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EC number: 219-210-0 | CAS number: 2387-03-3
- 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:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from study report
Data source
Reference
- Reference Type:
- publication
- Title:
- CARCINOGENESIS BIOASSAY of C.I. SOLVENT YELLOW 14 (CAS No. 842-07-9) IN F344/N RATS AND B6C3F1 MICE (FEED STUDY)
- Author:
- National Toxicology Program
- Year:
- 1 982
- Bibliographic source:
- NATIONAL TOXICOLOGY PROGRAM, Technical Report Series No. 226, NTP-80-80, NIH Publication No. 82-1782, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, Public Health Service, National Institutes of Health, September 1982, page no. 1-164
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as per mentioned below
- Principles of method if other than guideline:
- 14 day repeated dose toxicity study of C. I. Solvent Yellow 14 orally in B6C3F1 mice.
- GLP compliance:
- no
Test material
- Reference substance name:
- 1-phenylazo-2-naphthol
- EC Number:
- 212-668-2
- EC Name:
- 1-phenylazo-2-naphthol
- Cas Number:
- 842-07-9
- Molecular formula:
- C16H12N2O
- IUPAC Name:
- (1Z)-1-(phenylhydrazinylidene)naphthalen-2-one
- Details on test material:
- - Name of test material (as cited in study report):C. I. Solvent Yellow 14 - Molecular formula (if other than submission substance):C16-H12-N2-O- Molecular weight (if other than submission substance):248.284 g/mole - Substance type:Organic- Physical state:solid- purities (identity and concentrations): 94.1 % pure- Impurities (identity and concentrations):5.9 %
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Details on test animal and environmental conditions: TEST ANIMALS- Source: NCI Frederick Cancer Research Center (Frederick, MD)- Age at study initiation: 6 week old- Weight at study initiation: No data available - Fasting period before study: No data available - Housing: Mice were housed by species, five per cage, in solid-bottom polycarbonate cage supplied with hardwood chip bedding. Cages and bedding were changed twice per week. Rack Filters with Dupon 2024 Spun-Bonded polyester filters. - Diet (e.g. ad libitum): PurinaLaboratory Chow, ad libitum in feed hoppers that were changed weekly. - Water (e.g. ad libitum): Tap water supplied and analyzed by the Columbus, Ohio, water department, ad libitum via an automatic watering system.- Acclimation period: 2 weeks ENVIRONMENTAL CONDITIONS- Temperature (°C): 21° to 23°C- Humidity (%): 40%-60% (relative humidity)- Air changes (per hr): 15 times per hour- Photoperiod (hrs dark / hrs light): Standard white fluorescent lighting provided illumination 12 hours per day.IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: Feed (Purina Laboratory Chow animal meal)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Diets were formulated by mixing weighed amounts of Purina Laboratory Chow animal meal and the test chemical for 15 minutes in a Patterson-Kelly twin-shell blender equipped with an intensifier bar. DIET PREPARATION- Rate of preparation of diet (frequency): In every 10 days - Mixing appropriate amounts with (Type of food): Purina Laboratory Chow - Storage temperature of food: Formulated diets were stored at 23°C for no longer than 10 daysVEHICLE- Justification for use and choice of vehicle (if other than water): Purina Laboratory Chow - Concentration in vehicle: 6,000, 12,500, 25,000, 50,000 and 100,000 ppm- Amount of vehicle (if gavage): No data available- Lot/batch no. (if required): Not required - Purity: No data available
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analytical verification of doses were performed by using Gilford 2400-S spectrophotometer
- Duration of treatment / exposure:
- Daily
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:0, 6,000, 12,500, 25,000, 50,000 and 100,000 ppm (0, 1200, 2500, 5000, 1000 and 20000 mg/kg/day)Basis:nominal in diet
- No. of animals per sex per dose:
- Total: 600 ppm : 5 male, 5 female 6000 ppm : 5 male, 5 female12500 ppm : 5 male, 5 female25000 ppm : 5 male, 5 female50000 ppm : 5 male, 5 female100000 ppm : 5 male, 5 female
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Details on study design:- Dose selection rationale: No data available - Rationale for animal assignment (if not random): Animals assigned to cages according to a table of random numbers. - Rationale for selecting satellite groups: No data available - Post-exposure recovery period in satellite groups: No data available - Section schedule rationale (if not random): No data available
Examinations
- Observations and examinations performed and frequency:
- Observations and examinations performed & frequencyCAGE SIDE OBSERVATIONS: Yes - Time schedule: No data available - Cage side observations checked in table [No.?] were included: Mortality was observed. DETAILED CLINICAL OBSERVATIONS: Yes - Time schedule: No data availableBODY WEIGHT: No data available- Time schedule for examinations: No data availableFOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data available- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data available- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data available FOOD EFFICIENCY: No data available- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data available WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available - Time schedule for examinations: No data availableOPHTHALMOSCOPIC EXAMINATION: No data available - Time schedule for examinations: No data available- Dose groups that were examined: No data available HAEMATOLOGY: No data available - Time schedule for collection of blood: No data available- Anaesthetic used for blood collection: No data available- Animals fasted: No data available - How many animals: No data available- Parameters checked in table [No.?] were examined.CLINICAL CHEMISTRY: No data available - Time schedule for collection of blood: No data available- Animals fasted: No data available - How many animals: No data available- Parameters checked in table [No.?] were examined. No data availableURINALYSIS: No data available- Time schedule for collection of urine: No data available- Metabolism cages used for collection of urine: No data available - Animals fasted: No data available- Parameters checked in table [No.?] were examined. No data availableNEUROBEHAVIOURAL EXAMINATION: No data available - Time schedule for examinations: No data available- Dose groups that were examined: No data available- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data availableOTHER: No data available
- Sacrifice and pathology:
- Sacrifice and pathologyGROSS PATHOLOGY: Yes Gross pathological abnormalities were examined. HISTOPATHOLOGY: No data available
- Other examinations:
- No data available
- Statistics:
- No data available
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Mortality: When treated with 12500, 25000, 50000 and 100000 ppm, all male and female mice were died. Clinical signs: No sign of toxicity were observed in treated mice.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Mortality: When treated with 12500, 25000, 50000 and 100000 ppm, all male and female mice were died. Clinical signs: No sign of toxicity were observed in treated mice.
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 12500, 25000, 50000 and 100000 ppm, severe effects were observed in male and female mice. Dark red intestines and mildly congested livers were observed in 6000 ppm treated male and female mice.
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 2 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Effect on survival and gross pathology
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- LOAEL was considered to be 12500 ppm (2500 mg/kg/day) when B6C3F1 male and female mice treated with C. I. Solvent Yellow 14.
- Executive summary:
In a 14 day repeated dose toxicity study, B6C3F1male and female micetreated with C. I. Solvent Yellow 14 in the concentration of0,6,000, 12,500, 25,000, 50,000, or 100,000 ppmorally in diet. All male and female mice were died at 12500, 25000, 50000 and 100000 ppm dose. In addition, severe gross pathological effects such asdark red intestines and mildly congested livers were observed at12500 ppm and at higher doses. Therefore,LOAEL was considered to be 12500 ppm (2500 mg/kg/day) whenB6C3F1male and female micewere treated with C. I. Solvent Yellow 14. orally in diet for 14 days.
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