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EC number: 215-170-3 | CAS number: 1309-42-8
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Teratogenicity study of magnesium chloride hexahydrate in rats
- Author:
- Usami M. et al.
- Year:
- 1 996
- Bibliographic source:
- Eisi Shikenjo Hokoku [Bulletin of National Institute of Hygienic Sciences] 1996; 114: 16-20
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Magnesium chloride hexahydrate
- EC Number:
- 616-575-1
- Cas Number:
- 7791-18-6
- IUPAC Name:
- Magnesium chloride hexahydrate
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Magnesium chloride hexahydrate
- Molecular formula: MgCl:6H20
- Molecular weight: 203.30
- Analytical purity: 95% due to its being used as a food additive.
- Description: Colourless to white crystal
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan
- Age at study initiation: Female (10 weeks old) male (11 weeks old)
- Housing: Pregnant rats were kept in aluminum cages through the test period.
- Diet: Freely consume solid food (oriental yeast0
- Water: Tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Pregnant rats were kept at a set temperature of 25 ±2 °C.
- Humidity (%):55 ± 5%
- Air changes (per hr):15 cycles/hr
- Photoperiod (hrs dark / hrs light): Lighted at 12-hour intervals (period of light: 6:00 to 18:00)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Nulliparous females spent the night with males, then the next morning the rats were tested for pregnancy by checking if any sperm was in their vaginas. Gestation days were tabulated by setting the day on which the sperm was found as gestation day 0.
- Duration of treatment / exposure:
- Day 6 to day 15 of pregnancy
- Frequency of treatment:
- Once a day
- Duration of test:
- Day 6 to day 20 of pregnancy
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 200 mg/kg bw/day
- Remarks:
- actual ingested with doses based on the body weight at day 6 of gestation.
- Dose / conc.:
- 400 mg/kg bw/day
- Remarks:
- actual ingested with doses based on the body weight at day 6 of gestation.
- Dose / conc.:
- 800 mg/kg bw/day
- Remarks:
- actual ingested with doses based on the body weight at day 6 of gestation.
- No. of animals per sex per dose:
- 22
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Dose selection rationale: When setting dosage levels, doses of 0, 250, 500 and 1000 mg/kg/day and one group of 4 rats in a preliminary study were used. As a result, sedation, decreased body temperature, salivation, and watery stool were observed, while 2 rats died. No effects of Magnesium chloride hexahydrate were observed in the reproduction of surviving rats. Considering these results, in terms of group composition, 3 dosage levels of 200, 400 and 800 mg/kg/day were established to be administered to 3 magnesium chloride hexahydrate treatment groups.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATION: YES
The general condition of the animals was observed every day.
BODYWEIGHT: Yes
Body weight was measured at day 0, 1, 3, 6, 9, 12, 15, and 17 of pregnancy.
FOOD INTAKE: YES
Food intake was measured at day 0, 1, 3, 6, 9, 12, 15, and 17 of pregnancy.
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: The pregnant rats were slaughtered on gestation day 20 and the number of corpora lutea, the number of implants, and the number of dead implants were examined. - Ovaries and uterine content:
The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes- Fetal examinations:
- - External examinations: Yes: the exterior of live fetuses was examined for abnormalities and sex, then body weight was measured.
- Internal organ examinations: Yes: The internal organs of approximately one-half of the live fetuses were observed. In observing the internal organs, the macrosection technique was used for the cephalic and abdominal regions, and the microdissection technique for the thoracic region.
- Skeletal examinations: Yes: A sample of Alizarin red S-stained skeletal preparation was made for approximately one-half of the live fetuses.
- Head examinations: Yes half per litter (according to a gross sectioning technique) - Statistics:
- Either pregnant rats or litters were used as units of calculation. For tests with a significant difference between the control group and the magnesium chloride hexahydrate treatment groups, the Fisher direct method for frequency data was used. For quantitative data, after using the Bartlett homoscedastic test to determine whether there was a difference in variance between groups, variance analysis and the Scheffe method were then used. For quantitative data and enumerative data with an observed difference in variance between groups, the Kruskal-Wallis test and the Scheffe method were used.
