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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

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 02 December 2010 to 28 December 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Calcium tartrate
- EC Number:
- 221-621-5
- EC Name:
- Calcium tartrate
- Cas Number:
- 3164-34-9
- Molecular formula:
- C4H6O6.Ca
- IUPAC Name:
- Calcium carbonate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): TARTRATE DE CALCIUM
- Physical state: amber powder
- Analytical purity: 93.44%
- Lot/batch No.: CAMP 09-10
- Expiration date of the lot/batch: December 2011
- Storage conditions of test material: at room temperature, protected from light and humidity.
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: on the first day of the treatment period, the animals of the preliminary test were approximately 10 weeks old and the animals of the main test were approximately 9 weeks old
- Weight at study initiation: a mean body weight of 20.0 g +- 1.3 g
- Housing: housed individually in disposable crystal polystyrene cages (22.00 cm x 8.50 cm x 8.00 cm)
- Diet (e.g. ad libitum): free access to SSNIFF R/M-H pelleted maintenance diet
- Water (e.g. ad libitum): tap water (filtered using a 0.22 micron filter)
- Acclimation period: the animals were acclimated to the study conditions for at least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h (7:00 - 19:00).
IN-LIFE DATES: From: 02 December 2010 To: 28 December 2010.
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 0.5, 1, 2.5, 5 and 10%.
- No. of animals per dose:
- 4 animals per dose.
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: due to the unsatisfactory solubility of the test item in the first recommended vehicle (acetone/olive oil (4/1, v/v)),
dimethylformamide, methyl ethyl ketone, dimethylsulfoxide and 1% pluronic L92, propylene glycol was chosen as vehicle. A homogeneous
suspension was obtained under agitation at the maximum concentration of 10%.
- Irritation: no cutaneous reactions and no notable increase in ear thickness were observed at any of the tested concentrations.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: murine Local Lymph Node Assay (LLNA) based on the design adopted by ICCVAM (Interagency Coordination Committee on
the Validation of Alternative Methods, ICCVAM 1999) and ECETOC (Monograph No. 78 Skin sensitization Testing for the Purpose of Hazard
Identification and Risk Assessment, September 2000), with the addition of the evaluation of local irritation.
- Criteria used to consider a positive response: stimulation Indice SI >= 3.
TREATMENT PREPARATION AND ADMINISTRATION:
- Treatment preparation: the concentrations were expressed in % (w/v).
The test item was prepared at the chosen concentrations in PG. The dosage form preparations were homogenized by magnetic agitation.
The reference item was dissolved in AOO at the concentration of 25% (v/v).
- Administration: on days 1, 2 and 3, a dose-volume of 25 µL of the control or dosage form preparations was applied to the dorsal surface of both
ears, using an adjustable pipette fitted with a plastic tip.
In order to avoid licking and to ensure an optimized application of the test materials, the animals were placed under light isoflurane anesthezia during the administration.
No massage was performed but the tip was used to spread the preparation over the application sites. No rinsing was performed between each
application. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The mean cell viability in the vehicle group was higher than 70% and the threshold positive value of 3 for the SI was reached in the positive control
group. The study was therefore considered valid.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- DPM per group: Group 1: Vehicle: 504.00 Group 2: 0.5%: 488.00 Group 3: 1%: 355.00 Group 4: 2.5%: 701.00 Group 5: 5%: 330.00 Group 6: 10%: 424.00 DPM per node: Group 1: Vehicle: 63.00 Group 2: 0.5%: 61.00 Group 3: 1%: 44.38 Group 4: 2.5%: 87.63 Group 5: 5%: 41.25 Group 6: 10%: 53.00
- Key result
- Parameter:
- SI
- Value:
- 0.97
- Test group / Remarks:
- Group 2: 0.5%:
- Key result
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- Group 3: 1%
- Key result
- Parameter:
- SI
- Value:
- 1.39
- Test group / Remarks:
- Group 4: 2.5%
- Key result
- Parameter:
- SI
- Value:
- 0.65
- Test group / Remarks:
- Group 5: 5%
- Key result
- Parameter:
- SI
- Value:
- 0.84
- Test group / Remarks:
- Group 6: 10%
Any other information on results incl. tables
Clinical signs and mortality
Neither mortality nor clinical signs were observed during the study.
Body weight
The body weight change of treated animals was similar to that of control animals.
Local irritation
No cutaneous reactions and no notable increase in ear thickness were observed at any of the tested concentrations.
Proliferation assay
The mean cell viability in the vehicle group was higher than 70% and the threshold positive value of 3 for the SI was reached in the positive control group. The study was therefore considered valid.
No notable lymphoproliferation was noted with the test item at any tested concentrations.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test item, TARTRATE DE CALCIUM, did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay.
- Executive summary:
The objective of this study was to evaluate the potential of the test item, TARTRATE DE CALCIUM, to induce delayed contact hypersensitivity using the murine Local Lymph Node Assay (LLNA). Evaluation of local irritation was also carried out in parallel.
This study was conducted in compliance with the principles of Good Laboratory Practice.
Methods
A preliminary test was first performed in order to define the concentrations of test item to be used in the main test.
In the main test, 28 female CBA/J mice were allocated to 7 groups:
. five treated groups of four animals receiving the test item at the concentration of 0.5, 1, 2.5, 5 or 10% in propylene glycol (vehicle),
. one negative control group of four animals receiving the vehicle,
. one positive control group of four animals receiving the reference item, alpha-hexylcinnamaldehyde (HCA), a moderate sensitizer, at the concentration of 25% in a mixture acetone/olive oil (4/1; v/v).
During the induction phase, the test item, vehicle or reference item was applied over the ears (25 µL per ear) for 3 consecutive days (days 1, 2 and 3). After 2 days of resting, the proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of tritiated methyl thymidine (day 6). The obtained values were used to calculate Stimulation Indices (SI).
The irritant potential of the test item was assessed in parallel by measurement of ear thickness on days 1, 2, 3 and 6.
Results
Following the solubility assay, propylene glycol was chosen as vehicle. A homogeneous suspension was obtained under agitation at the maximum concentration of 10%.
Consequently, the concentrations selected for the preliminary test were 1, 2.5, 5 and 10%.
Since the test item was non-irritant in the preliminary test, the highest concentration retained for the main test was the maximal practicable concentration (10%).
Neither mortality nor clinical signs were observed during the study.
The body weight change of treated animals was similar to that of control animals.
No cutaneous reactions and no notable increase in ear thickness were observed at any of the tested concentrations.
As all acceptance criteria were met, this experiment was therefore considered valid.
The results are presented in the following table:
Treatment
Concentration
(%)
Irritation level
Stimulation Index
(SI)
Test item
0.5
non-irritant
0.97
Test item
1
non-irritant
0.70
Test item
2.5
non-irritant
1.39
Test item
5
non-irritant
0.65
Test item
10
non-irritant
0.84
HCA
25
-
12.40
No notable lymphoproliferation was noted with the test item at any tested concentrations.
Conclusion
Under the experimental conditions of this study, the test item, TARTRATE DE CALCIUM, did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay.
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