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Diss Factsheets
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EC number: - | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Acute Zinc lntoxication: Comparison of the Antidotal Efficacy of Several Chelating Agents
- Author:
- Domingo JL, Llobet JM, Paternain JL
- Year:
- 1 988
- Bibliographic source:
- Vet Hum Toxicol 30(3): 224-228
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- before 2002
- Deviations:
- yes
- Remarks:
- Lack of information about doses, controls, observation frequency, fasting period before study, age at study initiation and housing
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Zinc sulphate
- EC Number:
- 231-793-3
- EC Name:
- Zinc sulphate
- Cas Number:
- 7733-02-0
- Molecular formula:
- H2O4S.Zn
- IUPAC Name:
- zinc sulfate
- Details on test material:
- ZnSO4 is soluble in water, toxicity based on free ion concentration
Constituent 1
- Specific details on test material used for the study:
- - zinc was administered as zinc sulphate dihydrate (Merck, Germany)
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Panlab, Spain
- Rationale for use of males: not provided
- Weight at study initiation: 230-280 g
- Diet: standard pellet diet ad libitum
- Water: tap water ad libitum
- Acclimation period: 7 days
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- physiological saline
- Details on oral exposure:
- VEHICLE
- Amount of vehicle: 1 mL per 300 g body weight
DOSAGE PREPARATION: solution concentrations were adjusted so that a 300 g rat received 1 mL and a 30 g mouse 0.2 mL. All solutions were given at a pH between 6.0 and 7.0. Sodium bicarbonate was used to adjust the pH when necessary.
- Rationale for the selection of the starting dose: A preliminary screening with 3 rats was carried out. The LD50 values were then calculated according to the Litchfield and Wilcoxon method. - Doses:
- not reported
- No. of animals per sex per dose:
- 10
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: no
- Clinical signs including body weight: yes
- Mortality and clinical signs were checked 1, 2-3, 4-7 and 8-14 days after zinc administration. - Statistics:
- not reported
Results and discussion
- Preliminary study:
- A preliminary screening with a small group of 3 rats was carried out. The LD50 values were then calculated according to the Litchfield and Wilcoxon method.
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 710 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 260 - <= 2 330
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 623 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 460 - <= 846
- Remarks on result:
- other: LD50 values calculated for Zn2+
- Mortality:
- Mortality occurred during the first 24 h of the test material administration. No deaths occurred after three days.
- Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- Between day 2 and day 7, a slight decrease in food and water consumption and weight loss was observed.
Any other information on results incl. tables
Table 1: Severity of physical and clinical signs in rats after zinc intoxication in a single dose. Mortality rates and physical and observational examination of rats are average for all zinc compounds examined in this study (zinc acetate, chloride, nitrate and sulphate).
Symptomatology: + light; ++ moderate
| Number of days after zinc administration (d) | |||
| 1 | 2-3 | 4-7 | 8-14 |
Mortality rate | 90 % | 10 % | 0 % | 0 % |
Clinical signs |
|
|
|
|
Miosis | + | ++ | ++ | + |
Conjunctivitis | + | ++ | + | none |
Erythema, necrosis in nose | none | ++ | ++ | ++ |
Decreased food and water consumption, weight loss | none | + | + | none |
Haemorrhages, haematoma and necrosis in tail | none | ++ | ++ | + |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral LD50 of zinc sulphate dihydrate in Sprague-Dawley rats was determined to be 1710 mg/kg, which is equivalent to 623 mg of Zn2+/kg.
- Executive summary:
In the publication by Domingo et al., 1988, the acute oral toxicity of zinc sulphate dihydrate was examined in Sprague-Dawley rats similar to OECD guideline 401.
The test item was administered by gavage. In a preliminary study, three rats were used to determine the LD50 according to the Litchfield and Wilcoxon method. The main study was carried out with ten male rats. The publication lacks information about doses, controls, observation frequency, fasting period before study, age at study initiation and housing.
Mortality was observed, which occurred mainly in between 24 hours after dosing. No deaths occurred after three days. At the day after dosing, miosis and conjunctivitis occurred. From day 2-7 after dosing, miosis, conjunctivitis, erythema, decreased food and water consumption, weight loss and haemorrhages, haematoma and necrosis in the tail were reported. In between day 8-14 after dosing, miosis, erythema and haemorrhages, haematoma and necrosis in the tail were observed.
Based on these results, the acute oral LD50 of zinc sulphate dihydrate in male Sprague-Dawley rats was determined to be 1710 mg/kg bw, which is equivalent to 623 mg of Zn2+/kg bw.
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