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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
2010-04-28 to 2010-05-11
Reliability:
2 (reliable with restrictions)
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)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial gene mutation assay

Test material

Constituent 1
Reference substance name:
13319-75-0
EC Number:
603-716-7
Cas Number:
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: Boron Trifluoride Dihydrate

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
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
TA100, TA1535 (without S9 mix)
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
TA1537 (without S9 mix)
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
TA98 (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:
WP2 uvr A pKM 101 (without S9 mix)
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-Aminoanthracene
Remarks:
TA100, TA1535, WP2 uvrA (pKM101) (with 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

 Results obtained in the absence of metabolic activation: Test 2

Results obtained in the absence of metabolic activation: Test
Strain Addition Concentration per plate Mean revertants per plate Standard Deviation Fold increase relative to vehicle Individual revertant
colony counts
TA98 Water 35.0 1.7 34, 37, 34
Boron Trifluoride Dihydrate 50 µg 37.0 4.4 1.1 42, 34, 35
150 µg 32.3 3.8 0.9 28, 34, 35
500 µg 32.0 5.2 0.9 35, 26, 35
1500 µg 28.7 4.6 0.8 26, 26, 34
5000 µg 11.7 4.6 0.3 17 S, 9 S, 9 S
TA100 Water 142.3 9.8 148, 148, 131
Boron Trifluoride Dihydrate 50 µg 142.7 9.3 1.0 149, 132, 147
150 µg 138.3 19.0 1.0 158, 120, 137
500 µg 134.0 7.0 0.9 134, 127, 141
1500 µg 133.7 11.5 0.9 145, 134, 122
5000 µg 75.7 35.3 0.5 35 S, 94 S, 98 S
TA1535 Water 23.7 2.1 26, 22, 23
Boron Trifluoride Dihydrate 50 µg 21.7 0.6 0.9 21, 22, 22
150 µg 19.0 2.6 0.8 22, 18, 17
500 µg 22.7 4.5 1.0 23, 18, 27
1500 µg 21.7 6.7 0.9 20, 29, 16
5000 µg 11.3 0.6 0.5 11 S, 12 S, 11 S
TA1537 Water 11.3 1.2 10, 12, 12
Boron Trifluoride Dihydrate 50 µg 11.0 2.0 1.0 13, 9, 11
150 µg 8.0 2.6 0.7 11, 6, 7
500 µg 10.3 0.6 0.9 11, 10, 10
1500 µg 7.3 2.5 0.6 7, 10, 5
5000 µg 2.7 1.2 0.2 2 S, 2 S, 4 S
WP2 uvrA  Water 150.0 3.0 153, 147, 150
(pKM101) Boron Trifluoride Dihydrate 50 µg 138.3 5.5 0.9 132, 142, 141
150 µg 136.3 14.2 0.9 121, 139, 149
500 µg 143.3 21.1 1.0 161, 149, 120
1500 µg 127.3 10.1 0.8 121, 122, 139
5000 µg 45.7 9.5 0.3 53 S, 35 S, 49 S
TA98 2NF 2 µg 167.0 2.6 4.8 166, 170, 165
TA100 NaN3 2 µg 611.7 90.1 4.3 714, 544, 577
TA1535 NaN3 2 µg 814.0 36.4 34.4 791, 856, 795
TA1537 AAC 50 µg 585.0 63.4 51.6 658, 544, 553
WP2 uvrA (pKM101) NQO 2 µg 1997.3 739.3 13.3 1167, 2241, 2584

Results obtained in the presence of metabolic activation: Test 2

Strain Addition Concentration per plate Mean revertants per plate Standard Deviation Fold increase relative to vehicle Individual revertant
colony counts
TA98 Water 50.3 2.3 53, 49, 49
Boron Trifluoride Dihydrate 50 µg 47.3 8.4 0.9 57, 43, 42
150 µg 40.7 7.6 0.8 49, 39, 34
500 µg 47.3 1.2 0.9 46, 48, 48
1500 µg 47.7 3.5 0.9 48, 51, 44
5000 µg 9.0 3.0 0.2 12 S, 6 S, 9 S
TA100 Water 156.0 8.2 149, 165, 154
Boron Trifluoride Dihydrate 50 µg 159.7 5.7 1.0 155, 158, 166
150 µg 145.0 20.0 0.9 122, 158, 155
500 µg 149.0 33.4 1.0 119, 185, 143
1500 µg 145.0 14.1 0.9 132, 160, 143
5000 µg 53.7 7.5 0.3 61 S, 46 S, 54 S
TA1535 Water 21.7 1.2 21, 21, 23
Boron Trifluoride Dihydrate 50 µg 17.3 1.2 0.8 18, 16, 18
150 µg 20.7 2.5 1.0 23, 21, 18
500 µg 21.3 1.5 1.0 23, 21, 20
1500 µg 19.3 1.2 0.9 18, 20, 20
5000 µg 5.3 0.6 0.2 5 S, 5 S, 6 S
TA1537 Water 30.3 1.2 29, 31, 31
Boron Trifluoride Dihydrate 50 µg 28.0 3.6 0.9 29, 31, 24
150 µg 32.0 3.6 1.1 28, 35, 33
500 µg 26.3 4.5 0.9 26, 31, 22
1500 µg 28.7 5.5 0.9 23, 34, 29
5000 µg 9.3 0.6 0.3 10 S, 9 S, 9 S
WP2 uvrA  Water 152.3 9.0 153, 161, 143
(pKM101) Boron Trifluoride Dihydrate 50 µg 147.7 13.1 1.0 158, 133, 152
150 µg 151.7 13.7 1.0 158, 136, 161
500 µg 129.3 14.0 0.8 116, 128, 144
1500 µg 135.3 12.3 0.9 125, 132, 149
5000 µg 66.3 4.7 0.4 68 S, 61 S, 70 S
TA98 B[a]P 5 µg 236.0 40.6 4.7 247, 270, 191
TA100 AAN 5 µg 1895.3 169.0 12.1 1705, 1953, 2028
TA1535 AAN 5 µg 412.3 101.7 19.0 523, 391, 323
TA1537 B[a]P 5 µg 168.7 11.9 5.6 165, 182, 159
WP2 uvrA (pKM101) AAN 10 µg 503.0 7.2 3.3 501, 497, 511

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative