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Reaction mass of N-(4-(bis(4-(methylamino)phenyl)methylene)cyclohexa-2,5-dienylidene)-N-methylmethanaminium acetate and [4-[[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate and [4-[bis[4-(dimethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene]dimethylammonium acetate
EC number: 944-191-7 | 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
Endpoint summary
Administrative data
Description of key information
LD50 rat (oral)>300 and < 2000 mg/kg
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
- Specific details on test material used for the study:
- Liquid dark blue-violet
- Species:
- rat
- Strain:
- other: RccHan™:WIST albino
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Healthy nulliparous and non-pregnant
The animals were allocated without conscious bias to cages within the treatment groups.
They were housed in groups of one or four rats of the same sex.
Each animal was identified uniquely within the study by tail marking. Each cage label was color-coded and was identified uniquely with the study number, dose level and animal mark.
The animals were allowed to acclimatize to the conditions described below for at least five days before treatment. For those animals selected for this study, their body weights were in the range 160 to 181 g and they were approximately eight to twelve weeks of age prior to dosing (Day 1). The body weight variation did not exceed 20% of the mean body weight of any previously treated animals.
Animals were housed inside a limited access rodent facility (Building F21, Room 044/045). The facility was designed and operated to minimize the entry of external biological and chemical agents and to minimize the transference of such agents between rooms.
The animal room was kept at positive pressure with respect to the outside by its own supply of filtered fresh air, which was passed to atmosphere and not re-circulated. The temperature and relative humidity controls were set to maintain the range of 20 to 24C and 40 to 70% respectively. Any minor deviations from these ranges would not have had an adverse effect on the animals and would not affect the integrity or validity of the study.
Artificial lighting was controlled to give a cycle of 12 hours continuous light and 12 hours continuous dark per 24 hours. Environmental parameters are archived with the departmental raw data.
Periodic checks were made on the number of air changes in the animal rooms. Temperature and humidity were monitored daily.
The cages were solid bottomed polycarbonate cages with a stainless steel mesh lid. Each cage contained a quantity of autoclaved softwood bark-free fiber bedding. Cages, food hoppers, water bottles and bedding were changed at appropriate intervals.
The animals were allowed free access to a standard rodent diet (Teklad 2014C Diet), except for overnight prior to and approximately four hours after dosing. This diet contained no added antibiotic or other chemotherapeutic or prophylactic agent.
Potable water taken from the public supply was freely available via polycarbonate bottles fitted with sipper tubes.
Each cage of animals was provided with Aspen chew blocks or balls for environmental enrichment. Chew blocks or balls were provided throughout the study and were replaced when necessary. Each cage of animals was provided with a plastic shelter for environmental enrichment, which was replaced at the same time as the cages.
Each batch of diet was analyzed routinely by the supplier for various nutritional components and chemical and microbiological contaminants. Supplier’s analytical certificates were scrutinized and approved before any batch of diet was released for use. The quality of the water supply is governed by regulations published by the Department for Environment, Food and Rural Affairs. Certificates of analysis were received routinely from the water supplier.
Certificates of analysis were received routinely from the supplier of the chew blocks or balls.
Since the results of these various analyses did not provide evidence of contamination that might have prejudiced the study, they are not presented.
No other specific contaminants that were likely to have been present in the diet or water were analyzed, as none that may have interfered with or prejudiced the outcome of the study was known. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The test item was formulated at concentrations of 30 and 200 mg/mL in the vehicle, by adding the vehicle to the item and mixing. The formulation was administered at a volume of 10 mL/kg body weight
- Doses:
- dose range finding: 300 and 2000 mg/kg (In the absence of data regarding the toxicity of the test item, 300 mg/kg was chosen as the starting dose)
main study: 300 mg/kg - No. of animals per sex per dose:
- dose range finding: 1 female per dose
main study: 4 females at the selected dose - Control animals:
- no
- Details on study design:
- The appropriate dose volume of the test item was administered to each rat by oral gavage using a plastic syringe and plastic catheter.
Formulations were stirred before and throughout the dosing procedure - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- On Day 6 female number 22 dosed in the sighting study at 2000 mg/kg was sacrificed on humane grounds due to the severity of the clinical signs seen.
- Clinical signs:
- other: Clinical signs throughout the six days before death of the female dosed at 2000 mg/kg comprised salivation, purple staining in saliva, mouth and front paws, piloerection, partially closed eyelids, abnormally cold to touch, hunched posture, dark feces, dec
- Gross pathology:
- For the female that died at 2000 mg/kg macroscopic examination of the animal revealed congestion (characterized by darkened tissues/organs) of the subcutaneous tissue, heart, lungs and bronchi, liver, spleen and kidneys. Also, a small heart and spleen and enlarged, swollen or thickened tissues of the stomach were noted. A dark purple staining was observed in the stomach as well as purple fluid contents and dark purple staining in the duodenum, cecum and small and large intestines.
No abnormalities were noted in any surviving animal at the macroscopic examination at study termination on Day 15. - Conclusions:
- The substance was tested for acute oral toxicity following OECD 420. Under the experimental conditions the LD50 > 300 and < 2000 mg/kg.
- Executive summary:
The substance was tested for acute oral toxicity following OECD 420 (rats). Fasted female rats received a single oral gavage dose of the test item, formulated in purified water, at the following dose levels: Sighting investigations: 300 and 2000 mg/kg body weight
Main study: Based on the results of the sighting investigations a further four fasted females were similarly dosed at 300 mg/kg body weight.
During the study, clinical condition, body weight and macropathology investigations were undertaken. Under the experimental conditions the LD50 > 300 and < 2000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 300 mg/kg bw
Additional information
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:
For Acute toxicity oral route:
Category 1: ATE <= 5 mg/kg bw
Category 2: 5 < ATE <= 50 mg/kg bw
Category 3: 50 < ATE <= 300 mg/kg bw
Category 4: 300 < ATE <= 2000 mg/kg bw
The LD50 of the test substance was determined to be >300 and < 2000 mg/kg bw, therefore, the test substance is classified as category 4, H302 Acute toxicity by oral exposure.
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