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Reaction mass of 5,5'-{(phenylmethanediyl)bis[benzene-4,1-diyl-diazene-2,1-diyl]}bis{1-[3-(dimethylamino)propyl]-4-methyl-6-oxo-3-(pyridinium-1-yl)-1,6-dihydropyridin-2-olate} hydrochloride and 5,5’-[3,4’-(phenylmethanediyl)diphenylene]bis(diazene-2,1-diyl)bis{1-[3-(dimethylamino)propyl]-4-methyl-6-oxo-3-(pyridinium-1-yl)-1,6-dihydropyridin-2-olate} hydrochloride
EC number: 700-312-3 | CAS number: -
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2007-09-24 to 2008-01-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations, conducted with the analogue substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- analogue substance (refer to IUCLID chapter 13)
- IUPAC Name:
- analogue substance (refer to IUCLID chapter 13)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, Wölferstrasse 4, 4414 Füllinsdorf / Switzerland
- Age at study initiation: females 11 weeks, males 8 weeks
- Weight at study initiation: females 197.4 - 213.5 g, males 241 - 261.2 g
- Fasting period before study: no
- Housing: Individually in Makrolon type-3 cages with standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard rat/mouse maintenance diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark
IN-LIFE DATES: From: 2007-09-25 To: 2007-10-16
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: backs of the animals
- % coverage: ca. no data
- Type of wrap if used: The semi-occlusive dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was flushed with lukewarm tap water and dried with disposable paper towels
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 6 ml/kg bw
- Concentration (if solution): 333.3 mg/l
- Constant volume or concentration used: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): 6 ml/kg bw
- Purity: Purified water prepared at RCC Ltd (deionised water which was processed and treated by the PURELAB Option-R unit. This latter links four purification technologies: reverse osmosis, adsorption, ion-exchange and photo oxidation). - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality / Viability: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15.
Clinical signs: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalities were recorded.
Weighing: On test days 1 (prior to administration), 8 and 15.
Local Signs: Once daily during days 2-15. All abnormalities will be recorded.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Analogue substance.
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: No systemic signs of toxicity were observed. Local toxicity: At removal of the application patch the local skin reactions were not assessable in all animals due to a yellow staining produced by the test item. The
- Gross pathology:
- Effects on organs: No macroscopic findings were observed at necropsy.
- Other findings:
- - Organ weights: no data
- Histopathology: no data
- Potential target organs: not applicable
- Other observations:
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose of the test item after single dermal administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat) > 2000 mg/kg body weight. Based on the proposed read across approach, the LD50 of the substance registered can be assumed to be in the same range as for the analogue substance.
- Executive summary:
The acute dermal toxicity to rats of the analogue substance was being investigated following the testing protocol as given in OECD guideline 402.
Five male and five female rats were treated with the test item at 2000 mg/kg by dermal application. The test item was diluted in vehicle (purified water) at a concentration of 0.33 g/mL and administered at a volume dosage of 6 mL/kg. The application period was 24 hours.The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. Body weights were recorded. All animals were necropsied and examined macroscopically.
No deaths occurred during the study.
At removal of the application patch the local skin reactions were not assessable in all animals due to a yellow staining produced by the test item. The assessment was prevented up to day 6 in the females and day 7 in the males. The staining was present from day 7 in the females and on day 8 in the males.When assessable, a slight local erythema was noted in one male from days 8 to 9 and in all females from day 7 to 9 or 10. Slight scaling was present from day males and from days 7 or 8 up to day 10 in all females. Slight crusts were noted in one female from day 7 to 13.
The body weight of the animals was within the range commonly recorded for this strain and age.
No macroscopic findings were observed at necropsy.
The median lethal dose of the test item after single dermal administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat) > 2000 mg/kg body weight.
Given the applicability of the proposed read across approach (see IUCLID chapter 13), the respective LD50 values of the substance registered can safely be assumed to be in the same range as for the analogue substance, as (1) the molecules of the substance registered and the analogue substance show to a large extent structural similarities, and (2) furthermore the molecular weights of the analogue substance and the substance registered only differ by 2.5%.
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