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EC number: 224-736-9 | CAS number: 4468-02-4
- 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:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Bis(D-gluconato-O1,O2)zinc
- EC Number:
- 224-736-9
- EC Name:
- Bis(D-gluconato-O1,O2)zinc
- Cas Number:
- 4468-02-4
- Molecular formula:
- C12H22O14Zn
- IUPAC Name:
- bis(D-gluconato-O1,O2)zinc
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance : White cristalline powder:
- Batch number: 1700001575
- Manufacturing date: 10.08.2017
- Expiry date: 09.08.2020
Constituent 1
- Specific details on test material used for the study:
- The test compound "zinc gluconate granular" was supplied by the sponsor.
The sample is a white fine granular.
Storage at normal room-temperature, in darkness.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Substrain : SPF TNO ; Color : white
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Firma Winkelmann, Versuchstierzucht, 4791 Borchen 1, Gartenstraße 300
- Weight at study initiation: male = 194,1 - 219,2 g ; female = 146,5 - 183,0 g
- Housing: Collection caging (Cage type: Macrolon type III/max. 5 rats)
- Diet : ad libitum (Pellets, 2.4 cm large, 1.0 cm diameter ; Producer: Ssniff Versuchstierdiäten GmbH 4770 Soest/Westfalen ; composition detailed in the report)
- Water : ad libitum (Aqua fontana as for human consumption)
- Acclimation period: About 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 2°C
- Humidity (%): 50 - 85 %
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 7.00 a.m. - 7.00 p.m. with fluorescent light, 120 Lux
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.5%
- Justification for choice of vehicle: standard vehicle
MAXIMUM DOSE VOLUME APPLIED: 5.0 g/kg (volume = 0.73 to 0.91ml at maximum dose)
CLASS METHOD
- Rationale for the selection of the starting dose: highest dose following the range finding study - Doses:
- 5.0g/kg (only one dose applied according to the range finding study results).
- No. of animals per sex per dose:
- 2 groups of fasted 5 male and 5 female rats.
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: The body weights are recorded at day 0 (beginning of the experiment) and at day 14 (terminal necropsy) on the surviving animals.
- Frequency of observations: Records were made according to the following intervals: ca. 20', 1 h, 2 + 3 h, 6 h, 24/48 h, 7/14 days p.a.
- Necropsy of survivors performed: yes
- Other examinations performed: Necropsies performed on all animals at termination exhibited no gross pathological findings.
Results and discussion
- Preliminary study:
- This preliminary study (range finding) showed no mortalities.
Pairs of two female rats were employed in a preliminary range finding study. The dosages of the single oral administration were 2,5 g/kg and 5,0 g/kg.
In the light of the range finding results and in accordance with the OECD-guidelines, the following dosage was used for the definitive study: 5 g/kg
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality observed
- Clinical signs:
- Any signs of reaction were recorded during the 14-day observation period. At the tested dosage the sample did not induce any clinical-toxicological symptoms.
The evaluation of the clinical-toxicological signs (a modified Irvin-Screening) is done individually and depends on the nature of the signs. If the symptoms persist to the same degree for a longer period of time, this is noted in the corresponding protocoIs .
Only a change of symptoms is recorded. Records were made according to the following intervals: ca. 20', 1 h, 2 + 3 h, 6 h, 24/48 h, 7/14 days p.a. - Body weight:
- Body weight changes after the observation period showed a normal weight gain :
mean initial body weight = 132.31g
mean terminal weight = 217.93g - Gross pathology:
- No gross pathology observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The determination of the oral LD50 is > 5g/kg.
- Executive summary:
The objective of this study was to determine the acute median lethal dosage of "zinc gluconate granular" after its single oral application to rats in accordance with the OECD guidelines.
The acute oral toxicity was investigated in 2 groups of fasted 5 male and 5 female rats of the WISW-strain. Any signs of reaction and mortalities were recorded during the 14-day observation period, animals which died and those killed terminally were subjected to necropsy. In the tested dosage the sample did not induce any clinical-toxicological symptoms. Post-dosing weight gains (2 week values) of all animals did not show essential differences. No mortali ties were observed. Nothing abnormal was found in the animals necropsied on day 14. The determination of the oral LD50 is > 5g/kg.
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