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EC number: 221-621-5 | CAS number: 3164-34-9
- 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

Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1982
- 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:
- Short-term toxicity study of metatartaric acid in rats
- Author:
- Ingram AJ, Buttcrworth KR, Gaunt IF, Gangoli SD.
- Year:
- 1 982
- Bibliographic source:
- Food Chem Toxicol 1982; 20 (3): 253-257.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test substance is orally administered daily in graduated doses to several groups of experimental animals, one dose level per group for a period of 18 weeks. During the period of administration the animals are observed closely for signs of toxicity.
Animals which died or are killed during the test are necropsied and, at the conclusion of the test, surviving animals are also killed and necropsied. - GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- metatartaric acid
- EC Number:
- 609-694-5
- IUPAC Name:
- metatartaric acid
- Test material form:
- not specified
- Details on test material:
- Specification for the test material: an offwhite powder; content, 105.4% tartaric acid equivalent; esterified tartaric acid, 27-35%; specific absorption
E%cm: 0.0076; specific rotation [α]20 c + 132; matter insoluble in water at 20°C, 1-48%; pyruvic acid, 53 ppm, arsenic 0.02 ppm; lead, 0.16 ppm
Constituent 1
- Specific details on test material used for the study:
- Metatartaric acid manufactured by Wormser Oenologie, France, was supplied by Newmark Chemical Laboratories, London. It complied with the requirements of The Miscellaneous Additives
in Food Regulations 1974 (Statutory Instrument 1974, n. 1121) and had the following specification:
an offwhite powder;
content, 105 4% tartaric acid equivalent;
esterified tartaric acid, 27-35%;
specific absorption E1%-1cm:. 0.0076;
specific rotation: +13.2
matter insoluble in water at 20°C, 1-48%;
pyruvic acid, 53 ppm,
arsenic, 0.02 ppm;
lead, 0.16 ppm.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- Wistar rats obtained from a specified-pathogen-free breeding colony (SACI Laboratory Animai Division, Braintree, Essex) were fed ground Spratt's laboratory Diet No. 1 ad lib.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The animals were housed five per cage in air-conditioned rooms.
Rats were obtained from a specified-pathogen-free breeding colony.
Groups of 15 male rats (body weight approximately 85 g) and 15 females (body weight approximately 75 g)
Administration / exposure
- Route of administration:
- oral: drinking water
- Details on route of administration:
- no data
- Vehicle:
- water
- Details on oral exposure:
- Rats were fed ground Spratt's laboratory Diet n. 1 ad lib.
Rats were given drinking-water containing metatartaric acid ad lib. - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 18 weeks (additional group: 2 or 6 weeks)
- Frequency of treatment:
- no data
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 other: %
- Remarks:
- (Control)
- Dose / conc.:
- 0.1 other: %
- Dose / conc.:
- 0.5 other: %
- Dose / conc.:
- 3 other: %
- Dose / conc.:
- 0 other: %
- Remarks:
- in addition, five rats of each sex were given metatartaric acid for 2 or 6 wk
- Dose / conc.:
- 0.5 other: %
- Remarks:
- in addition, five rats of each sex were given metatartaric acid for 2 or 6 wk
- Dose / conc.:
- 3 other: %
- Remarks:
- in addition, five rats of each sex were given metatartaric acid for 2 or 6 wk
- No. of animals per sex per dose:
- not clearly stated.
- Control animals:
- yes
- Positive control:
- no data
Examinations
- Observations and examinations performed and frequency:
- Body weight: The animals were weighed before the star t of treatment, on days 1, 3 and 7 of the treatment period and subsequently at weekly intervals up to wk 18.
Food and water intakes: Food and water intakes were measured over a 24-hr period preceding each weighing.
