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Diss Factsheets
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EC number: 946-329-1 | CAS number: -
- 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
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Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22.06.2016 - 12.07.2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- issued by the Government of India, Department of Science and Technolog; National Good Laboratory Practice (GLP) Compliance Monitoring Authority (NGCMA)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction products of sodium glucoheptonate with zinc sulfate and sodium hydroxide
- EC Number:
- 946-329-1
- Molecular formula:
- Not specified (UVCB substance).Molecular formula of the main substance:C14H30O22SZn2
- IUPAC Name:
- Reaction products of sodium glucoheptonate with zinc sulfate and sodium hydroxide
- Test material form:
- solid
- Remarks:
- microgranulat
- Details on test material:
- - State of aggregation: solid (microgranulare)
- appearance: odorless pale brown
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Keep container tightly closed in a cool and well ventilated place.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 10 - 11 weeks
- Weight at study initiation: 170.2 -196.2 g
- Fasting period before study: Rats were fasted overnight prior to dosing until three hours post-dosing.
- Housing: 3 rats per cage. Polypropylene rat cages covered with stainless steel grid top were used. Autoclaved clean rice husk was used as the bedding material.
- Diet: ad libitum (Teklad Certified Global HIgh Fiber Rat/Mice Feed (Envigo, USA))
- Water: ad libitum (UV sterilized water filtered through Reverse Osmosis water filtration system)
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23 °C
- Humidity (%): 57 - 67 %
- Air changes (per hr): minimum 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Reverse Osmosis (RO) Water
- Details on oral exposure:
- The actual dose formulation was prepared using RO water as vehicle. Required quantity were mixed in RO water and the final volume was made up to 10 mL. Gavage solution were prepared freshly prior to dosing on all the occasions.
Individual dose volume was adjusted according to body weight. All rats were dosed by oral gavage (day 0) using a BD 1 mL disposable syringe. Rats were fasted overnight prior to dosing until three hours post-dosing. - Doses:
- 2000 mg/ kg bw
- No. of animals per sex per dose:
- Two sets of 3 female rats, each.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Rats were observed for signs of toxicity and mortality at 0.5, 1, 2, 3, 4 and 6 hours post-administration on the day of dosing. Subsequently, rats were observed twice a day for morbidity and mortality for 14 days following oral dosing. The clinical signs were recorded once a day. Individual body weight was recorded prior to dosing on day 0 and on days 7 and 14.
- Necropsy of survivors performed: yes. All rats were euthanised by carbon dioxide asphyxiation.
- Other examinations performed: gross pathology examiation, consisting of external examination and opnening of the abdominal and thoracic cavities. - Statistics:
- not reported
Results and discussion
- Preliminary study:
- not applicable
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in rats treated with 2000 mg test material /kg bw.
- Clinical signs:
- other: No clinical sign was observed in all rats treated with 2000 mg test material /kg bw.
- Gross pathology:
- In absence of any pathological lesions in terminally sacrificed rats, it is concluded that the test item did not produce any treatment related effect at the dose level used in the present study.
Applicant's summary and conclusion
- Interpretation of results:
- other: EU GHS (CLP) criteria not met
- Conclusions:
- The LD50 is >2000 mg/kg bw. Based on the results of this study, an indication of the classification of the test material is as follows: EU GHS (CLP) criteria not met.
- Executive summary:
In an oral toxicity study (OECD 423), two sets of fasted Wistar rats (3 femals/set) (10 - 11 weeks) were given a single oral dose of 2000 mg test material /kg bw and observed for 14 days. The conducted study was in compliance with GLP (GLP certificate issued by the Government of India, Department of Science and Technolog; National Good Laboratory Practice (GLP) Compliance Monitoring Authority (NGCMA). There were no treatment-related mortality, clinical signs and changes in body weight or necropsy findings observed so the LD50 is >2000 mg/kg bw. Based on the results of this study, an indication of the classification of the test material is as follows: EU GHS (CLP) criteria not met.
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