D-glucono-1,5-lactone

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:

1978

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

Test material information

Constituent 1

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

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:

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)