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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:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Adopted according to OECD SIDS (public available peer reviewed source). The original source is not available and has not been reviewed.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
1,3-Dichlorobut-2-ene - CAS No: 926-57-8
Author:
OECD SIDS
Year:
2007
Bibliographic source:
SIDS Initial Assessment Report for 22th SIAM, UNEP Publications
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Only 4 strains tested
Principles of method if other than guideline:
The assay was performed in the presence and absence of a rat-liver homogenate activation system similar to the method described by Ames et al. (1975). Mutat. Res., 31:347-364.
GLP compliance:
no
Remarks:
GLP was not mandatory at the time of the study
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,3-dichlorobut-2-ene
-Analytical purity: 99.5% (cis and trans)

Method

Target gene:
his operone
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9 mix from rat
Test concentrations with justification for top dose:
0, 10, 50, 100, 500, 1000, 2500 ug/plate (without metabolic activation); 0, 50, 100, 500, 1000, 2500 µg/plate (with metabolic activation)
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
N-ethyl-N-nitro-N-nitrosoguanidine
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: chloroethene
Details on test system and experimental conditions:
METHOD OF APPLICATION in agar (plate incorporation); preincubation; Spot Test in a Closed System; Plate Assay - Volatile Liquids

Evaluation criteria:
The test sample was classified as a non-mutagen when: 1) the probability was greater than 0.05 that the numbers of revertants at each of the test sample concentrations studied were not greater than the number of revertants in the solvent control and 2) the probability was greater than 0.05 that there was not a positive correlation between the numbers of revertants and increasing concentrations of the test substance.
The test substance was classified as a mutagen when: 1) the probability was less than 0.01 that the numbers of revertants at one or more of the test sample concentrations studied was not greater than the number of revertants in the solvent control, and 2) the probability was less than 0.01 that there was not a positive correlation between the number of revertants and increasing concentrations of the test substance.
Statistics:
Two analyses were performed. In the first analysis, the response observed at each concentration was compared to the control by a t-test of significance. In the second analysis, the significance of the dose-response relationship was tested. Linear, quadratic, and higher order dose-response effects were tested in an F-test of significance. In addition, an analysis was conducted to determine whether the dose-response was different in different trials

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with
Genotoxicity:
positive
Remarks:
TA100, plate incorporation assay
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
without
Genotoxicity:
positive
Remarks:
TA100, volatile liquid assay
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with
Genotoxicity:
positive
Remarks:
TA100 and TA1535, volatile liquid assay
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 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
positive
Remarks:
TA 1535, without an activation system in trial 2 of the volatile liquid assay, but not in trial 1
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
not valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive