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EC number: 942-582-7 | CAS number: -
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 7 April 2017 to 2 June 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- Relative humidity value (28%) outside the expected range of 30-70% was recorded at one time. This deviation was considered to have no impact on the outcome of the study.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- calcium dipotassium disodium trisulfate
- Molecular formula:
- SO42-, K+, Na+, Ca2+
- IUPAC Name:
- calcium dipotassium disodium trisulfate
- Test material form:
- solid
- Remarks:
- light to beige solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: EXP LIberica Lote Al16503047
- Expiration date of the lot/batch: 30 November 2019
- Purity test date: 1 February 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Controlled room temperature (15-25 deg Celsius, below 70% relative humidity) protected from light and humidity
- Stability under test conditions: not applicable
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item was ground to a fine powder before the application. Sufficient water was used to dampen the test material to ensure good contact with the skin.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Young adult rats
- Weight at study initiation: Between 219 g and 266 g
- Fasting period before study: No
- Housing: Type II. polypropylene/polycarbonate
- Diet (e.g. ad libitum): ssniff® SM R/M "Autoclavable complete diet for rats and mice breeding and maintenance", ad libitum
- Water (e.g. ad libitum): tap water from the municipal supply, as for human consumption from a 500 mL bottle, ad libitum
- Acclimation period: 5 Days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.4–24.7°C
- Humidity (%): 28–61%
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
IN-LIFE DATES: From: 6 April 2017 To: 25 April 2017
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back of the animals
- % coverage: approximately 10% area of the total body surface
- Type of wrap if used: Sterile gauze pads maintened with adhesive hypoallergenic plaster.The entire trunk was wrapped with semi occlusive plastic wrap for 24 hours
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing with water at body temperature
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): not applicable
- Constant volume or concentration used: adjusted to animal bodyweight
- For solids, paste formed: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose were used
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed on the day of treatment at 1 and 5 hours after application of the test item and once each day for 14 days thereafter. Observations included the skin and fur, eyes and mucous membranes, the respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. The body weights were recorded on Day 0 (before the test item administration) and on Days 7 and 14 (before necropsy). Adverse skin reactions at the site of application were recorded daily following the removal of the dressing.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The test item did not cause mortality at the dose level of 2000 mg/kg bw.
- Clinical signs:
- other: There were no systemic clinical signs noted in any animal throughout the study
- Gross pathology:
- There was no evidence of any gross macroscopic changes at a dose level of 2000 mg/kg bw.
- Other findings:
- No adverse local dermal signs were observed after treatment with the test item or during the 14 days observation period.
Any other information on results incl. tables
TABLE 1: Clinical Observations
DOSE LEVEL: 2000mg/kg bw SEX:MALE
Cage No. |
Animal No. |
Observations |
Observation days |
Frequency |
|||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||
1h |
5h |
||||||||||||||||||
1 |
7970 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
2 |
7971 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
3 |
7972 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
4 |
7973 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
5 |
7974 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
DOSE LEVEL: 2000mg/kg bw SEX:FEMALE
Cage No. |
Animal No. |
Observations |
Observation days |
Frequency |
|||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||
1h |
5h |
||||||||||||||||||
6 |
7985 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
7 |
7986 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
8 |
