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EC number: 221-618-9 | CAS number: 3164-29-2
- 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
Oral (no guideline followed), rat: LD50 > 3100 mg/kg bw
RA from source substance Monosodium L(+) tartrate (CAS 526 -94 -3)
Inhalation: no data available
Dermal: no data available
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: 2-year dietary feeding study (Repeated Dose Toxicity, oral)
- Short description of test conditions: Groups of 35 male and female Sprague-Dawley rats were subjected to a 2-year dietary feeding study, where they received daily doses of the test substance via the food (commercial diet) at dose levels of 25600, 42240, 60160, 76800 ppm. Mortality was assessed daily.
- Parameters analysed / observed: clinical signs, macroscopic pathology, tumorigenic response - GLP compliance:
- not specified
- Test type:
- other: 2-year dietary feeding study
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- CFY rats, hysterectomy-derived strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Anglia Laboratory Animals, Huntingdon, England
- Housing: 5 animals per cage in cages with wire mesh floors
- Diet: commercial diet (Spratt's Laboratory Animal Diet No. 2), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 50 ± 5
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DOSAGE PREPARATION (if unusual): Diet containing different concentrations of test substance.
- Doses:
- 25600, 42240, 60160 or 76800 ppm
which corresponds for males: 890, 1620, 2200 or 3100 mg/kg bw /day
which corresponds for females: 1190, 2050, 3030 or 4100 mg/kg bw /day - No. of animals per sex per dose:
- 35 males and 35 females per dose group
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 2 years
- Frequency of observations and weighing: animals were observed daily and individual body weights were determined weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: food intake and tumorigenic response - Statistics:
- Student's t-test assessing the significance of intergroup differences, mortality was analysed using Fisher's Exact Probability test used as a 'one-tailed' test
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 3 100 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 4 100 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period relevant for acute oral toxicity (14 days)
- Clinical signs:
- No clinical signs of toxicity were observed during the study period relevant for acute oral toxicity (14 days)
- Body weight:
- A dosage-related reduction in bodyweight gain compared to control animals could be observed in all treatment groups during the study period relevant for acute oral toxicity (14 days)
- Gross pathology:
- Necropsy and histopathological examination revealed no substance-related findings.
- Interpretation of results:
- other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 3 100 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 4 100 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
In a 2-year repeated dose toxity study with the source substance Sodium hydrogen tartrate (CAS 526-94-3) used for the assessment of acute toxicity following the oral route, no acute oral toxicity was observed. As explained in the analogue justification, this result is considered to be valid also for the target substance.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 100 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate, reliable (Klimisch score 2) study (Repeated dose toxicity: oral) from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products and similarities in PC/ECO/TOX properties (refer to endpoint discussion for further details).
Taken together, the information from these independent source is consistent and provides sufficient weight of evidence for hazard assessment leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No. 1907/2006. Therefore, the available information as a whole is sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, of Regulation (EC) No. 1907/2006.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute toxicity
Justification for read-across
There are no data for acute toxicity available for diammonium tartrate (CAS 3164 -29-2). To fulfil the standard data requirements defined in Regulation (EC) No. 1907/2006, Annex VII, 8.5, read-across from an appropriate substance is conducted in accordance with Regulation (EC) No. 1907/2006, Annex XI.
According to Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met”. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across) “to avoid the need to test every substance for every endpoint”.
For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read across, with regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substances are the basis of read-across. A detailed justification for the analogue read- across approach is provided in the technical dossier (see IUCLID Section 13).
As no experimental/measured data are available on acute toxicity of diammonium tartrate (CAS 3164 -29 -2) following the oral route, read-across to reliable data on the analogue substance sodium hydrogen tartrate (CAS 526 -94 -3) was conducted.
Oral
A repeated dose toxicity study (oral) (2-year study) was performed in rats without following any OECD Guideline and was used for assesing the acute oral toxicity (Hunter et al., 1977). The substance was administered via the diet, which contained different concentrations of the test substance. In this repeated dose toxicity study (oral) LD50 values >3100 mg/kg bw and >4100 mg/kg bw were estimated as these were the highest doses for males and females, respectively, and no mortality occured. These LD50 values are higher than the threshold of 2000 mg/kg bw and thus it can be concluded that the test substance does not show acute toxicity via the oral route.
Justification for classification or non-classification
Based on the analogue read-across approach, the available data on acute oral toxicity of the test substance do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
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.
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