Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 245-322-4 | CAS number: 22914-58-5
- 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
Endpoint summary
Administrative data
Description of key information
Two reliable acute toxicity studies are available by the oral and inhalation routes of exposure. These were conducted in accordance with GLP and OECD Guidelines.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- RccHan:WIST
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Limited
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: The bodyweight variation did not exceed +/- 20% of the mean bodyweight.
- Fasting period before study: Yes overnight fast before dosing and for approximately 3 to 4 hours after dosing.
- Housing: Suspended solid-floor polypropylene cages furnished with wood flakes.
- Diet (e.g. ad libitum): 2014C Teklad Global Rodent diet
- Water (e.g. ad libitum): Mains drinking water provided ad libitum.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): At least 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg/mL (300 mg/kg) and 200 mg/mL (2000 mg/kg).
- Justification for choice of vehicle: Standard vehicle as per guidelines.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/Kg
DOSAGE PREPARATION (if unusual): Prepared as a suspension in distilled water.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the absence of data regarding toxicity of the test substance, 300 mg/kg was chosen as the starting dose. - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 1 female treated at 300 mg/kg followed by a total of 5 females treated at 2000 mg/kg.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days (or other?): 14 day observation period
- Frequency of observations and weighing: Clinical observations were made 30 minutes, 1, 2, and hours after dosing and then daily for the observation period. Individual bodyweights were recorded on the day of dosing and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: None - Statistics:
- Not a requirement of the study guideline
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At both 300 and 2000 mg/kg no mortality was observed.
- Clinical signs:
- other: Tiptoe gait was noted in one animal on day 3 that received 2000 mg/kg. No other signs of toxicity were noted during the observation period and no signs were observed in the animal that received 300 mg/kg.
- Gross pathology:
- No abnormalities were noted at necropsy in any animals.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Reliable OECD guideline, GLP study available. No effects observed at the limit dose of 2000 mg/kg.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 433 draft (Acute Inhalation Toxicity: Fixed Concentration Procedure) (not officially approved)
- Version / remarks:
- The guideline has been formally now been approved on 28 June 2018.
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed concentration procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- RccHan®:WIST
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS Limited
- Age at study initiation: 69 to 76 days
- Weight at study initiation: 280 to 300 g
- Fasting period before study: No
- Housing: The animals were housed five per cage, unless this number was reduced by mortality or isolation. The cages were made of a polycarbonate body with a stainless steel mesh lid.
- Diet (e.g. ad libitum): Free access to a standard rodent diet. The diet contained no added antibiotic or other chemotherapeutic or prophylatic agent.
- Water (e.g. ad libitum): Potable water taken from the public supply was freely available via polycarbonate bottles fitted with sipper tubes.
- Acclimation period: For at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 40 to 70%
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- 2.7 µm
- Geometric standard deviation (GSD):
- >= 1.96 - <= 2.09
- Remark on MMAD/GSD:
- The mean MMAD value were within the ideal range of 1 to 4 microns (2.7 μm), indicating that the generated substance was respirable to the rat.
- Details on inhalation exposure:
- Exposure system:
The exposure system was composed of a flow-through nose only chamber. This was made from an aluminium alloy construction comprising a base unit, one animal exposure section with 20 exposure ports and a top section. The dimensions of the chamber give an internal volume of ca. 30L. Animals were restrained in a plastic nose-only restraint tube. Aerosol generation was performed by the use of a Wright Dust Feed Mechanism which is designed to produce and maintain test atmospheres containing dust by suspending material scraped from the surface of a compressed powder in a stream of dry air.
Inlet flow: from in-house compressed air system (breathing quality) at 19L/minute.
Extract airflow: Drawn by in-house vacuum system at 20L/minute.
Airflow monitoring: High quality tapered tube flowmeters and in-line flowmeters monitored continuously.
