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EC number: 206-156-8 | CAS number: 304-59-6
- 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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1973
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Justification for type of information:
- Although no GLP declaration accompanies the original 1973 report for this study, the level of detail contained threin, the fact that it has been sponsored and reviwed by the US
FDA and that it is the key development study for the consideration of tartaric acid as GRAS, warrants its classification a Klimisch 1.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- developmental toxicity
- Type of information:
- other: publication
- Adequacy of study:
- key study
- Study period:
- 1973
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Justification for type of information:
- Although no GLP declaration accompanies the original 1973 report for this study, the level of detail contained threin, the fact that it has been sponsored and reviwed by the US
FDA and that it is the key development study for the consideration of tartaric acid as GRAS, warrants its classification a Klimisch 1. - Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.31 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- no
- Specific details on test material used for the study:
- L(+) Tartaric acid. Reported as a fine white crystalline material.
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- Test animals: Virgin adult female albino rats (Wistar derived stock).
Housed individually in mexh bottom cages
Environmental conditions not stated but report indicates "temperature and humidity controlled quarters"
Food and water access: ad libitum
Average weights of pregnant females at day cero (at start of gestation) is 205-212 g. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- 1 ml / kg bw was administered on each dosing, containing the appropriate concentration to achieve the desired dose.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No information on analytical verificatipn provided.
- Details on mating procedure:
- Females mated with youn adult males of the same species.
Observation of vaginal sperm plug is considered day 0 of gestation. - Duration of treatment / exposure:
- Dosage by oral intubation (gavage) of test substance dissolved in water.
Dosing takes place daily between day 6 and trough to day 15 of gestation. - Frequency of treatment:
- Daily
- Duration of test:
- 10 days
- Dose / conc.:
- 1.81 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 8.41 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 39.1 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 181 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 22 - 25 females were mated per dose group and control. Of these a total of between 19 and 24 (average 21) animals survived at term.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Body weights were recoirded at 0, 6, 11, 15 and 20 days of gestation.
All animals were observed daily for appearance and hehaviour, with particular attention to food consumption and weight.
On day 20 all dams were subjected to Caesarean section under surgical anaesthesia and the numbers of implantation sites, resorption sites and live and dead foetuses was recorded. Body weights of live pups were also recorded.
The urogenital tract of each dam was examined in detail for anatomical abnormality.
All foetuses were examined grossly for the presence of external congenital anomalies. One third of the foetuses of each litter were subjected to detailed visceral examination employing the Wilson technique.
The remaining two-thirds were cleared in potassium hydroxide, stained with alizarin red S dye and examined for skeletal defects.
A positive control was used in the study. A group of 22 pregnant animals was treated with 250.0 mg/kg aspirin. This control resulted in a high incidence of encephalomyolecele, meningoencephalocele and, to a lesser extent exophthalmos, hydrocephalus and other abnormalities. - Maternal examinations:
- All animals were observed daily for appearance and hehaviour, with particular attention to food consumption and weight.
- Ovaries and uterine content:
- The urogenital tract of each dam was examined in detail for anatomical abnormality.
- Fetal examinations:
- All foetuses were examined grossly for the presence of external congenital anomalies. One third of the foetuses of each litter were subjected to detailed visceral examination employing the Wilson technique.
The remaining two-thirds were cleared in potassium hydroxide, stained with alizarin red S dye and examined for skeletal defects. - Dose descriptor:
- NOAEL
- Effect level:
- > 181 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- clinical signs
- dead fetuses
- food consumption and compound intake
- gross pathology
- number of abortions
- Remarks on result:
- not determinable
- Abnormalities:
- no effects observed
- Developmental effects observed:
- no
- Lowest effective dose / conc.:
- 181 mg/kg bw/day (nominal)
- Conclusions:
- The administration of up to 181 mg/kg bw of L(+) tartaric acid to groups of 20 pregnant female rats for 10 consecutive days starting on day 6 after gestation had no clear discernible effect on nidation or on maternal or foetal survival. The number of anomalies seen either in soft or skeletal tissues in the test groups did not differ from those occuring spontaneously in the control group.It is concluded that tartaric acid is not a developmental toxicant to the rat.