- Indices:
- no data
- Historical control data:
- no data
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Endocrine findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- no effects observed
- Details on maternal toxic effects:
- There were no differences between the groups with regard to general condition and death. Furthermore, no significant differences between the control group and magnesium chloride hexahydrate groups were observed with respect to body weight and food consumption. Regarding the number of corpora lutea, number of implants, number of living fetuses, sex ratio, fetal weight and mortality of implants/fetuses, no significant differences between control group and the magnesium chloride hexahydrate groups were observed.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 800 mg/kg bw/day
- Based on:
- test mat.
- Remarks on result:
- other: no effects at highest tested dose
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- not specified
- Anogenital distance of all rodent fetuses:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- One to 4 fetuses with gross malformations were found in each group. However, regarding the incidence rate, there was no significant difference between control group and magnesium chloride hexahydrate groups.
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In the 800 mg/kg/day group, one fetus had skeleton malformations, however, with regard to the incidence rate; there was no significant difference between control group and the magnesium chloride hexahydrate groups. Furthermore, no significant differences between control group and magnesium chloride hexahydrate groups were observed as far as the incidence rate of skeletal variations is concerned. Regarding the incidence rate of fetuses with lumbar rib and additional rib bones, there were no significant differences. No significant differences were found in the number of ossification centers, metacarpal and metatarsal bones as well as sacral and tail vertebrae. The aforementioned numbers were examined as indicators for the progress of ossification.Four to 6 fetuses in each group showed malformations, however, no significant difference were observed between control group and magnesium chloride hexahydrate groups.
- Visceral malformations:
- not specified
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 800 other: mg/kg/day
- Basis for effect level:
- other: no observed adverse effects at highest tested dose
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
No increased incidences of foetal malformation were noted, and no toxic signs were found in the pregnant rats and the foetuses.
Table 1. Fetal growth in pregnant rats treated with magnesium chloride hexahydrate
Dose (mg/kg/day) |
0 (Control) |
200 |
400 |
800 |
|
No. of litters |
22 |
22 |
22 |
22 |
|
No. of corpora lutea |
373 |
370 |
361 |
362 |
|
No. of implants |
364 |
340 |
345 |
345 |
|
No. of live foetuses |
346 |
326 |
324 |
332 |
|
Foetal weight (g) |
Male |
3.95 |
3.98 |
3.87 |
3.98 |
Female |
3.73 |
3.75 |
3.72 |
3.81 |
|
No. of dead implants |
18 |
14 |
21 |
13 |
|
Mortality (%) |
4.8 |
4.8 |
5.9 |
3.6 |
Table 2. Gross malformations in the foetuses from pregnant rats treated with magnesium chloride hexahydrate
Dose (mg/kg/day) |
0 (Control) |
200 |
400 |
800 |
No. of litters |
22 |
22 |
22 |
22 |
No. foetuses examined |
346 |
326 |
324 |
332 |
No. of litters with malformed foetuses |
3 |
1 |
3 |
1 |
No. of foetuses with malformation |
3 |
1 |
4 |
1 |
Applicant's summary and conclusion
- Conclusions:
- In conclusion, magnesium chloride hexahydrate has no teratogenicity in rats when given by gavage at the doses examined in this study. The no observed adverse effect level for magnesium chloride hexahydrate was determined to be >800 mg/kg/day for both pregnant rats and rat fetuses.
- Executive summary:
In a publication from Usami et al., teratogenicity of magnesium chloride hexahydrate was examined in rats. 22 male and female Wistar rats were orally treated with magnesium chloride hexahydrate (>95% purity) in water at doses of 0, 200, 400 and 800 mg/kg bw/day from Day 6 to Day 15 of pregnancy. The pregnant rats were sacrificed on day 20 of pregnancy and their fetuses were examined for malformation. It was found that magnesium chloride hexahydrate caused no increased incidences of fetal malformation and no toxic signs in the pregnant rats and the fetuses. Even a dose of 800 mg/kg bw/day, considered the maximum non-fatal dose of magnesium chloride hexahydrate in pregnant rats, did not increase the incidence of teratogenicity. The no observed adverse effect level for magnesium chloride hexahydrate was determined to be >800 mg/kg/day for both pregnant rats and rat fetuses, which is equal to 230 mg/kg bw/day magnesium hydroxide.
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