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EC number: 276-634-9 | CAS number: 72391-23-2
- 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:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Version / remarks:
- July 30, 1996
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Sodium 2(or 5)-[[1-amino-4-[[3-[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxo-2-anthryl]oxy]-5(or 2)-(tert-butyl)benzenesulphonate
- EC Number:
- 276-634-9
- EC Name:
- Sodium 2(or 5)-[[1-amino-4-[[3-[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxo-2-anthryl]oxy]-5(or 2)-(tert-butyl)benzenesulphonate
- Cas Number:
- 72391-23-2
- Molecular formula:
- C36H36ClN3O7S.Na
- IUPAC Name:
- sodium 2(or 5)-[[1-amino-4-[[3-[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxo-2-anthryl]oxy]-5(or 2)-(tert-butyl)benzenesulphonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 400047.32
- Expiration date of the lot/batch: December 1998
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 under test conditions: Stable in polyethylene glycol (PEG 400) for at least 24 hours.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, CH-4414 Füllinsdorf/ Switzerland
- Age at study initiation: Males - 8 weeks; Females - 10 weeks
- Weight at study initiation: Males - 200-214 g; Females - 183-189 g
- Fasting period before study: overnight
- Housing: Groups of five in Makrolon type-4 cages with standard softwood bedding
- Diet : ad libitum
- Water: ad libitum
- Acclimation period: One week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Details on oral exposure:
- The animals received a single dose of the test article at 2000 mg/kg body weight basis by oral gavage following fasting for approximately 16.5 h, but with free access to water. Food was provided again approximately 3 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. - Doses:
- 2000 mg/ kg body weight
- 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 and weighing: Clinical signs - Daily, Body weight - 1, 8 and 15 day
- Necropsy of survivors performed: yes - Statistics:
- The LOGIT-Model could not be 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:
- No deaths occurred during the study.
- Clinical signs:
- other: No clinical signs of toxicity were observed during the study period.
- Gross pathology:
- No macroscopic organ findings were observed at necropsy.
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean lethal dose (LD50) of FAT 21016/C after single oral administration in Wistar rats of both sexes is greater than 2000 mg/kg bw.
- Executive summary:
Following OECD Guidelines for the Testing of Chemicals, Number 401 "Acute Oral Toxicity", Wistar rats were exposed to test substance FAT 21016/C to determine median lethal concentration (LD50). A group of five male and five female Hanlbm: WIST (SPF) rats was treated with FAT 21016/C at 2000 mg/kg by oral gavage. The test article was suspended in vehicle (PEG 400) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg. Four times during day 1 and once daily during days 2-15 the animals were examined for clinical signs. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically. No deaths nor clinical signs of toxicity were observed during the observation period. The body weight of the animals was within the range of physiological variability known for rats of this strain and age. No macroscopic organ findings were observed at necropsy. In conclusion, the mean lethal dose (LD50) of FAT 21016/C after single oral administration in Wistar rats of both sexes is greater than 2000 mg/kg bw.
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