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EC number: - | CAS number: -
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- 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 : MnCl2 (Eramet)
- Molecular formula : MnCl2
- Molecular weight : Not reported
- Substance type: Light pink solid flakes
- Physical state: Solid
- Analytical purity: > 95 %
- Impurities (identity and concentrations): Not reported
- Composition of test material, percentage of components: Not reported
- Purity test date: Not reported
- Lot/batch No.: 104896-05
- Expiration date of the lot/batch: Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Room temperature in the dark
Constituent 1
Method
- Target gene:
- Histidine synthesis in the Salmonella typhimurium strains and tryptophan synthesis in the E. coli strain used.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: GC base pairing at the primary reversion site.
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: AT base pairing at the primary reversion site.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
For details on preparation and source please refer to field 'Any other information on materials and methods'. - Test concentrations with justification for top dose:
- 50, 150, 500, 1500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Sterile distilled water
- Justification for choice of solvent/vehicle: The test material was found to be soluble in sterile distilled water and dimethyl sulphoxide at 50 mg/mL. Sterile distilled water was chosen as the solvent.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2AA)
- Remarks:
- With S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- With S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Without S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Without S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
DURATION
- Preincubation period: 10 hours at 36 °C
- Exposure duration: 48 hours
- Expression time (cells in growth medium): Not reported - Evaluation criteria:
- Several criteria for determining a positive result. Dose-related increase in revertant frequency over the dose range tested and/or a reproducible increase at one or more concentrations in at least one bacterial strain with or without metabolic activation. Biological relevance of the results will be considered first, statistical methods, as recommended by the UKEMS can also be used as an aid to evaluation, however statistical significance will not be the only determining factor for a positive response.
- Statistics:
- The following was used to statistically evaluate the results from the mutagenicity test. Kirkland DJ (ED) (1989) Statistical Evaluation of Mutagenicity Test Data (UKEMS) sub-committee on Guidelines for Mutagenicity Testing. Report Part III - Cambridge University Press.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS: precipitation observed, please refer to 'Any other information on results'
RANGE-FINDING/SCREENING STUDIES: The test substance was found to be non-toxic in the range-finding study.
COMPARISON WITH HISTORICAL CONTROL DATA: The historical control values were found to concur with the results from the study for both positive and vehicle controls.
ADDITIONAL INFORMATION ON CYTOTOXICITY: please refer to 'Any other information on results'
Any other information on results incl. tables
Table 1: Range finding study – toxicity assay
With (+) or Without (-) S9-mix |
Strain |
Dose (µg/plate) |
||||||||||
0 |
0.15 |
0.5 |
1.5 |
5 |
15 |
50 |
150 |
500 |
1500 |
5000 |
||
- |
TA100 |
75 |
81 |
78 |
96 |
89 |
77 |
85 |
74 |
70 |
86P |
84P |
+ |
TA100 |
77 |
96 |
84 |
85 |
74 |
75 |
91 |
88 |
74 |
70P |
73P |
- |
WP2uvrA- |
25 |
23 |
25 |
23 |
27 |
30 |
23 |
35 |
31 |
22P |
27P |
+ |
WP2uvrA- |
37 |
24 |
27 |
34 |
29 |
25 |
36 |
32 |
38 |
30P |
24P |
P - Precipitate |
Table 2: Spontaneous Mutation Rates (Concurrent Negative Controls), Experiment 1
Number of Revertants (mean number of colonies per plate) |
||||
Base-pair substitution type |
Frameshift type |
