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EC number: 700-174-4 | CAS number: 1029600-34-7
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 10 June 1996 and 17 July 1996.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of Inspection: 22/01/1996 Date of signature: 27/02/1996
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of : Sodium or ammonium [1-{(E)-[2-(hydroxy-kO)-5-(2-methylbutan-2-yl)-3-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][3-{(Z)-[2-(hydroxy-kO)-5-(2-methylbutan-2-yl)-3-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-) Sodium or ammonium [3-{(E)-[2-(hydroxy-kO)-5-(2-methylbutan-2-yl)-3-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][1-{(E)-[2-(hydroxy-kO)-4-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-) Sodium or ammonium [3-{(E)-[2-(hydroxy-kO)-5-(2-methylbutan-2-yl)-3-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][1-{(E)-[2-(hydroxy-kO)-5-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-) Sodium or ammonium [1-{(E)-[2-(hydroxy-kO)-4-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][3-{(E)-[2-(hydroxy-kO)-4-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-) Sodium or ammonium [1-{(E)-[2-(hydroxy-kO)-4-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][3-{(E)-[2-(hydroxy-kO)-5-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-) Sodium or ammonium [1-{(E)-[2-(hydroxy-kO)-5-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][3-{(E)-[2-(hydroxy-kO)-5-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-)
- IUPAC Name:
- Reaction mass of : Sodium or ammonium [1-{(E)-[2-(hydroxy-kO)-5-(2-methylbutan-2-yl)-3-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][3-{(Z)-[2-(hydroxy-kO)-5-(2-methylbutan-2-yl)-3-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-) Sodium or ammonium [3-{(E)-[2-(hydroxy-kO)-5-(2-methylbutan-2-yl)-3-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][1-{(E)-[2-(hydroxy-kO)-4-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-) Sodium or ammonium [3-{(E)-[2-(hydroxy-kO)-5-(2-methylbutan-2-yl)-3-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][1-{(E)-[2-(hydroxy-kO)-5-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-) Sodium or ammonium [1-{(E)-[2-(hydroxy-kO)-4-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][3-{(E)-[2-(hydroxy-kO)-4-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-) Sodium or ammonium [1-{(E)-[2-(hydroxy-kO)-4-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][3-{(E)-[2-(hydroxy-kO)-5-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-) Sodium or ammonium [1-{(E)-[2-(hydroxy-kO)-5-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][3-{(E)-[2-(hydroxy-kO)-5-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-)
- Reference substance name:
- Reaction mass of :Sodium or ammonium [1-{(E)-[2-(hydroxy-kO)-5-(2-methylbutan-2-yl)-3-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][3-{(Z)-[2-(hydroxy-kO)-5-(2-methylbutan-2-yl)-3-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-)Sodium or ammonium [3-{(E)-[2-(hydroxy-kO)-5-(2-methylbutan-2-yl)-3-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][1-{(E)-[2-(hydroxy-kO)-4-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-)Sodium or ammonium [3-{(E)-[2-(hydroxy-kO)-5-(2-methylbutan-2-yl)-3-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][1-{(E)-[2-(hydroxy-kO)-5-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-)Sodium or ammonium [1-{(E)-[2-(hydroxy-kO)-4-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][3-{(E)-[2-(hydroxy-kO)-4-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-)Sodium or ammonium [1-{(E)-[2-(hydroxy-kO)-4-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][3-{(E)-[2-(hydroxy-kO)-5-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-)Sodium or ammonium [1-{(E)-[2-(hydroxy-kO)-5-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][3-{(E)-[2-(hydroxy-kO)-5-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-)
- EC Number:
- 700-174-4
- Cas Number:
- 1029600-34-7
- Molecular formula:
- See structure.
