Reaction mass of 1,4-dichlorobut-2-ene; 3,4-dichlorobut-1-ene

Genetic toxicity: in vitro

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

Reference

Reference 1

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 2

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

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

Test material information

Constituent 1

Reference substance name:

1,4-dichlorobut-2-ene

EC Number:

212-121-8

EC Name:

1,4-dichlorobut-2-ene

Cas Number:

764-41-0

Molecular formula:

C4H6Cl2

IUPAC Name:

1,4-dichlorobut-2-ene

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

Controls

Controls 1

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.

Controls 2

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.

Controls 3

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.

Controls 4

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.

Controls 5

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 results

Test results 1

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

Test results 2

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

Test results 3

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)