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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 231-105-1 | CAS number: 7439-96-5
- 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://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-07-03 to 2009-10-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to current accepted guidelines.
- Remarks:
- Study conducted on read-across material
- Justification for type of information:
- See the read-across report attached in Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- other: Read-across target
Reference
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read-across material.
- Justification for type of information:
- See the read-across report attached in Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Test material-induced toxicity was noted at the highest dose level employed in the test.
- Vehicle controls validity:
- not valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- manganese chloride
- IUPAC Name:
- manganese chloride
- Reference substance name:
- Manganese dichloride
- EC Number:
- 231-869-6
- EC Name:
- Manganese dichloride
- Cas Number:
- 7773-01-5
- Molecular formula:
- Cl2Mn
- IUPAC Name:
- manganese(2+) dichloride
- Details on test material:
- - Name of test material : Manganese chloride, MnCl2 (Eramet)
- Molecular formula : MnCl2
- Substance type: Light pink solid flakes
- Physical state: Solid
- Analytical purity: >95%
- Lot/batch No.: 104896-05
- Storage condition of test material: Room temperature in the dark
Constituent 1
Constituent 2
Method
- Target gene:
- TK locus
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Periodically checked for Mycoplasma contamination: yes
- Periodically "cleansed" against high spontaneous background: yes - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Please see table 1 under section Any other information on materials and methods incl. tables for dosing regime
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: R0 medium
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- In the absence of metabolic activation: 400 µg/mL and 150 µg/mL for the 4 hour and 24 hour exposures respectively.
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- In the presence of metabolic activation: 2 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 or 24 hours
- Generation time : 12 hours
- Selection time (if incubation with a selection agent): 2 days
SELECTION AGENT (mutation assays): 4 µg/mL 5-trifluorothymidine (TFT) selective medium
STAIN : MTT
NUMBER OF REPLICATIONS:Each dose level was performed in duplicate
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- Plate scoring: Microtitre plates were scored using a magnifying mirror box after ten to fourteen days incubation. The number of positive wells (wells with colonies) was recorded together with the total number of scorable wells (normally 96 per plate). The numbers of small and large colonies seen in the TFT mutation plates were also recorded. Colonies were scored manually by eye using qualitative judgement. Large colonies were defined as those that covered approximately 1/4 to 3/4 of the surface of the well and were generally no more than one or two cells thick. Generally all colonies less than 25% of the average area of the large colonies were scored as small colonies. Small colonies normally are more than two cells thick. 0.025 mL of MTT solution (2.5 mg/mL in PBS) was added to each well of the mutation plates to visualise the mutant colonies. The plates were incubated for two hours. MTT is a vital stain that is taken up by viable cells and metabolised to give a brown/black colour.
% Relative Suspension Growth (%RSG), Day 2 Viability (%V), Relative Total Growth (RTG) and Mutation Frequency (MF) were all calculated to assess the mutagenic potential. Please refer to section: Any other information on materials and methods incl. tables under the appropriate headings for full details.
For a test material to demonstrate a mutagenic response it must produce a statistically significant increase in the induced mutant frequency over the concurrent vehicle mutant frequency value. - Statistics:
- For a response to be considered positive, the induced mutation frequency value must exceed the set Global Evaluation Factor (GEF) value at 126 x 10^-6 for the microwell method. Any test material dose level that exhibits a mutation frequency value that is greater than the corresponding vehicle control by the GEF is considered positive. If a test material produces a modest increase in mutant frequency, which only marginally exceeds the GEF value and is not reproducible or part of a dose-related response, then it may be considered to have no toxicological significance. When a test material induced modest reproducible increases in the mutation frequencies that did not exceed the GEF value, then scientific judgement was applied. If the reproducible responses are significantly dose-related and include increases in the absolute numbers of mutant colonies then they may be considered to be toxicologically significant.
Small significant increases designated by the UKEMS statistical package were reviewed using the criteria set out above and disregarded at the discretion of the Study Director.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Test material-induced toxicity was noted at the highest dose level employed in the test.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitate of the test material was observed at and above 10 µg/mL in the 4-hour exposure groups in the absence of metabolic activation and at and above 20 µg/mL in the 4-hour exposure group in the presence of metabolic activation.
