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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

Endpoint summary
Administrative data
Description of key information
Tartaric acid and its salts does not have significant acute toxicity.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1975
- 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:
- no guideline followed
- Principles of method if other than guideline:
- no data
- GLP compliance:
- not specified
- Test type:
- other: no data
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- average body weight 349 g
- Route of administration:
- oral: unspecified
- Vehicle:
- physiological saline
- Details on oral exposure:
- The substance was pregared as a 29 (w/v) solution in 0.85% saline and administered orally
- Doses:
- one dose only: 5000 mg/kg bw
- No. of animals per sex per dose:
- ten male rats
- Control animals:
- not specified
- Statistics:
- no data
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No signs of toxicity or abnormal behavior was observed in the seven-day observation period
- Mortality:
- One death occurred on day 2.
- Clinical signs:
- other: no data
- Gross pathology:
- On necropsy no gross findings were observed (neither in the dead animal nor in the survivors)
- Other findings:
- no data
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 for compound FDA 71-55 (tartaric acid) is considered to be greater than 5000 mg/kg.
- Executive summary:
The acute oral LD50 for compound FDA 71-55 (tartaric acid) is considered to be greater than 5000 mg/kg.
Reference
Acute Toxicity Data
Dose (mg/kg) | Dead/Animals | Day of Death and Necropsy |
5000 | 1/10 | Day 5(1): no gross findings |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- 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 acute toxicity.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- 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:
- no guideline followed
- Principles of method if other than guideline:
- Subcutaneous exposition of in vivo animals to the substance to evaluate its acute toxicity.
- GLP compliance:
- not specified
- Test type:
- other: no data
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Duration of exposure:
- no data
- Doses:
- 400 mg/kg
800 mg/kg
1000 mg/kg - No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Sex:
- not specified
- Dose descriptor:
- other: lethal dose
- Effect level:
- ca. 400 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 6/7 animals died in 6-7 days
- Sex:
- not specified
- Dose descriptor:
- other: lethal dose
- Effect level:
- ca. 1 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no effects
- Sex:
- not specified
- Dose descriptor:
- other: lethal dose
- Effect level:
- >= 1 200 - <= 1 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Toxic
- Sex:
- not specified
- Dose descriptor:
- other: lethal dose
- Effect level:
- ca. 800 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 6/9 rabbits survived
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Sodium tartrate showed different tolerance which depended on diet following subcutaneous administration.
- Executive summary:
Sodium tartrate showed different tolerance which depended on diet following subcutaneous administration.
Reference
Animals which were fed oats or oats and cabbage succumbed to a dose of 0.4 gm. of the salt per kilo when given by subcutaneous injection, Suppression of urine was usually observed on the first day and death occurred in six to seven days. In starvation, slightly smaller doses were fatal to some rabbits. The resistance was increased considerably when the diet was changed to carrots, Such animals stood 1.0 gm. per kilo by subcutaneous injection, while 1.2-1.5 gm. per kilo were toxic. A moderate degree of tolerance for tartrates was induced in animals which were fed oats and cabbage. By gradually increasing the dose, a large proportion (6 out of 9) of rabbits survived 0.8 gm. per kilo which is twice the fatal dose. Rabbits which were receiving carrots did not acquire tolerance for tartrates.
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- A complete database is available for the acute toxicity by subcutaneous route. Although it does not contain data obtained by means of tests in accordance with standard testing guidelines, it is constituted by many data which are consistent about the absence of significant acute toxicity. Therefore, further investigation by dermal route are deemed to be not needed.
Additional information
The acute toxicity of tartaric acid and its salts was investigated by means of several tests principally performed by means of oral and subcutaneous administration. Almost all data support the absence of significant acute toxicity for both exposure routes. A single LD50 value of 920 mg/kg was observed for tartaric acid, in disagreement with all the others LD50 values for tartaric acid and its salts.
Overall, it is considered that the systemic acute toxicity of tartaric acid is similar to that ones of its salts (i.e. monosodium, monopotassium, sodium potassium, sodium, potassium and calcium tartrate) and, therefore, the assessment of these endpoints may be jointly performed using all available data for these substances. Therefore, tartaric acid and its salts are deemed to be not acutely toxic.
With regard to the specific target organ toxicity, adverse effects on kidney (i.e. nephritis) were reported in some tests. However, these effects were only observed at very high dose levels close to the lethal dose (> 2000 mg/kg bw).
Justification for selection of acute toxicity – oral endpoint
This study has been selected since it is well documented. Overall, the assessment of the acute oral toxicity of tartaric acid and its salts are based on the weight of evidence of the available data.
Justification for selection of acute toxicity – dermal endpoint
Several data are available about the acute toxicity by subcutaneous route. This study has been selected since it is well documented. Overall, the assessment of the acute oral toxicity of tartaric acid and its salts are based on the weight of evidence of the available data.
Justification for classification or non-classification
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the study results indicate that the substances should not be classified for acute oral toxicity because data are judged as "conclusive but not sufficient for classification".
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substances should not be classified for acute inhalation toxicity because of data lacking.
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the study results indicate that the substances should not be classified for acute dermal toxicity because the data currently available are judged as "inconclusive".
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, study results indicate that the substances should not be classified for specific target organ toxicity - single exposure because data are judged as "conclusive but not sufficient for classification".
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