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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 228-326-0 | CAS number: 6227-14-1
- 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:
- other: read across from similar substance
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- yes
- Remarks:
- No analysis of the test item formulation
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Trisodium 3-[[4-[[6-(anilino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]-5-methoxy-o-tolyl]azo]naphthalene-1,5-disulphonate
- EC Number:
- 228-327-6
- EC Name:
- Trisodium 3-[[4-[[6-(anilino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]-5-methoxy-o-tolyl]azo]naphthalene-1,5-disulphonate
- Cas Number:
- 6227-20-9
- Molecular formula:
- C34H27N5O11S3.3Na
- IUPAC Name:
- trisodium;3-[[4-[(2E)-2-(6-anilino-1-oxo-3-sulfonatonaphthalen-2-ylidene)hydrazinyl]-5-methoxy-2-methylphenyl]diazenyl]naphthalene-1,5-disulfonate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ENVIGO laboratories
- Health: rats were submitted to a sanitary control.
- Age at study initiation: 8-12 weeks
- Housing: 4 rats in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: free access to specific food. No food on the night before the test and for 3/4 hours after dosing.
- Water: tap water ad libitum. No water on the night before the test and for 3/4 hours after dosing.
- Acclimatation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30-70%
- Air changes (per hr): 15 air changes
- Photoperiod (hrs dark / hrs light): 12/12 by timer
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 300 and 2000 mg/Kg bw
- No. of animals per sex per dose:
- 1 female at 2000 mg/kg
5 female at 300 mg/kg - Control animals:
- not specified
- Details on study design:
- - Administration: oral administration by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fatsed bw at the time of the dosing.
- Duration of observation period following administration: up to 14 days
- Frequency of observations: In the first day frequent observations (30 min, 1, 2 and 4 hours), and then, once every working day
- Sacrifice: cervical dislocation
- Necropsy performed: gross necroscopy
Results and discussion
- Preliminary study:
- 1 female was trated with a dose of 2000 mg/kg bw. Due to mortality at this dose level, a 300 mg/kb bw was chosen for the fixed dose test.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Mortality at 2000 mg/Kg bw was observed 1 day after dosing.
No mortality at 300 mg/kg bw. - Clinical signs:
- There were no signs of systemic toxicity noted at a dose level of 300 mg/kg. Purple colored staining of the urine was noted in the animai treated at a dose level of 2000 mg/kg.
Black/purple colored staining of the feces was noted in the cage of the four additional animals treated at a dose level of 300 mg/kg. - Body weight:
- Normal body weight variation
- Gross pathology:
- Abnormalities noted at necropsy of the animai treated at a dose level of 2000 mg/kg were abnormally red lungs, dark liver, dark kidneys, dark purple coloured substance present in the stomach and purple colored staining of the small intestine. No abnormalities were noted at necropsy of animals treated at a dose level of 300 mg/kg.
- Other findings:
- No abnormalities were observed
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- LD50 oral rat = 300-2000 mg/Kg bw.
- Executive summary:
Based on the effects observed in the test, the LD50 value is 300 -2000 mg/kg bw. The substance needs to be classified as Acute Tox. Oral 4, H302 (Harmful if swallowed) based on the criteria in the Regulation (EC) 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.
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.