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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 274-403-7 | CAS number: 70210-06-9
- 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 the 19th February to the 05th of March, 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted according to internationally accepted testing guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Disodium 3-[[ethyl[4-[[4-[(3-sulphonatophenyl)azo]-1-naphthyl]azo]phenyl]amino]methyl]benzenesulphonate
- EC Number:
- 274-403-7
- EC Name:
- Disodium 3-[[ethyl[4-[[4-[(3-sulphonatophenyl)azo]-1-naphthyl]azo]phenyl]amino]methyl]benzenesulphonate
- Cas Number:
- 70210-06-9
- Molecular formula:
- C31H25N5O6S2.2Na
- IUPAC Name:
- disodium 3-[[ethyl[4-[[4-[(3-sulphonatophenyl)azo]-1-naphthyl]azo]phenyl]amino]methyl]benzenesulphonate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Diluited in bidistilled water
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Source: Charles River (France), Charles River Laboratories Espana S.A.
Weight at study initiation: 85 to 99 g
Weight at study initiation (preliminary): 115 to 120 g
Weight during the study: 120-142 g (males), 108-123 g (females)
Age: four weeks
Date of arriving: 5, 12 Fenruary 2003
Identification:by code, ear-punch technique, before the administration
Group size:
preliminary study (500 mg/Kg to a female and afterwards to another female at 2000 mg/Kg)
main study (2000 mg/Kg, 3 to 7 males, 8 to 12 females)
Housing: Makrolon cages (59x38.5x20), with Ultrasorb sawdust bedding, supplied by PanLab, Spain. max 5 rats per cage.
Sawdust bedding replaced during the period of fasting
Diet: rat food -UAR A04C (France), analysed to detect contaminants, Batches 21118 and 21206, ad libitum. Food was withdrawn 16-18 hours before the administration
Water: ad libitum, available in bottles, analysed to detect contaminants (Spain). After 3-4 following the tratment, free access to food
Acclimatization: at least for 5 days, for veterany observation
ENVIRONMENTAL CONDITIONS
Temperature: 21-25 °C
Humidity: 30-70 % (occasionally 75%)
Photoperiod (hrs dark / hrs light): 12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Gastric gavage with metal cannula
- Doses:
- One dose at volume 10 mL/kg, 500 mg/Kg, 2000 mg/Kg (Preliminary study)
One dose at volume 10 mL/kg, 2000 mg/Kg (Preliminary study)
The quantity of the test item calculated from the body weight - No. of animals per sex per dose:
- 10, 5 rats (5 male, 5 female)
- Details on study design:
- OBSERVATION
Preliminary study
Mortality in one animal
Signs of extreme toxicity in one animal
Twice a day for seven days
Main study
Mortality: immediately before administration and on days 7 and 14
Clinical signs: immediately before administration and on days 7 and 14 (changes in skin or furs, eyes and mucous membranes, respiratory, circulatory, central nervous and autonomic nervous systems, somatomotor activity and behaviour)
Body weight: dayly for three days
Necropsies: The animals were submitted to a gross necropsy at the end of the observation period. Inspection of intact animals and all superficial tissues, followed by the observation of the viscera of the cranial, thoracic and abdominals cavities.
Results and discussion
- Preliminary study:
- No mortalities occurred at 500 and 2000 mg/Kg bw (preliminary study)
No extreme toxicity occurred at 500 and 2000 mg/Kg bw (preliminary study)
Normal body weight at 500 and 2000 mg/Kg bw (preliminary study)
Sign of irritability 4-5 hours after the administration; dark coloured liquid faeces at 500 mg/Kg
Hunched back and ataxia from 4-5 hours after treatment; Ataxia and piloerection the first and the second day of the observation period, at 500 mg/Kg
Sign of irritability, hunched back and ataxia between 5-15 minutes and 5-6 hours after administration of 2000 mg/Kg.
Decreased motor activity and palpebral ptosis at 2-3 hours following treatment at 2000 mg/Kg
Ataxia on the first day of the observationanf third day, at 2000 mg/Kg
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities occurred at 2000 mg/Kg bw
- Clinical signs:
- other: Hunched back and ataxia were recorded after 90-120 minutes following the treatment in all the animals administered at the dose of 2000 mg/kg. These animals produced dark-coloured liquid faeces from 90-120 minutes. The dark colour of the faeces could be re
- Gross pathology:
- No macroscopic alterations were detected during the necropsies done on all the animals of the Main Study, except for one male administered at the dose of 2000 mg/kg which had a slightly dilated and congestive jejunum and one female treated at the same dose, in which a reddish area was observed on the intemal surface of the abdominal musculature.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Classification criteria according to the CLP Regulation 1272/2008 and its amendments
- Conclusions:
- Preliminary Study: 500 mg/kg no mortality
Main study: 2000 mg/kg no mortality - Executive summary:
Method
The acute oral toxicity was determined according to the EU Method B.1 (Acute Toxicity (Oral), in GLP.
In the Preliminary Study the test item was administered to one female at the dose of 500 mg/kg.
Observation
As no mortality was recorded in this animal, another female was administered at the dose of 2000 mg/kg, and this too survived the treatment.
Conclusion
In the Main Study five males and five females were treated at the dose of 2000 mg/kg and no mortality was recorded, hunched back, ataxia, irritability and liquid dark feaces were observed.
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.