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EC number: 204-934-1 | CAS number: 129-17-9
- 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
Carcinogenicity
Administrative data
Description of key information
The Carcinogenic NOAEL value for the test substance hydrogen [4-[4-(diethylamino)-2', 4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt is found to be 784.6 mg/kg bw. in rat. Thus hydrogen [4-[4-(diethylamino)-2', 4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt is found to be non carcinogenc in nature.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity
- Remarks:
- subcutaneous
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- The sequential histological changes and neoplastic response occurring in the subcutaneous tissue of rats after injection of Patent Blue V was performed to determine its carcinogenic potential.
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- other: Ash/CFE
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Details on test animal and environmental conditions: TEST ANIMALS- Source: No data available- Age at study initiation: No data available- Weight at study initiation: average 100g- Fasting period before study: No data available- Housing: No data available- Diet (e.g. ad libitum): Spillers small laboratory animal diet, ad libitum- Water (e.g. ad libitum): Water, ad libitum- Acclimation period: No data availableENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 1 °C - Humidity (%): 50%- Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): No data availableIN-LIFE DATES: From: To: No data available
- Route of administration:
- subcutaneous
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: Co2 free distilled water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Solutions were prepared using CO2 free distilled water. Colouring (Blue VRS) were filtered and buffered to pH 7.0 beforeand prepared freshly before injection in a volum of 0.5 mlDIET PREPARATION- Rate of preparation of diet (frequency): No data available- Mixing appropriate amounts with (Type of food): No data available- Storage temperature of food: No data availableVEHICLE- Justification for use and choice of vehicle (if other than water): CO2 free distilled water - Concentration in vehicle: 2%- Amount of vehicle (if gavage): No data available- Lot/batch no. (if required): No data available- Purity: No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 60 weeks
- Frequency of treatment:
- Twice weekly
- Post exposure period:
- No data available
- Remarks:
- Doses / Concentrations:784.6 mg/Kg (2%)Basis:no data
- No. of animals per sex per dose:
- 132 in total
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- N-methyl-N-nitrosourea (MNU) and N-nitroquinoline-N-oxide (NQO) were used as positive control.
- Observations and examinations performed and frequency:
- Observation and examinations performed and frequency:CAGE SIDE OBSERVATIONS:Yes- Time schedule:- Cage side observations checked in table [No.?] were included.: Survival were observed. DETAILED CLINICAL OBSERVATIONS: Yes - Time schedule: throughout the study experimentDERMAL IRRITATION (if dermal study): No data available - Time schedule for examinations:BODY WEIGHT: No data available- Time schedule for examinations:FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data availableFOOD EFFICIENCY: No data availableOPHTHALMOSCOPIC EXAMINATION: No data available HAEMATOLOGY: No data availableCLINICAL CHEMISTRY: No data availableURINALYSIS: No data available OTHER: The subcutaneous injection was given in the right flank of each rat and the injection site was shaved with electric clippersTissue reactions to Blue VRS were studied in two ways—A) Rats injected throughout the experimental periodB) Rats injected for only part of the experimental period
- Sacrifice and pathology:
- GROSS PATHOLOGY: No data available HISTOPATHOLOGY: Yes
- Other examinations:
- No data available
- Statistics:
- No data available
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Gross Pathology: No macroscopical abnormalities at the injection site were observed in treated male and female rats as compared to controls. Histopathology: neoplastic:No resolution was observed in any rat treated with 784.6 mg/kg that had received more than 25 injections, although areas of fatty tissue could be seen between the collagen strands in animals receiving less than 40 injections.In rats that had received more than 40 injections thick scar tissue containing wide collagen bands filled the subcutaneous area, and foci of fibroblastic activity were observed in several animals. Other animals had developed sarcomata locally.
- Dose descriptor:
- NOAEL
- Effect level:
- 784.6 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect on survival and histopathology
- Remarks on result:
- other:
- Remarks:
- Effect type: other: Tumorogenic (migrated information)
- Conclusions:
- NOAEL was considered to be 78436 mg/kg when Ash/CFE male and female rats were treated with Blue VRS subcutaneously for 60 weeks.
