Registration Dossier
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EC number: 206-156-8 | CAS number: 304-59-6
- 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
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: RSS reported in published OECD SIDS for disodium succinate and assigned Klimish 1 rating. Abundant data in RSS seems to support K1 rating.
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Test substance: disodium succinate hexahydrate (CAS No. 6106-21-4), Nippon Shokubai Co., Ltd., Purity 99.9%.
Lot No. 9P01B
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Not described in source RSS but presumably according to OECD guidance.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Males were dosed daily for 52 days. Females were exposed from 14 days before mating to day 4 of lactation.
The frequency of treatment was once per day. - Details on mating procedure:
- Not stated in source RSS but likely as study done under GLP and OECD guidance stated as followed.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Not stated in source RSS but likely as study done under GLP and OECD guidance stated as followed.
- Duration of treatment / exposure:
- Males: 52 days
Females: Females were exposed from 14 days before mating to day 4 of lactation - Frequency of treatment:
- Once daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
100 mg/kg bw/day
Basis:
actual ingested
hexahydrate salt
- Remarks:
- Doses / Concentrations:
300 mg/kg bw/day
Basis:
actual ingested
hexahydrate salt
- Remarks:
- Doses / Concentrations:
1000
Basis:
actual ingested
hexahydrate salt
- No. of animals per sex per dose:
- 12 males and 12 females per group
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Referred to disodium succinate hexahydrate
- Dose descriptor:
- NOAEL
- Effect level:
- > 600 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: Expressed as anhydrous disodium succinate
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- no effects observed
Details on results (P1)
Potassium Sodium Tartrate or any sodium or potassium salt of tartaric acid. Toxicokinetic information indicates
rapid metabolism and elimination of tartaric acid and of its salts and available information corresponding to an
oral chronic toxicity test performed in rat with monosodium tartrate do not indicate any abnormalities in testes or
ovaries after a 2-year study (see report in section 7.5.1.). In addition its low toxicity and absence of indication of
reproductive effects after a long history of dietary exposure of humans to tartrates do no warrant the performance
of a specific reproductive toxicity study
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Non dose related low body weight in lactation period in some animals
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Details on results (F1)
Potassium Sodium Tartrate or any sodium or potassium salt of tartaric acid. Toxicokinetic information indicates
rapid metabolism and elimination of tartaric acid and of its salts and available information corresponding to an
oral chronic toxicity test performed in rat with monosodium tartrate do not indicate any abnormalities in testes or
ovaries after a 2-year study (see report in section 7.5.1.). In addition its low toxicity and absence of indication of
reproductive effects after a long history of dietary exposure of humans to tartrates do no warrant the performance
of a specific reproductive toxicity study
Effect levels (F1)
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- The results obtained upon surrogate substance disodium succinate hexahydrate in OECD combined repeated dose and developmental toxicity screening test indicate that up to 1000 mg/ kg bw/day there are no significant effects upon the parental animals’s ability to reproduce or upon the health and viability of their offspring (as determined up to the 4th day of lactation).
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
1) Copulation and fertility
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.
2) Parturition and lactation
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.
3) Morphology, body weight and necroptic findings of neonates
In the external examination in neonates, anophthalmia and polydactyly were observed in 1 animal each in the 300 mg/kg group. Body weight during lactation period was significantly low on days 0 and 4 of lactation in males and dayfemales in the 100 mg/kg group and on day
4 inmales in the 300 mg/kg group, which was the change not associated
with the dose. In the necropsy of dead offspring during the lactation period, pyelectasia
was observed in 1 animal in the 100 mg/kg group. In the necropsy on day 4 of lactation, red patches on the plantar were observed in 15 males and 13 females in the 100 mg/kg group, and the number of occurrences significantly increased in both males and females compared with the control group. However, this finding occurred in litters in 2 broods in both males and females. In addition, dilation of the ureter was observed in 3, 4 and 3 males and 5, 1 and 2 females in the 100, 300 and 1000 mg/kg groups, respectively, and the number of occurrences significantly increased in the male 100 mg/kg group. However, dilation of the ureter in the female 100 mg/kg group was observed in litters in 4 of 5 animals. Other findings included thymic remnant in the neck in 3, 1, 2 and 3 male animals in the control, 100, 300 and 1000 mg/kg groups and in 1, 2
and 2 female animals in the control, 100 and 300 mg/kg groups, nodes in the liver in 1 animal each in the male and female 1000 mg/kg groups, white patches in the liver in 1 animal in the male 100 mg/kg group, pyelectasia in 3 animals each in the male 100, 300 and 1000 mg/kg groups and in 2 and 1 animal in the female 300 and 1000 mg/kg groups, anophthalmia in 1 animal in the female 300 mg/kg group, cysts in the hindlimbs in 1 animal in the female 100 mg/kg group and polydactyly in 1 animal in the female 300 mg/kg group.
Applicant's summary and conclusion
- Conclusions:
- The results obtained upon surrogate substance disodium succinate hexahydrate in OECD combined repeated dose and developmenmental toxicity screening test indicate that up to 1000 mg/ kg bw/day there are no significant effects upon the parental animals ability to reproduce or upon the health and viability of their offspring (as determined up to the 4th day of lactation).
- Executive summary:
The results obtained upon surrogate substance disodium succinate hexahydrate in OECD combined repeated dose and developmenmental toxicity screening test indicate that up to 1000 mg/ kg bw/day there are no significant effects upon the parental animals ability to reproduce or upon the health and viability of their offspring (as determined up to the 4th day of lactation).
These results are considered relevant towards the assessment of the reproductive toxicity of Potassium Sodium Tartrate, as both are structurally very similar C4 dicarboxillic acids. These results support further teratology studies performed with tartaric acid.
In a weight of evidence aproach it is considered unnecesary to propose a specific 1 or 2 generation reproductive toxicity test on the reference substance Potassium Sodium Tartrate.
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