Registration Dossier
Registration Dossier
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EC number: 271-766-3 | CAS number: 68607-67-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Guideline study to GLP, 2017
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Schiff bases, C11-14-tert-alkyl methylene
- EC Number:
- 271-766-3
- EC Name:
- Schiff bases, C11-14-tert-alkyl methylene
- Cas Number:
- 68607-67-0
- Molecular formula:
- C14H29N
- IUPAC Name:
- Schiff bases, C11-14-tert-alkyl methylene
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Batch Number:
HMK/370/12/1
CAS number:
68607-67-0
Purity:
>98% active of CAS number 68607-67-0
Physical state/Appearance:
Pale straw coloured liquid
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 in standard co-factors
- Test concentrations with justification for top dose:
- The dose range for Experiment 1 was predetermined and was 1.5 to 5000 μg/plate
Experiment 2 ranged between 0.15 and 1500 μg/plate, depending on bacterial strain type and presence or absence of S9-mix in view of toxicity at highest levels - Vehicle / solvent:
- Acetone
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-Aminoanthracene (2AA)
- Details on test system and experimental conditions:
- Experiment 1: eight concentrations of the test item (1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate) were assayed in triplicate against each tester strain, using the direct plate incorporation method.
Experiment 2: All strains (absence of S9): 0.15, 0.5, 1.5, 5, 15, 50, 150, 500 μg/plate and in presence of S9 0.5, 1.5, 5, 15, 50, 150, 500, 1500 μg/plate.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 1500 ug/plate with and > 500 ug/plate without S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 1500 ug/plate with and > 500 ug/plate without S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 1500 ug/plate with and > 500 ug/plate without S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 1500 ug/plate with and > 500 ug/plate without S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 1500 ug/plate with and > 500 ug/plate without S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Considered negative.
Tested up to toxicity limit, with greater toxicity in the absencve of S9
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