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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Remarks:
- the study is a DRF of a sub-chronic toxicity study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- the study is a DRF of a sub-chronic toxicity study performed acoording to guideline 408
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
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:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Age at study initiation: 6 – 7 weeks
acclimatisation: 5 days
Housing conditions:
- Grouping: 2 animals of the same sex in one cage
- Food: complete pelleted diet for rats
- Water: drinking water ad libitum, quality corresponding to the Regulation No. 252/2004 of Czech Coll. of Law
- Light cycle: 12 hour light / 12 hour dark
Microclimate: 22 + 3 °C, relative humidity 30-70 %, air changes: 15 per hour
- Bedding: sterilised Lignocel or sterilized shavings of soft wood
Selection of animals: random selection according to the internal rule – at the beginning of the study the weight variation of animals in groups of each sex should not exceed + 20% of the mean weight
Identification of animals: the animals will be identified by the colour marks on their fur; each cage will be marked with the number of animals, sex, number of cage, name and dose level of the test item
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Aqua pro iniectione
- Details on oral exposure:
- The application form of the test item will be administered to the stomach by gavage.
Animals will be fasted 2 hours before to test item administration. After the test item will be administered, the animals will not get food for next 2 hours.
The test item concentration at single dose level will be adjusted so that the administered volume will be constant at all dose levels – 1 ml/100 g body weight. The administration form of the test item will be prepared daily before administration and during administration it will be mixed by the magnetic stirrer. - Duration of treatment / exposure:
- 21 days
- Frequency of treatment:
- once at day
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- Health condition control: performed once a day during animal handling before the application of the test item.
Body weight: recorded on automatic balances with group average computing module.
First weighing was performed before the first application and then weekly. Weight increment was computed as an average per group per week (in grams).
Clinical observations: in natural conditions in animals' cages.
Haematological examination:
Before necropsy of animals the blood samples will be collected from the orbital plexus by glass micropipette under the light diethyl ether narcosis into the PVC test tubes containing anticoagulation systems. Basic blood parameters (total erythrocyte count, total leucocyte count, mean corpuscule volume, haematocrit, haemoglobin concentration, total platelet count) was determined on haematology analyser.
Pathological examination:
During the necropsy (on the 21st day of study) a revision of the external surface of the body, of all orifices and the cranial, thoracic and abdominal cavities was carried out. - Sacrifice and pathology:
- GROSS PATHOLOGY: During the necropsy (on the 21st day of study), a revision of the external surface of the body, of all orifices and the cranial, thoracic and abdominal cavities was carried out.
HISTOPATHOLOGY: Not performed
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food efficiency:
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Haematological parameters did not show significant differences among dose levels, both for males and females. All mean values are comparable with control range.
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Effect levels
- Dose descriptor:
- dose level: dose for selection of maximum tested dose in the main study
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- haematology
Target system / organ toxicity
- Critical effects observed:
- no
Any other information on results incl. tables
Result of the study in tabular form:
dose (mg/kg) | notes | ||||
0 | 100 | 300 | 1000 | ||
Body weight (grams, at 1st day and necropsy 21st days), males | 330.08 ± 10.90 | 329.95 ± 12.67 420.78 ± 16.96 | 329.77 ± 12.42 | 329.77 ± 12.42 | The mean values of body weights and weight increments were similar to control group. |
Body weight (grams, at 1st day and necropsy 21st day), females | 241.53 ± 23.67 | 237.78 ± 11.50 | 245.25 ± 10.94 | 250.75 ± 20.95 | The mean values of body weights were similar to control group. |
Body weight increment (grams, at 1st, 2nd and 3rd week), males | 39.62/27.93/26.39 | 36.19/31.85/22.75 | 40.95/35.07/26.46 | 39.27/33.46/26.88 | |
Body weight increment (grams, at at 1st, 2nd and 3rd week), females | 18.06/5.6/12.04 | 12.25/8.33/12.11 | 8.40/14.98/16.24 | 17.64/8.05/18.62 | |
Signs of toxicity (health condition), males, females | no effects | no effects | no effects | no effects | No changes of animal health status and clinical symptoms of intoxication were observed in treated animals |
Haematological tests with relevant baseline values, M and F | no effects | no effects | no effects | no effects | Haematological parameters did not show significant differences among dose levels. All mean values are comparable with historical control range |
Necropsy findings, M and F | no effects | no effects | no effects | no effects | No macroscopical changes were observed during necropsy of treated males/females and control males/females |
Applicant's summary and conclusion
- Conclusions:
- At the dose level 1000 mg/kg/day, mean values of different parameters analyzed are comparable with historical control range. Based on these findings, the highest tested dose for the main study was selected.
- Executive summary:
In the dose-range finding experiment with test item, no animal died during the application period.
Clinical observations did not detect any impact of the test item on the health condition of animals at all dose levels.
The administration of the test item did not induce treatment-related toxicologically significant changes.
No macroscopical changes were observed during necropsy of treated animals.
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.