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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 212-668-2 | CAS number: 842-07-9
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- 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:
- no guideline available
- 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
- Limit test:
- 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:
- 1-[(E)-2-phenyldiazen-1-yl]naphthalen-2-ol
- 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
- Specific details on test material used for the study:
- - Name of test material: C. I. Solvent Yellow 14 (1-phenylazo-2-naphthol)
- Molecular formula: C16H12N2O
- Molecular weight: 248.284 g/mol
- Substance type: Organic
- Physical state: solid
- Impurities (identity and concentrations): 5.9 %
- Purity: 94.1% pure
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system 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 were used.
- Diet (e.g. ad libitum): Purina Laboratory 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
- Details on route of administration:
- No data
- 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 to give a dose range of 0, 1200, 2500, 5000, 10000 and 20000 mg/kg/day.
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 days
VEHICLE
- 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 (0, 1200, 2500, 5000, 10000 and 20000 mg/kg/day)
- 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:
- 14 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- 0, 6,000, 12,500, 25,000, 50,000 and 100,000 ppm (0, 1200, 2500, 5000, 10000 and 20000 mg/kg/day)
nominal in diet
- No. of animals per sex per dose:
- Total: 60
0 mg/Kg/day : 5 male, 5 female
1200 mg/Kg/day : 5 male, 5 female
2500 mg/Kg/day : 5 male, 5 female
5000 mg/Kg/day : 5 male, 5 female
10000 mg/Kg/day : 5 male, 5 female
20000 mg/Kg/day : 5 male, 5 female - Control animals:
- yes, concurrent vehicle
- 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
- Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- CAGE 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 available
BODY WEIGHT: No data available
- Time schedule for examinations: No data available
FOOD 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 available
OPHTHALMOSCOPIC 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 available
URINALYSIS: 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 available
NEUROBEHAVIOURAL 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 available
OTHER: No data available - Sacrifice and pathology:
- GROSS 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:
- no effects observed
- Mortality:
- mortality observed, treatment-related
- 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
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- Clinical signs and mortality :
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 gain: No data available
Food consumption and compound intake: No data available
Food efficiency: No data available
Water consumption and compound intake: No data available
Opthalmoscopic examination: No data available
Haematology: No data available
Clinical chemistry: No data available
Urinanalysis: No data available
Neurobehaviour: No data available
Organ weights: No data available
Gross pathology: When treated with 2500, 5000, 10000 and 20000 mg/kg/day, severe effects were observed in male and female mice. Dark red intestines and mildly congested livers were observed in 1200 mg/Kg/day treated male and female mice. Dark red intestines and mildly congested livers were observed in 6000 ppm treated male and female mice.
Histopathology: No data available
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant alterations were noted at the mentioned dose level
Target system / organ toxicity
- Critical effects observed:
- no
Any other information on results incl. tables
Table: Survival of mice in 14 days study period
Dose (mg/Kg/day) |
Survival |
|
Male |
Female |
|
1200 |
5/5 |
5/5 |
2500 |
0/5 |
0/5 |
5000 |
0/5 |
0/5 |
10000 |
0/5 |
0/5 |
20000 |
0/5 |
0/5 |
Applicant's summary and conclusion
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) was 1200 mg/kg/day when B6C3F1 male and female mice were treated with 1-phenylazo-2-naphthol (C. I. Solvent Yellow 14).
- Executive summary:
Repeated dose oral toxicity study was performed on mice to determine the toxic nature of C. I. Solvent Yellow 14. In a 14 day repeated dose toxicity study , B6C3F1 male and female mice were treated with C. I. Solvent Yellow 14 in the concentration of 0,6,000, 12,500, 25,000, 50,000, or 100,000 ppm orally in diet. All male and female mice were died at 12500, 25000, 50000 and 100000 ppm (2500, 5000, 1000 and 20000 mg/kg/day) dose. The mice were observed for clinical signs and mortality, gross and histopathology. No clinical signs of toxicity were noted and severe gross pathological effects such as dark red intestines and mildly congested livers were observed at 2500 mg/Kg/day and at higher doses. Therefore, No Observed Adverse Effect Level (NOAEL) was 1200 mg/kg/day when B6C3F1 male and female mice were treated with 1-phenylazo-2-naphthol (C. I. Solvent Yellow 14).
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.