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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 278-174-4 | CAS number: 75284-35-4
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 09 November, 1978 to 6 December, 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Groups of 5 male and 5 female rats each were administered test dose of 4000, 5000, 6000 and 7000 mg/kg bw respectively. Mortality and clinical signs were observed for each group for a period of 14 days.
- GLP compliance:
- no
- Remarks:
- Study predates GLP
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Trisodium [μ-[3-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-4,5-dihydroxynaphthalene-2,7-disulphonato(7-)]]dicuprate(3-)
- EC Number:
- 278-174-4
- EC Name:
- Trisodium [μ-[3-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-4,5-dihydroxynaphthalene-2,7-disulphonato(7-)]]dicuprate(3-)
- Cas Number:
- 75284-35-4
- Molecular formula:
- C39H20Cu2N5O15S3.3Na
- IUPAC Name:
- trisodium [μ-[3-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-4,5-dihydroxynaphthalene-2,7-disulphonato(7-)]]dicuprate(3-)
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Batch No.: EN 80524/76
Physical appearance: Solid
Test material received: October 17, 1978
Test animals
- Species:
- rat
- Strain:
- other: Tif. RAI rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Inbred rats (male and females) : CIBA-GEIGY Limited, Basel, Switzerland.
- Strain : Tif: RAIf (SPF)
- Age at study initiation: 7 to 8 weeks.
- Weight at study initiation: Average weight of 205 gm.
- Housing : Macrolon cages (Type 3)
- Diet : Rats received ad libitum rat food - NAFAG, Gossau SG.
- Water : ad libitum.
- Acclimation period: 4 days.
ENVIRONMENTAL CONDITIONS
- Temperature : 22 +/- 1 °C
- Humidity : 55 +/- 5 %
- Photoperiod : 10 hours light cycle day.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Details on oral exposure:
- Test material and formulation:
FAT 11127/B was suspended in PEG 400. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer. Animals fasted overnight were treated by oral intubation.
Volume fed: 20 ml/kg bw. - Doses:
- 4000, 5000, 6000 and 7000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 1, 2, 4, 6 and 24 hours after dosing on Day 1 and daily thereafter till Day 14
- Weighing: Day 1, 7 and 14
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 7 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 2 female rats of 5000 mg/kg group were found dead within 24 hours of dosing. No mortality was observed with any other groups.
- Clinical signs:
- other: Sedation and diarrhoea were observed in all test groups in first 24 hours. Dyspnoea persisted till Day 8 in all test groups. Exophthalmos was seen till Day 6. Ruffled fur was observed in till day 8, while curved body position lasted in all test groups til
- Gross pathology:
- No substance related gross organ changes were seen.
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 of FAT 11127/B in rats of both sexes observed over a period of 14 days is greater than 7000 mg/kg bw.
- Executive summary:
FAT 11127/B was tested for acute oral toxicity potential (LD50) using methodology similar to OECD Guideline 401. 5 rats per sex per group were tested with doses of 4000, 5000, 6000 and 7000 mg/kg bw. The test substance was administered using oral gavage. Animals were observed for 14 days for mortality, clinical signs and changes in bodyweights. They were submitted at random to a necropsy whenever they died, survivors at the end of the observation period.
2 animals were found dead at the dose of 5000 mg/kg bw within 24 hours of observation. No other mortality was seen at any of the tested doses. Clinical signs observed included sedation, diarrhoea, dyspnoea, exopthalmos, ruffled fur and curved body position. The surviving animals recovered within 8 days. No significant changes in body weights was observed. No gross pathological changes were observed. Hence, based on the above findings, the oral LD50 for FAT 11127/B was determined to be >7000 mg/kg bw.
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.