7987 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
9 |
7988 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
10 |
7989 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
Remarks: += present
h =hour(s) Treatment day = Day0
Frequency of observation = number of occurence of observation / total number of observations
TABLE 2: Body Weight Data
DOSE LEVEL: 2000mg/kgbw SEX:MALE
Cage No. |
Animal No. |
Body weight (g) Days |
Body Weight Gain (g) |
||||
0 |
7 |
14 |
0-7 |
7-14 |
0-14 |
||
1 |
7970 |
253 |
310 |
369 |
57 |
59 |
116 |
2 |
7971 |
238 |
272 |
307 |
34 |
35 |
69 |
3 |
7972 |
242 |
305 |
361 |
63 |
56 |
119 |
4 |
7973 |
241 |
285 |
339 |
44 |
54 |
98 |
5 |
7974 |
234 |
273 |
313 |
39 |
40 |
79 |
Mean: |
241.6 |
289.0 |
337.8 |
47.4 |
48.8 |
96.2 |
|
Standard deviation: |
7.1 |
17.7 |
27.7 |
12.2 |
10.6 |
22.1 |
DOSE LEVEL: 2000mg/kgbw SEX:FEMALE
Cage No. |
Animal No. |
Body weight (g) Days |
Body Weight Gain (g) |
||||
0 |
7 |
14 |
0-7 |
7-14 |
0-14 |
||
6 |
7985 |
264 |
276 |
298 |
12 |
22 |
34 |
7 |
7986 |
266 |
272 |
277 |
6 |
5 |
11 |
8 |
7987 |
256 |
270 |
279 |
14 |
9 |
23 |
9 |
7988 |
234 |
238 |
246 |
4 |
8 |
12 |
10 |
7989 |
219 |
257 |
260 |
38 |
3 |
41 |
Mean: |
247.8 |
262.6 |
272.0 |
14.8 |
9.4 |
24.2 |
|
Standard deviation: |
20.5 |
15.5 |
19.8 |
13.6 |
7.4 |
13.3 |
TABLE 3: Macroscopic Findings
DOSE LEVEL: 2000mg/kgbw SEX:MALE
Cage No. |
Animal No. |
Necropsy Date/ Necropsy Day |
External Observations |
Internal Observations |
Organ/ Tissue |
1 |
7970 |
25 April 2017 Day 14 |
No external observations |
No internal observations |
Not applicable |
2 |
7971 |
25 April 2017 Day 14 |
No external observations |
No internal observations |
Not applicable |
3 |
7972 |
25 April 2017 Day 14 |
No external observations |
No internal observations |
Not applicable |
4 |
7973 |
25 April 2017 Day 14 |
No external observations |
No internal observations |
Not applicable |
5 |
7974 |
25 April 2017 Day 14 |
No external observations |
No internal observations |
Not applicable |
DOSE LEVEL: 2000mg/kgbw SEX:FEMALE
Cage No. |
Animal No. |
Necropsy Date/ Necropsy Day |
External Observations |
Internal Observations |
Organ/ Tissue |
6 |
7985 |
25 April 2017 Day 14 |
No external observations |
No internal observations |
Not applicable |
7 |
7986 |
25 April 2017 Day 14 |
No external observations |
No internal observations |
Not applicable |
8 |
7987 |
25 April 2017 Day 14 |
No external observations |
No internal observations |
Not applicable |
9 |
7988 |
25 April 2017 Day 14 |
No external observations |
No internal observations |
Not applicable |
10 |
7989 |
25 April 2017 Day 14 |
No external observations |
No internal observations |
Not applicable |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test item Sulfates of potassium, sodium and calcium, by-product from fermentation was found to be greater than 2000 mg/kg body weight in male and female Crl:WI rats. According to the CLP criteria, the test item was not classified for Acute Dermal Hazard.
- Executive summary:
The purpose of this GLP compliant study was to assess the potential Acute Toxicity of the test substance Sulfates of potassium, sodium and calcium, by-product from fermentation, when applied dermally on Wistar rats, perfomed according to OECD 402 method.
A limit test was carried out at 2000 mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was powdered and was applied as a single dermal 24- hour exposure followed by a 14-day observation period.
Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14 (before necropsy). Gross macroscopic examination was performed on all animals at the end of the 2-week observation period (Day 14).
Test item did not cause mortality at the dose level of 2000 mg/kg bw.
There were no systemic clinical signs noted in any animal throughout the study.
No adverse local dermal signs were observed after treatment with the test item or during the 14 days observation period.
There were no treatment related effects on body weight or body weight gain during the observation period.
There was no evidence of any macroscopic changes at a dose level of 2000 mg/kg bw.
The acute dermal median lethal dose (LD50) of the test item Sulfates of potassium, sodium and calcium, by-product from fermentation was found to be greater than 2000 mg/kg body weight in male and female Crl:WI rats. According to the CLP criteria, the test item was not classified for Acute Dermal Hazard.
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