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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2010-01-12 to 2010-03-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC No. 440/2008, L 142
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The testing using the guinea pig maximisation test protocol was completed before the LLNA 429 was formally adopted by the OECD on the 22 July 2010.
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 used in study report: Magnesium chloride hexahydrate
- Batch no.: M 1197
- Purity: 100.8%
- Colour: colourless
- Physical state: solid crystals
- Expiry date: 28 July 2012
- Storage: at room temperature
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Crl:HA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles RIver, 97633 Sulzfeld, Germany
- Age at study initiation: Approximately 5 weeks old
- Weight at study initiation:354 - 408 g
- Housing: The animals were kept in groups inTerluran- cages on Altromin saw fibre bedding in an air-conditioned room.
- Diet: Free access to autoclaved hay and to Altromin 3122 maintenance diet for guinea pigs
- Water: Free access to tap water
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 55 ± 10%
- Air changes (per hr): At least 10 x/ hour
IN-LIFE DATES: From: 25 January 2010 To: 25 February 2010
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- in the preliminary test one animal was treated intradermally with concentrations of 5% and 2.5% of the test item. Two animals were treated topically with concentrations of 100% and 50% of the test item for 24 as well as 48 hours.
Based on the results of this preliminary test, a concentration of 5% was chosen for the intradermal application of the main test and a concentration of 50% was selected for the dermal induction.
A concentration of 50% was found to be the highest dose suspended in vehicle which did not cause any signs of irritation after topical treatment over 24 hours and therefore was chosen for the challenge application in the main test.
Challengeopen allclose all
- Route:
- other: topical
- Vehicle:
- physiological saline
- Concentration / amount:
- in the preliminary test one animal was treated intradermally with concentrations of 5% and 2.5% of the test item. Two animals were treated topically with concentrations of 100% and 50% of the test item for 24 as well as 48 hours.
Based on the results of this preliminary test, a concentration of 5% was chosen for the intradermal application of the main test and a concentration of 50% was selected for the dermal induction.
A concentration of 50% was found to be the highest dose suspended in vehicle which did not cause any signs of irritation after topical treatment over 24 hours and therefore was chosen for the challenge application in the main test.
- No. of animals per dose:
- Number of animals in the test group: 10
Number of animals in the negative control group: 5
NUmber of animals in the dose range finding study: 3 - Details on study design:
- RANGE FINDING TESTS:
1 animal was treated intradermally with a concentration of 5% (left side) and 2.5% (right side) of the test item, suspended in physiological saline 0.9% NaCl.
2 animals were treated topically with concentrations of 100% (left side) and 50% (right side) of the test item for 24 as well as for 48 hours.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 injections (intradermal), 1 topical application
- Exposure period: 7 days (intradermal) 48 hours (topical application)
- Test groups: 1
- Control group: 1
- Site: shoulder region
- Frequency of applications: 3
- Concentrations: 5% (intradermal induction), 50% (dermal induction)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 20
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Site: left flank (test item), right flank (control)
- Concentrations: 50%
- Evaluation (hr after challenge): Approximately 24 and 48 hours after removing the patch the skin reaction was observed and recorded - Challenge controls:
- A patch loaded with 0.5 mL of the vehicle
- Positive control substance(s):
- yes
- Remarks:
- mercaptobenzothiazole
Results and discussion
- Positive control results:
- The sensitisation rate after application of the positive-control substance was 100% confirming the reliabiliy of the test system. For individual results see Table 2 in "Any other information on results incl. tables."
