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EC number: 220-293-0 | CAS number: 2706-28-7
- 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
The test chemical Fast Yelow Ab is not likely to classify as a toxicant upon repeated exposure by oral route.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- 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 publication
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Subchronic toxicity study was performed to evaluate the toxic nature of the test compound disodium 2-amino-5-[(4-sulphonatophenyl)azo]benzenesulphonate upon repeated application by the oral route of exposure.
- GLP compliance:
- no
- Limit test:
- yes
- Species:
- pig
- Strain:
- other: SPF pigs of Danish Landrace
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data available
- Age at study initiation: No data available
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%): No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To: No data available - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- Details on oral exposure
PREPARATION OF DOSING SOLUTIONS: No data available
DIET 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 available
VEHICLE
- Justification for use and choice of vehicle (if other than water): No data available
- Concentration in vehicle: No data available
- 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
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 77 days
- Frequency of treatment:
- daily
- Remarks:
- Doses / Concentrations:
1000 & 1500mg/kg
Basis:
actual ingested - No. of animals per sex per dose:
- 2 male and female
- Control animals:
- yes
- Details on study design:
- Details on study design
- Dose selection rationale: No data available
- Rationale for animal assignment (if not random): No data available
- 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
- Observations and examinations performed and frequency:
- Observations and examinations performed & frequency
CAGE SIDE OBSERVATIONS: No data
- Time schedule: No data
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: No data
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): yes- daily
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
FOOD EFFICIENCY:
- 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
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined:
HAEMATOLOGY: Yes
- Time schedule for collection of blood: From truncus jugularis 2 days prior to and 5, 19 and 68 days following the start of the dosing period.
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined.
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined:
- Battery of functions tested: No data sensory activity / grip strength / motor activity / other: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- No data
- Statistics:
- No data
- 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:
- no effects observed
- Description (incidence and severity):
- No significant effect observed
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No significant effect observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- No data
- Dose descriptor:
- NOAEL
- Effect level:
- 1 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No any significant toxic effects on the examined liver and blood parameters.
- Critical effects observed:
- not specified
- Conclusions:
- In conclusion, there is no any significant toxic effects on the examined liver and blood parameters were observed at dose level. Therefore the NOAEL value is 1500mg/kg/day.
- Executive summary:
Sub chronic repeated dose toxicity test was carried out with 2 male and 2 female SPF pigs of Danish Landrace to evaluate the toxic nature of the test compound Fast Yellow AB upon repeated application by the oral route of exposure. All pigs are dosed with 1000mg/kg or 1500mg/kg by gavage for total 77 days. Hematological examinations were performed at intervals and organ histopathology was performed at necropsy. No effects were detected and no Heinz bodies were found in the red blood cells. There were no significant toxic effect on the clinical & hematological parameters and on the examined liver and blood parameters. Therefore the No Observed Adverse Effect Level (NOAEL) value was reported to be 1500mg/kg/day. Thus the test chemical is not likely to classify as a toxicant upon repeated exposure by oral route.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 500 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- pig
- Quality of whole database:
- Data is from K2 peer reviewed publication
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity: Oral
Data from the test chemical studies and read across data have been reviewed to determine the toxic nature of the test compound upon repeated exposure by the oral route. The summary is as mentioned below:
Sub chronic repeated dose toxicity test was carried out by Sondergaard et al (1977) with 2 male and 2 female SPF pigs of Danish Landrace to evaluate the toxic nature of the test compound Fast Yellow AB upon repeated application by the oral route of exposure. All pigs are dosed with 1000mg/kg or 1500mg/kg by gavage for total 77 days. Hematological examinations were performed at intervals and organ histopathology was performed at necropsy. No effects were detected and no Heinz bodies were found in the red blood cells. There were no significant toxic effect on the clinical & hematological parameters and on the examined liver and blood parameters. Therefore the No Observed Adverse Effect Level (NOAEL) value was reported to be 1500mg/kg/day. Thus the test chemical is not likely to classify as a toxicant upon repeated exposure by oral route.
Based on the available data summarized, the test chemical Fast Yelow Ab is not likely to classify as a toxicant upon repeated exposure by oral route.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Data is from peer reviewed publication
Justification for classification or non-classification
Based on the available data summarized, the test chemical Fast Yelow Ab is not likely to classify as a toxicant upon repeated exposure by oral route.
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