Registration Dossier

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:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): potassium-gluconate
- Physical state: white-colored crystalline powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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:
Within a few hours after dosing the rats showed sluggishness, humpback behaviour and severe diarrhoea.
Body weight:
Individual body weight measurements were not reported. A range of body weights was reported only at the beginning of the study.
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)