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Toxicological information

Genetic toxicity: in vitro

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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:
1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
Deviations:
no
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Source: Wako Pure Chemcials Industries, Osaka,, Japan
- Purity 2-EH: 98%

Method

Species / strain
Species / strain / cell type:
other: bacteria. S. typhimurium TA98, TA100, TA1535, TA1537; TA1538; E. coli (WP2uvrA)
Additional strain / cell type characteristics:
other:
Metabolic activation:
with and without
Metabolic activation system:
rat liver S9 mix from polychlorinated biphenyl KC 500) induced male animals
Test concentrations with justification for top dose:
0, 1, 5, 10, 50, 100, 500, 1000 µg/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: experiments w/o S9 mix: AF-2 for TA100, TA 98, WP2uvrA; ENNG for TA 1535; 9AC for TA 1537, 4NQO for TA 1538; experiments with S9 mix: B(a)P for TA 100, TA 98, TA 1537 and TA 1538, 2AA for TA 1535 and WP2uvrA
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium; preincubation;

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hours
- Selection time (if incubation with a selection agent): 48 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 48 hours

SELECTION AGENT (mutation assays): histidine or tryptophan deficiency
SPINDLE INHIBITOR (cytogenetic assays): not applicable (n..a.)
STAIN (for cytogenetic assays): n.a.

NUMBER OF REPLICATIONS: 2

NUMBER OF CELLS EVALUATED: n.a.

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: no data

OTHER EXAMINATIONS:
- Determination of polyploidy: no
- Determination of endoreplication: no
Evaluation criteria:
no data
Statistics:
no data

Results and discussion

Test results
Species / strain:
other: S. typhimurioum and E.coli
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS

ADDITIONAL INFORMATION ON CYTOTOXICITY: growth inhibition was noted in all test strains except TA1537 at 500 and 1000 µg/plate
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Except for TA 1537 toxicity was observed at doses of 500 and 1000 µg/plate in
all tester strains.  
Mean number of revertants:
Dose (µg/plate)
TA100
TA1535
E. coli
WP uvrA
TA98
-S9
+S9
-S9
+S9
-S9
+S9
-S9
+S9
0 water
149
161
28
15
32
33
29
39
0 DMSO
150
154
30
15
30
34
32
42
1
144
170
39
23
32
31
24
44
5
166
171
23
19
30
26
33
61
10
161
149
26
18
27
31
29
48
50
155
147
33
13
26
33
28
57
100
133
151
19
14
28
33
37
51
500
0*
0*
0*
0*
0*
0*
0*
0*
1000
0*
0*
0*
0*
0*
0*
0*
0*
Positive control
501
1084
1101
440
1082
359
278
809
 

Dose (µg/plate)
TA1537
TA1538
-S9
+S9
-S9
+S9
0 water
16
21
21
28
0 DMSO
18
22
22
28
1
13
36
25
24
5
11
28
33
30
10
15
23
29
25
50
16
30
25
30
100
12
26
18
30
500
12
39
0*
0*
1000
16
28
0*
0*
Positive control
889
313
270
354
 0* = growth inhibition

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with and without metabolic activation

2-EH was not mutagenic in Salmonella typhimurium and E. coli with and without metabolic activation.
Executive summary:

The mutagenicity of 2 -EH was tested in bacterial test sytems (S. tyhimurium TA98, TA100, TA1535, TA1537, TA1538, and E. coli WP2 uvrA) according to OECD TG 471 and TG 472 both with and without metabolic activation in a dose range from 1 to 1000 µg/plate (Shimizu et al., 1985). 2 -EH did not increase the number of revertants in any of the test strains. Growth inhibition was seen at 500 and 1000 µg/plate. The negative and positive controls performed as expected. Therefore, 2 -EH was not mutagenic in baterial test systems in-vitro.