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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 418-220-4 | CAS number: - RED JB 747
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 26, 1994 - May 10, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 1992
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Trisodium bis[(3'-nitro-5'-sulfonato-(6-amino-2-[4-(2-hydroxy-1-naphtylazo)phenylsulfonylamino]pyrimidin-5-azo)benzene-2',4-diolato)]chromate(III)
- EC Number:
- 418-220-4
- EC Name:
- Trisodium bis[(3'-nitro-5'-sulfonato-(6-amino-2-[4-(2-hydroxy-1-naphtylazo)phenylsulfonylamino]pyrimidin-5-azo)benzene-2',4-diolato)]chromate(III)
- Molecular formula:
- C52H32CrN18Na3O20S4
- IUPAC Name:
- chromium(3+) trisodium bis(6-amino-2-{4-[2-(2-hydroxynaphthalen-1-yl)diazen-1-yl]benzenesulfonamido}-5-[2-(3-nitro-2-oxido-5-sulfonatophenyl)diazen-1-yl]pyrimidin-4-olate)
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wñlferstrasse 4, CH-4414 Füllinsdorf/Switzerland
- Age at study initiation: males at 9 weeks; females at 11 weeks
- Weight at study initiation: males at 256.0 - 269.6; females at 189.0 - 209.7 g
- Diet: pelleted standard Kliba 343. Batch nos. 86/93 and 87/93 rat maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum (except for over-night fasting period prior to application).
- Water: community tap water from Fülllnsdorf, available ad libitum.
- Acclimation period: one week under laboratory conditions» after health examination. Only animals without any visual signs of illness were used for the study.
- Identification: by unique cage number and corresponding color-coded spots on the tail.
- Randomization: randomly selected at time of delivery Into groups of five
ENVIRONMENTAL CONDITIONS
- Temperature: continuously monitored environment with a temperature of 22 ± 2 °C
- Humidity: 36 - 64 %
- Air changes: 10-15 ACH
- Photoperiod: 12 hours artificial fluorescent light (approx. 100 Lux) / 12 hours dark (light period between 6.00 a.m. to 6.00 p.m.), music during the light period
- Cage: during acclimatization in groups of five in Makrolon type-4 cages (size: 33 x 55 x 20 cm) with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz); during treatment and observation individually in Makrolon type-3 cages (size: 22 X 37.5 x 15 cm) with standard softwood bedding.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- bi-distilled
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 24 hours before treatment, the backs of the animals were clipped with an electric clipper. On test day 1, the test article was applied at a dose of 2000 mg/kg body weight evenly on the intact skin with a syringe.
- % coverage: area of approximately 10 % of the total body surface.
- Type of wrap if used: semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.
- Rationale: dermal administration was used because this is one possible route of human exposure during manufacture, handling and use of the test article.
REMOVAL OF TEST SUBSTANCE
- Washing: the skin was washed with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: twenty-four hours after the application.
TEST MATERIAL
- Amount applied: 4.0 ml/kg
- For solids, paste formed: no
- Preparation: the test article was placed into a glass beaker on a tared Mettier PM 480 balance, and the vehicle, (bi-distilled water) was added. A weight by volume dilution was prepared using a homogenizer (Ultra-Turrax, Janke & Kunkel, D-79219 Staufen).
Homogeneity of the test article in the vehicle was maintained during treatment using a magnetic stirrer (Janke & Kunkel, D-79219 Staufen).
The preparation was made shortly before dosing. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw, single dose
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: on test day 1 (pre-administration), 8 and 15.
- Necropsy: necropsies were performed by experienced prosectors. At the end of the observation period all animals were anesthetized by intraperitoneal injection of NARCOREN at a dose of at least 2.0 ml/kg body weight and sacrificed by exsanguination. The animals were examined macroscopically.
- Other examinations performed: each animal was examined for changes in behaviour and appearance (with special emphasis on the application area, except for the time when the semi-occlusive dressing was in place) four times during day 1, and once dally during days 2-15. - Statistics:
- The LOGIT-Model could not be used as no deaths occurred,
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Value not quantified since higher than tested concentrations
- Mortality:
- No deaths observed.
- Clinical signs:
- other: No clinical signs of systemic toxicity.
- Gross pathology:
- No organ abnormalities were observed at necropsy.
- Other findings:
- A red discoloration of the skin at the application site was evident in all animals after the removal of the dressing on test day 2 and persisted until test day 3 - 6.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- LD50 (males and females) > 2000 mg/kg b.w.
- Executive summary:
The test article was administered to a group of 5 male and 5 female rats by semi-occlusive dermal application with a single dose of 2000 mg test article/kg body weight.
- No deaths occurred during the study period.
- No clinical signs of systemic toxicity were observed during the observation period.
- A red discoloration of the skin at the application site was evident in all animals after the removal of the dressing on test day 2 and persisted until test day 3 - 6.
- There were no test article-related effects on the body weight of the animals during the observation period. The slight reduction in body weight gain during the first observation week was considered to be a consequence of the semi occlusive dressing.
- The macroscopic examination at study termination revealed no organ abnormalities.
In conclusion, the mean lethal dose after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated, because no deaths occurred at the maximal dose of 2000 mg test article/kg body weight.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)