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Diss Factsheets
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EC number: 700-501-0 | 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:
- 2008-03-18 to 2008-06-02
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- first addendum
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction product of Acid Yellow 42, Acid Black 2 and Basic Violet 1
- IUPAC Name:
- Reaction product of Acid Yellow 42, Acid Black 2 and Basic Violet 1
- Reference substance name:
- Acid Yellow 42: 6375-55-9
- IUPAC Name:
- Acid Yellow 42: 6375-55-9
- Reference substance name:
- Acid Black 2: reaction product of 8005-03-6 and 68510-98-5
- IUPAC Name:
- Acid Black 2: reaction product of 8005-03-6 and 68510-98-5
- Reference substance name:
- Basic Violet 1: 8004-87-3
- IUPAC Name:
- Basic Violet 1: 8004-87-3
- Details on test material:
- - Name of test material: Reaction product of Acid Yellow 42, Acid Black 2 and Basic Violet 1
- Lot/batch No.: 2008041541
- Expiration date of the lot/batch: 2010-01-31
- Stability under test conditions: see expiry date
- Storage condition of test material: store cool and dry
- Analytical purity: 100 % (96.8 %; UVCB substance)
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (Europe) Laboratories Inc., TOXI COOP Ltd. 1103 Budapest, Cserkesz u. 90.
- Age at study initiation: Young adult rats, 9-10 weeks old
- Weight at study initiation: 184-197 g
- Housing: Group caging (3 animals/cage)
- Diet (e.g. ad libitum): Animals received ssniff® R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany, ad libitum
- Water (e.g. ad libitum): tap water from the municipal supply, ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 8-12 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/day
Administration / exposure
- Route of administration:
- oral: gavage
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation, body weights were measured on day 0 (beginning of the study), on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Mortality:
- F 46 Black did not cause mortality at 2000 mg/kg bw dose levels in female CRL: (WI) BR rats.
- Clinical signs:
- other: 2000 mg/kg bw - Treatment group 1: no clinical signs were noted for these animals (3/3). 2000 mg/kg bw - Treatment group 2: all the three animals were symptom-free on the day of treatment and during the 14-day observation period
- Gross pathology:
- 2000 mg/kg bw – Treatment group 1 and Treatment group 2:
No macroscopic alterations related to any toxic effect of the test item were found.
Gross pathology examinations revealed pulmonary alterations due to the method of anaesthesia and exsanguination, which are also observable in untreated animals after anaesthesia. Pale raised areas (1/3 in treatment group 1; 1/3 in treatment group 2) reddish mottled colour (1/3 in treatment group 1) and pinprick sized haemorrhages (2/3 in treatment group 2) were observed in the lungs at the necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present study, a single oral administration of the test item F 46 Black did not reveal any toxic effects in female CRL:(WI)BR rats up to the limit concentration of 2000 mg/kg bw. The LD0 was 2000 mg/kg bw and the LD50 > 2000 mg/kg bw.
- Executive summary:
Based on a study according to EU method B.1 tris and OECD 423, a single oral administration of the test item F 46 Black up to the limit concentration did not reveal any toxic effects in female CRL:(WI)BR rats. The LD0 was 2000 mg/kg bw and the LD50 > 2000 mg/kg bw.
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