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EC number: 212-769-1 | CAS number: 868-14-4
- 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:
- publication
- Title:
- Unnamed
- Year:
- 1 973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- not specified
- 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:
- tartaric acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Sample: Fine white crystalline material
Marking: FDA 71-55 (Tartaric acid)
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- Virgin adult female albino CD-1 outbred mice were gang-housed in disposable plastic cages in temperature and humidity-controlled
quarters with free access to food and fresh tap water. They were mated with young adult males, and observation of the vaginal sperm
plug was considered Day 0 of gestation.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- 10 mL/kg bw
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Beginning on Day 6 and continuing daily through Day 15 of gestation, the females were dosed with the indicated dosages by oral intubation; the controls were sham treated.
- Duration of test:
- 10 consecutive days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
274 mg/Kg/bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 32 mated and 22 pregnants at 274 mg/kg
- Control animals:
- yes, sham-exposed
Examinations
- Maternal examinations:
- Body weights were recorded on Days 0, 6, 11, 15, and 17 of gestation. All animals were observed daily for appearance and behavior
with particular attention to food consumption and weight, in order to rule out any abnormalities which may have occurred as a result
of anorexic effects in the pregnant female animal.
On Day 17 all dams were subjected to Caesarean section under surgical anesthesia, and the numbers of implantations sites,
resorptions site, and live dan dead fetus were recorded.
The body weights of the live pups were also recorded. The urogenital tract of each dam was examined in detail for anatomical
normality.
All fetuses were examined grossly for the presence of external congenital abnormalities. One-third of the fetus of each litter
underwent detailed visceral examinations employing the Wilson technique. The remaining two-thirds were cleared in potassium
hydroxide (KOH), stained with alizarin red S dye and examined for skeletal defects.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no data
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 274 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: other:
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
at 274 mg/kg the results were the following:
Pregnancies:
total: 22, died before day 17°: 0, to term: 22
Live litters:
total: 21
Implant sites:
total: 243, average/dam: 11.1
Resorption:
total: 18, dams with one or more site resorbed: 8, dams with all sites resorbed: 1, partial resorptions: 36.4%, total resorptions: 4.55%
Live fetuses:
total: 222, average/dam: 10.1, sex ratio (M/F): 0.87
dead fetuses:
total: 3, dams with one or more dead: 3, dams with all dead: -, partial dead: 13.6%, all dead: -, average fetus weight: 0.91.
Skeletal findings (fetuses affected/litters affected):
Live fetuses examined (at term): 155/21
Sternebrae: incomplete oss.: 32/17, bipartite: 4/3, missing: 6/4
Ribs: More than 13: 37/16
Vertebrae: 2/2
Extremities: incomplete oss: 2/2
Miscellaneous: Hyoid missing: 26/11, Hyoid reduced: 11/9
Soft tissue abnormalities:
1 pups Gastroschisis
Applicant's summary and conclusion
- Conclusions:
- The administration of up to 274 mg/Kg (body weight) of the test material to pregnant mice for 10 consecutive days had no clearly discernible effect on nidation or 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 occuring spontaneously in the sham-treated controls.
- Executive summary:
The administration of up to 274 mg/Kg (body weight) of the test material to pregnant mice for 10 consecutive days had no clearly discernible effect on nidation or 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 occuring spontaneously in the sham-treated controls.
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