Registration Dossier
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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

Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- 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 methodology and the extent of available details, the study has been jugded as reliable with restrictions.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 478 (Rodent Dominant Lethal Test)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- rodent dominant lethal assay
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
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 280-350 g
- Assigned to test groubs randomly: yes
- Housing: 1 to 5 per cage, sanitary cages and bedding were used, and changed two times per week, at which time water containers were cleaned, sanitized and filled. Once a week, cages were repositoned on racks; racks were repositioned within rooms monthly.
- Diet (e.g. ad libitum): ad libitum (4% fat diet)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4-11 days
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Vehicle(s)/solvent(s) used: physiol. saline
- Duration of treatment / exposure:
- acute: single oral dose
subacute: five consecutive daily oral doses - Frequency of treatment:
- acute: single oral dose
subacute: five consecutive daily oral doses - Post exposure period:
- 8 weeks in acute test
7 weeks in subacute test
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1.25 mg/kg bw/day (nominal)
- Remarks:
- Basis: actual ingested both in acute and subacute tests
- Dose / conc.:
- 12.5 mg/kg bw/day (nominal)
- Remarks:
- Basis: actual ingested both in acute and subacute tests
- Dose / conc.:
- 125 mg/kg bw/day (nominal)
- Remarks:
- Basis: actual ingested both in acute and subacute tests
- No. of animals per sex per dose:
- 10 male rats were assigned to each of 5 group in acute and subacute. Following treatment, the males were sequentially mated to 2 virgin females per week for 8 weeks (7 in subacute study).
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- triethylenemelamine
- Dose: 0.3 mg/kg bw
Examinations
- Tissues and cell types examined:
- Corpora lutea, early fetal deaths, late fetal and total implantations per uterine born
- Statistics:
- a. the fertility index
The number of pregnant females/number of mated females with the chi-square was used to compare each treatment to the control. Arbitrages's trend was used for linear proportions to test whether the fertility index was linearly related to arithmetic or log dose.
b. totle number of implantations
the t-test was used to determine significant differences between average number of implantations per pregnant female for each treatment compared to the control. Regression techniques were used to determine whether the average number of implantations per female was related to the arithmetic or log dose.
c. total number of corpora lutea
the t-test was used to determine significant differences between average number of corpora lutea per pregnant female for each treatment compared to the control.
d. preimplantation losses
preimplantation loses were computed for each female by subtracting the number of implantations from the number of corpora lutea, Freeman-Tukey transformation was used on the preomplantation losses for each female and then the t-test was used to compare each treatment to control. Regression technique was used to determine whether the average number of preimplantation losses per female was related to the arithmetic or log dose.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- ambiguous
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative. Comparing all data by rodent dominant lethal asseys, no dose- response or time-trend patterns were observed; thus, tartaric acid did induce dominant lethal mutations.
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