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EC number: 225-403-0 | CAS number: 4826-71-5
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 10, 2017 - May 24, 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- calcium tetrahydrate chloride [2-(trimethylazaniumyl)ethyl] phosphate
- Cas Number:
- 72556-74-2
- Molecular formula:
- C5H21CaClNO8P
- IUPAC Name:
- calcium tetrahydrate chloride [2-(trimethylazaniumyl)ethyl] phosphate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- SPF Caw
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: JANVIER LABS (53940 Legenest St. Isle - France)
- Females nulliparous and non-pregnant: yes
- Age at study initiation: males: 7 weeks old; females: 8 weeks old
- Weight at study initiation: males: 257.4 ± 9.1; females: 214.2 ± 5.7
- Fasting period before study: overnight
- Housing: Groups of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry.
- Diet (e.g. ad libitum): Foodstuff (ENVIGO -2016) ad libitum
- Water (e.g. ad libitum): Tap-water from public distribution system ad libitum. Microbiological and chemical analyses of the water were carried out once every six months by Bureau Veritas- Eurofins (France)
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19ºC - 25ºC. A temperature lower than 19ºC was registered on 18 of May 2017. The minimum value measured was 27ºC.
- Humidity (%): 30% - 70%. A relative humidity lower than 30% was registered on 10, 13, 16, 17, 23 and 24 of May 2017. The minimum value measured was 18%.
- Air changes (per hr): 10 changes/hour
- Photoperiod (hrs dark / hrs light): 12 h light (7 - 19 h) / 12 h darkness
IN-LIFE DATES: From: 10 May 2017 To: 24 May 2017
Administration / exposure
- Type of coverage:
- other: non-occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk of the animal
- % coverage: 10% of the body surfade area
- Type of wrap if used: non-occlusive porous gauze dressing (50 mm x 50 mm non woven swab, 4-layer patch, MEDISTOCK) secured in position with a strip of surgical adhesive tape (50 mm wides hypoallergenic micropore TM adhesive tape from 3M)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after removing the gauze dressings, the treated area was rinsed with destilled water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg bw
- Concentration (if solution): 0.2 g/ml
- Constant volume or concentration used: yes
- For solids, paste formed: no
VEHICLE
- Amount(s) applied (volume or weight with unit): 10 mL/Kg bw - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Remarks:
- Study No. TAD-2016-004 (see "Other information on results").
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations, the animals were weighed on day 0 (just before administering the test item) then on day 2, day 7, and day 14.
- Necropsy of survivors performed: yes.
At the end of the study, the animals were euthanized with sodium pentobarbital (Dolethal®). Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. No organ was removed and preserved in view to microscopic examinations.
Gross pathology: On D14, the animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels. Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. Parameters examined: Oesophagus, Stomach, Duodenum, Jejunum, Ileon, Caecum, Colon, Rectum, Spleen, Liver, Thymus, Trachea, Lungs, Heart, Kidneys, Urinary Bladder, Ovaries, Uterus, Treatment Area, Adrenals and Pancreas.
- Other examinations performed:
Clinical signs: Spontaneous activity, Preyer's reflex (noise), Respiratory rate, Convulsions, Tremors, Body temperature, Muscle tone, Palpebral opening, Pupil appearance, Salivation, Lachrymation, Righting reflex, Treatment site, Mortality.
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:
- No mortality occurred during the study.
- Clinical signs:
- Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed.
- Body weight:
- The body weight evolution of the animals remained normal throughout the study.
- Gross pathology:
- The macroscopic examination of the animals at the end of the study did not reveal treatment-related changes.
Any other information on results incl. tables
Table 1. Test item at 2000 mg/kg bw. Body weight and weight gain in grams.
MALES |
D0 |
D2 |
D2-D0 |
D7 |
D7-D0 |
D14 |
D14-D0 |
||||
Rm 1455 |
261 |
266 |
5 |
310 |
49 |
354 |
93 |
||||
Rm 1456 |
255 |
261 |
6 |
313 |
58 |
360 |
105 |
||||
Rm 1457 |
258 |
262 |
4 |
311 |
53 |
348 |
90 |
||||
Rm 1458 |
244 |
256 |
12 |
298 |
54 |
344 |
100 |
||||
Rm 1459 |
269 |
280 |
11 |
318 |
49 |
369 |
100 |
||||
MEAN |
257.4 |
265.0 |
7.6 |
310.0 |
52.6 |
355.0 |
97.6 |
||||
Standard deviation |
9.1 |
9.1 |
3.6 |
7.4 |
3.8 |
9.9 |
6.0 |
||||
FEMALES |
D0 |
D2 |
D2-D0 |
D7 |
D7-D0 |
D14 |
D14-D0 |
||||
Rf 1460 |
211 |
216 |
5 |
231 |
20 |
300 |
89 |
||||
Rf1461 |
220 |
218 |
-2 |
238 |
18 |
269 |
49 |
||||
Rf 1462 |
218 |
219 |
1 |
240 |
22 |
264 |
46 |
||||
Rf 1463 |
206 |
212 |
6 |
216 |
10 |
248 |
42 |
||||
Rf 1464 |
216 |
228 |
12 |
239 |
23 |
256 |
40 |
||||
MEAN |
214.2 |
218.6 |
4.4 |
232.8 |
18.6 |
267.4 |
53.2 |
||||
Standard deviation |
5.7 |
5.9 |
5.3 |
10.0 |
5.2 |
19.9 |
20.3 |
||||
GENERAL APPEARANCE BEFORE AUTOPSY: Normal
Observations: Nothing to report.
Current control Study:
The study identified No. TAD -2016 -004 was performed to assess the comportament of the strain of rat used at the laboratory in the environment and to give additional historical data. The method was designed to meet the requirements of the following: OECD Guideline No. 402 (February 24th, 1987) and Method B.3 of Council regulation No. 440/2008.
Test item : Distilled water
Study dates: 20 September 2016 to 04 October 2016
Results:
- Clinical examinations: Nothing to report. Animal normal (10/10)
- Bodyweight evolution: normal during the test.
- Necropsy: No treatment related changes were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 of the test item in rats is greater than 2000 mg/kg bw.
- Executive summary:
A limit test was performed to determine the acute dermal toxicity of the test item in rats according to OECD 402 and EU method B.3, following GLP. The test item was applied onto the intact skin of 10 Sprague Dawley rats (5 males, 5 females) at a dose of 2000 mg/kg bw. All animals were observed once daily for 14 days, survival and body weight were monitored. There were no mortality and systemic clinical signs related to the administration of the test item during the study. Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed. Normal changes in body weights and none macroscopic findings were found. In conclusion, the test item was found to be non toxic by dermal route, with an LD50 > 2000 mg/kg bw in rats.
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