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EC number: 205-503-0 | CAS number: 141-82-2
- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test [OECD TG 422], Crj: CD (SD) IGS rats were given disodium succinate hexahydrate by gavage at 0, 100, 300, or 1,000 mg/kg bw/day. Males were dosed for 52 days from day 14 before mating and females were dosed from day 14 before mating to day 4 of lactation throughout the mating and pregnancy period. The study showed that the reproduction/developmental parameters, i.e., mating, pregnancy, delivery, lactation, and viability and body weight of pups, were not affected by disodium succinate hexahydrate at up to 1,000 mg/kg bw/day. The NOAEL of disodium succinate hexahydrate for reproduction/developmental toxicity was considered to be 1,000 mg (highest dose tested, equivalent to 600 mg of disodium succinate)/kg bw/day in rats.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- Succinic acid may be used as an analogue for malonic acid, based on the following considerations. Firstly, dicarboxylic acids are naturally occurring metabolic products of fatty acid oxidation, and are rapidly beta-oxidised. A category approach for short-medium chain dicarboxylic acids, including malonic acid and succinic acid, has been validated and used by various bodies including the Cosmetics Ingredient Review Panel and the European Food Safety Authority.Disodium succinate may be used as an analogue for succinic acid as there is no significant difference in toxicity expected between succinic acid and disodium succinate, since both substances will dissociate into succinate ion under physiological conditions.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Test substance: disodium succinate hexahydrate (CAS No. 6106-21-4),Nippon Shokubai Co., Ltd., Purity 99.9%, Lot No. 9P01B
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Duration of treatment / exposure:
- Males; for 52 daysFemales; from 14 days before mating to day 4 of lactation
- Frequency of treatment:
- Once daily
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 300 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- No. of animals/group: males 12, females 12
- Control animals:
- yes, concurrent vehicle
- Parental animals: Observations and examinations:
- Clinical observations
- Litter observations:
- Yes
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Reproductive function: oestrous cycle:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Critical effects observed:
- no
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In the external examination in neonates, anophthalmia and polydactyly were observed in 1 animal each in the 300 mg/kg group.
- Body weight and weight changes:
- effects observed, non-treatment-related
- 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.
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Critical effects observed:
- no
- Reproductive effects observed:
- no
- Conclusions:
- There is no evidence that disodium succinate has reproductive/developmental toxicity in rats. The NOAEL for reproduction/developmental toxicity wasconsidered to be 1000 mg/kg bw/day as disodium succinate hexahydrate (600 mg/kg bw/day as disodium succinate.
- Executive summary:
In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test [OECD TG 422], Crj: CD (SD) IGS rats were given disodium succinate hexahydrate by gavage at 0, 100, 300, or 1,000 mg/kg bw/day. Males were dosed for 52 days from day 14 before mating and females were dosed from day 14 before mating to day 4 of lactation throughout the mating and pregnancy period. The study showed that the reproduction/developmental parameters, i.e., mating, pregnancy, delivery, lactation, and viability and body weight of pups, were not affected by disodium succinate hexahydrate at up to 1,000 mg/kg bw/day. The NOAEL of disodium succinate hexahydrate for reproduction/developmental toxicity was considered to be 1,000 mg (highest dose tested, equivalent to 600 mg of disodium succinate)/kg bw/day in rats.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 600 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 600 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Justification for classification or non-classification
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.