Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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

Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: Chronic
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- no data
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Details on exposure:
- Sodium salts of tartaric acids was incorporated into the diets of the test animals.
The diets and water were provided ad libitum throughout the test period. - Details on mating procedure:
- no data
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 150 days
- Frequency of treatment:
- no data
- Details on study schedule:
- no data
- Remarks:
- Doses / Concentrations:
7.7%
Basis:
no data - No. of animals per sex per dose:
- Sixty rabbits (male), randomly divided into 4 groups of 15 animals each.
- Control animals:
- yes
- Details on study design:
- The mary purpose of the study was to acquire additional information relating to the safety of sodium tartratee when fed at high dietary levels to rabbits and to investigate the effects on the rabbit's testes.
- Positive control:
- no data
- Parental animals: Observations and examinations:
- Each animal was examined daily, and food intake and body weights were recorded at weekly intervals.
- growth and survival
- blood and urine studies
- organ weights
- pathology
At the conclusion of the study (150 days), all surviving animals were sacrificed, and gross and histologic studies were carried out.
For organ weights: mean ± standard deviation, expressed as g/kg bw. - 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):
- no data
- Statistics:
- no data
- Reproductive indices:
- no data
- Offspring viability indices:
- no data
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Other effects:
- effects observed, treatment-related
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- effects observed, treatment-related
- Description (incidence and severity):
- 3 animals exhibited small testes, and 1 control animal showed calcification of the right testicle. The smaller gonads appeared to be related to an inguinal position
- Reproductive performance:
- not specified
- Dose descriptor:
- NOAEL
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No significant toxic effeet oceurred in rats fed diets containing 7.7% of sodium tartrate
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified Generation: no data (migrated information)
- Clinical signs:
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Reproductive effects observed:
- not specified
- Conclusions:
- No significant differences attributable to the experimental feeding could be found in any case; either grossly or microscopically. Thus, the rabbit does not appear to be affected by the inclusion of these substances in the diet for a period of 150 days.
It must be noted that the rabbits' testes are generally small, diffuse, easily dehydrated, and subject to variation in size and position. This species, therefore, is not ideai for the study of testicular pathology. - Executive summary:
The effects of sodium tartrate when fed to rabbits for 150 days at concentrations equivalent to 5.0% of the organic acid in the diet were investigated. Particular attention was given to the possible appearance of testicular toxicity. No significant gross or histopathologic changes attributable to the experimental feeding could be found in any case.
Reference
The following organs were weighed at autopsy: adrenals, bladder, brain, heart, kidneys, liver, lung, prostate, spleen, stomach, testes, and thyroid. The histologic changes observed in the experimental groups were similar to those seen in the control group. Mild focal pyelonephritis, moderate congestion, mild hyperplasia of tubular epithelium, and occasionai protein casts and hyaline droplet' degeneration were noted in the kidneys, while livers of rabbits in ali groups exhibited pericholangitis, bile duct proliferation, and dilatation as well as moderate congestion. These changes are not unusual in rabbits and are not to be attributed to the experimental feeding.
Examination of the testes revealed that the seminiferous tubules, the interstitial cells, and spermatogenesis were normal in all groups. Slight peritubular fibrosis and mild stromal hyalinization were observed in each group after 150 days of feeding.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- chronic
- Species:
- rabbit
- Quality of whole database:
- Database does not contain data obtained by means of tests in accordance with standard testing guidelines; however, it is constituted by many data which are consistent about the absence of significant toxicity to the fertility of tartaric acid and its salts.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Tartaric acid was investigated for its toxicity to the fertility in rabbits, mice, rats and hamsters. The substance did not affect the parameters related to the reproductive performance.
Based on the chemical structure, it is considered that the toxicity to reproduction of tartaric acid is the same of that ones of its salts (i.e. monosodium, monopotassium, sodium potassium, sodium, potassium and calcium tartrate) and, therefore, the assessment of this endpoint may be jointly performed using all available data for these substances.
Overall, tartaric acid and its salts do not have toxicity to reproduction.
Short description of key information:
Tartaric acid and its salts do not have toxicity to reproduction.
Justification for selection of Effect on fertility via oral route:
Although an endpoint study record has been selected, the assessment of the toxicity to the fertility is based on the weight of evidence since the available studies took into account different relevant parameters.
Effects on developmental toxicity
Description of key information
Tartaric acid and its salts do not have developmental toxicity.
Link to relevant study records
- 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.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- not specified
- GLP compliance:
- not specified
- 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. - 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
- 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
- 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. - Details on maternal toxic effects:
- Maternal toxic effects:no data
- 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
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- 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.
Reference
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
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- subacute
- Species:
- mouse
- Quality of whole database:
- Database does not contain data obtained by means of tests in accordance with standard testing guidelines; however, it is constituted by many data which are consistent about the absence of significant developmental toxicity of tartaric acid and its salts.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Tartaric acid was investigated for its developmental toxicity in mice, rats and rabbits. The substance did not cause significant increases in skeletal abnormalities, fetal survival or in other parameters, compared with the controls.
Based on the chemical structure, it is considered that the toxicity of tartaric acid is the same of that ones of its salts (i.e. monosodium, monopotassium, sodium potassium, sodium, potassium and calcium tartrate) and, therefore, the assessment of this endpoint may be jointly performed using all available data for these substances.
Overall, tartaric acid and its salts do not have developmental toxicity.
Justification for selection of Effect on developmental toxicity: via oral route:
The study selected is exhaustively documented, it allows to evaluate the reliability of the test.
Justification for classification or non-classification
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substances should not be classified for the toxicity to reproduction/development because the data are judged as "conclusive but not sufficient for classification".
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

EU Privacy Disclaimer
På den här webbplatsen används kakor. Syftet är att optimera din upplevelse av den.