|||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
93 |
15 |
22 |
14 |
10 |
96 (95) |
19 (18) |
20 (22) |
16 (17) |
13 (12) |
97 |
21 |
24 |
20 |
13 |
Table 3: Spontaneous Mutation Rates (Concurrent Negative Controls), Experiment 2
Number of Revertants (mean number of colonies per plate) |
||||
Base-pair substitution type |
Frameshift type |
|||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
123 |
22 |
33 |
22 |
12 |
123 (118) |
25 (23) |
25 (29) |
25 (24) |
12 (12) |
109 |
21 |
29 |
24 |
13 |
Table 4: Test Results, Experiment 1 – Without Metabolic Activation
Test Period |
From 19 July 2009 |
To 22 July 2009 |
|||
Test Substance (µg/plate) |
Number of revertants (mean number of colonies per plate) |
||||
Base-pair substitution type |
Frameshift type |
||||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
|
0 |
95 111 (102) 99 8.3# |
16 20 (18) 19 2.1 |
23 25 (23) 20 2.5 |
26 21 (23) 23 2.5 |
15 13 (14) 13 1.2 |
50 |
112 96 (104) 104 8.0 |
16 20 (19) 20 2.3 |
18 25 (22) 23 3.6 |
21 22 (22) 24 1.5 |
14 13 (12) 10 2.1 |
150 |
115 110 (109) 102 6.6 |
21 13 (18) 21 4.6 |
26 15 (20) 19 5.6 |
16 20 (21) 27 5.6 |
12 11 (12) 13 1.0 |
500 |
103 92 (95) 90 7.0 |
18 19 (17) 14 2.6 |
21 23 (25) 30 4.7 |
21 21 (21) 20 0.6 |
15 15 (12) 15 0.0 |
1500 |
110 P 95 P (103) 104P 7.5 |
19P 18P (18) 16P 1.5 |
22 24P (23) 22P 1.2 |
22P 23P (25) 26P 3.2 |
13P 15P (12) 9P 3.1 |
5000 |
88P 117P (105) 111P 15.3 |
18P 21P (19) 18P 1.7 |
26P 21P (24) 24P 2.5 |
25P 23P (25) 26P 1.5 |
9P 12P (12) 16P 3.5 |
Name Concentration No. colonies per plate |
ENNG |
ENG |
ENNG |
4NQO |
9AA |
3 |
5 |
2 |
0.2 |
80 |
|
475 526 (492) 476 29.2 |
99 150 (115) 95 30.7 |
145 145 (145) 145 0.0 |
123 118 (119) 115 4.0 |
345 462 (400) 394 58.8 |
|
ENNG – N-ethyl-N’-nitro-N-nitrosoguanidine 4NQO – 4-Nitroquinoline-1-oxide 9AA – 9-Aminoacridine P – Precipitate # - Standard deviation |
Table 5: Test Results, Experiment 1 – With Metabolic Activation
Test Period |
From 19 July 2009 |
To 22 July 2009 |
|||
Test Substance (µg/plate) |
Number of revertants (mean number of colonies per plate) |
||||
Base-pair substitution type |
Frameshift type |
||||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
|
0 |
97 96 (98) 100 8.3# |
12 12 (11) 9 1.7 |
23 29 (28) 32 4.6 |
25 24 (23) 20 2.6 |
14 9 (12) 14 2.9 |
50 |
117 101 (106) 100 9.5 |
11 9 (10) 10 1.0 |
31 25 (25) 19 6.0 |
20 21 (20) 18 1.5 |
12 12 (12) 12 0.0 |
150 |
97 102 (101) 103 3.2 |
10 9 (9) 9 0.6 |
25 23 (25) 27 2.0 |
26 22 (24) 24 2.0 |
15 10 (12) 11 12.6 |
500 |
115 74 (94) 92 20.6 |
13 8 (10) 9 2.6 |
29 19 (23) 21 5.3 |
31 20 (24) 20 6.4 |
16 15 (15) 13 1.5 |
1500 |
90 P 82 P (88) 91P 4.9 |
12P 9P (11) 13P 2.1 |
26P 24P (23) 20P 3.1 |
19P 18P (24) 20P 6.4 |
11P 15P (12) 9P 3.1 |
5000 |
92P 104P (95) 90P 7.6 |
12P 9P (11) 11P 1.5 |
24P 24P (23) 20P 2.3 |
20P 24P (22) 22P 2.0 |
12P 9P (11) 13P 2.1 |
Name Concentration No. colonies per plate |
2AA |
2AA |
2AA |
BP |
2AA |
1 |
2 |
10 |
5 |
2 |
|
2248 2526 (2506) 2743 248.1 |
209 151 (179) 177 29.1 |
172 225 (184) 154 36.9 |
206 184 (197) 202 11.7 |
278 217 (247) 247 30.5 |
|
2AA – 2-Aminoanthracene BP – Benzo(a)pyrene P – Precipitate # - Standard deviation |
Table 6: Test Results, Experiment 2 – Without Metabolic Activation
Test Period |
From 19 July 2009 |
To 22 July 2009 |
|||
Test Substance (µg/plate) |
Number of revertants (mean number of colonies per plate) |
||||
Base-pair substitution type |
Frameshift type |
||||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
|
0 |
101 95 (104) 115 10.3# |
20 16 (19) 20 2.3 |
21 24 (23) 25 2.1 |
26 26 (25) 23 1.7 |
11 16 (14) 15 2.6 |
50 |
106 97 (104) 106 5.2 |
21 21 (21) 21 0.0 |
18 26 (24) 29 5.7 |
20 26 (25) 2 9 4.6 |
8 15 (12) 13 3.6 |
150 |
113 107 (111) 114 3.8 |
24 20 (21) 20 2.3 |
22 29 (25) 23 3.8 |
20 19 (22) 27 4.4 |
10 8 (9) 10 1.2 |
500 |
96 104 (102) 106 5.3 |
16 22 (17) 14 4.2 |
23 24 (24) 25 1.0 |
23 25 (26) 30 3.6 |
15 8 (9) 10 1.2 |
1500 |
118P (118) 119P 1.0 117 * |
24P 20P (23) 26P 3.1 |
21P 24P (22) 22P 1.5 |
