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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
Study period:
1974
Reliability:
2 (reliable with restrictions)
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:
1,4-Dichlorobut-2-ene- CAS No: 764-41-0
Author:
OECD SIDS
Year:
2006
Bibliographic source:
SIDS Initial Assessment Report for 22th SIAM, UNEP Publications
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Only 3 strains were tested
Principles of method if other than guideline:
Plate and suspension test
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): 1,4-dichlorobut-2-ene
- Analytical purity: no data

Method

Target gene:
his operon
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA 1535, TA 1537, TA 1538
Metabolic activation:
with and without
Metabolic activation system:
S9 mix from liver, lung and testes from rats, mice or monkeys
Test concentrations with justification for top dose:
0.03 and 0.063 %
Vehicle / solvent:
saline or DMSO were used as solvent controls
Controlsopen allclose all
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
Solvent controls with saline or DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
ethylmethanesulphonate
Remarks:
Migrated to IUCLID6: -S9. Dose not reported.
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
Solvent controls with saline or DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-nitrosofluorene, -S9. Dose not reported.
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
Solvent controls with saline or DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: quinacrine mustard, -S9. Dose not reported.
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
Solvent controls with saline or DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: Dimethylnitrosamine, +S9. Dose not reported.
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
Solvent controls with saline or DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
2-acetylaminofluorene
Remarks:
Migrated to IUCLID6: + S9. Dose not reported.
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation) and Suspension Tests

DETERMINATION OF CYTOTOXICITY
- Method: cell survival

Evaluation criteria:
No data
Statistics:
No data

Results and discussion

Test resultsopen allclose all
Species / strain:
other: Salmonella typhimurium TA 1535, TA 1537, TA 1538
Metabolic activation:
with and without
Genotoxicity:
positive
Remarks:
TA 1535 (Plate Tests)
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
no cell survival at 0.5 %
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
other: Salmonella typhimurium TA 1535, TA 1537, TA 1538
Metabolic activation:
without
Genotoxicity:
positive
Remarks:
highly mutagenic to strain TA-1535 and weakly mutagenic to strain TA-1538 (SUSPENSION TESTS)
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
no cell survival at 0.5 %
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
other: Salmonella typhimurium TA 1535, TA 1537, TA 1538
Metabolic activation:
with
Genotoxicity:
positive
Remarks:
TA-1535 (SUSPENSION TEST)
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
no cell survival at 0.5 %
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
PLATE TESTS
The substance was mutagenic at a concentration of 0.063 % (v/v; density 1.14 g/cm³; ca.720 µg/mL) in all plate tests with strain TA1535 with and without metabolic activation with S9 mix from liver, lung and testes from rats, mice or monkeys, respectively. No mutagenic effects were seen in any plate tests with TA-1537 or TA-1538 with and without metabolic activation.
SUSPENSION TESTS
The substance was highly mutagenic to strain TA-1535 and weakly mutagenic to strain TA-1538 without metabolic activation. In the presence of S9 mix from liver, lung or testes of mice the substance was mutagenic to strain TA-1535 only.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive TA 1535 (Plate Tests)