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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

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:
28 April 2010 to 11 May 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to internationally accepted guidelines and to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial gene mutation assay

Test material

Constituent 1
Reference substance name:
13319-75-0
IUPAC Name:
13319-75-0
Constituent 2
Reference substance name:
Boron trifluoride dihydrate
IUPAC Name:
Boron trifluoride dihydrate
Details on test material:
- Name of test material (as cited in study report): Boron Trifluoride Dihydrate
- Physical state: Colourless liquid
- Analytical purity: 66.0% BF3 content; 44.0% water content
- Purity test date: 10 November 2009
- Lot/batch No.: R.F. L.A.P. 154.19
- Expiration date of the lot/batch: November 2014
- Storage condition of test material: Room temperature

Method

Species / strainopen allclose all
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 liver homogenate S9 mix
Test concentrations with justification for top dose:
5, 15, 50, 150, 500, 1500, 5000 µg per plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: test substance soluble in water
Controlsopen allclose all
Untreated negative controls:
yes
True negative controls:
no
Positive controls:
yes
Remarks:
sodium azide (2 µg/plate for strains TA100 and TA1535), 9-aminoacridine (50 μg/plate for strain TA1537) , 2-nitrofluorene (2 μg/plate for strain TA98), 4-nitroquinoline-N-oxide 2 μg/plate for strain WP2 uvrA (pKM101)
Remarks:
Absence of S9 mix
Untreated negative controls:
yes
True negative controls:
no
Positive controls:
yes
Remarks:
2-Aminoanthracene
Remarks:
5 μg/plate for strains TA100 and TA1535, 10 μg/plate for strain WP2 uvrA (pKM101); presence of S9 mix
Untreated negative controls:
yes
True negative controls:
no
Positive controls:
yes
Remarks:
benzo(a)pyrene (5 μg/plate for strains TA98 and TA1537)
Remarks:
Presence of S9 mix
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation

DURATION
- Preincubation period: 30 minutes
- Exposure duration: 72 hours

NUMBER OF REPLICATIONS: 3 per concentration
Evaluation criteria:
For a test to be considered valid, the mean of the vehicle control revertant colony numbers for each strain should lie within or close to the 99% confidence limits of the current historical control range of the laboratory unless otherwise justified by the Study Director. The historical range is maintained as a rolling record over a maximum of five years. Also, the positive control compounds must induce an increase in mean revertant colony numbers of at least twice (three times in the case of strains TA1535 and TA1537) the concurrent vehicle controls. Mean viable cell counts in the 10-hour bacterial cultures must be at least 10E9/mL.
If exposure to a test substance produces a reproducible increase in revertant colony numbers of at least twice (three times in the case of strains TA1535 and TA1537) the concurrent vehicle controls, with some evidence of a positive dose-response relationship, it is considered to exhibit mutagenic activity in this test system. No statistical analysis is performed.

Results and discussion

Test resultsopen allclose all
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:
not determined
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
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:
not determined
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Results obtained in the presence of metabolic activation: test 1
Strain Addition Concentration per plate Mean revertants per plate Standard Deviation Fold increase relative to vehicle Individual revertant
colony counts
TA98 Water   28.3 0.6   28, 29, 28
  Boron Trifluoride Dihydrate 5 µg 35.7 5.9 1.3 40, 29, 38
  15 µg 34.3 3.5 1.2 34, 31, 38
  50 µg 33.3 4.0 1.2 29, 37, 34
  150 µg 27.3 1.5 1.0 29, 26, 27
  500 µg 32.7 5.5 1.2 38, 33, 27
  1500 µg 28.3 1.2 1.0 29, 29, 27
  5000 µg 28.7 0.6 1.0 29, 28, 29
TA100 Water   168.0 8.2   177, 161, 166
  Boron Trifluoride Dihydrate 5 µg 162.0 8.9 1.0 159, 155, 172
  15 µg 153.0 17.4 0.9 133, 165, 161
  50 µg 164.7 11.0 1.0 154, 164, 176
  150 µg 145.3 24.9 0.9 164, 117, 155
  500 µg 138.3 18.9 0.8 160, 130, 125
  1500 µg 149.0 28.5 0.9 178, 121, 148
  5000 µg 136.7 16.0 0.8 153, 121, 136
TA1535 Water   20.7 4.2   16, 24, 22
  Boron Trifluoride Dihydrate 5 µg 20.3 0.6 1.0 20, 21, 20
  15 µg 20.7 4.9 1.0 24, 23, 15
  50 µg 17.7 2.5 0.9 20, 18, 15
  150 µg 19.3 1.2 0.9 20, 18, 20
  500 µg 18.7 2.3 0.9 16, 20, 20
  1500 µg 19.3 2.9 0.9 16, 21, 21
  5000 µg 16.7 0.6 0.8 16, 17, 17
TA1537 Water   10.7 1.2   12, 10, 10
  Boron Trifluoride Dihydrate 5 µg 11.0 4.0 1.0 15, 7, 11
  15 µg 15.3 2.9 1.4 17, 17, 12
  50 µg 10.7 5.5 1.0 11, 5, 16
  150 µg 11.7 0.6 1.1 12, 12, 11
  500 µg 11.0 1.7 1.0 12, 12, 9
  1500 µg 9.0 3.0 0.8 9, 6, 12
  5000 µg 10.3 1.2 1.0 11, 11, 9
WP2 uvrA  Water   129.7 14.6   132, 114, 143
(pKM101) Boron Trifluoride Dihydrate 5 µg 123.3 7.1 1.0 122, 117, 131
  15 µg 127.3 8.1 1.0 120, 136, 126
  50 µg 134.7 5.8 1.0 128, 138, 138
  150 µg 117.0 2.6 0.9 115, 120, 116
  500 µg 113.3 18.6 0.9 94, 131, 115
  1500 µg 128.0 8.2 1.0 137, 121, 126
  5000 µg 103.0 10.8 0.8 100, 115, 94
TA98 2NF 2 µg 220.7 27.5 7.8 248, 221, 193
TA100 NaN3 2 µg 493.0 74.0 2.9 557, 510, 412
TA1535 NaN3 2 µg 1130.7 173.7 54.7 1259, 1200, 933
TA1537 AAC 50 µg 1158.7 54.3 108.6 1189, 1191, 1096
WP2 uvrA (pKM101) NQO 2 µg 1869.7 74.6 14.4 1793, 1874, 1942

