Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 232-094-6 | CAS number: 7786-30-3
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 2009 till december 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- December 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- magnesium chloride hexahydrate
- IUPAC Name:
- magnesium chloride hexahydrate
- Reference substance name:
- 7791-18-6
- Cas Number:
- 7791-18-6
- IUPAC Name:
- 7791-18-6
- Details on test material:
- water content (specification): 51-55 % (53.4 %)
Colour: colourless
Physical state: solid, crystals
Storage: at room temperature, in a tightly closed package
Solvent: water
Stability after opening: instable after repeated contact to air
pH: 5.5 - 7.0 (5 % solution at 20 °C)
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Magnesium chloride hexahydrate
- EC-Number: 232-094-6
- Physical state: Colourless; Solid, crystals
- Stability after opening: Instable after repeated contact to air
- Storage condition of test material: At room temperature, in a tightly closed package.
- pH: 5.5 - 7.0 (5% solution at 20 °C)
- Solvent: Water
No further information on the test material was stated.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species/strain: Healthy rats, WISTAR rats Crl: WI(Han) (Full-Barrier)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: female, non-pregnant, nulliparous
Age at the beginning of the study: 8 - 12 weeks old
Body weight at the beginning of the study: animals no. 1 – 3, step 1: 151 – 158 g and animals no. 4 – 6, step 2: 161 – 170 g;
The animals were derived from a controlled full barrier maintained breeding system (SPF).
Housing and Feeding Conditions: full-barrier in an air-conditioned room, temperature: 22 (+/-3) °C, relative humidity: 55 (+/-10) %, artificial light, sequence being 12 hours light, 12 hours dark, air change: 10 x / hour, free access to Altromin 1324 maintenance diet, free access to tap water, sulphur acidified to a pH value of approx. 2.8, the animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding, adequate acclimatisation period (at least five days).
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Aqua ad injectionem
- Details on oral exposure:
- The test item was administered at a single dose by gavage using a feeding tube.
The test item was administered at a dose volume of 5 mL/kg body weight. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3 per step (two steps) (Total: 6 female rats)
- Control animals:
- no
- Details on study design:
- The animals were marked for individual identification by tail painting.
Prior to the administration, a detailed clinical observation was made of all animals.
Prior to the administration food was withheld from the test animals for 16 to 19 hours (access to water was permitted). Following the period of fasting, the animals were weighed and the test item was administered. Food was provided again approximately 3-4 hours post dosing.
All animals were observed for 14 days after dosing for general clinical signs, morbidity and mortality.
The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded.
Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhea, lethargy, sleep and coma.
At the end of the observation period, the animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally at a dosage of approx. 8 mL/kg bw. All animals were subjected to gross necropsy. All gross pathological changes were recorded. - Statistics:
- No
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 cut off
- Key result
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived until the end of the study.
- Clinical signs:
- other: All animals survived without showing any signs of toxicity.
- Gross pathology:
- At necropsy, no macroscopical findings were observed in any animal of any step.
Any other information on results incl. tables
Table1: Results per Step
Step |
Sex/no. |
Dose (mg/kg) |
Number of animals |
Number of intercurrent deaths |
1 |
f/1-3 |
2000 |
3 |
0 |
2 |
f/4-6 |
2000 |
3 |
0 |
Table 2: Absolute Body Weights in g and Body Weight Gain in %
Animal no. / sex |
g |
g |
g |
% |
Step 1 |
||||
1 / female |
158 |
182 |
192 |
+22 |
2 / female |
155 |
176 |
187 |
+21 |
3 / female |
151 |
165 |
171 |
+13 |
Step 2 |
||||
4 / female |
170 |
203 |
215 |
+26 |
5 / female |
161 |
182 |
199 |
+24 |
6 / female |
162 |
194 |
204 |
+26 |
Table 3: Macroscopical Findings - Individual Data
Animal no. / sex |
Organ |
Findings at the necropsy |
1 / female |
-- |
NAD |
2 / female |
-- |
NAD |
3 / female |
-- |
NAD |
4 / female |
-- |
NAD |
5 / female |
-- |
NAD |
6 / female |
-- |
NAD |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the condition of this test, a single oral application of Magnesium chloride hexahydrate to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality. The median lethal dose of Magnesium chloride hexahydrate after a single oral administration to female rats, observed over a period of 14 days, is 5000 mg/kg body weight (LD50 cut off).
- Executive summary:
The study was performed according to the OECG guideline 423 and was GLP compliant.
Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with Magnesium Chloride hexahydrate by oral gavage administration at a dosage of 2000 mg/kg body weight.
The test item was dissolved in a vehicle (Aqua ad injectionem (sterile water)) at a concentration of 0.4 g/mL and administered at a dose volume of 5 mL/kg.
The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs. All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
Throughout the 14-day observation period, all animals survived until the end of the study without showing any signs of toxicity and the weight gain of the animals was within the expected range. Also at necropsy, no macroscopical findings were observed in any animal of any step.
In conclusion, the median lethal dose of Magnesium chloride hexahydrate after a single oral administration to female rats, observed over a period of 14 days is 5000 mg/kg body weight (LD50 cut off).
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.