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EC number: 431-090-3 | CAS number: 190085-41-7
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The subject material was negative when tested in a bacterial reverse mutation assay following OECD guidelines 471 and 472. It was negative in vitro in a chromosomal aberration test with human lymphocytes following OECD guideline 473. A surrogate material was negative in an in vitro mammalian cell gene mutation assay with Chinese hamster lung fibroblast (V79) cells.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was conducted from 3 March 1998 to 16 March 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Dated 1983
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Version / remarks:
- Dated 1983
- Qualifier:
- according to guideline
- Guideline:
- other: Proposal for replacement of Guidelines 471 and 472, dated 1997
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Annex to Directive 92/69/EEC (1992) Part B: Methods for Determination of Toxicity, B.13 and B.14
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA 40 CFR Part 799 (1997) Toxic Substances Control Act Test Guidelines, Sub-section 799.9510
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Salmonella typhimurium:
TA 1535, TA 100: hisG46
TA 1537: hisC3076
TA 98: hisD3052
Escherichia coli CM891 (WP2uvrA/pKM101):
contains ochre mutation; deficient in DNA repair system 9uvrA); contains the pKM101 plasmid - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat S9
- Test concentrations with justification for top dose:
- Test 1
5, 15, 50, 150, 500, 1500 and 5000 microg/plate
Test 2
50, 150, 500, 1500 and 5000 microg/plate - Vehicle / solvent:
- Dimethyl sulfoxide (DMSO).
The solubility of the test substance was assessed at 50 mg/ml in DMSO, in which it dissolved. Therefore, DMSO (Aldrich, ACS spectrophotometric grade, lot. No. 09347HN, >/= 99.9% pure) was used as solvent in this study. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Pos. Control for TA98 (+S9), TA100 (+S9), TA1537 (+S9) Migrated to IUCLID6: 5 microg/plate
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Pos Control for TA98 (-S9), Migrated to IUCLID6: 1 microg/plate
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Pos Control for TA100 (-S9), TA1535 (-S9) Migrated to IUCLID6: 3 microg/plate
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2 microg/plate)
- Remarks:
- Pos Control for TA1535 (+S9)
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Pos Control for TA 1537 (-S9) Migrated to IUCLID6: 80 microg/plate
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (10 microg/plate)
- Remarks:
- Pos Control for E. coli (+S9)
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Pos Control for E. coli (-S9) Migrated to IUCLID6: 2 microg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
A standard plate incorporation method was employed.
Test 1:
Tests were conducted in the presence or absence of S9. Eight dose levels and controls were tested up to and including 5,000 microg/plate at approximately half-log intervals. All tests were performed in triplicate.
- To a series of tubes were added 0.5 ml of S-9 mix or 0.1 M PO4 buffer (pH4), 0.1 ml of a 10-hour bacterial culture, and 0.1 ml of the solvent or test chemical mixture followed immediately by the addition of 2.0 ml of molten agar supplemented with 0.5 mM L-histidine / d-biotin / trryptophan. The contents of the resulting tubes were mixed and poured onto previously prepared petri dishes containing 25 ml minimal agar. After solidification, plates were inverted and incubated at 37 deg C for 72 hours. The negative control was the chosen solvent, DMSO. The application of positive controls was also included.
Test 2:
As a clear negative response was obtained in Test 1, a variation to the test procedure was used for the second test. A variation of the pre-incubation assay was used in which the tubes were incubated at 27 deg C for 30 minutes with shaking before the addition of the agar overlay. Only 5 concentrations were used in this second test.
NUMBER OF REPLICATIONS:
3 replicates/strain
DETERMINATION OF CYTOTOXICITY
Any toxic effects of the test substance would be detected by a substantial reduction in revertant colony counts or by the absence of a complete bacterial lawn. - Evaluation criteria:
- For a test to be considered valid, the mean of the solvent control and revertant colony numbers for each bacterial strain should lie in the range as stated in the appropriate Standard Operating Procedure or quoted by Gatehouse et al. (1990). Also, the positive control substance must cause at least a doubling of mean revertant colony numbers over the negative control.
The mean number of revertant colonies for all treatment groups were compared with those obtained for the solvent control groups. The mutagenic activity of the test substance was assessed by applying the following criteria:
a) If treatment produced an increase in revertant colony numbers of at least twice the concurrent controls, with some evidence of a positive dose-response, in two separate experiments, with any bacterial strain in the presence or absence of S9 mix, it was considered evidence of a mutagenic response. No statistical analysis was performed.
b) If treatment did not cause a reproducible increase of at least 1.5 times the concurrent solvent controls in either mutation test, it was considered to show no evidence of mutagenic activity. No statistical analysis was performed.
c) If results failed to satisfy the criteria for clear positive or clear negative response, additional testing would be performed to resolve the issue of the mutagenic activity.
If no clear positive or negative response could be obtained, the test data may be subjected to analysis to determine the statistical significance of any observed increases in revertant colony numbers. The statistical procedures will be those of Mahon et al. (1989) and will usually be analysis of variance followed by Dunnett's test. - Statistics:
- See above.
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Refer to Tables 1 to 4 for complete study results.
- Conclusions:
- Interpretation of results (migrated information):
negative with or without S9 activation
It was concluded that, when tested in DMSO, HallBrite BHB showed no evidence of mutagenic activity in any of the bacterial strains tested. - Executive summary:
In a first test, no substantial increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to HallBrite BHB at any concentration in either the presence or absence of S9 mix. There was no measured cytotoxicity, as judged by thinning of the background lawn of non-revertant cells, following exposures. A top exposure concentration of 5000 microg/plate was then selected for use in a second test.
