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EC number: 947-802-5 | CAS number: -
Toxicological information
Genetic toxicity: in vitro
Currently viewing:
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Light-induced genetic toxicity of thimerosal and benzalkonium chloride in commercial contact lens solutions
- Author:
- Thomas J. Lovely, David E. Levin and Ed Klekowski
- Year:
- 1 980
- Bibliographic source:
- Mutation Research, 101 (1982) 11-18 - Elsevier Biomedical Press
- Report date:
- 1980
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- plate incorporation asay
- Qualifier:
- according to guideline
- Guideline:
- other:
- Version / remarks:
- Rosenkranz E coli assay
- Principles of method if other than guideline:
- publication of (Ames 1975) served as basis for OECD guideline 471 : Ames, B.N., McCann, J. and Yamasaki, E. (1975). Methods for Detecting Carcinogens and Mutagens with the Salmonella/Mammalian-Microsome Mutagenicity Test. Mutation Res., 31, 347-364.
Secondary assay on E. Coli: Rosenkranz, H S, B Gutter and W T Speck, Microbial assay procedures Experience with two systems, in F J De Serres et al (Eds), In Vitro Metabolic Activation in Mutagene~ls Testing, Elsevier, Amsterdam, 1976, pp 337-361 - GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-Benzyl-N,N-dimethyl-1-tridecanaminium chloride
- Cas Number:
- 8001-54-5
- Molecular formula:
- C22H40ClN
- IUPAC Name:
- N-Benzyl-N,N-dimethyl-1-tridecanaminium chloride
- Reference substance name:
- Disodium dihydrogen ethylenediaminetetraacetate
- EC Number:
- 205-358-3
- EC Name:
- Disodium dihydrogen ethylenediaminetetraacetate
- Cas Number:
- 139-33-3
- Molecular formula:
- C10H16N2O8.2Na
- IUPAC Name:
- disodium dihydrogen 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate
- Details on test material:
- obtained from Sigma Chemical Co. Benzalkonlum chloride is a mixture of alkyldlmethylbenzylammonium chlorides.
Constituent 1
additive 1
Method
- Target gene:
- Histidine gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 1537
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- E. coli, other: strain W3110 (polA +) and the mutant strain p3478 (polA-)
- Additional strain / cell type characteristics:
- DNA polymerase A deficient
- Remarks:
- Increased sensitivity to UV light in mutants lacking the enzyme. Polymerase A strains have a reduced capacity to repair damaged DNA.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- Standard plate Incorporation assays were done with volumes of test solution ranging between 0.1 and 0.5 ml, with 0.1 ml of culture and 0.5 ml of $9 mix (if indicated) in 2.0 ml of top agar
Benzalkonium chloride doses 0.01%, 0.02%, 0.1%
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- disodium edetate
- True negative controls:
- yes
- Remarks:
- chloramphenicol
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- benzo(a)pyrene
- methylmethanesulfonate
- other: daunomycin for TA98,
- Details on test system and experimental conditions:
- Dark/ light: After incubation at 37°C for 48 h either in the dark, or under a combination of fluorescent(15 W) and incandescent (40W) lights (General Electric Cool White, 350 750 nm emission), at 24 inches, the plates were scored for His + revertant colonies. The fluence rate (556 nm) at this distance was 635 ~W/cm ~.
- Evaluation criteria:
- mutagenicity
Results and discussion
Test resultsopen allclose all
- Key result
- 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:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium, other: TA1536
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli, other: strain W3110 (polA +)
- Metabolic activation:
- not specified
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli, other: strain mutant p3478 (polA-)
- Remarks:
- increased sensitivity to UV light and reduced capacity to repair damaged DNA.
- Metabolic activation:
- not specified
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- no dose/response relationship, no replicate nor statistical analysis
Applicant's summary and conclusion
- Conclusions:
- Non mutagenic in the Ames test (protocole comparable to OECD 471 assay).
- Executive summary:
Non mutagenic in the Ames test (protocole comparable to OECD 471 assay).
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