Concentration (aerosol samples collected as follows):
Sample type: Glass microfiber filter, held in an open face filter holder
Sample flow: 2 L/minute
Sample volume: Measured by wet-type gas meter
Sample frequency: Nine samples collected during Group 1 exposure and ten samples collected during Group 2 exposure
Sample location: Animal exposure port
Sample analysis: Gravimetric
Aerosol samples were collected at irregular intervals due to adjustments to operating conditions. A time-weighted average mean aerosol concentration was calculated in order to prevent undue biasing of repeat samples in the overall mean.
Particle size distribution:
Impactor type: Marple 290 Series Personal Cascade Impactor
Configuration: 298
Collection media: Stainless steel substrates and glass microfiber final stage filter
Sample flow: 2L/minute
Sample frequency: Two samples collected during each exposure
Sample location: Animal exposure port
Sample analysis: Gravimetric (MMAD and GSD derived) - Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 4 h
- Remarks on duration:
- Standard as per OECD guidelines
- Concentrations:
- Group 1 (target 5 mg/L): Provided a TWA of 4.80 mg/L (SD 0.340).
Group 2 (target 1.0 mg/L): Provided a TWA of 1.06 mg/L (SD 0.0891)
The mean achieved aerosol concentration values were 96% and 106% of target, for groups 1 and 2 respectively. - No. of animals per sex per dose:
- 5 males per exposure group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Rats were weighed at least once during the week prior to exposure and on Day 1 (prior to exposure) and on Days 2, 4, 8, 15 or at death. Clinical signs were recorded prior to exposure, at hourly intervals during exposure, immediately following exposure and then at 1 hour and 2 hours post-exposure. During the observation period, the animals were observed once in the morning and once toward the end of the experimental day. On the day of study termination there was one observation (morning only).
- Necropsy of survivors performed: yes - Statistics:
- Not performed as not a guideline requirement
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 1.06 - < 4.8 mg/L air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- All males exposed to 4.80 mg/L were found dead or euthanized after a single exposure. Two animals exposed to 4.80 mg/L were found dead on Day 2 and two animals exposed to 4.80 mg/L were euthanized on Day 2. The remaining animal exposed to 4.80 mg/L was euthanized on Day 3. No mortality was noted in animals exposed to 1.06 mg/L.
- Clinical signs:
- other: Following exposure at 4.80 mg/L, all animals were observed with clinical signs, including irregular and/or shallow breathing, wet rales, unsteady gait, closed/partially closed eyes, decreased activity and/or hunched posture. Two animals were found dead at
- Body weight:
- On the day following exposure at 1.06 mg/L, body weight losses were evident in all animals. Body weight gains were observed from Day 4 or Day 8, which continued to increase for the remainder of the observation period.
- Gross pathology:
- Decedents in Group 1 (4.8 mg/L)
Lungs and bronchi: Abnormal color (dark) and incomplete deflation was observed in all males exposed to 4.80 mg/L. Pale areas were observed in the two males exposed to 4.80 mg/L found dead on Day 2.
Stomach: Abnormal contents (blue) were noted in the stomach of four males exposed to 4.80 mg/L either found dead or euthanized on Day 2.
Group 2 (1.06 mg/L)
Lungs and bronchi: Pale areas were observed in the majority of animals exposed to 1.06 mg/L. - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the conditions of this study, the LC50 (4 hour) of Zinc Molybdate is in excess of 1.06 mg/L (for male rats) but less than 4.80 mg/L where mortality was observed. This test item is Category 4 according to the Globally Harmonized System (GHS; UNITED NATIONS) and the EU CLP Regulation (EC No. 1272/2008, as amended).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Quality of whole database:
- Reliable OECD guideline, GLP study available. Mortality was observed at 4.8 mg/L with no mortality observed at 1.06 mg/L. LC50 is between these values and accordingly no value for chemical safety assessment is included.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The results of the acute oral toxicity study indicated no mortality was observed at the limit dose of 2000 mg/kg. As such, classification in accordance with the CLP Regulation (EC No. 1272/2008, as amended) is not warranted. In the acute inhalation study whole group mortality was observed in animals exposed to 4.80 mg/L whereas no mortality was observed in animals exposed to 1.06 mg/L. As the LC50 would fall between these values (i.e. the 1 and 5 mg/L band) classification as Category 4 (H332) is appropriate for this substance.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.