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EC number: 309-916-8 | CAS number: 101357-19-1
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 Aug 2017 - 22 Feb 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Benzenamine, N,N-dimethyl-, oxidized, molybdatetungstatephosphates
- EC Number:
- 309-916-8
- EC Name:
- Benzenamine, N,N-dimethyl-, oxidized, molybdatetungstatephosphates
- Cas Number:
- 101357-19-1
- Molecular formula:
- Reaction mass of C25 H30 N3. P Moy Wz O40 (y +z = 12) , C24 H28 N3. P Moy Wz O40 (y +z = 12) and C23 H26 N3. P Moy Wz O40 (y +z = 12)
- IUPAC Name:
- Reaction mass of [4-[bis[4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]-dimethyl-ammonium. molybdatetungstatephosphates, [4-[[4-(dimethylamino)phenyl]-[4-(methylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]-dimethyl-ammonium. molybdatetungstatephosphates and [4-[bis[4-(methylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]-dimethyl-ammonium. molybdatetungstatephosphates
- Test material form:
- solid: nanoform, no surface treatment
- Details on test material:
- SOURCE OF TEST MATERIAL
-Product number: 0345N (skin sensitisation, OECD 422, eye irritation, acute oral toxicity)
0345F (Ames test)
- Purity Preparation containing ≥80% (treat as 100%)
- Physical form/colour: Violet powder
- Expiry date: Stable for at least 5 years from delivery date
-Shape Category: spheroidal
-Shape: spherycal
-pure shape: yes
-Typical composition: ca. 100%
-range >50 and < 100%
-D10, typical value: 30 nm, range: >1.5 and < 50nm
-D50, typical value: 45 nm, range: >15 and <100nm
-D90, typical value: 60nm, range: >25 and < 150nm
-Fraction in size range 1-100nm: > 50 and <100%
-Crystallinity:
Structure:
amorphous, pure structure
-SSA: BET surface area typically ca. 32-40 m2/g for product number 345F and 0345N)
Range > 10 and < 200 m2/g
-.no surface treatment
Storage conditions: Stored at ambient conditions in the dark (away from direct light)
- Safety precautions: Routine hygienic procedures (nitrile gloves, goggles, face mask)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10 weeks
- Weight at study initiation: Males: 331-431 g Females: 179-245 g
- Housing: Cages with standard, granulated, S8-15 sawdust bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30 - 70
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/ 12
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- Oral, by gastric gavage. For each dose group the order of administration was all males first and then all females. Each day of treatment the starting order was alternated between males and females.
- Vehicle:
- arachis oil
- Details on oral exposure:
- - VEHICLE
- Batch number KMO9422, KM09047
- Expiry date: August 2018
- Storage conditions: Stored at ambient conditions
- Safety precautions: Routine hygienic procedures (nitrile gloves, goggles, face mask)
- Concentration in vehicle: 0, 100, 300 and 1000 mg/kg/day
- Administration volume: 5 mL/kg - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Validation done at 20-200 mg/mL demonstrates that formulations were stable for 8 days at room temperature (20 ± 5 ºC) and in the dark.
The results showed that analyzed formulations were within 19% of their nominal concentration. The coefficient of variation (CV) was not more than 2.13%. Preparation of all formulations was considered correct, taking into account the acceptance ranges.
The analysis of control group formulations showed that no contamination was present. - Duration of treatment / exposure:
- 5 - 8 weeks
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 3 groups of 12 females
3 gouprs of 12 males
1 control group of 12 females
1 control group of 12 males - Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- VIABILITY/ MORTALITY/ CAGE-SIDE OBSERVATIONS
Visually inspected twice daily for evidence of reaction to treatment or ill-health.
BODY WEIGHT:
- Time schedule for examinations: On day 1 and weekly thereafter
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The changes observed in the brain weights in males and females and in liver weights in males at 1000 mg/kg/day when compared to control were considered incidental taking into account the magnitude of the change, the lack of a dose-effect relationship and that there was no correlation with clinical pathology or histopathology.
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not specified
Effect levels
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- ca. 1 000 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food consumption and compound intake
- other: clinical pathology, organ weights or histopathology
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The No Observed Effect Level (NOEL) for systemic toxicity was considered to be 1000 mg/kg/day, taking into account that there was no effect on body weight, food consumption, clinical signs, clinical pathology, organ weights or histopathology.
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