- Executive summary:
The administration of up to 181 mg/kg bw of L(+) tartaric acid to groups of 20 pregnant female rats for 10 consecutive days starting on
day 6 after gestation had no clear discernible effect on nidation or on maternal or foetal survival. The number of anomalies seen either in
soft or skeletal tissues in the test groups did not differ from those occuring spontaneously in the control group.It is concluded that tartaric
acid is not a developmental toxicant to the rat.
This test, performed essentially according to EU test method B.31 (although no test method is not quoted) is considered of full relevance
to the reference substance Potassium Sodium Tartrate, as the salt dissociates fully at physiological pH.
TABLE 1. FATE
SUMMARY (RATS)
GROUP | MATERIAL | DOSE** | TOTAL | SURVIVING AT TERM | ||
(mg/Kg) | Mated | Pregnant | Total | Pregnant(1) | ||
271 | Sham | 0 | 25 | 22 | 25 | 22 |
272 | Aspirin* | 250 | 22 | 21 | 22 | 21 |
273 | FDA 71 -55 | 1.81 | 25 | 19 | 25 | 19 |
274 | FDA 71 -55 | 8.41 | 24 | 19 | 24 | 19 |
275 | FDA 71 -55 | 39.1 | 25 | 23 | 25 | 23 |
276 | FDA 71 -55 | 181.1 | 25 | 24 | 25 | 24 |
* Positive Control: 250,0 mg/kg
** Administered as a water solution (See Appendix I)
(1) Includes all dams examined at term
TABLE 2: REPRODUCTION DATA (RATS)
GROUP | 271 | 272 | 273 | 274 | 275 | 276 |
DOSE (mg/Kg) | Sham | Aspirin** | 1.81 | 8.41 | 39.1 | 181 |
Pregnancies | ||||||
Total No. | 22 | 21 | 19 | 19 | 23 | 24 |
Died or aborted (before Day 17) | 0 | 0 | 0 | 0 | 0 | 0 |
To Term (on day 17) | 22 | 21 | 19 | 19 | 23 | 24 |
Live Litters | ||||||
Total No. | 22 | 20 | 19 | 19 | 23 | 24 |
Implant Sites | ||||||
Total No. | 251 | 225 | 225 | 235 | 274 | 273 |
Average/dam* | 11,4 | 10,7 | 11.8 | 12.4 | 11.9 | 11.4 |
Resorptions | ||||||
Total No. | 6 | 27 | 3 | 4 | 2 | 4 |
Drams with all sites resorbed | 4 | 9 | 2 | 3 | 2 | 3 |
Drams with all sites resorbed | - | 1 | - | - | - | - |
Per cent partial resorptions | - | 4.76 | - | - | - | - |
Live Fetuses | ||||||
Total No. | 245 | 198 | 222 | 231 | 272 | 269 |
Average/dam* | 11.1 | 9.43 | 11.7 | 12.2 | 11.8 | 11.2 |
Sex ratio (M/F) | 0.9 | 1.06 | 1 | 0.85 | 1.11 | 1.05 |
Dead fetuses | ||||||
Total* | ||||||
Drams with 1 or more dead | - | - | - | - | - | - |
Drams with all dead | - | - | - | - | - | - |
Per cent patrial dead | - | - | - | - | - | - |
Per cent all dead | - | - | - | - | - | - |
Average Fetus Weight, g | 9.39 | 2.68 | 3.97 | 3.77 | 3.83 | 3.97 |
*Includes only those dams examined al term | ||||||
**Positive Control: 150.0 mg/Kg |
TABLE 3: SUMMARY OF SKELETAL FINDINGS* (RATS)
GROUP No. | 271 | 272 | 273 | 274 | 275 | 276 |
DOSE (mg/Kg) | Sham | Aspirin** | 1.81 | 8.41 | 39.1 | 181 |
Finding | ||||||
Live Fetuses Examined (at term) | 173/22 | 137/20 | 152/19 | 161/19 | 186/23 | 188/24 |
Sternebrae | ||||||
