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Diss Factsheets
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EC number: 947-596-7 | CAS number: -
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11.09. – 27.09.2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-[(p-nitrophenyl)azo]acetoacetanilide
- EC Number:
- 216-754-0
- EC Name:
- 2-[(p-nitrophenyl)azo]acetoacetanilide
- Cas Number:
- 1657-16-5
- Molecular formula:
- C16H14N4O4
- IUPAC Name:
- 2-[(4-nitrophenyl)diazenyl]-3-oxo-N-phenylbutanamide
- Reference substance name:
- Unknown impurities
- Molecular formula:
- Not available
- IUPAC Name:
- Unknown impurities
- Reference substance name:
- Resin acids and Rosin acids, aluminum salts
- EC Number:
- 263-075-0
- EC Name:
- Resin acids and Rosin acids, aluminum salts
- Cas Number:
- 61789-65-9
- Molecular formula:
- Not available - UVCB substance
- Test material form:
- solid: particulate/powder
Constituent 1
impurity 1
additive 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- monitored quality
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: breeding farm VELAZ s.r.o., Lysolaje, Czech Republic, RČH CZ 21760118- Age at study initiation: 8 weeks- Weight at study initiation: Step No.1 average 139.3 g; Step No.2 average 156.7 g- Housing: animal room with monitored conditions – 3 animals of one sex in one plastic breeding cage with sterilized shavings of soft wood- Diet (e.g. ad libitum): pelleted diet for rats and mice Altromin ad libitum- Water (e.g. ad libitum): drinking water ad libitum quality corresponding to Regulation No. 252/2004 of Czech Coll. of Law- Acclimation period: 5 daysENVIRONMENTAL CONDITIONS- Temperature: 22 ± 3°C, permanently monitored- Humidity: 30 – 70 %, permanently monitored- Photoperiod: 12 hour light/12 hour dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLEolive oil - Lot/batch no.: 8002182001 (expiration 07/2018), producer Dr. Kulich Pharma, s.r.o., Czech RepublicDOSING: On the basis of information about no toxicity of the test substance, the starting dose of 2000 mg/kg body weight was used. Because this dose caused no death of females, same dose of 2000 mg/kg level was sequentially applied for confirmation (application with time distance 24 hours) to group of 3 females. No death of animals was observed in this group of 3 females.PREPARATION AND APPLICATION OF THE TEST SUBSTANCEImmediately before application the test substance was weighed, mixed with vehicle (olive oil) and resulting suspension was administered to the stomach by tube. All prepared suspensions of the test substance in olive oil were mixed by magnetic stirrer during administration.
- Doses:
- 2000 mg/kg (first step)2000 mg/kg (confirmation)
- No. of animals per sex per dose:
- 3 animals per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days- Frequency of observations and weighing: 1st day: twice (30 minutes and 3 hours after application), 2nd day: twice (in the morning and in the afternoon), thereafter days: once a dayClinical signs: observations included changes in skin and fur, eyes, visible mucous membranes, behaviour of animals, somatomotor activity, reactions to stimuli, and presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system. The results of the observations were recorded on special data sheets.- Necropsy of survivors performed: yes- Other examinations performed: nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated. All gross macroscopic changes of organs and tissues were recorded on special data sheets.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death of animals.
- Clinical signs:
- No clinical signs of intoxication were observed after dosing 2000 mg/kg/body weight.
- Body weight:
- Body weight was recorded and weight increments were calculated in all surviving animals at the end of study. Weight increments were adequate to species, sex and age of animals in experiment. No reduction of body weight was observed
- Gross pathology:
- No pathologic macroscopic changes were diagnosed during pathological examination.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance toxicity was evaluated on the basis of mortality, clinical signs of intoxication, body weight increments during the observation period and necropsy findings at the end of study. The test substance administered at the dose of 2000 mg/kg caused no death of females. No serious clinical signs of intoxication were detected at this dose during whole study. No pathologic macroscopic changes were diagnosed during pathological examination.According to the study results the value of LD50 of the test substance, Pigment Yellow 4, for female rats is higher than 2000 mg/kg of body weight.
- Executive summary:
The aim of the study was to investigate acute toxic effects of the test substance, Pigment Yellow 4, after a single oral administration to Wistar Han rats.
The testing was performed according Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
The test substance was administered in a single dose as a suspension in vehicle (Olive oil), given orally via gavage to female Wistar rats. The volume of administered suspension was 1 ml/100 g body weight of animals.
The dose level of 2000 mg/kg was used as the starting dose.
The dosing was performed sequentially in three groups of three females: group No. 1 - first step using the starting dose of 2000 mg/kg of body weight and group No. 2 – second step using the same dose 2000 mg/kg.
The test substance administered at the dose of 2000 mg/kg caused no death of animals. No serious clinical signs of intoxication were detected during whole study. No pathologic macroscopic changes were diagnosed during pathological examination.
According to the study results the value of LD50 of the test substance Pigment Yellow 4, for female rats is higher than 2000 mg/kg of body weight.
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