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EC number: 213-067-8 | CAS number: 921-53-9
- 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:
- two-generation reproductive toxicity
- Remarks:
- based on test guideline (migrated information)
- Type of information:
- other: Data sharing dispute
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study has been assessed for the use in a category approach. According to the met hodology and to the extent of available details, the study has been judged as reliable with restrictions.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Teratologic evaluation tartaric acid in hamster
- Author:
- Kenneth Morgareidge
- Year:
- 1 973
- Bibliographic source:
- Food and drug research laboratories, inc.
- Reference Type:
- other: secondary source
- Title:
- Safety Assessment for Tartaric Acid, CAS Number 82-69-4
- Author:
- Tobacco Documents Library
- Year:
- 1 996
- Bibliographic source:
- Tobacco Documents Library
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OTS 798.4700 (Reproduction and Fertility Effects)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- (+)-tartaric acid
- EC Number:
- 201-766-0
- EC Name:
- (+)-tartaric acid
- Cas Number:
- 87-69-4
- Molecular formula:
- C4H6O6
- IUPAC Name:
- (2R,3R)-2,3-dihydroxybutanedioic acid
- Test material form:
- not specified
Constituent 1
- Specific details on test material used for the study:
- no data
Test animals
- Species:
- hamster
- Strain:
- not specified
- Details on species / strain selection:
- no data
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- other: oral intubation
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- water
- Details on exposure:
- 5 consecutive days
- Details on mating procedure:
- no data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 5 consecutive days
- Frequency of treatment:
- no data
- Details on study schedule:
- no data
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2.3 other: mg/kg bw
- Dose / conc.:
- 225 other: mg/kg bw
- No. of animals per sex per dose:
- 25 mated and 22 pregnants
- Control animals:
- yes, sham-exposed
- Positive control:
- no data
Examinations
- Parental animals: Observations and examinations:
- nidation or maternal survival
- Oestrous cyclicity (parental animals):
- no data
- Sperm parameters (parental animals):
- no data
- Litter observations:
- no data
- Postmortem examinations (parental animals):
- no data
- Postmortem examinations (offspring):
- soft or skeletal tissue defects in the offspring were recorded
- Statistics:
- no data
- Reproductive indices:
- no data
- Offspring viability indices:
- no data
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Description (incidence and severity):
- no data
- Dermal irritation (if dermal study):
- not specified
- Description (incidence and severity):
- no data
- Mortality:
- not specified
- Description (incidence):
- no data
- Food consumption and compound intake (if feeding study):
- not specified
- Description (incidence and severity):
- no data
- Food efficiency:
- not specified
- Description (incidence and severity):
- no data
- Water consumption and compound intake (if drinking water study):
- not specified
- Description (incidence and severity):
- no data
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Description (incidence and severity):
- no data
- Clinical biochemistry findings:
- not specified
- Description (incidence and severity):
- no data
- Urinalysis findings:
- not specified
- Description (incidence and severity):
- no data
- Behaviour (functional findings):
- not specified
- Description (incidence and severity):
- no data
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Description (incidence and severity):
- no data
- Histopathological findings: non-neoplastic:
- not specified
- Description (incidence and severity):
- no data
- Histopathological findings: neoplastic:
- not specified
- Description (incidence and severity):
- no data
- Other effects:
- not specified
- Description (incidence and severity):
- no data
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Description (incidence and severity):
- no data
- Reproductive function: sperm measures:
- not examined
- Description (incidence and severity):
- only female were administered the substance.
- Reproductive performance:
- not specified
- Description (incidence and severity):
- no data
Effect levels (P0)
- Dose descriptor:
- other: highest dose tested
- Effect level:
- ca. 225 mg/kg bw (total dose)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: No maternal toxicity is observed. No teratogenicity is observed
- Remarks on result:
- not determinable
- Remarks:
- no NOAEC identified Generation: P and F1 (migrated information)
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- not specified
- Description (incidence and severity):
- no data
- Dermal irritation (if dermal study):
- not specified
- Description (incidence and severity):
- no data
- Mortality:
- not specified
- Description (incidence):
- no data
- Body weight and weight changes:
- not specified
- Description (incidence and severity):
- no data
- Food consumption and compound intake (if feeding study):
- not specified
- Description (incidence and severity):
- no data
- Food efficiency:
- not specified
- Description (incidence and severity):
- no data
- Water consumption and compound intake (if drinking water study):
- not specified
- Description (incidence and severity):
- no data
- Ophthalmological findings:
- not specified
- Description (incidence and severity):
- no data
- Haematological findings:
- not specified
- Description (incidence and severity):
- no data
- Clinical biochemistry findings:
- not specified
- Description (incidence and severity):
- no data
- Urinalysis findings:
- not specified
- Description (incidence and severity):
- no data
- Behaviour (functional findings):
- not specified
- Description (incidence and severity):
- no data
- Immunological findings:
- not specified
- Description (incidence and severity):
- no data
- Organ weight findings including organ / body weight ratios:
- not specified
- Description (incidence and severity):
- no data
- Gross pathological findings:
- not specified
- Description (incidence and severity):
- no data
- Neuropathological findings:
- not specified
- Description (incidence and severity):
- no data
- Histopathological findings: non-neoplastic:
- not specified
- Description (incidence and severity):
- no data
- Histopathological findings: neoplastic:
- not specified
- Description (incidence and severity):
- no data
- Other effects:
- not specified
- Description (incidence and severity):
- no data
- Details on results:
- no data
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not specified
- Description (incidence and severity):
- no data
- Reproductive function: sperm measures:
- not specified
- Description (incidence and severity):
- no data
- Reproductive performance:
- not specified
- Description (incidence and severity):
- no data
Details on results (P1)
Effect levels (P1)
- Dose descriptor:
- other: not specified
- Based on:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Description (incidence and severity):
- no data
- Dermal irritation (if dermal study):
- not specified
- Description (incidence and severity):
- no data
- Mortality / viability:
- not specified
- Description (incidence and severity):
- fetal survival were recorded but no data were reported , only qualitative data are available.
