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EC number: 941-151-0 | CAS number: 1690331-63-5
- 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:
- From 06 November 2012 to 27 November 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The reliability is rated 1 because the study followed the standard guideline of reference (OECD 471), which describes a procedure designed to evaluate this endpoint, the results were reviewed for reliability and assessed as valid, and the study was conducted under GLP condition.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- [bis(phenylamino)methylidene]azanium 3-[(1E)-2-[4-(phenylamino)phenyl]diazen-1-yl]benzene-1-sulfonate
- EC Number:
- 941-151-0
- Cas Number:
- 1690331-63-5
- Molecular formula:
- C31H28N6SO3
- IUPAC Name:
- [bis(phenylamino)methylidene]azanium 3-[(1E)-2-[4-(phenylamino)phenyl]diazen-1-yl]benzene-1-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Sepisol Fast Yellow MG-DPG
- Physical state: Power
- Stability under test conditions: Stable
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle - France)
- Age at study initiation: 8 or 9 weeks old
- Weight at study initiation: between 196 g and 239 g
- Fasting period before study: Food removed on D-1 and redistributed 4 hours after the test administration
- Housing: Solid-bottomed clear poycarbonate cages with a stainless steel mesh lid, containing sawdust bedding changed once a week. Cages are placed in conventional air contitioned animal hyusbandryµ.
- Diet : Food stuff (A04, SAFE) is supplied ad libitum
- Water : Tap water from public distribution system (microbiologicaly and chemicaly analysed every 6 months) is supplie ad libitum.
- Acclimation period: Five days at least.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70% RH
- Air changes (per hr): 10 to 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2.0219 g of test item for the first step and 0.3025 or 0.3013 g of test item for the second and third step in 10 mL of DMSO.
- Amount of vehicle (if gavage): 10 mL/kg/bw of preparation
- Justification for choice of vehicle: the use of distilled water or olive oil gives a suspension. Because the use of the DMSO gives a homogeous solution the DMSO was chosen as the vehicule of the study. - Doses:
- Step 1: 2000 mg/kg/bw
Steps 2 and 3: 300 mg/kg/bw - No. of animals per sex per dose:
- 3 females per dose per step.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily examination. Weighing on D0 (prio administration), D2, D7 and D14.
- Necropsy of survivors performed: yes
- Other examinations performed: Observation and mortality report carried out every day : examination of behavioural or toxic effects on the major physiological functions:
* Body weight
* Clinical signs (spontaneous activity, Preyer's reflex, respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, mydriasis, salivation, lachrymation, righting reflex, piloerection, mortality) - Statistics:
- no statistic was used
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- <= 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Step 1 at 2000 mg/kg/bw: death of the rats at 3 hrs post-dose.
Step 2 and 3 at 300 mg/kg/bw : no mortality occured. - Clinical signs:
- other: At 2000 mg/kg/bw: absence or decrease in spontaneous activity (3/3), in Preyer's reflex (1/3), in muscle tone (3/3) and in righting reflex (3/3), polypnea (1/3), dyspnea (2/3), myosis (2/3) and salivation (1/3) before death At 300 mg/kg/bw during the fir
- Gross pathology:
- At 2000 mg/kg/bw: The macroscopic examination revealed a thinnning of the forestomach (3/3), associated with an orange coloration of the forestomach (3/3) and red spots and orange coloration of the corpus (3/3).
At 300 mg/kg/bw: at the end of the study, no treatment related changes were observed at the macroscopic examination.
Any other information on results incl. tables
Control study N° TA0 -2012 -009 on DMSO used as the vehicule in the study.
The study was performed to assess the comportment of the strain of rat used at Phycher laboratory in its environment and to give additional historical data.
The method was designed to meet the requirements of the following:
- OECD guideline for the testing of chemicals N°423 dated December 17th, 2001
- Method B.1tris of the council regulation N°440/2008
Three animals received the DMSO, administered by gavage under a volume of 10 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.
No clinical signs, body weight changes nor treatment related changes were reported (3/3 animals normal)
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information according to the Regulation EC N° 1272/2008 Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of the test item is higher than 300 mg/kg/bw and lower than 2000 mg/kg/bw by oral route in rats.
In accordance with the OECD guideline N°423, the LD50 cut-off of the test item may be considered as 500 mg/kg/bw by oral route in the rat.
In accordance with the E.E.C directives 67/548, 2001/59 and 99/45, the test item must be classified R22 "harmful is swallowed". The symbol "Xn" and the warning label "Harmful" are required.
In accordant with the regulation EC 1272/2008, the test item must be classified in category 4. The signal word "Warning" and hazard statement H302 "Harmful is swallowed" are required. - Executive summary:
The test item Sepisol Fast Yellow MG-DPG was administered to a group of 3 female Sprague Dawley rats at the single dose of 2000 mg/kg/bw and then to a group of 6 females Sprague Dawley at the single dose of 300 mg/kg/bw. The experimental protocol was established according to the official method as defined in the OECD guideline No. 423 date December 17th, 2001, and the test method B.1tris of the Council regulation No. 440/2008.
It was noted the death of the 3 rats treated at 2000 mg/kg/bw at 3 hrs post-dose. The mortalities were preceded by absence or decrease in spontaneous activity (3/3), in Preyer's reflex (1/3), in muscle tone (3/3) and in righting reflex (3/3), polypnea (1/3) dyspnea (2/3), myosis (2/3) and salivation (3/3).
The macroscopic examination of the dead animals revealed a thinning of the forestomach (3/3) associated with an orange coloration of the forstomach (3/3) and red spots and orange coloration of the corpus (3/3).
No mortality occured in animals treated at 300 mg/kg/bw.
An absence or decrease in spontaneous activity (6/6), in muscle tone (3/6), and in righting reflex (3/6), increase in muscle tone (3/6), sakuvatuib (1/6), lacrymation (1/6), chromodacryorrhea (1/6), partial ptosis (1/6) and piloerection (1/6) were noted during the first hours of the test. the naimals recovered anormal behavior between 24 and 72 hrs post-dose.
A lower body weight gain was noted in the animals on day 2 comprated to day 0 :+2% versus +13% in the historical control group. The animals recovered a normal body weight evolution on day 7.
The macroscopic examination of the animals at the end of the study did not revel treatment related changes.
In conclusion, the LD50 of the test item is higher the 300 mg/kg/bw and lower than 2000 mg/kg/bw by oral route in rats.
In accordance with the OECD guidelin No. 423, the LD50 cut-off ot the test item may be considered as 500 mg/kg/bw by oral route in rats.
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C directives 67/548, 2001/59 and 99/45, the test item must be classified R22 "Harmful is swallowed". The item must be characterised by the symbol "Xn" and the warning label "Harmful".
In accordance with the regulation EC No. 1272/2008, the test item must be classified in category 4. The signal word "Warning" and hazard statement H302 "Harmful is swallowed" are required.
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