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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: genome mutation
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with restrictions: E. coli was not included to detect cross-linking, no data on cytotoxicity

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
E. coli was not included to detect cross-linking, no data on cytotoxicity
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
phenyl glycidyl ether
IUPAC Name:
phenyl glycidyl ether
Details on test material:
- Name of test material (as cited in study report): phenyl glycidyl ether
No further information.

Method

Species / strain
Species / strain / cell type:
other: S. typhimurium TA 1535, TA 97, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9 fraction from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver
Test concentrations with justification for top dose:
0, 3, 10, 33, 100, 166, 333, 666, 1000 µg/plate (TA1535, TA97 and TA100)
0, 10, 33, 100, 333, 1000 µg/plate (TA98)
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: with S9: 2-aminoanthracene (all strains); without S9: 2-nitrofluorene (TA98), sodium azide (TA100, TA1535), 9-aminoacridine (TA97),
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 Min.
Evaluation criteria:
No data.

Results and discussion

Test resultsopen allclose all
Species / strain:
other: S. typhimurium TA 1535, TA 97 and TA 100
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
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

Table 1:

Strain: TA100
Dose No Activation No Activation 10% HLI 10% HLI 10% RLI 10% RLI
(Positive) (Positive) (Positive) (Positive) (Positive) (Positive)
Protocol Preincubation Preincubation Preincubation Preincubation Preincubation Preincubation
ug/Plate Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM
0      143 3.2 119 14.2 125 8.6 123 7.2 123 3.7 112 7.1
3          138 1.2                
10      193 10.5 171 7.5 140 14.5     124 7.5    
33      342 16.5 278 22.8 131 10.6     122 17.3    
100      672 23.9 519 13.7 153 11.8 137 12 142 20.4 145 11.3
166                  158 7.8     153 8.6
333      1427 52.5 882 24.9 139x 72.9 232 18.5 297 18.2 259 15.1
666                  439 25.2     494 19.1
1000      1984 261.9     701 94.5 619 35.6 1087 53.4 657 16.6
Positive Control 694 18.1 368 15.8 1329 24.8 501 75.1 1007 35.3 689 15.1
Strain: TA1535
Dose No Activation No Activation 10% HLI 10% HLI 10% RLI 10% RLI
(Positive) (Positive) (Positive) (Positive) (Positive) (Positive)
Protocol Preincubation Preincubation Preincubation Preincubation Preincubation Preincubation
ug/Plate Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM
0      41 1.3 18 2 14 2.3 10 2 11 0.6 9 0.3
3          22 2.8                
10      105 8.2 31 2.8 11 2.6     13 2.5    
33      225 3.8 89 5.5 10 1.5     13 2.8    
100      463 20.2 193 7.1 14 4.2 15 1.3 21 3.3 13 0.9
166                  12 0.9     18 2.8
333      826 69.2 473 57.3 26 3.2 30 4.3 63 9.2 50 3
666                  157 4.6     187 11.8
1000      738 122.2     280 15.1 290 20.8 424 44.6 329 15.6
Positive Control 795 12.9 267 12.5 431 5.5 259 7.8 291 3.4 126 6.9
Strain: TA97
Dose No Activation No Activation 10% HLI 10% HLI 10% RLI 10% RLI
(Positive) (Positive) (Positive) (Positive) (Positive) (Positive)
Protocol Preincubation Preincubation Preincubation Preincubation Preincubation Preincubation
ug/Plate Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM Mean ± SEM
0      120 19.9 132 2.6 177 1.2 156 3.5 181 4.2 155 8.4
3          168 5.4                
10      185 16.3 179 8.4 216 17.4     196 9.9    
33      230 3.2 225 13.9 196 14.6     199 18.4    
100      338 4.9 343 16.4 212 6.4 171 12.9 215 14.3 209 4.2
166                  199 14.8     212 17.9
333      658 76.2 614 44.4 246 10.7 233 12.8 291 3.7 277 17.9
666                  403 18.6     494 14.8
1000      21 8.8     746 15.6 605 24.4 872 59.1 697 37.2
Positive Control 1514 22.1 364 23 910 42.6 546 10 666 36.9 436 6.4
Strain: TA98
Dose No Activation 10% HLI 10% RLI
(Negative) (Negative) (Negative)
Protocol Preincubation Preincubation Preincubation
ug/Plate Mean ± SEM Mean ± SEM Mean ± SEM
0      26 4.6 43 6.8 32 4.4
10      29 4 53 2 29 4.9
33      29 6.2 46 1.5 35 5.5
100      30 4.9 45 5 36 3.3
333      33 2.7 46 1 34 1.2
1000      31 3.3 52 5 40 3.5
Positive Control 973 20.8 1061 80.4 643 2.3
Abbreviations:
RLI = induced male Sprague Dawley rat liver S9
HLI = induced male Syrian hamster liver S9
s = Slight Toxicity; p = Precipitate; x = Slight Toxicity and Precipitate; T = Toxic; c = Contamination

Applicant's summary and conclusion