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EC number: - | CAS number: 42355-78-2
- 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:
- From September 29 to Ocober 15, 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 17 December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- tetrasodium 2,2'-ethene-1,2-diylbis[5-({4-[diethylamino]-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]
- Cas Number:
- 42355-78-2
- Molecular formula:
- C40H40N12Na4O12S4
- IUPAC Name:
- tetrasodium 2,2'-ethene-1,2-diylbis[5-({4-[diethylamino]-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SPF breeding, VELAZ s.r.o., Únětice, Czech Republic
- Age at study initiation: 8 - 10 weeks at the time application
- Fasting period before study: twenty hours before oral administration the animals were not fed.
- Housing: animal room with monitoring conditions – 3 animals of one sex in one plastic breeding cage Velaz T4.
- Bedding: sterilized shavings of soft wood.
- Diet: ad libitum, ST - 1, VELAS a.s., Hrabanov 535, 289 22 Lysá nad Labem, CZ 801080-01.
- Water: ad libitum, drinking tap water ad libitum (quality corresponding to Regulation No. 252/2004 Czech Coll. of Law).
- Acclimation period: 20 days
- Health condition: certificate of good health condition from breeding farm; no signs of diseases were observed at clinical check-in, during the acclimatisation period and before the start of study.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 – 70 %
- Photoperiod: light period 12-hour light/12 hour dark.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Aqua pro injection
- Details on oral exposure:
- Preparation and application of the test substance: immediately before application the test substance was weighed and mixed in vehicle. The test substance was administered dissolved in water pro injection.
Dosing: the test substance was administered to the stomach by tube. The single volume of administered solution was 1 ml/100 g of animal body weight. - Doses:
- 2000 mg/kg of body weight
- No. of animals per sex per dose:
- 6 females (3 per group)
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: immediately before application the animals were weighed, 8th day and at the 15th day, before euthanasia of animals.
- Necropsy of survivors performed: yes.
- Clinical examination: after application the animals were observed individually. The first day twice (30 minutes and 3 hours after application), the second day twice (in the morning and in the afternoon) and daily thereafter for 14 days. Observations included changes in skin and fur, eyes, visible mucous membranes, behaviour of animals, somatomotor activity, reactions to stimuli, and presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system.
- Pathological examination: all test animals survived to the end of study were sacrificed on the 15th day by injection of veterinary preparation T61 (1 ml iv.) and gross necropsy was carried out. Nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death occured.
- Clinical signs:
- other: No clinical signs of intoxication were observed during the study.
- Gross pathology:
- No pathologic changes were recorded.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- The LD50 of the test substance for female rats is higher than 2000 mg/kg of body weight.
- Executive summary:
Method
The aim of the study was to investigate acute toxic effects of the test substance after a single oral administration to Wistar CRL rats.
The testing was performed according Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008. The test substance was administered dissolved in water pro injection as a single dose, given orally via gavage to three groups of three female Wistar CRL rats.
The dosing was performed sequentially in two groups of three females:
group No. 1 - first step using the starting dose of 2000 mg/kg of body weight
group No. 2 - second step using the same dose 2000 mg/kg.
Results
The test substance administered at the dose of 2000 mg/kg caused no death of animals. No clinical signs of intoxication were detected during whole study. No pathologic macroscopic changes were diagnosed during pathological examination.
According to the study results the value of LD50 of the test substance for female rats is higher than 2000 mg/kg of body weight.
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