A second test gave results consistent with the first.
It was concluded that HallBrite showed no evidence of mutagenic activity in the bacterial systems tested.
Reference
Table 1: Results Test 1 With S9 Activation
Revertant colony counts (mean 3 replicates) |
|||||
Addition (micrograms/plate) |
TA98 |
TA100 |
TA1535 |
TA1537 |
E. coli |
Sterility Check |
0 |
0 |
0 |
0 |
0 |
5000 |
32 |
88 |
23 |
9 |
90 |
1500 |
43 |
97 |
22 |
14 |
91 |
500 |
37 |
100 |
19 |
11 |
91 |
150 |
45 |
90 |
27 |
9 |
99 |
50 |
38 |
109 |
23 |
13 |
92 |
15 |
30 |
94 |
25 |
11 |
96 |
5 |
32 |
104 |
24 |
14 |
96 |
DMSO (0.1 ml) |
37 |
92 |
21 |
16 |
96 |
2-Benzo[a]pyrene (5) |
311 |
431 |
- |
216 |
|
2-Aminoanthracene (2) |
200 |
||||
2-Aminoanthracene (10) |
231 |
Table 2: Results Test 1 Without S9 Activation
Revertant colony counts (mean 3 replicates) |
|||||
Addition (micrograms/plate) |
TA98 |
TA100 |
TA1535 |
TA1537 |
E. coli |
Sterility Check |
0 |
0 |
0 |
0 |
0 |
5000 |
34 |
86 |
17 |
15 |
92 |
1500 |
38 |
83 |
14 |
15 |
88 |
500 |
40 |
103 |
15 |
17 |
97 |
150 |
33 |
97 |
16 |
14 |
102 |
50 |
43 |
95 |
19 |
13 |
98 |
15 |
37 |
92 |
21 |
14 |
88 |
5 |
27 |
103 |
18 |
12 |
85 |
DMSO (0.1 ml) |
39 |
100 |
21 |
15 |
103 |
2-Nitrofluorene (1) |
314 |
||||
ENNG (3) |
344 |
||||
ENNG (5) |
109 |
||||
9-Aminoacridine (80) |
3812 |
||||
ENNG (2) |
963 |
Table 3: Results Test 2 (Pre-incubation) With S9 Activation
Revertant colony counts (mean 3 replicates) |
||||
Addition (micrograms/plate) |
TA98 |
TA100 |
TA1535 |
TA1537 |
Sterility Check |
0 |
0 |
0 |
0 |
5000 |
34 |
89 |
17 |
8 |
1500 |
32 |
93 |
19 |
10 |
500 |
35 |
98 |
16 |
9 |
150 |
39 |
91 |
14 |
8 |
50 |
32 |
92 |
17 |
12 |
DMSO (0.1 ml) |
35 |
97 |
19 |
11 |
2-Benzo[a]pyrene (5) |
291 |
372 |
164 |
|
2-Aminoanthracene (2) |
206 |
Table 4: Results Test 2 (Pre-incubatioin) Without S9 Activation
Revertant colony counts (mean 3 replicates) |
||||
Addition (micrograms/plate) |
TA98 |
TA100 |
TA1535 |
TA1537 |
Sterility Check |
0 |
0 |
0 |
0 |
5000 |
29 |
90 |
22 |
8 |
1500 |
28 |
94 |
25 |
9 |
500 |
36 |
91 |
18 |
10 |
150 |
31 |
98 |
23 |
11 |
50 |
36 |
79 |
14 |
10 |
DMSO (0.1 ml) |
30 |
99 |
18 |
10 |
2-Nitrofluorene (1) |
308 |
|||
ENNG (3) |
382 |
|||
ENNG (5) |
236 |
|||
9-Aminoacridine (80) |
2532 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Additional information from genetic toxicity in vitro:
In an guideline study (OECD 471/472) in bacterial S. typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvrA pkM 101, the subject material was negative for mutagenicity either in the presence or absence of rat liver S9 activation up to a maximum plate incorporation level of 5000 ug/plate.
The subject material was tested for clastogenicity in a guideline study (OECD 473) with cultured human lymphocytes either in the presence or absence of rat liver S9 activation. In a first test, cultures were exposed for 3 hours and harvested 17 hours later. In a second test, cultures receiving S9 were treated in the same way but cultures without S9 were tested continuously for 20 hours before harvest. There were no biologically or statistically significant increases in the frequency of chromosomal aberrations in the first study. In the second study and when gaps were excluded, there were statistically significant increases in aberration frequency at the highest exposure concentration of 2500 ug/mL in the presence of S9. However, the aberration frequency exceeded the historical control range in only one of the two replicates indicating a lack of reproducibility. Under the conditions of this test, the subject material was not considered a clastogen.
A surrogate material, 2 -ethylhexyl salicylate (CAS 118 -60 -5), was tested in a guideline OECD 476 study with Chinese hamster lung fibroblast (V79) cells. In a first experiment, the treatment period was 4 hours with and without metabolic activation. In a second experiment, treatment times of 4 hours with and 24 hours without metabolic activation were employed. No substantial and reproducible dose dependent increase in mutation frequencies (HPRT locus) was observed in either experiment. Under the conditions of the study, the surrogate material was judged to be negative for mutagenicity.
Justification for selection of genetic toxicity endpoint
Well conducted studies on the subject material or a surrogate following OECD guidelines 471, 472, 473 and 476 indicated a lack of genetic toxicity.
Justification for classification or non-classification
Based on the results of in vitro studies with either the subject material or a surrogate, the subject material would not be classified for Germ Cell Mutagenicity according to EU CLP (Regulation (EC) No. 1272/2008).
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