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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 400-920-6 | CAS number: 89857-06-7
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 5th to February 26th, 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted MAy 12, 1981
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- EWG Directive 84/449/ EWG, Amtsblatt der Europaeischen Gemein-schaften L 251, Jahrgang 27, 19. 9. 84. B.3. Akute Toxizitaet - dermal/ 103
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 400-920-6
- EC Name:
- -
- Cas Number:
- 89857-06-7
- Molecular formula:
- C50 H53 N11 O14 S
- IUPAC Name:
- 5'-[2-(7-{2-[4-(2-{1'-[3-(dimethylazaniumyl)propyl]-6'-hydroxy-4'-methyl-2'-oxo-1',2'-dihydro-1λ⁵-[1,3'-bipyridin]-1-ylium-5'-yl}diazen-1-yl)phenyl]diazen-1-yl}-8-hydroxy-6-sulfonatonaphthalen-2-yl)diazen-1-yl]-6'-hydroxy-3,4'-dimethyl-2'-oxo-1',2'-dihydro-1λ⁵-[1,3'-bipyridin]-1-ylium bis(2-hydroxypropanoate)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- KFM-Han
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable)
- Source: Kleintier farm Madoerin AG, CH 4414 Fuellinsdorf / Switzerland
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: 228 - 252 g males; 180 - 198 g females
- Housing: individually in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, Switzerland)
- Diet: pelleted standard Kliba 343, Batch 15/84 rat maintenance diet ("Kliba", Klingentalmuehle AG, Switzerland), ad libitum
- Water: community tap water from Itingen, ad libitum
- Acclimation period: one week under laboratory conditions, after veterinary examination
- Method of randomisation in assigning animals to test and control groups: computer-generated random algorithm
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Air changes: 10 -15 per hour
- Photoperiod: 12 hours artificial fluorescent light / 12 hours dark, at least 8 hours music/light period
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 2% solution of CMC, carboxymethyl cellulose natrium salt purum, visc. 100 CPS
- Details on dermal exposure:
- VEHICLE
- Concentration: 2% solution of CMC, Carboxymethylcellulose natriumsalt purum, visc. 100 CPS, Fluka AG 9470 Buchs/Switzerland in distilled water
MAXIMUM DOSE VOLUME APPLIED: Group 1: 4 ml at 2000 mg/kg
DOSE PREPARATION
Test article was placed into a glass beaker on a tared Mettler PK 4800 balance and the vehicle was added. A weight/volume dilution was prepared using a homogenizer. Homogeneity of the test article was maintained during treatment using a magnetic stirrer. The preparations were made immediately prior to each dosing. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- Approximately 24 hours before treatment, the backs of the animals were shaved with an electric clipper, exposing an area of approximately 20 square centimeters.
0n test day 1 the test article was applied evenly on the skin and covered with an occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.
Twenty-four hours after the application, the dressing was removed and the skin reaction was assessed according to the method of Noaks and Sanderson (Noaks, D.N. and Sanderson, 0.11. "A Method for Determining the Dermal Toxicity of Pesticides". Brit. J. Industr. Med., 26, 59-64, 1969).
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: 4 times during test day 1 and daily during days 2 - 15 for mortality/viability. Test days 1 (pre-administration), 8 and 15 for body weights. Each animal was examined for changes in appearance and behaviour 4 times during day 1, and daily during days 2 - 15.
- Necropsy of survivors performed: yes. Necropsies were performed by experienced prosectors. AII animals were necropsied. AII animals surviving to the end of the observation period were anesthetized by intraperitoneal injection of sodium pentobarbital and killed by exsanguination.
- Clinical signs including body weight
- Examinations performed: clinical signs, body weight, pathology,: Observations included general behavior, nose, respiration, eye, motility, body position, motor susceptibility, skin... - Statistics:
- The LOGIT-Model could not be applied to the observed rates of death. The LD50 was estimated without use of a statistical model.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- No changes were observed.
- Gross pathology:
- No gross pathological changes were observed in any of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to CLP Regulation (EC no. 1272/2008)
- Conclusions:
- LD50 (male/female rats) > 2000 mg/kg
- Executive summary:
The test item was evaluated for acute dermal toxicity when administered to Wistar rats by a single occlusive dermal application, followed by an observation period of 15 days. The study was performed fallowing the OECD Guideline No. 402.
The test item was administered to rats of both sexes at a dose of 2000 mg/kg. The following death rate was observed: 0% at 2000 mg/kg. No local or systemic symptoms were observed in any treated animal. No macroscopic organ changes were observed.The LD50 of the test item was estimated to be greater than 2000 mg/kg.
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.