Registration Dossier
Registration Dossier
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EC number: 264-867-9 | CAS number: 64396-12-9
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:
- GLP study to OECD guidelines in 2017
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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:
- Dodecenylsuccinic acid, compound with 2,2',2''-nitrilotriethanol (1:1)
- EC Number:
- 264-867-9
- EC Name:
- Dodecenylsuccinic acid, compound with 2,2',2''-nitrilotriethanol (1:1)
- Cas Number:
- 64396-12-9
- Molecular formula:
- C16H28O4.C6H15NO3
- IUPAC Name:
- Succinic acid, dodecenyl-, triethanolamine salt (1:1)
- Test material form:
- liquid
- Details on test material:
- Commercial grade containing approximately 45% actives
Constituent 1
- Specific details on test material used for the study:
- Identification:
Physical state/Appearance: Slightly opaque amber coloured viscous liquid
Batch: KB17040598
Purity: 41.6%
Expiry Date: 01 May 2019
Storage Conditions: Room temperature in the dark
Formulated concentrations were adjusted to allow for the stated water/impurity content (58.4%) of the test item.
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver homogenate metabolising system (10% liver S9 in standard co-factors)
- Test concentrations with justification for top dose:
- The dose range for Experiment 1 was 1.5 to 5000 μg/plate actives
The dose range for Experiment 2 was 5 to 5000 μg/plate actives - Vehicle / solvent:
- Water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- 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)
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Without S-9, > 500 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Without S-9, > 1500 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Without S-9 > 1500 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Without S-9 > 1500 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Without S-9 > 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Slight cytotoxicty at highest concentrations only seen in the second experiment
No precipitate
Applicant's summary and conclusion
- Conclusions:
- Negative at up to limits of toxicity at ca 5000 ug/plate actives
This is consistent with expectation of alkly succinic acids and tertiary amines
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