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EC number: 205-778-7 | CAS number: 150-90-3
- 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
Endpoint summary
Administrative data
Description of key information
Repeated dose toxicity: Oral
The NOAEL was considered to be 2500 mg/kg/day) when Sprague Dawley male rats were treated with test substance.
Repeated dose toxicity: Inhalation
Disodium succinate has a particle size distribution of 53-150 micron, so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated dose toxicity by inhalation route is considered for waiver.
Repeated dose toxicity: Dermal
The acute toxicity value for Disodum succinate (150-90-3) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that 2 Disodum succinate shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that Disodum succinate shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- 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
- 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
- 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 - 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
- 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
- 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
- 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
- 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
- Critical effects observed:
- not specified
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 2 500 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Data is from peer reviewed publication
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Waiver
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: dermal, other
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Waiver
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Data available for the target chemical was reviewed to determine the toxic nature of Disodum succinate (150-90-3). The studies are as mentioned below:
Repeated dose toxicity: Oral
In Combined repeated dose & carcinogenicity study F344 male rats were treated with test substance in concentration of 0 and 5% (0 and 5000 mg/kg/day) orally in diet. The treated animals were observed body weight, food and water consumption changes weekly. For urinary electrolyte analysis, samples of urine were obtained from the five rats used for labeling index evaluation in each group. For urine collection, rats were housed individually in metabolic cages without food or water for 4 h in the morning. Sodium, potassium and chloride were analyzed. Five rats received a single i.p. injection of BrdU at a dose of 50 mg/kg body wt 1 h before death. Then the urinary bladders were excised, inflated and fixed in 10% phosphate- buffered formalin and embedded in paraffin. Epithelial cells incorporating BrdU were demonstrated in histological sections by the avidin-biotin-peroxidase complex imrnunomstochemical method (20) with anb-BrdU monoclonal antibody. Numbers of labeled cells per 1000 cells were counted by light microscopy and labeling indices were expressed as percentage values. The urinary bladders of five rats from each group were inflated with 2% glutaraldehyde in 0.1 M cacodylate buffer and divided in half longitudinally. One half was processed for light microscopy and the other half for SEM. The ephhelia of 40 urinary bladders (10 rats in each group) were stripped off, suspended in 0.5 ml of 50 mM Tris (pH 7.5) containing 0.25 M sucrose, and disrupted by sonication for 30 s (Sonifer). In each group, the epithelia from two rats were pooled as one sample. The sonicated suspensions were centrifuged at 100 000 g for 30 min and the supernatant was assayed for SAT activity by measurement of the amount of acetyl moiety transferred from [l-14C]acetyl coenzyme A to spermidine. Hematuria, significantly increased urinary pH, sodium ion concentration and significantly decreased concentrations of potassium and chloride was observed in treated rat as compared to control. The concentrations of calcium and phosphorus showed no consistent pattern of differences relative to the controls. No Necrotic lesions were observed in treated rat. Simple hyperplasia was observed in treated rat. The luminal surfaces of the urinary bladder epithelial cells in rats given the sodium salts were covered with ropy or Jeafy microridges and short, uniform microvilli. The grading of cell surface alterations in rats treated with 2Na-Suc was higher. Pleomorphic microvilli were occasionally observed on the urinary bladder epithelial cell surfaces of rats treated with 2Na-Suc. Significantly increased in BrdU uptake was observed in treated rat. Increased levels of SAT in urinary bladder epithelium of treated rats were observed as compared to control. Based on the observations made, the lowest-observed-adverse-effect level (LOAEL) for test substance is considered to be 5 % (5000 mg/Kg/day) when F344 male rat treated with the test chemical for 8 weeks.
Supported by other study. 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 5000 mg/Kg/day.
Repeated dose toxicity: Inhalation
Disodium succinate has a particle size distribution of 53-150 micron, so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated dose toxicity by inhalation route is considered for waiver.
Repeated dose toxicity: Dermal
The acute toxicity value for Disodum succinate (150-90-3) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that 2 Disodum succinate shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that Disodum succinate shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.
Disodium succinate is considered to be toxic at high doses as high as 5000 mg/Kg. However, the estimated daily per capita intake on the basis of "Maximised Survey-derived Daily Intake” (MSDI) appraoch ( EFSA Journal 2011; 9(7):2164) is 1500 µg/person/day. Based on these considerations and from the data available from the read across chemical, Disodium succinate is considered to be safe at low dose levels of use.
Justification for classification or non-classification
Disodium succinate is considered to be toxic at high doses as high as 5000 mg/Kg. However, the estimated daily per capita intake on the basis of "Maximised Survey-derived Daily Intake” (MSDI) appraoch ( EFSA Journal 2011; 9(7):2164) is 1500 µg/person/day. Based on these considerations and from the data available from the read across chemical, Disodium succinate is considered to be safe at low dose levels of use.
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