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EC number: 276-012-7 | CAS number: 71786-55-5
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From March 14th to April 5th, 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The study was conducted with the old version of guideline, which did not include the use of Escherichia Coli
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reference Substance 02
- IUPAC Name:
- Reference Substance 02
- Test material form:
- solid
- Remarks:
- blue powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : liver microsomal fraction was obtained from the liver of 8-12 weeks old male Wistar rats
- method of preparation of S9 mix: Before the experiment an appropriate quantity of S9 supernatant was thawed and mixed with S9 cofactor solution in a ratio 3:7.
- concentration or volume of S9 mix: 500 microliters - Test concentrations with justification for top dose:
- Pre-experiment for toxicity: the plates with the test article showed normal background growth up to 5000 microliters/plate in strain TA 98 and TA 100, respectively.
According to the dose selection criteria, the test article was tested at the following concentrations:
10.0, 100.0, 333.3, 1000.0, 5000.0 microliters/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water bidest
- Justification for choice of solvent/vehicle: the solvent was chosen because of its solubility properties.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 4-nitro-o-phenylene-diamine / 2-aminoanthracene
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration : for each strain and dose level, including the controls, a minimum of three plates were used
- Number of independent experiments : two
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period: 10 hours
- Exposure duration/duration of treatment: 48 hours
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- not determined
- Remarks:
- Old guideline, E.coli not included
- Cytotoxicity / choice of top concentrations:
- not determined
- Remarks:
- Old guideline, E.coli not included
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- only at 5000 µg/plate in exp. II
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- exp. I and II
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- exp. I and II
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- Exp. I and II
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Without S9 mix
Revertants/plate |
||||||||
Dose |
TA 1535 |
TA 1535 |
TA 1537 |
TA 1537 |
TA 98 |
TA 98 |
TA 100 |
TA 100 |
Neg. Contr. |
14 |
11 |
11 |
7 |
29 |
21 |
100 |
80 |
Solv. Contr. |
15 |
15 |
11 |
7 |
27 |
15 |
92 |
87 |
10 |
21 |
10 |
10 |
8 |
33 |
17 |
106 |
71 |
100 |
16 |
9 |
12 |
8 |
26 |
16 |
103 |
81 |
333.3 |
15 |
9 |
12 |
4 |
28 |
12 |
93 |
84 |
1000 |
13 |
10 |
11 |
4 |
29 |
17 |
88 |
75 |
5000 |
15 |
8 |
10 |
4 |
27 |
13 |
77 |
76 |
Positive controls |
||||||||
Sodium azide (10 μg/plate) |
1180 |
830 |
1172 |
675 |
||||
4-Nitro-o-phenylene-diamine (50μg/plate) |
281 |
195 |
2394 |
1474 |
With S9 mix
Revertants/plate |
||||||||
Dose |
TA 1535 |
TA 1535 |
TA 1537 |
TA 1537 |
TA 98 |
TA 98 |
TA 100 |
TA 100 |
Neg. Contr. |
15 |
15 |
11 |
6 |
49 |
25 |
146 |
99 |
Solv. Contr. |
18 |
12 |
15 |
5 |
44 |
30 |
131 |
105 |
10 |
19 |
15 |
15 |
6 |
52 |
36 |
142 |
101 |
100 |
15 |
16 |
14 |
8 |
43 |
62 |
134 |
106 |
333.3 |
18 |
13 |
12 |
7 |
47 |
36 |
132 |
106 |
1000 |
18 |
10 |
12 |
5 |
42 |
21 |
123 |
114 |
5000 |
15 |
12 |
8 |
7 |
31 |
18 |
116 |
93 |
Positive controls |
||||||||
2-amino-anthracene (2.5 μg/plate) |
362 |
306 |
314 |
255 |
2156 |
1623 |
2158 |
1644 |
Applicant's summary and conclusion
- Conclusions:
- It can be stated that during the described mutagenicity test and under the experimental conditions reported, the test substance did not induce point mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore the test substance is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay. - Executive summary:
This study was performed to investigate the potential of the test substance to induce gene mutations according to the plate incorporation test using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100.
The assay was performed in two independent experiments, using identical procedures, both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test substance was tested as the following concentrations: 10.0, 100.0, 333.3, 1000.0 and 5000.0 µg/plate.
Toxic effects, evidenced by a reduction in the number of revertants, occured only in strain TA 1535 at 5000.0 µg/plate withoutn metabolic activation in experiment II.
The plates incubated with the test substance showed normal back-ground growth up to 5000.0 µg/plate with and without S9 mix in all strains used.
Up to the highest investigated dose, neither a significant and reproducibile increase of the number of revertants was found in any strain as compared to the solvent control nor a concentration-dependent enhancement of the revrtant number exists. The presence of liver microsomal activation did not influence the findings.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test article did not induce point mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore the test substance is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.
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