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Injection site 1
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- erythema grade 2 in 5/5 control
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Injection site 1
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- erythema grade 2 in 10/10 test animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: test group and control. Dose level: Injection site 1 . Total no. in groups: 15.0. Clinical observations: erythema grade 2 in 5/5 control and 10/10 test animals.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Injection site 1
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- oedema grade 2 in 10/10 test animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: test group and control. Dose level: Injection site 1. Total no. in groups: 15.0. Clinical observations: oedema grade 2 in 4/5 control and 10/10 test animals.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Injection site 1
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Clinical observations:
- oedema grade 1 in 1/5 control animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: Injection site 1. Total no. in groups: 15.0. Clinical observations: oedema grade 1 in 1/5 control animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Injection site 2
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- erythema grade 1 in 9/10 test animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Injection site 2. Total no. in groups: 15.0. Clinical observations: erythema grade 1 in 9/10 test animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Injection site 2
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- eschar in 8/10 test animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Injection site 2. Total no. in groups: 15.0. Clinical observations: eschar in 8/10 test animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: test and control group
- Dose level:
- Injection site 3
- No. with + reactions:
- 2
- Total no. in group:
- 15
- Clinical observations:
- erythema grade 2 in 1/5 control and 1/10 test animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: test and control group. Dose level: Injection site 3. Total no. in groups: 15.0. Clinical observations: erythema grade 2 in 1/5 control and 1/10 test animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: test and control group
- Dose level:
- Injection site 3
- No. with + reactions:
- 10
- Total no. in group:
- 15
- Clinical observations:
- erythema grade 1 in 1/5 control and 9/10 test animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: test and control group. Dose level: Injection site 3. Total no. in groups: 15.0. Clinical observations: erythema grade 1 in 1/5 control and 9/10 test animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: test and control
- Dose level:
- Injection site 3
- No. with + reactions:
- 2
- Total no. in group:
- 15
- Clinical observations:
- oedema grade 2 in 1/5 control and 1/10 test animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: test and control. Dose level: Injection site 3 . Total no. in groups: 15.0. Clinical observations: oedema grade 2 in 1/5 control and 1/10 test animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: test and control group
- Dose level:
- Injection site 3
- No. with + reactions:
- 2
- Total no. in group:
- 15
- Clinical observations:
- oedema grade 1 in 1/5 control and 2/10 test animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: test and control group. Dose level: Injection site 3. Total no. in groups: 15.0. Clinical observations: oedema grade 1 in 1/5 control and 2/10 test animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: test and control group
- Dose level:
- Injection site 3
- No. with + reactions:
- 7
- Total no. in group:
- 15
- Clinical observations:
- eschar in 1/5 control and 6/10 test animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: test and control group. Dose level: Injection site 3. Total no. in groups: 15.0. Clinical observations: eschar in 1/5 control and 6/10 test animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: test and control group
- Dose level:
- Injection site 1
- No. with + reactions:
- 4
- Total no. in group:
- 15
- Clinical observations:
- erythema grade 2 in 1/5 control and 3/10 test animals
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: test and control group. Dose level: Injection site 1. Total no. in groups: 15.0. Clinical observations: erythema grade 2 in 1/5 control and 3/10 test animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: test and control group
- Dose level:
- Injection site 1
- No. with + reactions:
- 11
- Total no. in group:
- 15
- Clinical observations:
- erythema grade 1 in 4/5 control and 7/10 test animals
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: test and control group. Dose level: Injection site 1 . Total no. in groups: 15.0. Clinical observations: erythema grade 1 in 4/5 control and 7/10 test animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: test and control group
- Dose level:
- Injection site 1
- No. with + reactions:
- 4
- Total no. in group:
- 15
- Clinical observations:
- oedema grade 2 in 1/5 control and 3/10 test animals
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: test and control group. Dose level: Injection site 1. Total no. in groups: 15.0. Clinical observations: oedema grade 2 in 1/5 control and 3/10 test animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: test and control group
- Dose level:
- Injection site 1
- No. with + reactions:
- 11
- Total no. in group:
- 15
- Clinical observations:
- oedema grade 1 in 4/5 control and 7/10 test animals
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: test and control group. Dose level: Injection site 1. Total no. in groups: 15.0. Clinical observations: oedema grade 1 in 4/5 control and 7/10 test animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Injection site 1
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- necrosis in 1/10 test animals
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Injection site 1. Total no. in groups: 15.0. Clinical observations: necrosis in 1/10 test animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: test and control group
- Dose level:
- Injection site 1
- No. with + reactions:
- 2
- Total no. in group:
- 15
- Clinical observations:
- eschar in 1/5 control and 1/10 test animals
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: test and control group. Dose level: Injection site 1. Total no. in groups: 15.0. Clinical observations: eschar in 1/5 control and 1/10 test animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Injection site 2
- No. with + reactions:
- 4
- Total no. in group:
- 5
- Clinical observations:
- erythema grade 1 in 4/5 test animals
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Injection site 2. Total no. in groups: 15.0. Clinical observations: erythema grade 1 in 4/5 test animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: test and control group
- Dose level:
- Injection site 3
- No. with + reactions:
- 11
- Total no. in group:
- 15
- Clinical observations:
- erythema grade 1 in 2/5 control and 9/10 test animals
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: test and control group. Dose level: Injection site 3. Total no. in groups: 15.0. Clinical observations: erythema grade 1 in 2/5 control and 9/10 test animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: test and control group
- Dose level:
- Injection site 3
- No. with + reactions:
- 2
- Total no. in group:
- 15
- Clinical observations:
- oedema grade 1 in 1/5 control and 1/10 test animals
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: test and control group. Dose level: Injection site 3. Total no. in groups: 15.0. Clinical observations: oedema grade 1 in 1/5 control and 1/10 test animals.