- Body weight and weight changes:
- not specified
- Description (incidence and severity):
- no data
- Food consumption and compound intake (if feeding study):
- not specified
- Description (incidence and severity):
- no data
- Food efficiency:
- not specified
- Description (incidence and severity):
- no data
- Water consumption and compound intake (if drinking water study):
- not specified
- Description (incidence and severity):
- no data
- Ophthalmological findings:
- not specified
- Description (incidence and severity):
- no data
- Haematological findings:
- not specified
- Description (incidence and severity):
- no data
- Clinical biochemistry findings:
- not specified
- Description (incidence and severity):
- no data
- Urinalysis findings:
- not specified
- Description (incidence and severity):
- no data
- Sexual maturation:
- not specified
- Description (incidence and severity):
- no data
- Organ weight findings including organ / body weight ratios:
- not specified
- Description (incidence and severity):
- no data
- Gross pathological findings:
- not specified
- Description (incidence and severity):
- no data
- Histopathological findings:
- not specified
- Description (incidence and severity):
- no data
- Other effects:
- not specified
- Description (incidence and severity):
- soft or skeletal tissue defects in the offspring were recorded but no data were reported, only qualitative data are available.
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
- Description (incidence and severity):
- no data
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
- Description (incidence and severity):
- no data
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- other: Not relevant
- Generation:
- other: Not relevant
- Based on:
- other: Not relevant
- Sex:
- not specified
- Basis for effect level:
- other: Not relevant
- Remarks on result:
- other: Not relevant The substance was administered to the pregnant dams only.
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- not examined
- Description (incidence and severity):
- no data
- Dermal irritation (if dermal study):
- not examined
- Description (incidence and severity):
- no data
- Mortality / viability:
- not examined
- Description (incidence and severity):
- no data
- Body weight and weight changes:
- not examined
- Description (incidence and severity):
- no data
- Food consumption and compound intake (if feeding study):
- not examined
- Description (incidence and severity):
- no data
- Food efficiency:
- not examined
- Description (incidence and severity):
- no data
- Water consumption and compound intake (if drinking water study):
- not examined
- Description (incidence and severity):
- no data
- Ophthalmological findings:
- not examined
- Description (incidence and severity):
- no data
- Haematological findings:
- not examined
- Description (incidence and severity):
- no data
- Clinical biochemistry findings:
- not examined
- Description (incidence and severity):
- no data
- Urinalysis findings:
- not examined
- Description (incidence and severity):
- no data
- Sexual maturation:
- not examined
- Description (incidence and severity):
- no data
- Organ weight findings including organ / body weight ratios:
- not examined
- Description (incidence and severity):
- no data
- Gross pathological findings:
- not examined
- Description (incidence and severity):
- no data
- Histopathological findings:
- not examined
- Description (incidence and severity):
- no data
- Other effects:
- not examined
- Description (incidence and severity):
- no data
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not examined
- Description (incidence and severity):
- no data
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not examined
- Description (incidence and severity):
- no data
Details on results (F2)
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
at 225 mg/kg the results were the following:
Pregnancies:
total: 22, died before day 14°: 1, to term: 21
Live litters:
total: 21
Implant sites:
total: 300, average/dam: 14.3
Resorption:
total: 4, dams with one or more site resorbed: 4, dams with all sites resorbed: -, partial resorptions:
19.1%, total resorptions: -
Live fetuses:
total: 295, average/dam: 14.1, sex ratio (M/F): 1.01
dead fetuses:
total: 1, dams with one or more dead: 1, dams with all dead: -, partial dead: 4.76%, all dead: -,
average fetus weight: 1.76
Skeletal findings (fetuses affected/litters affected):
Live fetuses examined (at term): 203/21
Sternebrae: incomplete oss.: 73/20, bipartite: 22/12, missing: 38/14
Ribs: More than 13: 33/15
Vertebrae: 6/4
Extremities: incomplete oss.: 7/5
Miscellaneous: Hyoid missing: 4/2, Hyoid reduced: 5/4
Soft tissue abnormalities:
1 pups Gastroschisis
Applicant's summary and conclusion
- Conclusions:
- The administration of up to 225 mg/kg bw of the test material to pregnant hamster for 5 consecutive
days had no clearly discernible effects on nidationor on maternal or fetal survival. The number of
abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number
occurring spontaneously in the sham-treated controls. - Executive summary:
A test was conducted to determine the teratogenic potential off L(+)-tartaric acid.
Pregnant hamsters orally administered doses of L(+)-tartaric acid ranging from 2.3-225 mg/kg bw for
5 days.
The animals were subjected to Cesarean section on day 14. The substance under investigation exhibited
no teratogenic activity (nidation, maternal or fetal survival, or soft or skeletal tissue defects in the
offspring) in hamsters under the given test conditions.
No clearly discernible effects on nidationor on maternal or fetal survival. The number of abnormalities
seen in either soft or skeletal tissues of the test groups did not differ from the number occurring
spontaneously in the sham-treated controls.
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