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Diss Factsheets
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EC number: 278-014-3 | CAS number: 74878-48-1
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Fluorescent Brightener 363
- IUPAC Name:
- Fluorescent Brightener 363
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Rats: Tif: RAIf (SPF) strain.
- Weight at study initiation: ranged from 160 to 180 grams.
- Fasting period before study: the rats were starved during one night before starting the treatment.
- Housing: animals were housed in groups of 5 in Macroloncages (type 3).
- Diet: rat food - NAFAG, Gossau SG -, ad libitum.
- Water: ad libitum.
- Acclimation period: the animals were adapted to our laboratories for a minimum of 4 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1° C
- Relative humidity: 55 ± 5 %
- Photoperiod: 14 hours light cycle day.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- Test item was suspended with polyethylene glycol (PEG 400). Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.
- Doses:
- 4640, 6000 and 7750 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: physical condition and rate of deaths were monitored throughout the whole observation period.
- Necropsy of survivors performed: yes; surviving animals were submitted for necropsy whenever they died, survivors at the end of the observation period.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 7 700 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed at 4640 and 6000 mg/kg bw, while 3 females out of 5 died at the dose of 7750 mg/kg bw.
- Clinical signs:
- other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. The surviving animals recovered within 8 to 12 days.
- Gross pathology:
- No substance related gross organ changes were seen.
Any other information on results incl. tables
Dose mg/kg | Concentration % of formulation | No animals | Died within | ||||||||||
1 hr | 24 hrs | 48 hrs | 7 days | 14 days | |||||||||
M | F | M | F | M | F | M | F | M | F | M | F | ||
4640 | 30 | 5 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
6000 | 30 | 5 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
7750 | 30 | 5 | 5 | 0 | 0 | 0 | 3 | 0 | 3 | 0 | 3 | 0 | 3 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- LD50 (rat M/F): 7700 mg/kg
- Executive summary:
Acute oral toxicity of the test substance was evaluated in a study conducted according to a methodology equivalent to OECD Guideline 401. Three groups each consisting of 5 males and 5 females were administered the test substance through oral route at the doses of 4640, 6000 and 7750 mg/kg bw. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. The surviving animals had recovered within 8 to 12 days. No mortality was observed at 4640 and 6000 mg/kg bw, while 3 females out of 5 died at the dose of 7750 mg/kg bw. Surviving animals were killed and autopsied after an observation period of 14 days. No substance related gross organ changes were seen. Hence, based on the findings of the study, it can be concluded that the acute oral LD50 in rats of both sexes observed over a period of 14 days is approximately 7700 mg/kg bw.
Conclusion
LD50 (rat M/F): 7700 mg/kg
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