Results obtained in the presence of metabolic activation: test 1

Strain Addition Concentration per plate Mean revertants per plate Standard Deviation Fold increase relative to vehicle Individual revertant
colony counts
TA98 Water   42.3 3.1   39, 45, 43
  Boron Trifluoride Dihydrate 5 µg 46.7 4.0 1.1 51, 43, 46
  15 µg 43.3 5.7 1.0 48, 37, 45
  50 µg 49.3 6.5 1.2 49, 56, 43
  150 µg 39.3 7.2 0.9 31, 44, 43
  500 µg 44.7 1.5 1.1 43, 46, 45
  1500 µg 39.0 6.6 0.9 38, 46, 33
  5000 µg 42.7 2.5 1.0 43, 45, 40
TA100 Water   197.3 10.1   209, 191, 192
  Boron Trifluoride Dihydrate 5 µg 195.7 32.6 1.0 232, 169, 186
  15 µg 176.0 45.2 0.9 167, 136, 225
  50 µg 183.3 23.6 0.9 175, 210, 165
  150 µg 206.7 32.5 1.0 232, 218, 170
  500 µg 186.3 10.7 0.9 192, 174, 193
  1500 µg 179.3 22.9 0.9 161, 172, 205
  5000 µg 195.3 11.7 1.0 185, 208, 193
TA1535 Water   23.7 3.1   27, 21, 23
  Boron Trifluoride Dihydrate 5 µg 17.3 0.6 0.7 17, 18, 17
  15 µg 18.0 1.7 0.8 20, 17, 17
  50 µg 19.7 1.5 0.8 18, 21, 20
  150 µg 18.7 2.9 0.8 17, 22, 17
  500 µg 19.7 3.5 0.8 23, 20, 16
  1500 µg 19.7 4.5 0.8 24, 20, 15
  5000 µg 21.0 1.7 0.9 20, 23, 20
TA1537 Water   30.7 2.5   31, 33, 28
  Boron Trifluoride Dihydrate 5 µg 27.0 7.5 0.9 26, 20, 35
  15 µg 24.3 2.3 0.8 27, 23, 23
  50 µg 32.3 5.1 1.1 28, 31, 38
  150 µg 28.3 2.5 0.9 31, 28, 26
  500 µg 29.0 9.2 0.9 39, 21, 27
  1500 µg 29.0 3.5 0.9 27, 27, 33
  5000 µg 25.7 2.5 0.8 26, 28, 23
WP2 uvrA  Water   144.3 19.7   152, 122, 159
(pKM101) Boron Trifluoride Dihydrate 5 µg 153.0 17.8 1.1 159, 133, 167
  15 µg 147.0 14.2 1.0 131, 152, 158
  50 µg 144.0 21.7 1.0 131, 132, 169
  150 µg 141.0 9.5 1.0 142, 150, 131
  500 µg 147.7 13.3 1.0 163, 141, 139
  1500 µg 149.7 6.8 1.0 152, 142, 155
  5000 µg 137.3 5.1 1.0 136, 143, 133
TA98 B[a]P 5 µg 225.0 43.9 5.3 273, 187, 215
TA100 AAN 5 µg 2877.3 645.7 14.6 3324, 3171, 2137
TA1535 AAN 5 µg 410.0 45.1 17.3 453, 414, 363
TA1537 B[a]P 5 µg 148.3 8.1 4.8 154, 152, 139
WP2 uvrA (pKM101) AAN 10 µg 465.7 3.5 3.2 469, 462, 466

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

It is concluded that Boron Trifluoride Dihydrate showed no evidence of mutagenic activity in this bacterial system under the test conditions employed.
Executive summary:

In this in vitro assessment of the mutagenic potential of Boron Trifluoride Dihydrate (OECD 473, GLP) histidine-dependent auxotrophic mutants ofSalmonella typhimurium, strains TA1535, TA1537, TA98 and TA100, and a tryptophan-dependent mutant ofEscherichia coli, strain WP2 uvrA (pKM101), were exposed to Boron Trifluoride Dihydrate diluted in water. Water was also used as a negative control.

Two independent mutation tests were performed in the presence and absence of liver preparations (S9 mix) from rats treated with phenobarbital and 5,6-benzoflavone. The first test was a standard plate incorporation assay; the second included a pre-incubation stage.

Concentrations of Boron Trifluoride Dihydrate up to 5000 µg/plate were tested.

No signs of toxicity were observed towards the tester strains in the first mutation test.  Toxicity (observed as slight thinning of the background lawn of non-revertant colonies, together with a reduction in revertant colony numbers) was seen in all strains following exposure to Boron Trifluoride Dihydrate at 5000 µg/plate in the second mutation test.

No evidence of mutagenic activity was seen at any concentration of Boron Trifluoride Dihydrate in either mutation test.

The concurrent positive controls demonstrated the sensitivity of the assay and the metabolising activity of the liver preparations. The mean revertant colony counts for the vehicle controls were within or close to the 99% confidence limits of the current historical control range of the laboratory.

In conclusion Boron Trifluoride Dihydrate showed no evidence of mutagenic activity in this bacterial system under the test conditions employed.