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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
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data from secondary source
Data source
Referenceopen allclose all
- Reference Type:
- other: j -check
- Title:
- Reproductive toxicity study of Disodium succinate hexahydrate
- Author:
- National Institute Of Technology and Evaluation
- Year:
- 2 018
- Bibliographic source:
- Japan Chemical Collaborative Knowledge Database, 2018
- Reference Type:
- secondary source
- Title:
- SIDS Initial Assessment Report For Disodium succinate hexahydrate
- Author:
- OECD SIDS
- Year:
- 2 003
- Bibliographic source:
- SIDS Initial Assessment Report For SIAM 16, 2003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- Reproductive toxicity evaluation of test chemical administered by gavage.
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data available
Test material
- Reference substance name:
- Disodium succinate hexahydrate
- EC Number:
- 612-073-1
- Cas Number:
- 6106-21-4
- Molecular formula:
- C4H6O4.6H2O.2Na
- IUPAC Name:
- Disodium succinate hexahydrate
- Details on test material:
- - Name of test material: Disodium succinate hexahydrate
- Molecular formula: C4H6O4.6H2O.2Na
- Molecular weight: 270.1404 g/mol
- Substance type: Organic
- Physical state: No data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Details on species / strain selection:
- No data available
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Water for injection
- Details on exposure:
- Details on exposure
PREPARATION OF DOSING SOLUTIONS:
Test materials dissolved in Water for injection
DIET PREPARATION
- Rate of preparation of diet (frequency):No data available
- Mixing appropriate amounts with (Type of food )
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Test material dissolved in Water for injection
- Concentration in vehicle: 0 (vehicle), 100, 300, 1000 mg/kg
- Amount of vehicle (if gavage):
- Lot/batch no. (if required): No data available
- Purity: No data available - Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Males, 52 days
Females, from 14 days before mating to day 4 of lactation - Frequency of treatment:
- Once daily
- Details on study schedule:
- No data available
Doses / concentrations
- Remarks:
- 0 (vehicle), 100, 300, 1000 mg/kg
- No. of animals per sex per dose:
- Total:96
0 mg/kg bw/day:12 male and 12 female
100mg/kg bw/day:12 male and 12 female
300mg/kg bw/day:12 male and 12 female
1000 mg/kg bw/day:12 male and 12 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- Parental animals observation and examinations
CAGE SIDE OBSERVATIONS: yes
DETAILED CLINICAL OBSERVATIONS:
Time schedule:
BODY WEIGHT: Yes
Time schedule for examinations:
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):.
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: Yes / No / No data: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
Time schedule for examinations - Oestrous cyclicity (parental animals):
- yes
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: [yes/no]
- If yes, maximum of [...] pups/litter ([...]/sex/litter as nearly as possible); excess pups were killed and discarded.
PARAMETERS EXAMINED
The following parameters were examined in [F1] offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities, were observed.
GROSS EXAMINATION OF DEAD PUPS: no
[no / yes, for external and internal abnormalities; possible cause of death was/was not determined for pups born or found dead.]
ASSESSMENT OF DEVELOPMENTAL NEUROTOXICITY:No
ASSESSMENT OF DEVELOPMENTAL IMMUNOTOXICITY:No - Postmortem examinations (parental animals):
- Postmortem examinations (Parent Animal)
SACRIFICE:
Male animals: yes on 53 days
Female animals: yes on day 5 of lactation
All surviving animals [describe when, e.g. after the last litter of each generation was weaned :
GROSS NECROPSY: yes
HISTOPATHOLOGY / ORGAN WEIGHTS - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring were sacrificed at [5] days of age.
- These animals were subjected to postmortem examinations (macroscopic and/or microscopic examination) as follows:
GROSS NECROPSY
- Gross necropsy consisted of [external examinations ]
HISTOPATHOLOGY / ORGAN WEIGTHS : No
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively. - Statistics:
- No data available
- Reproductive indices:
- Yes
- Offspring viability indices:
- yes
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No treatment-related clinical signs were observed
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No deaths were observed in any treatment group in either sex
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- 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
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- No adverse effects were observed in terms of the estrus cycle.In the observation of estrous cycle, there was no intergroup difference in the mean estrous cycle. The abnormal estrous cycle was observed in 1 animal each in the 100 and 1000 mg/kg groups. There was no intergroup difference in the incidence of abnormal estrous cycle.
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- Copulation and conception were all established, and both the copulation index and the fertility index were 100% in all groups.The gestation period was significantly shortened in the 100 and 1000 mg/kg groups compared with the control group. There was no abnormality in the conditions of parturition, and the numbers of corpora lutea, implantation sites, delivered offspring and live delivered offspring showed almost the same values. There were no intergroup differences in the delivery index, implantation index, parturition index, live birth index, sex ratio and viability index of neonates on day 4 of lactation
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- reproductive function (oestrous cycle)
- reproductive performance
- Remarks on result:
- other: No effects on reproductive performance
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No treatment-related clinical signs were observed
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Body weight during lactation period was significantly low on days 0 and 4 of lactation in males and day 4 in females in the 100 mg/kg group and on day 4 in males in the 300 mg/kg group, which was the change not associated with the dose.
- Food consumption and compound intake (if feeding study):
- not specified
- 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
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No abnormal findings related to the test substance were noted on external examination,
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- viability
- sexual maturation
- clinical signs
- mortality
- body weight and weight gain
- gross pathology
- Remarks on result:
- other: overall no effects on developmental parameters
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No Observed Adverse Effect Level (NOAEL) for maternal and foetal toxicity was considered to be 1000mg/kg/day. When male and female Crj: CD(SD) rats treated with test chemical orally.
- Executive summary:
The one generation reproductive toxicity study of test chemical was performed in male and femaleCrj: CD(SD) rats. The test material was dissolved in Water for injection and administered in dose concentration 0 (vehicle), 100, 300, 1000 mg/kg to Males for 52 days and Females from 14 days before mating to day 4 of lactation. Each dose group contain 12 male and 12 female. All the animals were observed for clinical signs and body weight changes. Males were scarified on day 53 while females were killed on day 5 of lactation.
No treatment-related clinical signs were observed in parents as well as offspring.No deaths were observed in any treatment group in either sex. Copulation and conception were all established, and both the copulation index and the fertility index were 100% in all groups. In the observation of estrous cycle, there was no intergroup difference in the mean estrous cycle. The abnormal estrous cycle was observed in 1 animal each in the 100 and 1000 mg/kg groups. There was no intergroup difference in the incidence of abnormal estrous cycle. The gestation period was significantly shortened in the 100 and 1000 mg/kg groups compared with the control group. There was no abnormality in the conditions of parturition, and the numbers of corpora lutea, implantation sites, delivered offspring and live delivered offspring showed almost the same values. There were no intergroup differences in the delivery index, implantation index, parturition index, live birth index, sex ratio and viability index of neonates on day 4 of lactation. Body weight during lactation period was significantly low on days 0 and 4 of lactation in males and day 4 in females in the 100 mg/kg group and on day 4 in males in the 300 mg/kg group, which was the change not associated with the dose.No abnormal findings related to the test substance were noted on external examination. HenceNo Observed Adverse Effect Level (NOAEL) for maternal and foetal toxicity was considered to be 1000mg/kg/day.When male and female Crj: CD(SD) rats treated with test chemical orally.
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