- IUPAC Name:
- Reaction mass of :Sodium or ammonium [1-{(E)-[2-(hydroxy-kO)-5-(2-methylbutan-2-yl)-3-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][3-{(Z)-[2-(hydroxy-kO)-5-(2-methylbutan-2-yl)-3-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-)Sodium or ammonium [3-{(E)-[2-(hydroxy-kO)-5-(2-methylbutan-2-yl)-3-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][1-{(E)-[2-(hydroxy-kO)-4-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-)Sodium or ammonium [3-{(E)-[2-(hydroxy-kO)-5-(2-methylbutan-2-yl)-3-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][1-{(E)-[2-(hydroxy-kO)-5-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-)Sodium or ammonium [1-{(E)-[2-(hydroxy-kO)-4-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][3-{(E)-[2-(hydroxy-kO)-4-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-)Sodium or ammonium [1-{(E)-[2-(hydroxy-kO)-4-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][3-{(E)-[2-(hydroxy-kO)-5-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-)Sodium or ammonium [1-{(E)-[2-(hydroxy-kO)-5-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO][3-{(E)-[2-(hydroxy-kO)-5-nitrophenyl]diazenyl}naphthalen-2-olato(2-)-kO]chromate(1-)
- Details on test material:
- - Name of test material (as cited in study report): Valifast Black 3810
- Substance type: Black Powder
- Physical state: Solid
- Lot/batch No.: X-10543
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
Charles River (UK) Ltd., Margate, Kent, UK.
- Age at study initiation:
five to eight weeks of age.
- Weight at study initiation:
Males weighed 150 to 178 g, and the females 146 to 168g.
- Fasting period before study:
overnight fast immediately before dosing
- Housing:
The animals were housed in groups of up to five by sex in suspended solid floor polypropylene cages furnished with woodflakes.
- Diet ad libitum):
(Rat and Mouse Expanded Diet No.1, special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study.
- Water ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
19 to 24°C
- Humidity (%):
48 to 57%
- Air changes (per hr):
The rate of air exchange was at least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light):
Lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
IN-LIFE DATES: From: Day 1 To: Day 14
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200mg/ml
- Amount of vehicle (if gavage):
10 ml
- Justification for choice of vehicle:
Not stated
- Lot/batch no. (if required):
Not stated
- Purity:
Not stated
MAXIMUM DOSE VOLUME APPLIED:
10 ml/kg
DOSAGE PREPARATION (if unusual):
Not applicable
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
Based on the results from the range finding study, a dose level of 2000 mg/kg bodyweight was selected for the main study. - Doses:
- Following a sighting test at dose levels of 2000 mg/kg, a further group of five fasted females and five fasted males was given a single oral dose of test material at a dose level of 2000 mg/kg bodyweight.
- No. of animals per sex per dose:
- 6 females at 2000 mg/kg
6 males at 2000 mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration:
14 days
- Frequency of observations and weighing:
Clinical observations were made ½, 1, 2, and 4 hours after dosing and then daily for fourteen days. Morbidity and mortality checks were made twice daily. Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed:
Yes
- Other examinations performed:
At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Statistics:
- Not applicable
Results and discussion
- Preliminary study:
- There were no deaths or clinical signs of toxicity. Based on this information, a dose level of 2000 mg/kg bodyweight was selected for the main study.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no deaths.
- Clinical signs:
- Black-coloured staining of fur was noted in all animals up to six days after dosing. Black-coloured staining of the faeces was noted in all animals four hours and one day after dosing. The eyes, tail and feet of all animals appeared grey in colour two to nine days after dosing. The eyes, tail and feet or tail only, of all animals, appeared grey in colour ten days after dosing. The tail only, of all animals, appeared grey in colour eleven to fourteen days after dosing.
No signs of systemic toxicity were noted during the study. - Body weight:
- All animals showed expected gains in bodyweight.
- Gross pathology:
No abnormalities were noted at necropsy.- Other findings:
- Organ weights:
Not recorded
- Histopathology:
Not recorded
- Potential target organs:
Not recorded
- Other observations:
None
Any other information on results incl. tables
Results are shown in Tables 1-4 which are attached.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the Sprague Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight.
- Executive summary:
A study was performed to assess the acute oral toxicity of the test material in the Sprague Dawley CD strain rat. The method followed that in the OECD Guidelines for Testing of Chemicals No.401 "Acute Oral Toxicty" (adopted 24 February 1987) and Method B1 of Commission Directive 92/69/EEC (which constitutes Annex Y of council Directive 67/548/EEC).
Following a range finding study, a group of ten fasted animals ( five males and five females) was given a single oral dose of test material as a suspension in arachis oil BP at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed and subjected to gross pathological examination.
There were no deaths. Black coloured staining of the faeces was noted. The eyes, tails and feet of all animals appeared grey in colour. No signs of systemic toxicity were noted.
All animals showed an expected gain in bodyweight during the study.
No abnormalities were noted at necropsy.
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