Incomplete oss. | 82/20 | 91/20 | 78/15 | 42/13 | 52/14 | 46/15 |
Scrambled | ||||||
Bispartite | 3/3 | 5/4 | 1/1 | 1/1 | 1/1 | 1/1 |
Fused | - | - | - | - | 1/1 | - |
Extra | - | - | 1/1 | - | - | - |
Missing | 2/2 | 86/19 | 7/4 | 5/2 | 8/ 5 | 6/4 |
Other | - | - | - | - | - | - |
Ribs | - | - | - | - | - | - |
Incomplete oss | - | 1/1 | - | - | 3/2 | - |
Fused/split | - | 1/1 | - | - | - | - |
Wavy | 1/1 | 46/16 | 22/7 | 13/7 | 18/10 | 18/9 |
Less than 12 | 2/2 | 2/1 | - | - | - | - |
Les Than 13 | 7/3 | 91/19 | - | 1/1 | - | 5/5 |
Other | - | - | - | - | - | - |
Vertebrae | ||||||
Incomplete oss. | - | 101/19 | 2/2 | 8/6 | 5/4 | 10/7 |
Srambied | - | - | - | - | - | - |
Fused | - | - | - | - | - | - |
Extra ctrs. Oss | - | - | - | - | - | - |
Scoliosis | 1/1 | - | - | - | - | - |
Tail defects | - | - | - | - | - | - |
Other | - | - | - | - | - | - |
Skull | ||||||
Incomplete closure | 26/14 | 47/16 | 49/14 | 19/9 | 40/17 | 32/16 |
Missing | - | 6/2 | - | - | - | - |
Extra | - | - | - | - | - |
- |
Miscellaneous | ||||||
Hyoid; missing | 15/8 | 65/18 | 17/9 | 19/10 | 15/10 | 31/13 |
Hyoid; reduced | 20/9 | 19/10 | 22/9 | 17/8 | 29/15 | 13/10 |
* Numerator = Number of fetuses affected; Denominator = number of litters affected
** Possitive control: 150,0 mg/kg
TABLE 3-A: SUMMARY OF SOFT TISSUE ABNORMALITIES (RATS)
GROUP | MATERIAL | DOSE LEVEL | DAM | NUMBER OF | DESCRIPTION |
|
|
|
mg/Kg |
|
PUPS |
|
|
272 |
Apirin* |
250 |
A 4882 |
6 |
Encephalomyelocele |
|
|
|
|
|
2 |
Exophthalmos |
|
|
|
|
|
1 |
Gastroschisis |
|
|
|
|
A4888 |
1 |
Meningeoncephalocele |
|
|
|
|
A4892 |
1 |
Encephalomyelocele |
|
|
|
|
|
3 |
Meningeoncephalocele |
|
|
|
|
A4899 |
1 |
Hydrocephalus |
|
|
|
|
|
1 |
Encephalomyelocele |
|
273 |
FDA 71 -55 |
1.81 |
I 4006 |
1 |
Subcutaneous hematoma |
|
|
|
|
I 4009 |
1 |
Umbilical hernia |
|
275 | FDA 71 -55 | 39.1 | I 4064 | 1 | Umbilical hernia |
*Positive control: 250,0 mg/kg
TABLE 4: AVERAGE BODY WEIGHTS* (RATS)
GROUP | MATERIAL | DOSE LEVEL | DAY | ||||
(mg/Kg) | 0 | 6 | 11 | 15 | 20** | ||
271 | Sham | 0 | 212 | 232 | 250 | 268 | 331 (22) |
272 | Aspirin*** | 250 | 212 | 282 | 246 | 265 | 215 (21) |
273 | FDA 71 -55 | 1.81 | 213 | 234 | 253 | 274 | 340 (19) |
274 | FDA 71 -55 | 8.41 | 211 | 232 | 250 | 272 | 345 (19) |
275 | FDA 71 -55 | 39.1 | 205 | 225 | 243 | 266 | 333 (23) |
276 | FDA 71 -55 | 181 | 218 | 235 | 256 | 278 | 345 (24) |
* Of pregnant dams
**Number of surviving dams in parentheses (c.f. Table 1)
*** Positive control: 250,0 mg/kg
Data source
Materials and methods
Test material
- Reference substance name:
- Potassium sodium tartrate
- EC Number:
- 206-156-8
- EC Name:
- Potassium sodium tartrate
- Cas Number:
- 304-59-6
- Molecular formula:
- C4H6O6.K.Na
- IUPAC Name:
- potassium sodium tartrate
- Test material form:
- solid: crystalline
1
Administration / exposure
- Duration of treatment / exposure:
- .