29P 21P (25) 26P 4.0 |
10P 11P (10) 9P 1.0 |
5000 |
101P 104P (105) 110P 4.6 |
22P 23P (22) 21P 1.0 |
27P 24P (24) 21P 3.0 |
26P 25P (25) 24P 1.0 |
12P 13P (11) 9P 2.1 |
Name Concentration No. colonies per plate |
ENNG |
ENG |
ENNG |
4NQO |
9AA |
3 |
5 |
2 |
0.2 |
80 |
|
295 312 (309) 320 12.8 |
209 222 (212) 206 8.5 |
416 492 (462) 477 40.3 |
246 217 (228) 220 15.9 |
1078 2042 (1426) 1157 535.2 |
|
ENNG – N-ethyl-N’-nitro-N-nitrosoguanidine 4NQO – 4-Nitroquinoline-1-oxide 9AA – 9-Aminoacridine P – Precipitate # - Standard deviation * p≤0.05 |
Table 7: Test Results, Experiment 2 – With Metabolic Activation
Test Period |
From 19 July 2009 |
To 22 July 2009 |
|||
Test Substance (µg/plate) |
Number of revertants (mean number of colonies per plate) |
||||
Base-pair substitution type |
Frameshift type |
||||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
|
0 |
108 106 (108) 109 1.5# |
10 9 (11) 13 2.1 |
25 27 (26) 26 1.0 |
22 21 (22) 22 0.6 |
16 16 (15) 12 2.3 |
50 |
93 91 (106) 107 8.7 |
15 9 (12) 13 3.1 |
22 22 (25) 31 5.2 |
21 26 (22) 22 0.6 |
13 15 (15) 16 1.5 |
150 |
98 89 (99) 110 10.5 |
13 8 (10) 13 3.1 |
22 23 (22) 31 0.6 |
19 24 (22) 22 2.5 |
14 14 (12) 7 4.0 |
500 |
91 106 (102) 110 10.0 |
12 14 (12) 9 2.5 |
30 29 (30) 30 0.6 |
26 21 (23) 22 2.6 |
16 14 (14) 12 2.0 |
1500 |
81P 100P (96) 110P 10.0 |
9P 13P (10) 9P 2.3 |
25P 31P (27) 25P 3.5 |
25P 25P (24) 22P 1.7 |
9P 16P (14) 16P 4.0 |
5000 |
90P 84P (92) 102P 9.2 |
11P 10P (10) 8P 1.5 |
26P 23P (25) 27P 2.1 |
24P 21P (22) 22P 1.5 |
12P 15P (12) 10P 2.5 |
Name Concentration No. colonies per plate |
2AA |
2AA |
2AA |
BP |
2AA |
1 |
2 |
10 |
5 |
2 |
|
2474 2427 (2510) 2629 105.7 |
374 332 (332) 291 41.5 |
342 264 (313) 333 42.7 |
261 620 (457) 490 181.8 |
497 494 (498) 504 5.1 |
|
2AA – 2-Aminoanthracene BP – Benzo(a)pyrene P – Precipitate # - Standard deviation |
The test material was found to cause no visible reduction in growth of the bacterial background lawn at any dose and was therefore tested up to the maximum dose level of 5000 µg/plate A particulate precipitate was at 1500 µg/plate and above. This was considered not to prevent the scoring of revertant colonies. No toxicologically significant increases in the frequency of revertant colonies were recorded for and of the bacterial strains, with any dose of the test material, with or without metabolic activation. In the TA100 revertant colony, a small but statistically significant increase was observed on the 1500 µg/plate in Experiment 2 (increase of less than 1.5 times). However these were within the range specified by the Standard Test Method, this increase proved non-reproducible over two separate experiments. This was concluded to have no biological or toxicological relevance. All of the positive control substances induced marked increases in the frequency of revertant colonies, confirming the activity of the S9-mix and the sensitivity of the bacterial strains.
Applicant's summary and conclusion
- Conclusions:
- The test material has been found to be non-mutagenic under the test conditions reported.
- Executive summary:
MnCl2was tested for gene mutation in a GLP compliant study according to OECD Guideline 471 in the strains S. typhimurium TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2 uvr A.The test material was found to cause no visible reduction in growth of the bacterial background lawn at any dose and was therefore tested up to the maximum dose level of 5000 µg/plate A particulate precipitate was at 1500 µg/plate and above. This was considered not to prevent the scoring of revertant colonies. No toxicologically significant increases in the frequency of revertant colonies were recorded for any of the test strains, with any dose of the test material with or without metabolic activation. All of the positive control substances induced marked increases in the frequency of revertant colonies, confirming the activity of the S9-mix and the sensitivity of the bacterial strains
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