Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 268-159-0 | CAS number: 68015-93-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- key study
- Study period:
- 27 Oct 2015 to 23 March 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Refer to the main study report
- GLP compliance:
- yes
- Remarks:
- Refer to the main study report
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Octadec-2-enylsuccinic acid
- EC Number:
- 268-159-0
- EC Name:
- Octadec-2-enylsuccinic acid
- Cas Number:
- 68015-93-0
- Molecular formula:
- C22H40O4
- IUPAC Name:
- 2-octadec-2-en-1-ylsuccinic acid
- Test material form:
- other: Pale amber waxy solid (per Certificate of Analysis)
- Details on test material:
- - Name of test material (as cited in study report): EXP1505385
- Molecular weight (if other than submission substance): 368.6 g/mol
- Physical state: Pale amber waxy solid (per Certificate of Analysis)
- Analytical purity: 100%
- Composition of test material, percentage of components: >=90-<=100% Alkyl ester carboxylic acid
- Purity test date: 08 Oct 2015
- Lot/batch No.: E00974-38D&F(Batch/Lot/Notebook Ref No) E00350-288 (Label Lot)
- Expiration date of the lot/batch: 22 Jun 2018
- Storage condition of test material: Room temperature, protected from light
Constituent 1
Method
- Target gene:
- The Salmonella strains contain mutations in the histidine operon, thereby imposing a requirement for histidine in the growth medium. These strains contain the deep rough (rfa) mutation, which deletes the polysaccharide side chain from the lipopolysaccharides of the bacterial cell surface. This increases cell permeability of larger substances. The other mutation is a deletion of the uvrB gene, which codes for a protein of the DNA nucleotide excision repair system, resulting in an increased sensitivity in detecting many mutagens. This deletion also includes the nitrate reductase (chi) and biotin (bio) genes (bacteria require biotin for growth). Tester strains TA98 and TA100 contain the R-factor plasmid, pKM101. These strains are reverted by a number of mutagens that are detected weakly or not at all with the non-R-factor parent strains. pKM101 increases chemical and spontaneous mutagenesis by enhancing an error-prone DNA repair system, which is normally present in these organisms. The tester strain Escherichia coli WP2 uvrA carries the defect in one of the genes for tryptophan biosynthesis. Tryptophan-independent mutants (revertants) can arise either by a base change at the site of the original alteration or by a base change elsewhere in the chromosome so that the original defect is suppressed. This second possibility can occur in several different ways so that the system seems capable of detecting all types of mutagens, which substitute one base for another. Additionally, the strain is deficient in the DNA nucleotide excision repair system.
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:
- Aroclor 1254-induced rat liver S9
- Test concentrations with justification for top dose:
- Preliminary toxicity assay: 6.67, 10.0, 33.3, 66.7, 100, 333, 667, 1000, 3333 and 5000 µg per plate for all test conditions
Mutagenicity assay: 33.3, 100, 333, 1000, 3333 and 5000 µg per plate (for TA98, TA1537 and WP2A uvrA) and 1.00, 3.33, 10.0, 33.3, 100, 333 and 1000 µg per plate (for TA100 and TA1535) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO (test substance, 2 aminoanthracene, 2-nitrofluorene, 9-aminoacridine, methyl methanesulfonate); water (sodium azide)
- Justification for choice of solvent/vehicle: DMSO was the vehicle of choice based on the solubility of the test substance and compatibility with the target cells. The test substance formed a clear solution in DMSO at a concentration of approximately 500 mg/mL with sonication at 35.8ºC for 10 minutes in the solubility test conducted at BioReliance.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 to 72 hours
NUMBER OF REPLICATIONS: 1 in the preliminary toxicity assay; 3 in the mutagenicity assay
NUMBER OF CELLS EVALUATED: >/= 0.3 * 10^8 cells/plate
DETERMINATION OF CYTOTOXICITY
- Method: other: Counting of revertant colony numbers and evaluation of the condition of the bacterial background lawn. - Evaluation criteria:
- The revertant colony numbers were determined for each plate (counted either manually or by automatic colony counter). The mean and standard deviation of the number of revertants per plate were calculated and reported.
For the test article to be evaluated positive (mutagenic), it must cause a dose-related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentrations of test article as specified below:
Strains TA1535 and TA1537
Data sets were judged positive if the increase in mean revertants at the peak of the dose response was equal to or greater than 3.0-times the mean vehicle control value.
Strains TA98, TA100 and WP2 uvrA
Data sets were judged positive if the increase in mean revertants at the peak of the dose response was equal to or greater than 2.0-times the mean vehicle control value.
An equivocal response is a biologically relevant increase in a revertant count that partially meets the criteria for evaluation as positive. This could be a dose-responsive increase that does not achieve the respective threshold cited above or a non-dose responsive increase that is equal to or greater than the respective threshold cited. A response was evaluated as negative if it was neither positive nor equivocal. - Statistics:
- According to the test guidelines, the biological relevance of the results is the criterion for the interpretation of the results, and a statistical evaluation of the results is not regarded as necessary.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Toxicity, either background or as a reduction in revertant count, was observed beginning at 100 or at 1000 µg per plate with tester strains TA100 and TA1535 in the presence and absence of S9 activation
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- 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):
negative
Under the conditions of this study, The Substance did not induce reverse mutations at selected loci of several tester strains in either the presence or absence of Aroclor induced rat liver S9. A confirmatory (independent repeat) assay was not required as the study was concluded to be unequivocally negative - Executive summary:
The test Substance was tested to evaluate its mutagenic potential by measuring its ability to induce reverse mutations at selected loci of several strains of Salmonellatyphimuriumand at the tryptophan locus ofEscherichia colistrain WP2 uvrA in the presence and absence of an exogenous metabolic activation system. Dimethyl Sulfoxide (DMSO) was used as the vehicle. All criteria for a valid study were met as described in the protocol.
In the preliminary toxicity assay, the dose levels tested were 6.67, 10.0, 33.3, 66.7, 100, 333, 667, 1000, 3333 and 5000 µg per plate. Precipitate of the test material was observed from3333-5000 µg per plate. Toxicity, either background or as a reduction in revertant count, was observed beginning at 33.3, 66.7, 100 or 333 µg per plate with tester strains TA100 and TA1535 in the presence and absence of S9 activation. No toxicity was observed in other tester strains treated. Based upon these results, the maximum dose tested in the mutagenicity assay was 5000 µg per plate (for TA98, TA1537 and WP2AuvrA) and 1000 µg per plate (for TA100 and TA1535).
In the mutagenicity assay, the dose levels tested were 33.3, 100, 333, 1000, 3333 and 5000 µg per plate (for TA98, TA1537 and WP2AuvrA) and 1.00, 3.33, 10.0, 33.3, 100, 333 and 1000 µg per plate (for TA100 and TA1535). Precipitate was observed from 3333-5000 µg per plate. Toxicity, either background or as a reduction in revertant count, was observed beginning at 100 or at 1000 µg per plate with test strains TA100 and TA1535 in the presence and absence of S9 activation. No toxicity was observed in other tester strains treated. No positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation.
All criteria for a valid study were met as described in the protocol. Under the conditions of this study, test Substance was negative for the ability to induce reverse mutations at selected loci of several strains ofSalmonellatyphimurium and at the tryptophan locus of Escherichia colistrain WP2 uvrA in the presence and absence of an exogenous metabolic activation system.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.