Registration Dossier
Registration Dossier
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EC number: 205-778-7 | CAS number: 150-90-3
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Effect of Sorbitol, Fructose, Succhiate, Asportate, Glutamate and Fat on Growth and Survival Time of Biotin-deficient Rats
- Author:
- M. S. Patel
- Year:
- 1 996
- Bibliographic source:
- J. Nutrition
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Subacute oral toxicity study was performed for the test chemical using rats.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium succinate
- EC Number:
- 205-778-7
- EC Name:
- Disodium succinate
- Cas Number:
- 150-90-3
- Molecular formula:
- C4H6O4.2Na
- IUPAC Name:
- disodium succinate
- Details on test material:
- - Name of test material: Sodium succinate
- Molecular formula: C4H6O4.2Na
- Molecular weight: 162.052 g/mol
- Substance type: Organic
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- No data
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- - Age at study initiation: weanling rats
- Weight at study initiation: 32-38 g
- Fasting period before study: No data available
- Housing: housed individually in metal cages with raised wire screens
- Diet (e.g. ad libitum): Basal diet ad libitum
- Water (e.g. ad libitum): Water ad libitum
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Regulated
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: feed
- Details on route of administration:
- No data
- Vehicle:
- other: Basal diet
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Dose was prepared by adding 5 or 10% (5000 or 10000 mg/Kg) of Sodium succinate to the basal diet at the expense of an equivalent amount of glucose.
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): Basal diet
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Basal diet
- Concentration in vehicle: 0, 5 and 10 % (0, 5000 or 10000 mg/Kg)
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 7 weeks
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 5 and 10 % (0, 2500 and 5000 mg/kg/day)
- No. of animals per sex per dose:
- Total: 30
0 % : 10 male
5 % : 10 male
10 % : 10 male - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: No data available
- Rationale for animal assignment (if not random): Animal were assignment to group on the basis of mean body weight and a similar weight distribution in each group (RGB design).
- Rationale for selecting of satellite groups: No data available
- Post-exposure recovery period in satellite groups: No data available
- Section schedule rationale (if not random): No data available - Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
Time schedule: Daily
- Cage side observations checked in table [No.?] were included: Mortality was observed.
DETAILED CLINICAL OBSERVATIONS: No data available
- Time schedule: No data available
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly intervals
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data available
FOOD EFFICIENCY: No data available
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data No data available
- Time schedule for examinations: No data available
OPHTHALMOSCOPIC EXAMINATION: No data No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
HAEMATOLOGY: No data No data available
- Time schedule for collection of blood: No data available
- Anaesthetic used for blood collection: Yes (identity) / No / No data No data available
- Animals fasted: Yes / No / No data No data available
- How many animals: No data available
- Parameters checked in table [No.?] were examined. No data available
CLINICAL CHEMISTRY: No data No data available
- Time schedule for collection of blood: No data available
- Animals fasted: Yes / No / No data No data available
- How many animals: No data available
- Parameters checked in table [No.?] were examined. No data available
URINALYSIS: No data No data available
- Time schedule for collection of urine: No data available
- Metabolism cages used for collection of urine: Yes / No / No data No data available
- Animals fasted: Yes / No / No data No data available
- Parameters checked in table [No.?] were examined. No data available
NEUROBEHAVIOURAL EXAMINATION: No data No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data available - Sacrifice and pathology:
- No data available
- Other examinations:
- No data available
- Statistics:
- No data available
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Description (incidence and severity):
- Clinical signs: No data available
- Mortality:
- no mortality observed
- Description (incidence):
- No effect were observed on survival of treated rats as compared to control.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Slight decrease in weight gain was observed in 5 and 10 % treated rat as compared to control.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No effect was observed on food consumption of treated rat as compared to control.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- Although addition of 5 or 10% sodium succinate led to a slight decrease in weight gain it had no effect on survival time of the treated animals
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 2 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Slight decrease in body weight gain was observed
- Remarks on result:
- other: No toxic effects were observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL was considered to be 2500 mg/kg/day) when Sprague Dawley male rats were treated with test substance.
- Executive summary:
Subacute oral toxicity study was performed for the test chemical using weanling male Sprague Dawley rats deficient in biotin. The test chemical was mixed with feed at dose level of 0, 5 or 10% (0, 2500 or 5000 mg/Kg). The animals were fed the diet containing the test chemical for 7 weeks. Body weights were recorded at about weekly intervals. The animals were observed for Survival time. Slight decrease in weight gain was observed in 5 and 10 % treated rat as compared to control it had no effect on survival time of the treated rats. Based on the observations made, the NOAEL for test chemical was considered to be 2500 mg/Kg/day.
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