Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 221-621-5 | CAS number: 3164-34-9
- 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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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 methodology and to the extent of available details, the study has been judged as reliable with restrictions.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Evaluation of the Health Aspects of Potassium Acid Tartrate, Sodium Potassium Tartrate, Sodium Tartrate and Tartaric Acid as Food Ingredients
- Author:
- Federation of American Societies for Experimental Biology, Bethesda, MD
- Year:
- 1 979
- Bibliographic source:
- Food and Drug Administration, Washington, 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- no data
- GLP compliance:
- not specified
Test material
- Reference substance name:
- L-tartaric acid
- IUPAC Name:
- L-tartaric acid
- Test material form:
- not specified
- Details on test material:
- No details on test material identity are available.
Constituent 1
- Specific details on test material used for the study:
- no data
Test animals
- Species:
- other: chick embryos
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- The teratogenic potential of L(+) tartaric acid was studied in 96-hour.
Administration / exposure
- Route of administration:
- other:
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Details on exposure:
- Dose levels of 8 mg per kg and above were toxic when injected into the air cell or yolk.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Details on mating procedure:
- no data
- Duration of treatment / exposure:
- 96-hour
- Frequency of treatment:
- no data
- Duration of test:
- 96-hour
Doses / concentrations
- Dose / conc.:
- 8 other: mg/kg
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Details on study design:
- no data
Examinations
- Maternal examinations:
- no data
- Ovaries and uterine content:
- no data
- Fetal examinations:
- no data
- Statistics:
- no data
- Indices:
- no data
- Historical control data:
- no data
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not examined
- Description (incidence and severity):
- no data
- Dermal irritation (if dermal study):
- not examined
- Description (incidence and severity):
- no data
- Mortality:
- not examined
- Description (incidence):
- 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
- Behaviour (functional findings):
- not examined
- Description (incidence and severity):
- no data
- Immunological findings:
- 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
- Neuropathological findings:
- not examined
- Description (incidence and severity):
- no data
- Histopathological findings: non-neoplastic:
- not examined
- Description (incidence and severity):
- no data
- Histopathological findings: neoplastic:
- not examined
- Description (incidence and severity):
- no data
- Other effects:
- not examined
- Description (incidence and severity):
- no data
- Details on results:
- no data
Maternal developmental toxicity
- Number of abortions:
- not examined
- Description (incidence and severity):
- no data
- Pre- and post-implantation loss:
- not examined
- Description (incidence and severity):
- no data
- Total litter losses by resorption:
- not examined
- Description (incidence and severity):
- no data
- Early or late resorptions:
- not examined
- Description (incidence and severity):
- no data
- Dead fetuses:
- not examined
- Description (incidence and severity):
- no data
- Changes in pregnancy duration:
- not examined
- Description (incidence and severity):
- no data
Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not examined
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.DescriptionIncidenceAndSeverityEffectsOnPregnancyDuration): no data - Changes in number of pregnant:
- not examined
- Description (incidence and severity):
- no data
- Other effects:
- not examined
- Description (incidence and severity):
- no data
- Details on maternal toxic effects:
- no data
Effect levels (maternal animals)
- Dose descriptor:
- other: not relevant
- Based on:
- other: not relevant
- Basis for effect level:
- other: not relevant
- Remarks on result:
- other: not relevant
Results (fetuses)
- Fetal body weight changes:
- not specified
- Description (incidence and severity):
- no data
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not specified
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.DescriptionIncidenceAndSeverityFetalPupBodyWeightChanges): no data - Reduction in number of live offspring:
- not specified
- Description (incidence and severity):
- no data
- Changes in sex ratio:
- not specified
- Description (incidence and severity):
- no data
- Changes in litter size and weights:
- not specified
- Description (incidence and severity):
- no data
- Changes in postnatal survival:
- not specified
- Description (incidence and severity):
- no data
- External malformations:
- not specified
- Description (incidence and severity):
- no data
- Skeletal malformations:
- not specified
- Description (incidence and severity):
- no data
- Visceral malformations:
- not specified
- Description (incidence and severity):
- no data
- Other effects:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The teratogenic potential of the substance L(+) tartaric acid was studied in chick embryos.
Statistical evaluation of the occurrence of abnormalities in tartaric acid treated embryos failed to indicate that the substance was teratogenic. - Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No abnormalities occurs
Effect levels (fetuses)
- Dose descriptor:
- dose level:
- Effect level:
- ca. 8 other: mg/kg
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: teratogenicity
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
no data
Applicant's summary and conclusion
- Conclusions:
- Statistical evaluation of the occurrence of abnormalities in tartaric acid treated embryos failed to indicate that the substance was teratogenic.
- Executive summary:
Statistical evaluation of the occurrence of abnormalities in tartaric acid treated embryos failed to indicate that the substance was teratogenic at dose levels of 8 mg/kg and above.
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.
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