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Diss Factsheets
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EC number: 913-747-0 | 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline-equivalent proprietary study.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- No method is stated, however the method is equivalent to the contemporary OECD 471 guideline.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Type:
- Constituent
- Details on test material:
- White powder, 89.5% purity
Method
- Target gene:
- Reversion to histidine independence in histidine-deficient mutant Salmonella typhimurium strains.
Species / strain
- 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: pKM 101 plasmid, deep rough, uv repair deficient
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced male Sprague-Dawley rat liver S9 fraction
- Test concentrations with justification for top dose:
- 0 (solvent control), 20, 100, 500, 2500 and 12500 ug/plate; initial assay.
0 (solvent control), 775, 1550, 3100, 6200 and 12400 ug/plate; confirmatory assay - Vehicle / solvent:
- Demineralised water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide, nitrofurantoin, 4-phenylenediamine (-S9); 2-aminoanthracene (+S9)
- Details on test system and experimental conditions:
- Plate incorporation method: 48-hour exposure time
- Evaluation criteria:
- A reproducible and concentration-related increase (of at least twice the negative control count) in the number of revertant colonies of at least one strain was stated to be the criteria for a positive response.
- Statistics:
- Not applicable.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In some strains
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- No further information
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
No evidence of mutagenicity was seen under the conditions of this assay.
Initial assay |
||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Solvent control |
17 |
29 |
102 |
116 |
13 |
18 |
13 |
12 |
20 |
17 |
32 |
90 |
113 |
16 |
17 |
13 |
15 |
100 |
23 |
34 |
117 |
110 |
12 |
16 |
12 |
13 |
500 |
30 |
35 |
121 |
103 |
19 |
16 |
16 |
11 |
2500 |
19 |
17 |
114 |
117 |
13 |
10 |
15 |
13 |
12500 |
15 |
12 |
59 |
71 |
8 |
- |
7 |
- |
Positive control |
202 |
1020 |
385 |
698 |
1080 |
167 |
183 |
76 |
Confirmatory assay |
||||||||
Solvent control |
15 |
22 |
65 |
98 |
13 |
13 |
13 |
9 |
775 |
13 |
30 |
70 |
90 |
12 |
20 |
8 |
13 |
1550 |
14 |
31 |
60 |
82 |
13 |
15 |
10 |
11 |
3100 |
15 |
26 |
66 |
68 |
14 |
14 |
10 |
11 |
6200 |
11 |
14 |
62 |
59 |
11 |
11 |
5 |
5 |
12400 |
10 |
- |
60 |
- |
13 |
- |
4 |
4 |
Positive control |
88 |
832 |
241 |
696 |
1021 |
224 |
107 |
89 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without S9
The test material was not found to be mutagenic under the conditions of this study. - Executive summary:
The mutagenicity of sodium hydrogensulphate monohydrate was investigated in an Ames test (plate incorporation method) using Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537. Quuadruplicate cultures of each strain were exposed for 48 hours to the test material (dissolved in demineralised water) in the absence and presence of an exogenous metabolic acitvation system (Aroclor 1254 -induced male Sprague-Dawley rat S9 fraction) at concentrations of 0 (solvent control), 20, 100, 500, 2500 and 12500 ug/plate.
Evidence of cytotoxicity (reduced numbers of revertant colonies) was seen at the highest concentration in the absence of S9 and at 2500 and 12500 ug/plate in the presence of S9. Exposure to the test material did not induce any increase in the numbers of revertant colonies of any strain. Appropriate positve control compounds (sodium azide, nitrofurantoi, 4 -nitrophenylenediamine and 2 -aminoanthracene) produced large increases in the numbers of revertant colonies, confirming the sensitivity of the assay. Results were confirmed in an independently repeated assay using concentrations of 0 (solvent control), 775, 1550, 3100, 6200 and 12400 ug/plate; cytotoxicity (reduced numbers of revertant colonies) was seen at 6200 and 12400 ug/plate.
No evidence of mutagenicity was seen under the conditions of this assay.
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