- Reading:
- other: Immediately after removing the patch
- Hours after challenge:
- 48
- Group:
- other: test and control group
- No. with + reactions:
- 3
- Total no. in group:
- 15
- Clinical observations:
- Desquamation in 1/5 control animals, erythema grade 1 in 2/10 test animals
- Remarks on result:
- other: Reading: other: Immediately after removing the patch. . Hours after challenge: 48.0. Group: other: test and control group. Total no. in groups: 15.0. Clinical observations: Desquamation in 1/5 control animals, erythema grade 1 in 2/10 test animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Injection site 1
- No. with + reactions:
- 4
- Total no. in group:
- 5
- Clinical observations:
- Oedema grade in 4/5 control animals
Any other information on results incl. tables
Preliminary Test:
One animal was treated intradermally with concentrations of 5% and 2.5% of the test item. Two animals were treated topically with concentrations of 100% and 50% of the test item for 24 as well as 48 hours.
Based on the results of this preliminary test, a concentration of 5% was chosen for the intradermal application of the main test and a concentration of 50% was selected for the dermal induction.A concentration of 50% was found to be the highest dose suspended in vehicle which did not cause any signs of irritation after a topical treatment over 24 hours and therefore was chosen for the challenge application in the main test.
Main test:
Signs of irritation during the induction:
Intradermal Induction I (24 hours reading)
Injection site 1: erythema grade 2 in 5/5 control and 10/10 test,oedema grade 2 in 4/5 control and 10/10 test animals and oedema grade 1 in 1/5 control animals.
Injection site 2: erythema grade 1 in 9/10 test animal
eschar in 8/10 test animals.
Injection site 3: erythema grade 2 in 1/5 control and 1/10 test animals, erythema grade 1 in 1/5 control and 9/10 test animals, oedema grade 2 in 1/5 control and 1/10 test animals, oedema grade 1 in 1/5 control and 2/10 test animals and eschar in 1/5 control and 6/10 test animals.
Intradermal Induction I (48 hours reading):
Injection site 1: erythema grade 2 in 1/5 control and 3/10 test animals, erythema grade 1 in 4/5 control and 7/10 test animals, oedema grade 2 in 1/5 control and 3/10 test animals, oedema grade 1 in 4/5 control and 7/10 test animals, necrosis in 1/10 animals and eschar in 1/5 control and 1/10 test animals.
Injection site 2: erythema grade 1 in 4/5 test animals
injection site 3: erythema grade 1 in 2/5 control and 9/10 test animals, oedema grade 1 in 1/5 control and 1/10 test animals.
Dermal Induction II (48 hours exposure, occlusive):
Immediately after removing the patch: Desquamation in 1/5 control animals, erythema grade 1 in 2/10 test animasl.
24 hours after removing the patch: Eschar in 5/5 control and 10/10 test animals, erythema grade 1 in 1/10 test animals, desquamation in 1/10 test animals.
Challenge exposure:
No erythema was observed in any of the test animals at any time. Erythema grade 1 was observed after 24 hours in one animal of the control group. No oedema was observed in any animal at any time. There was no evidence of sensitisation in the test item group at the challenge and the percentageof animals sensitised was 0%.
The animals of the test group showed no reduced weight gain compared to historical data.
Table 1: Classification System:
Patch test reaction |
|
|
Grade |
No visible change |
0 |
Discrete or patchy erythema |
1 |
Moderate and confluent erythema |
2 |
Intense erythema and swelling |
3 |
Table 2: Frequency of Sensitisation in Positive-Control Animals
Hours | Erythema grade 0 | Erythema grade 1 | Erythema grade 2 | Erythema grade 3 | Oedema grade 0 | Oedema grade 1 | Oedema grade 2 | Oedema grade 3 | % animals sensitised |
24 | 0 | 6 | 4 | 0 | 4 | 6 | 0 | 0 | 100 |
48 | 0 | 3 | 7 | 0 | 10 | 0 | 0 | 0 | 100 |
72 | 0 | 7 | 3 | 0 | 10 | 0 | 0 | 0 | 100 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study it can be stated that the test item Magnesium chloride hexahydrate caused no reactions identified as sensitisating at the tested concentration.
- Executive summary:
In a dermal sensitisation study conducted according to OECD guideline 406 with magnesium chloride hexahydrate (purity 100%) in 0.9% physiological saline, 10 female young adult Crl: HA- guinea pigs were tested using the method of the guinea pig maximisation test.
At the daily clinical observation the animals did not show any visible clinical symptoms and no mortality occurred.
During the induction phase slight signs of irritation were observed. These findings confirmed the validity of the study.
In the challenge phase no erythema was observed in any of the test animals at any time. Erythema grade 1 was observed after 24 hours in one animal of the control group. No oedema was observed in any animal at any time.
There was no evidence of sensitisation at the challenge and the percentage of animals sensitised was 0%.
The positive control mercaptobenzothiazole did induce an appropriate response.
Under the conditions of the present study, it can be stated that the test item Magnesium chloride hexahydrate caused no reactions identified as sensitising at the tested concentration.
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