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EC number: 274-105-7 | CAS number: 69762-08-9
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Details on the read across are reported in section 13. Source study has reliability 1.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Acid Yellow 049 acid
- IUPAC Name:
- Acid Yellow 049 acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: s.p. Valez, Prague.
- Weight at study initiation: females 160 - 170 g; males 150 - 156 g.
- Fasting period before study: day before application.
- Housing: plastic polypropylene cages T4.
- Diet: commercial produced granulated feed mixture Altromin 1320. ca 15 g/item/day
- Water: ad libitum.
- Acclimation period: one week.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Relative humidity: 50 ± 15 %
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Appropriate amount of sample needed to prepare a 20 % aqueous suspension was weight, for the selected dose level of logarithmic. The sample was added to a calculated volume of water and thorough stirring with a glass rod.
- Log. dose level: 15.85 g/kg
- Sample weight: 36.00 g
- Added to the volume of water: 180 ml - Doses:
- 15000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: immediately after application, i.e. within 30 minutes, 3 hours after application, the following morning and afternoon and the next day at least once a day, for 14 days. Clinical diagnosis was focused on observing the appearance of skin, hair, visible mucous and nutritional status, mental activity, somatomotor activity, responses to stimuli, focusing on sensibility and reactivity, lacrimation, functional assessment of the respiratory, digestive, urogenital and circulation system.
- Necropsy of survivors performed: yes. Animals that died during the experiment are weighed and dissected; the surviving animals were weighed after 14 days, killed and dissected. Organs and muscle examined macroscopically. After exenterations internal organs were judged according to their colour, size, consistency and structure. If the post mortem bladder resulted to be filled with urine, the urine biochemical tests were carried out focusing on finding proteins, blood sugar, ketone, bilirubin, urobilinogen and pH.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 15 000 mg/kg bw
- Based on:
- test mat.
- Clinical signs:
- other: Throughout the experiment no clinical symptoms of intoxication were observed. Visual check revealed that coat the skin and visible mucous membranes appeared without abnormalities. Good nutritional status, normal mental and motor activity, reactivity and s
- Gross pathology:
- Hair, skin and visible mucous membranes: a normal appearance.
The subcutaneous tissue and muscle did not show macroscopic pathomorphological changes.
Nutritional status: good.
Lungs pinkish color, spongy, airy without macroscopic pathomorphological changes.
Heart: maroon, stiffer consistency, without macroscopic pathomorphological changes.
Liver: dark reddish-brown color, smooth surface, stiffer consistency.
Spleen: reddish-brown color, stiffer consistency, without macroscopic pathomorphological changes.
Kidney: maroon on a smooth surface, stiffer consistency, without macroscopic pathomorphological changes.
Head, neck, stomac, gut and bladder did not show macroscopic pathomorphological changes.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- LD50 is greater than 15000 mg/kg
- Executive summary:
Method
The acute oral toxicity of the substance has been assayed following the testing procedures outlined into the OECD guideline 401. The substance was administered, as water solution, by gavage to 10 rats, i.e. 5 males and 5 females; a single dose of 15000 mg/kg was given. Animals were observed for the successive 14 days. Clinical diagnosis was focused on observing the appearance of skin, hair, visible mucous and nutritional status, mental activity, somatomotor activity, responses to stimuli, focusing on sensibility and reactivity, lacrimation, functional assessment of the respiratory, digestive, urogenital and circulation system. At the end of the observation period, surviving animals were killed and dissected.
Results
Throughout the experiment no clinical symptoms of intoxication were observed.
Main observations were:
- lungs: pinkish colour, spongy, airy, without macroscopic pathomorphological changes;
- heart: maroon, with stiffer consistency, without macroscopic pathomorphological changes.
- liver: dark reddish-brown color, smooth surface, stiffer consistency.
- spleen: reddish-brown color, stiffer consistency, without macroscopic pathomorphological changes.
- kidney: maroon on a smooth surface, stiffer consistency, without macroscopic pathomorphological changes.
- head, neck, stomac, gut and bladder did not show macroscopic pathomorphological changes.
The LD50 resulted to be greater than 15000 mg/kg.
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