- Executive summary:
- In a Tumorogenecity study, Ash/CFE male and female rats were treated with Blue VRS in the concentration of 2 % (784.6 mg/kg) subcutaneously as a Solutions prepared using CO2 free distilled water. Colouring (Blue VRS) were filtered and buffered to pH 7.0 before injection. No macroscopical abnormalities at the injection site were observed in treated male and female rats as compared to controls. In addition, No resolution were observed in any rat treated with 784.6 mg/kg that had received more than 25 injections, although areas of fatty tissue could be seen between the collagen strands in animals receiving less than 40 injections. In rats that had received more than 40 injections thick scar tissue containing wide collagen bands filled the subcutaneous area, and foci of fibroblastic activity were observed in several animals. Other animals had developed sarcomata locally. Therefore, NOAEL was considered to be 78436 mg/kg when Ash/CFE male and female rats were treated with Blue VRS subcutaneously for 60 weeks.
Reference
Incidence of local tissue response elicited by surfactants in rats after increasing number of injections
Rats injected throughout the experimental period and killed 24 hrs after the last injection | ||||
No. of injections | Total rats | Quiescent scar tissue | Foci of fibroblastic activity | Sarcomata |
1-24 | 12 | 0 | 6 | 0 |
32-52 | 14 | 4 | 10 | 0 |
56-76 | 12 | 1 | 10 | 1 |
80-96 | 11 | 1 | 8 | 2 |
100-117 | 11 | 0 | 3 | 8 |
Rats injected for only part of the experimental period and killed at termination of experiment or when tumors developed | ||||
No. of injections | Total rats | Quiescent scar tissue | Foci of fibroblastic activity | Sarcomata |
1-28 | 15 | 0 | 0 | 0 |
32-60 | 15 | 9 | 5 | 1 |
64-92 | 15 | 5 | 4 | 6 |
96-117 | 17 | 4 | 10 | 3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 784.6 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Data from K2 publication.
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Additional information
Based on available data for target Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt (CAS no 129-17-9) for carcinogenicity is summaries below
In a study conducted by Hoosonet al(1973), Tumorogenecity was evaluated in Ash/CFE male and female rats by using Blue VRS in the concentration of 2 % (784.6 mg/kg) subcutaneously as a Solutions prepared using CO2free distilled water. Colouring (Blue VRS) were filtered and buffered to pH 7.0 before injection. No macroscopical abnormalities at the injection site were observed in treated male and female rats as compared to controls. In addition, No resolution were observed in any rat treated with 784.6 mg/kg that had received more than 25 injections, although areas of fatty tissue could be seen between the collagen strands in animals receiving less than 40 injections. In rats that had received more than 40 injections thick scar tissue containing wide collagen bands filled the subcutaneous area, and foci of fibroblastic activity were observed in several animals. Other animals had developed sarcomata locally. Therefore, NOAEL was considered to be 78436 mg/kg when Ash/CFE male and female rats were treated with Blue VRS subcutaneously for 60 weeks.
In a study given by EFSA Panel (2013), combined repeated dose & carcinogenicity was evaluated in male and female mice by using Patent Blue Vin the concentration of0, 0.1, 0.3 and 1 % (equivalent to 0, 150, 500 and 1500 mg/kg body weight/day) orally. Slightly increased in mortality,Significant decrease in body weight of male mice andSignificant reduction in haemoglobin, haematocrit, red blood cell counts and reticulocyte count, increase in the total number of white blood cells inmale and female rat were observed at 1 % dose group as compared to control. Increased in relative heart and caecal weights were observed in female at 1 % dose group. In addition,Non-neoplastic lesions of lungs, kidneys and liver were observed. Adrenocortical adenoma and carcinoma, adenoma of mammary gland were observed but the observed changes were mainly isolated findings, of commonly occurring tumours showing no dose-response relationship. Therefore, NOAEL was considered to be 1500 mg/kg body weight /day when male and female mice were treated with Patent Blue V orally for approx. 32 weeks.
Thus, based on above available data forfor target Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt (CAS no 129-17-9) is likely to be non hazardous as carcinogen.
Justification for selection of carcinogenicity via oral route endpoint:
There was some evidence of carcinogenic activity in male and female Ash/CFE rats based Tumorogenic effect of the test animals.
The carcinogenic Low Observed Adverse Effect Level (NOAEL) for the given test material is found to be 1000 mg/kg bw.
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