Urine: Urine was collected during the final week of treatment and examined for appearance, microscopic constituents and tbe presence of albumin, glucose, ketone bodies, bile salts and blood. A urinary concentration and dilution test was carried out at the same time by measuring the specific gravity and volume of urine voided during a 6-hr period of water deprivation and in a 2-hr period fOllowing a water load of 25 ml/kg bw . Cells were counted in this urine specimen. In addition at wk 6 and 18 the same measurements were made on the urine collected during a 4-hr period cornmencing after water deprivation for 16 hr.
Blood and serum: Samples of blood were obtained from haematological examination and serum analyses.
Blood samples were examined for haemoglobin content packed cell volume and counts of erythrocytes and total and differential leucocytes. In the absence of treatment-related changes in the erythrocyte counts, reticulocytes were not examined. Differential leucocyte counts were carried out on all the groups at wk 2 but were confined to the control and highest treatment groups at wk 6 and 18. Serum was analysed for the content of urea. glucose, total protein and albumin and for the activities of glutamic-oxalacetic and glutamic-pyruvic transaminases and lactate dehydrogenas
Organs: The animals were examined for macroscopic abnormalities and the brain, pituitary, thyroid, heart, liver, spleen, kidneys, adrenal glands, stomach, small intestine and caecum (with and without its contents) were weighed. Samples of these organs and of oesophagus, trachea lung, salivary grand, aorta, thymus, various lymph nodes, urinary bladder, colon rectum, pancreas, prestate, seminai vesicles, uterus. spinal cord, skeletal muscle, sciatic nerve, eye and Harderian gland and other
tissues that appeared abnormal were preserved in 16% buffered formalin. Paraffin-wax sections 5 µm thick were stained with haematoxylin and eosin.
Microscopic examination of the sections was confined to tissues taken at 18 wk from ali of the rats given 3% metatartaric acid and half of the animals in the 0.5% and control groups. - Sacrifice and pathology:
- At the end of treatment the animals were killed by exsanguination from the aorta under barbiturate anaesthesia, following an overnight period without food.
- Other examinations:
- no data
- Statistics:
- Student's t test was performed.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- One female rat in the group given 3% metatartaric acid died and no other deaths occurred during the treatment period and the animals appeared normal.
- Mortality:
- not specified
- Description (incidence):
- One female rat in the group given 3% metatartaric acid died and no other deaths occurred during the treatment period and the animals appeared normal.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Reductions in the rate of body-weight gain were statistically significant in male rats given 3% metatartaric acid but not in other groups
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- the intake of food was lower in the treated groups than in the controls.
the consequent reductions in the mean values for the whole period were dose related.
The mean intakes of metatartaric acid from the 0.1, 0.5 and 3% solutions were 0.08, 0.33 and 1.81 gfkg/day, respectively, for the male rats and 0.13, 0.52 and 2. 52 g/kg/day for the females - Food efficiency:
- not specified
- Description (incidence and severity):
- no data
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- the intake of water lower in the treated groups than in the controls.
the consequent reductions in the mean values for the whole period were dose related, those for water intake being statisticaliy significant at all dose levels and those for food intake at the two higher doses. - Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The haematological findings did not show any treatment-related effects (no treated group had both a low red cell count and a reduced packed cell volume).
The observed reduction from control values in the erythrocyte count at wk 18 in male rats on 0.5% metatartaric acid was not accompanied by a corresponding change in the
packed celi volume Similarly, the reduced packed cell volume in the females given 3% was not associated with a comparable change in the red cell count. The results of the serum analyses were similar in the treatment and control groups. - Clinical biochemistry findings:
- not specified
- Description (incidence and severity):
- no data
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- Cell excretion and urinary constituents were normal in the treated animals.
The results of the urine analyses compared with the controls. rats given 0.5 or 3% metatartaric acid for 2, 6 or 18 wk excreted less urine of higher specifìc gravity when deprived of water for 6hr or during the 2hr period following a water load.
In contrast, at wk 18, male rats given O.5 or 3% metatartaric acid excreted urine of lower specifìc gravity in larger volumes than control animals in the 16--20 hr after the water load. No comparable effects were seen in the females.
