was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 10 %, indicating that the test system function properly.
Finally, it is concluded that this test is valid and that Disperse Blue 359 is a non-irritant in the in vitro skin irritation test under the experimental conditions described.
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:
- comparable to 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
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, -‘s Hertogenbosch, The Netherlands), where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter. Eyes were collected and transported in a physiological saline in a suitable container under cooled conditions.The eyes were checked for unacceptable defects, such as opacity, scratches, pigmentation and neovascularization by removing them from physiological saline and holding them in the light. Those exhibiting defects were discarded.
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 318-391 mg of Disperse Blue 359
- Duration of treatment / exposure:
- Corneas were first incubated in cMEM for a minimum of 1 hour at 32 ± 1 °C, the corneas were then incubated with the tests material in a horizontal position for 240 ± 10 minutes at 32 ± 1 °C.
- Number of animals or in vitro replicates:
- 9 samples in total, 3 replicates each for Disperse Blue 359, the positive control and the negative control.
- Irritation parameter:
- in vitro irritation score
- Value:
- >= -0.7
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Remarks:
- The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas.
- Positive controls validity:
- valid
- Remarks:
- The mean in vitro irritancy score of the positive control was 159 and within two standard deviations of the current historical positive control mean. It was therefore concluded that test conditions were adequate and that test system functioned properly.
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (20% (w/v) Imidazole) was 159 and within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. Disperse Blue 359 did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of -0.7 after 240 minutes of treatment. Since Disperse Blue 359 induced an IVIS ≤3, no classification is required for eye irritation or serious eye damage.
- Executive summary:
Study describes the potency of chemicals to induce serious eye damage using isolated bovine corneas. The eye damage of Disperse Blue 359 was tested through the topical application for approximately 240 minutes. Procedures were based on the most recent OECD guideline. Since no workable suspension of test material in physiological saline solution could be obtained, the test item was used as delivered and added pure on top of the corneas.
The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (20% (w/v) Imidazole) was 159 and within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. Disperse Blue 359 did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of -0.7 after 240 minutes of treatment. Since Disperse Blue 359 induced an IVIS ≤3, no classification is required for eye irritation or serious eye damage.
Reference
The individual in vitro irritancy scores for the negative controls ranged from -0.8 to -0.9. The individual positive control in vitro irritancy scores ranged from 140-187. The corneas treated with the positive control were turbid after the 240 minutes of treatment.
The corneas treated with Disperse Blue 359 showed opacity values ranging from -1.2 to -0.4 and permeability values ranging from 0 to 0.0037. The corneas were clear were clear after the 240 minutes of treatment with Disperse Blue 359. No pH effect of the test item was observed on the rinsing medium. Hence, the in vitro irritancy scores ranged from -1.2 to 0.2 after 240 minutes of treatment with Disperse Blue 359.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
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.