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Registration Dossier
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EC number: 208-401-4 | CAS number: 526-95-4
Toxicological information
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- -reliability scoring based on OECD 423 (2001) guideline
- Deviations:
- yes
- Remarks:
- -purity, physico-chemical properties, age, and individual body weight measurements were not provided, 5 animals/sex/group was tested as opposed to 3 animals/group, and other deviations listed in the materials and methods section below
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Potassium gluconate
- EC Number:
- 206-074-2
- EC Name:
- Potassium gluconate
- Cas Number:
- 299-27-4
- IUPAC Name:
- potassium 2,3,4,5,6-pentahydroxyhexanoate (non-preferred name)
- Details on test material:
- - Name of test material (as cited in study report): potassium-gluconate
- Physical state: white-colored crystalline powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Institute's colony (Central Institute for Nutrition and Food Research)
- Age at study initiation: Young (exact age not reported)
- Weight at study initiation: 240 to 382 (males); 156 to 206 (females)
- Fasting period before study: Before dosing, rats were fasted overnight.
- Housing: Housed in groups of 5 in stainless steel cages
- Diet (e.g. ad libitum): After treatment, the rats received stock diet ad libitum.
- Water (e.g. ad libitum): After treatment, the rats received tap water ad libitum.
- Acclimation period: Not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 to 25
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30% (w/v) aqueous solution
- Amount of vehicle (if gavage): Not reported
- Justification for choice of vehicle: Not reported
MAXIMUM DOSE VOLUME APPLIED: 20.7 mL/kg body weight
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Not reported - Doses:
- 10.0, 12.0, 14.4, 17.3, or 20.7 mL/kg body weight (or 3.00, 3.60, 4.32, 5.19, or 6.21 g/kg body weight)
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Not reported
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, macroscopic examinations of the survivors at autopsy - Statistics:
- Statistical analysis was not performed. LD50 and 95% confidence limits were calculated.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 6.06 other: g/kg body weight
- 95% CL:
- 5.64 - 6.51
- Remarks on result:
- other: Authors calculated the LD50 value based on mortality-figures
- Mortality:
- The number of male deaths in the 3.00, 3.60, 4.32, 5.19, or 6.21 g/kg body weight groups was 0, 0, 0, 1, and 4 animals, respectively. The number of female deaths in the 3.00, 3.60, 4.32, 5.19, or 6.21 g/kg body weight groups was 0, 0, 0, 1, and 3 animals, respectively. Deaths occurred between 5 and 21 hours after treatment. Afterwards the survivors recovered gradually and looked quite healthy again at the end of the observation period.
- Clinical signs:
- other: Within a few hours after dosing the rats showed sluggishness, humpback behaviour and severe diarrhoea.
- Gross pathology:
- Macroscopic examination of the survivors at autopsy revealed no treatment-related gross alterations.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP (EC 1278/2008)
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