Cell excretion and urinary constituents were normal in the treated animals. - Behaviour (functional findings):
- not specified
- Description (incidence and severity):
- no data
- Immunological findings:
- not specified
- Description (incidence and severity):
- no data
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Some statistically significant differences from control values were observed in the recorded and/or relative weights of organs of rats given 3% metatartaric acid (kidney weight).
The recorded weights showed a lower value in males at wk 2 and an increase (P < 0.05) in females at wk 18, while the relative weights showed increases in females at wk 6 and 18 and in males at wk 18.
Similar findings were recorded for the relative weight of the empty caecum, with statistically significant increases in females at wk 6 and in males at wk 18. - Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- In the group of male rats given 3% metatartaric acid for 18 wk, polymorphonuclear infiltration of the submucosal layer of the stomach was observed in three animals and in two cases this was accompanied by hyperplasia of the non-glandular epithelium
- Neuropathological findings:
- not specified
- Description (incidence and severity):
- no data
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- slight fatty change and small foci of necrosis in the liver of some of the treated animals and in controls
- Histopathological findings: neoplastic:
- not specified
- Description (incidence and severity):
- no data
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- In the group of male rats given 3% metatartaric acid for 18 wk, polymorphonuclear infiltration of the submucosal layer of the stomach was observed in three animals and in two cases this was accompanied by hyperplasia of the non-glandular epithelium.
- Details on results:
- no data
Effect levels
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 0.5 other: %
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: a possible adverse effect on renal function
- Remarks on result:
- other: The results have equivocai nature, these findings are difficult to interpret, but the possibility of treatmentrelated adverse eftects on the kidney cannot be excluded
- Dose descriptor:
- NOAEL
- Effect level:
- 0.1 other: %
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Target system / organ toxicity
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 0.5 other: %
- System:
- urinary
- Organ:
- kidney
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Any other information on results incl. tables
The acidity of the compound in solution was sufficiently corrosive at 3% concentration to produce gastric irritation and probably rendered metatartaric acid solutions unpalatable, a likely explanation for the observed dose-related decrease in water consumption.
The consequent depression in body weight was statistically significant in male rats at the 3% dose level throughout the study.
The increased weights of this organ cannot be confidently interpreted as an adverse effect in the absence of any treatment-related pathological lesions, and most of the changes noted in the urine tests can be explained in terms of the reduced water intake.
However the apparent inability of males given 0.5 or 3% metatartaric acid to concentrate urine under conditions of prolonged dehydration may suggest some impairment of renal function. In view of their equivocai nature, these findings are difficult to interpret, but the possibility of treatmentrelated adverse eftects on the kidney cannot be excluded.
The increase in relative caecum weight at wk 6 in females and wk 18 in males on 3% metatartaric acid is of doubtful toxicological
significance and may bave resulted in part from the osmotic effect of the solution administered.
Applicant's summary and conclusion
- Conclusions:
- In 3.0% group were observed irritation of the gastric mucosa, reduced body-weight gain and an increase in relative kidney weight, a possible adverse effect on renal function.
In 0.5% group was observed a possible adverse effect on renal function.
The no-untoward-effect level (no observed adeverse effect level) in this study was 0.1% of metatartaric acid in drinking water. - Executive summary:
Groups of rats were given metatartaric acid in the drinking-water in concentrations of 0 (control), 0.1, 0.5 or 3.0% for 18wk.
No effects associated with treatment were seen in the results of the haematological examinations and serum analyses.
The treated ammals consumed less water and food than the controls, probably because of the unpalatability of the test material. Administration of the 3% solution was associated in males with a reduced growth rate, some impairment of urine-concentrating ability during prolonged water deprivation (also seen in males on 0.5%) and histopathological changes in the stomach indicative of an inftammatory response in the submucosal layer. Both sexes of the 3% group showed an increase in relative kidney weight, without accompanymg histopathological change. The no-untoward-effect level in this study was 0.1% metatartaric acid in the drinking-water. equtvalent to a mean daily intake of 80 mg/kg body weight in the males and 130 mg/kg in the females.
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