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- > 181 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- dead fetuses
- food consumption and compound intake
- gross pathology
- number of abortions
Results (fetuses)
Effect levels (fetuses)
- Remarks on result:
- not determinable
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
- Lowest effective dose / conc.:
- 181 mg/kg bw/day (nominal)
Any other information on results incl. tables
TABLE 1. FATE
SUMMARY (RATS)
GROUP | MATERIAL | DOSE** | TOTAL | SURVIVING AT TERM | ||
(mg/Kg) | Mated | Pregnant | Total | Pregnant(1) | ||
271 | Sham | 0 | 25 | 22 | 25 | 22 |
272 | Aspirin* | 250 | 22 | 21 | 22 | 21 |
273 | FDA 71 -55 | 1.81 | 25 | 19 | 25 | 19 |
274 | FDA 71 -55 | 8.41 | 24 | 19 | 24 | 19 |
275 | FDA 71 -55 | 39.1 | 25 | 23 | 25 | 23 |
276 | FDA 71 -55 | 181.1 | 25 | 24 | 25 | 24 |
* Positive Control: 250,0 mg/kg
** Administered as a water solution (See Appendix I)
(1) Includes all dams examined at term
TABLE 2: REPRODUCTION DATA (RATS)
GROUP | 271 | 272 | 273 | 274 | 275 | 276 |
DOSE (mg/Kg) | Sham | Aspirin** | 1.81 | 8.41 | 39.1 | 181 |
Pregnancies | ||||||
Total No. | 22 | 21 | 19 | 19 | 23 | 24 |
Died or aborted (before Day 17) | 0 | 0 | 0 | 0 | 0 | 0 |
To Term (on day 17) | 22 | 21 | 19 | 19 | 23 | 24 |
Live Litters | ||||||
Total No. | 22 | 20 | 19 | 19 | 23 | 24 |
Implant Sites | ||||||
Total No. | 251 | 225 | 225 | 235 | 274 | 273 |
Average/dam* | 11,4 | 10,7 | 11.8 | 12.4 | 11.9 | 11.4 |
Resorptions | ||||||
Total No. | 6 | 27 | 3 | 4 | 2 | 4 |
Drams with all sites resorbed | 4 | 9 | 2 | 3 | 2 | 3 |
Drams with all sites resorbed | - | 1 | - | - | - | - |
Per cent partial resorptions | - | 4.76 | - | - | - | - |
Live Fetuses | ||||||
Total No. | 245 | 198 | 222 | 231 | 272 | 269 |
Average/dam* | 11.1 | 9.43 | 11.7 | 12.2 | 11.8 | 11.2 |
Sex ratio (M/F) | 0.9 | 1.06 | 1 | 0.85 | 1.11 | 1.05 |
Dead fetuses | ||||||
Total* | ||||||
Drams with 1 or more dead | - | - | - | - | - | - |
Drams with all dead | - | - | - | - | - | - |
Per cent patrial dead | - | - | - | - | - | - |
Per cent all dead | - | - | - | - | - | - |
Average Fetus Weight, g | 9.39 | 2.68 | 3.97 | 3.77 | 3.83 | 3.97 |
*Includes only those dams examined al term | ||||||
**Positive Control: 150.0 mg/Kg |
TABLE 3: SUMMARY OF SKELETAL FINDINGS* (RATS)
GROUP No. | 271 | 272 | 273 | 274 | 275 | 276 |
DOSE (mg/Kg) | Sham | Aspirin** | 1.81 | 8.41 | 39.1 | 181 |
Finding | ||||||
Live Fetuses Examined (at term) | 173/22 | 137/20 | 152/19 | 161/19 | 186/23 | 188/24 |
Sternebrae | ||||||
Incomplete oss. | 82/20 | 91/20 | 78/15 | 42/13 | 52/14 | 46/15 |
Scrambled | ||||||
Bispartite | 3/3 | 5/4 | 1/1 | 1/1 | 1/1 | 1/1 |
Fused | - | - | - | - | 1/1 | - |
Extra | - | - | 1/1 | - | - | - |
Missing | 2/2 | 86/19 | 7/4 | 5/2 | 8/ 5 | 6/4 |
Other | - | - | - | - | - | - |
Ribs | - | - | - | - | - | - |
Incomplete oss | - | 1/1 | - | - | 3/2 | - |
Fused/split | - | 1/1 | - | - | - | - |
Wavy | 1/1 | 46/16 | 22/7 | 13/7 | 18/10 | 18/9 |
Less than 12 | 2/2 | 2/1 | - | - | - | - |
Les Than 13 | 7/3 | 91/19 | - | 1/1 | - | 5/5 |
Other | - | - | - | - | - | - |
Vertebrae | ||||||
Incomplete oss. | - | 101/19 | 2/2 | 8/6 | 5/4 | 10/7 |
