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

Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: Chronic
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparative subacute toxicity for rabbits of citric, fumaric, and tartaric acids
- Author:
- Packman EW, Abbott DD and Harrisson JWE
- Year:
- 1 963
- Bibliographic source:
- Toxicology and applied pharmacology 1963; 5 (2): 163-167.
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:
- sodium tartrate
- IUPAC Name:
- sodium tartrate
- Test material form:
- not specified
- Details on test material:
- No further information on test material idendity are available.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
Administration / exposure
- 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
Doses / concentrations
- 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
Examinations
- 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
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- 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 / performance (P0)
- 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
Effect levels (P0)
- 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)
Results: F1 generation
General toxicity (F1)
- 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
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- 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.
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.