RANGE-FINDING/SCREENING STUDIES: All three exposure groups employed in the screening test exhibited a marked reduction in the Relative Suspension Growth (%RSG) of cells treated with the test material when compared to the concurrent vehicle controls. A precipitate of the test material was observed at and above 78.75 µg/mL in the 4-hour exposure group in the absence of metabolic activation, at and above 39.98 µg/mL in the 4-hour exposure group in the presence of metabolic activation, and at and above 19.69 µg/mL in the 24-hour exposure group in the absence of metabolic activation. In the mutagenicity experiments the maximum dose level was limited by test-material-induced toxicity. - Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
Table 2: Results from the preliminary toxicity test
Dose (µg/mL) |
%RSG (-S9) 4-Hour Exposure |
%RSG (=S9) 4-Hour Exposure |
%RSG (-S9) 24-Hour Exposure |
0 |
100 |
100 |
100 |
4.92 |
102 |
89 |
33 |
9.84 |
96 |
100 |
11 |
19.69 |
89 |
89 |
1 |
39.38 |
72 |
75 |
0 |
78.75 |
2 |
57 |
0 |
157.5 |
9 |
1 |
0 |
315 |
1 |
0 |
0 |
630 |
0 |
0 |
0 |
1260 |
0 |
0 |
0 |
Table 3: Summary of results for main experiment, 4 hour exposure
Treatment (µg/mL) |
4-Hours –S9 |
Treatment (µg/mL) |
4-Hours +S9 |
||||
%RSG |
RTG |
MF§ |
%RSG |
RTG |
MF§ |
||
0 |
100 |
1.00 |
81.37 |
0 |
100 |
1.00 |
74.20 |
2.5† |
97 |
|
|
20 |
91 |
1.04 |
64.08 |
5 |
95 |
1.06 |
73.26 |
40 |
68 |
0.86 |
78.58 |
10 |
91 |
0.94 |
96.72 |
60 |
43 |
0.41 |
116.75 |
20 |
101 |
1.24 |
90.28 |
80 |
37 |
0.32 |
96.12 |
40 |
44 |
0.46 |
104.53 |
100 |
32 |
0.22 |
104.65 |
60 |
19 |
0.08 |
128.81 |
120 |
26 |
0.15 |
104.12 |
80 |
17 |
0.13 |
91.23 |
140 |
25 |
0.18 |
100.39 |
120† |
14 |
|
|
160‡ |
13 |
0.04 |
42.87 |
Linear trend |
NS |
Linear trend |
|||||
EMS |
|
|
|
CP |
|
|
|
400 |
71 |
0.62 |
656.51 |
2 |
55 |
0.22 |
1662.80 |
† Not plated for viability or 4-TFT resistance MF§ 5-TFT resistant mutants/106viable cells 2 days after treatment NS Not significant ‡ Treatment excluded from test statistics due to toxicity |
Table 4: Summary of results for main experiment, 24 hour exposure
Treatment (µg/mL) |
4-Hours –S9 |
||
%RSG |
RTG |
MF§ |
|
0 |
100 |
1.00 |
103.16 |
0.31 |
97 |
0.99 |
91.33 |
0.63 |
105 |
0.97 |
79.60 |
1.25 |
95 |
1.07 |
50.22 |
2.5 |
76 |
0.81 |
100.92 |
5 |
41 |
0.38 |
173.75* |
7.5 |
14 |
0.11 |
372.63* |
10† |
7 |
|
|
15† |
4 |
|
|
Linear trend |
*** |
||
EMS |
|
|
|
150 |
54 |
0.32 |
1211.25 |
† Not plated for viability or 4-TFT resistance * p<0.05 *** p<0.001 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: Negative With and without metabolic activation.
The test material did not induce any toxicologically significant increases in the mutant frequency at the TK +/- locus in L5178Y cells and is therefore considered to be non-mutagenic under the conditions of the test.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)