Registration Dossier
Registration Dossier
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.
reaction mass of: 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4- hydroxynaphthalene-2-sulfonic acid, Na/K salt; 7-amino-3-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-hydroxy-8-[4-(2-sulfoxyethylsulfonyl)-2- sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-8-[4-(2-sulfoxyethylsulfonyl)-phenylazo]-4-hydroxy-3-[4-(2-sulfoxyethylsulfonyl)- 2-sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]-4-hydroxynaphthalene-2- sulfonic acid, Na/K salt
EC number: 429-070-4 | CAS number: 214362-06-8 SCARLET DER 8107
- 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:
- 22 Sep 1998 to 13-Nov-1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Amendment to Protocol: location of the animals changed, additional "Study-Coordinator" was nominated and Tap water from Füllinsdorf and Itingen was presented to the animals
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 92/69/CEE, B.1
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Switzerland GLP
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- reaction mass of: 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4- hydroxynaphthalene-2-sulfonic acid, Na/K salt; 7-amino-3-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-hydroxy-8-[4-(2-sulfoxyethylsulfonyl)-2- sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-8-[4-(2-sulfoxyethylsulfonyl)-phenylazo]-4-hydroxy-3-[4-(2-sulfoxyethylsulfonyl)- 2-sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]-4-hydroxynaphthalene-2- sulfonic acid, Na/K salt
- EC Number:
- 429-070-4
- EC Name:
- reaction mass of: 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4- hydroxynaphthalene-2-sulfonic acid, Na/K salt; 7-amino-3-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-hydroxy-8-[4-(2-sulfoxyethylsulfonyl)-2- sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-8-[4-(2-sulfoxyethylsulfonyl)-phenylazo]-4-hydroxy-3-[4-(2-sulfoxyethylsulfonyl)- 2-sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]-4-hydroxynaphthalene-2- sulfonic acid, Na/K salt
- Cas Number:
- 214362-06-8
- Molecular formula:
- C26H(25-y-x)KyN5NaxO16S5 / C26H(25-y-x)KyN5NaxO19S6 / C26H(25-y-x)KyN5NaxO19S6 / C26H(25-y-x)KyN5NaxO22S7
- IUPAC Name:
- octapotassium octasodium 7-amino-4-hydroxy-3,8-bis(2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2-sulfonate 7-amino-4-hydroxy-3,8-bis(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2-sulfonate 7-amino-4-hydroxy-3-(2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-8-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2-sulfonate 7-amino-4-hydroxy-8-(2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-3-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Test item name: Reactive Brown 49
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: TVR 50
- Expiration date of the lot/batch: September 01, 2004
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In the original container at room temperature (approx. 20 °C) away from direct sunlight.
- Stability of the test substance in the vehicle: Stable in bi-distilled water for at least 24 h
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Hanlbm: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source : RCC Ltd, Biotechnology & Animal Breeding Division, Wolferstrasse 4, CH-4414 Füllinsdorf/ Switzerland
Number of animals per group : 3 males and 3 females
Age when treated : Males 8 weeks ; females 10 weeks.
Body weight range when treated : Males: 173.9 - 209.1 g ; Females : 168.4 - 175.9 g
Identification : By unique cage number and corresponding color-coded spots on the tail.
Acclimatization : One week under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study
Diet: Pelleted standard Kliba 3433, batch nos. 25/98 and 28/98 rat maintenance diet (Kliba Mühlen AG, CH-4303 Kaiseraugst) available ad libitum (except for the overnight fasting period prior to intubation). Results of analyses for contaminants are archived at RCC.
Water: Community tap water from Füllinsdorf (September 28 to October 23, 1998) and Itingen (October 23 to 29, 1998), available ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 38 - 66
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12-h artificial fluorescent light, 12-h dark cycle.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- bi-distilled water
- Doses:
- 2000 mg/kg diluted in bi-distilled water at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg.
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- The purpose of this study was to assess the acute oral toxicity of FAT 40'571/A when administered by single oral gavage to rats, followed by an observation period of 14 days. This study should provide a rational basis for risk assessment.
The test article was placed into a glass beaker on a tared Mettler PM 460 balance and the vehicle (bi-distilled water) was added. A weight by volume dilution was prepared using a magnetic stirrer as homogenizer. Homogeneity of the test article in the vehicle was maintained during treatment.
The preparation was made shortly before each dosing.
The animals received a single dose of the test article on a mg/kg body weight basis by oral gavage following fasting for approximately 17 to 21 h, but with free access to water. Food was provided again approximately 3 to 4 h after dosing.
Dose / kg body weight: 2000 mg
Application volume/kg body weight : 10 ml
Rationale Oral administration was used as this is one possible route of human exposure during manufacture, handling and use of the test article.
OBSERVATIONS
Mortality / Viability Four times during test day 1 and once daily during days 2 to 15.
Body weights On test day 1 (pre-administration), 8 and 15.
Clinical signs Each animal was examined for changes in appearance and behaviour four times during day 1, and once daily during days 2-15. All abnormalities were recorded. - Statistics:
- No statistical analysis was 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.
- Mortality:
- Male and female: 0
- Clinical signs:
- other: No clinical signs were observed during the observation period in females. In males excretion of red feces caused by test article was noted on days 2 and 3 only.
- Gross pathology:
- No effects on organs were seen.
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose (LD50) of FAT 40'571/A after single oral administration to rats is greater than 2000 mg/kg body weight.
- Executive summary:
An acute oral gavage toxicity study was carried out with FAT 40571/A according to OECD 401 guideline in Male and female Wistar rats at the dose level of 2000 mg/kg bw. There were no no clinical signs were observed during the observation period in females except in males, excretion of red feces caused by test article was noted on days 2 and 3 only. There waas no mortality and gross lesions found. There was no treatment related effects on body weight.
Based on the study results and absence of mortality, the median lethal dose (LD50) of FAT 40'571/A after single oral administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/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.