Srambied | - | - | - | - | - | - |
Fused | - | - | - | - | - | - |
Extra ctrs. Oss | - | - | - | - | - | - |
Scoliosis | 1/1 | - | - | - | - | - |
Tail defects | - | - | - | - | - | - |
Other | - | - | - | - | - | - |
Skull | ||||||
Incomplete closure | 26/14 | 47/16 | 49/14 | 19/9 | 40/17 | 32/16 |
Missing | - | 6/2 | - | - | - | - |
Extra | - | - | - | - | - |
- |
Miscellaneous | ||||||
Hyoid; missing | 15/8 | 65/18 | 17/9 | 19/10 | 15/10 | 31/13 |
Hyoid; reduced | 20/9 | 19/10 | 22/9 | 17/8 | 29/15 | 13/10 |
* Numerator = Number of fetuses affected; Denominator = number of litters affected
** Possitive control: 150,0 mg/kg
TABLE 3-A: SUMMARY OF SOFT TISSUE ABNORMALITIES (RATS)
GROUP | MATERIAL | DOSE LEVEL | DAM | NUMBER OF | DESCRIPTION |
|
|
|
mg/Kg |
|
PUPS |
|
|
272 |
Apirin* |
250 |
A 4882 |
6 |
Encephalomyelocele |
|
|
|
|
|
2 |
Exophthalmos |
|
|
|
|
|
1 |
Gastroschisis |
|
|
|
|
A4888 |
1 |
Meningeoncephalocele |
|
|
|
|
A4892 |
1 |
Encephalomyelocele |
|
|
|
|
|
3 |
Meningeoncephalocele |
|
|
|
|
A4899 |
1 |
Hydrocephalus |
|
|
|
|
|
1 |
Encephalomyelocele |
|
273 |
FDA 71 -55 |
1.81 |
I 4006 |
1 |
Subcutaneous hematoma |
|
|
|
|
I 4009 |
1 |
Umbilical hernia |
|
275 | FDA 71 -55 | 39.1 | I 4064 | 1 | Umbilical hernia |
*Positive control: 250,0 mg/kg
TABLE 4: AVERAGE BODY WEIGHTS* (RATS)
GROUP | MATERIAL | DOSE LEVEL | DAY | ||||
(mg/Kg) | 0 | 6 | 11 | 15 | 20** | ||
271 | Sham | 0 | 212 | 232 | 250 | 268 | 331 (22) |
272 | Aspirin*** | 250 | 212 | 282 | 246 | 265 | 215 (21) |
273 | FDA 71 -55 | 1.81 | 213 | 234 | 253 | 274 | 340 (19) |
274 | FDA 71 -55 | 8.41 | 211 | 232 | 250 | 272 | 345 (19) |
275 | FDA 71 -55 | 39.1 | 205 | 225 | 243 | 266 | 333 (23) |
276 | FDA 71 -55 | 181 | 218 | 235 | 256 | 278 | 345 (24) |
* Of pregnant dams
**Number of surviving dams in parentheses (c.f. Table 1)
*** Positive control: 250,0 mg/kg
Applicant's summary and conclusion
- Conclusions:
- The administration of up to 181 mg/kg bw of L(+) tartaric acid to groups of 20 pregnant female rats for 10 consecutive days starting on day 6 after gestation had no clear discernible effect on nidation or on maternal or foetal survival. The number of anomalies seen either in soft or skeletal tissues in the test groups did not differ from those occuring spontaneously in the control group.It is concluded that tartaric acid is not a developmental toxicant to the rat.
- Executive summary:
The administration of up to 181 mg/kg bw of L(+) tartaric acid to groups of 20 pregnant female rats for 10 consecutive days starting on
day 6 after gestation had no clear discernible effect on nidation or on maternal or foetal survival. The number of anomalies seen either in
soft or skeletal tissues in the test groups did not differ from those occuring spontaneously in the control group.It is concluded that tartaric
acid is not a developmental toxicant to the rat.
This test, performed essentially according to EU test method B.31 (although no test method is not quoted) is considered of full relevance
to the reference substance Potassium Sodium Tartrate, as the salt dissociates fully at physiological pH.
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.

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