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EC number: 941-810-2 | CAS number: -
- 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
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Start of experimental phase: 04 July 2017; End of experimental phase: 31 July 2017; Study completion: 06 November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Adopted July 1997
- Deviations:
- yes
- Remarks:
- - Test item formulation in the preliminary toxicity test was carried out without correction for the test item displacement - In the Preincubation method, the test item was assayed at a maximum concentration of 10000 µg/plate, instead of 5000 µg/plate
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sophorolipids: fermentation products of glucose and fatty acids, C18-unsatd., esters with glycerol with yeast Candida Bombicola, partially hydrolysed
- EC Number:
- 941-809-7
- IUPAC Name:
- Sophorolipids: fermentation products of glucose and fatty acids, C18-unsatd., esters with glycerol with yeast Candida Bombicola, partially hydrolysed
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- The test item was examined for the ability to induce gene mutations in tester strains of Salmonella typhimurium and Escherichia coli, as measured by reversion of auxotrophic strains to prototrophy.
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Remarks:
- The E.coli used for this study was the strain WP2 uvrA.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver homogenate from rats pre-treated with Phenobarbital and 5,6-Benzoflavone.
- Test concentrations with justification for top dose:
- Preliminary toxicity test: 5000, 1580, 500, 158 and 50.0 µg/plate
Main Assay I:
- TA1535, WP2 uvrA, TA98: ± S9: 5000, 2500, 1250, 625 and 313 µg/plate
- TA1537: ± S9: 5000, 2500, 1250, 625, 313 and 156 µg/plate
- TA100 : ± S9: 2500, 1250, 625, 313 ,156 and 78.1 µg/plate
Main Assay II:
- TA1535, WP2 uvrA: ± S9: 10000, 5000, 2500, 1250 and 625 µg/plate
- TA100: :+ S9: 10000, 5000, 2500, 1250 and 625 µg/plate
- TA1537, TA100: - S9: 5000, 2500, 1250, 625, 313 and 156 µg/plate
- TA1537: +S9: 10000, 5000, 2500, 1250, 625 and 313 µg/plate
- TA98: ± S9: 10000, 5000, 2500, 1250, 625 and 313 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: sterile water for injection.
- Justification for choice of solvent/vehicle: compatible with the survival of the bacteria and the S9 metabolic activity.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene
- Remarks:
- Marked increases in revertant numbers were obtained in these tests following treatment with the positive control items, indicating that the assay system was functioning correctly.
- Details on test system and experimental conditions:
- The preliminary toxicity test and the first experiment were performed using a plate-incorporation method.
The second experiment was performed using a pre-incubation method. - Evaluation criteria:
- For the test item to be considered mutagenic, two-fold (or more) increases in mean revertant numbers must be observed at two consecutive dose levels or at the highest practicable dose level only. In addition, there must be evidence of a dose-response relationship showing increasing numbers of mutant colonies with increasing dose levels.
- Statistics:
- Doubling rate (Chu et al. 1981); Regression line.
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:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- 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
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- 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:
- cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The test item did not induce two-fold increases in the number of revertant colonies, in the plate incorporation or pre-incubation assay, at any dose level, in any tester strain, in the absence or presence of S9 metabolism.
Applicant's summary and conclusion
- Conclusions:
- It is concluded that the test item does not induce reverse mutation in Salmonella typhimurium or Escherichia coli in the absence or presence of S9 metabolism, under the reported experimental conditions.
- Executive summary:
The test item HH-2015-623 was examined for the ability to induce gene mutations in tester strains of Salmonella typhimurium and Escherichia coli, as measured by reversion of auxotrophic strains to prototrophy. The five tester strains TA1535, TA1537, TA98, TA100 and WP2 uvrA were used. Experiments were performed both in the absence and presence of metabolic activation, using liver S9 fraction from rats pre-treated with phenobarbital and 5,6-benzoflavone.
The test item was used as a solution in sterile water for injection.
Toxicity test
The test item HH-2015-623 was assayed in the toxicity test at a maximum concentration of 5000 µg/plate and at four lower concentrations spaced at approximately half-log intervals: 1580, 500, 158 and 50.0 µg/plate. No precipitation of the test item was observed at the end of the incubation period at any concentration tested in the absence or presence of S9 metabolic activation. Toxicity, as indicated by thinning of the background lawn and/or reduction in revertant colonies, was observed with TA1537 and TA100 tester strains at the highest or two highest dose levels both in the absence and presence of S9 metabolic activation. No increase in revertant numbers was observed at any concentration tested with any tester strain/activation condition combinations.
Main Assays
On the basis of toxicity test results, in Main Assay I, using the plate incorporation method, the test item was assayed at the following dose levels:
- TA1535, WP2 uvrA, TA98: ± S9: 5000, 2500, 1250, 625 and 313 µg/plate
- TA1537: ± S9: 5000, 2500, 1250, 625, 313 and 156 µg/plate
- TA100 : ± S9: 2500, 1250, 625, 313 ,156 and 78.1 µg/plate
Toxicity was observed at the highest or two highest dose levels with TA1537 tester strain both in the absence and presence of S9 metabolism and with TA100 only in its absence. As no relevant increase in revertant numbers was observed at any concentration tested, Main Assay II was performed including a pre-incubation step for all treatments.The following dose levels were used:
- TA1535, WP2 uvrA: ± S9: 10000, 5000, 2500, 1250 and 625 µg/plate
- TA100: :+ S9: 10000, 5000, 2500, 1250 and 625 µg/plate
- TA1537, TA100: - S9: 5000, 2500, 1250, 625, 313 and 156 µg/plate
- TA1537: +S9: 10000, 5000, 2500, 1250, 625 and 313 µg/plate
- TA98: ± S9: 10000, 5000, 2500, 1250, 625 and 313 µg/plate
Toxicity, as indicated by thinning of the background lawn and/or reduction in revertant numbers, was observed at the highest dose level tested with TA1537 and TA100 tester strains both in the absence and presence of S9 metabolism.
No precipitation of the test item was observed at the end of the incubation period in any experiment, at any concentration tested, in the absence or presence of S9 metabolic activation.
The test item did not induce two-fold increases in the number of revertant colonies in the plate incorporation or pre-incubation assay, at any dose level, in any tester strain, in the absence or presence of S9 metabolism.
Conclusion
It is concluded that the test item HH-2015-623 does not induce reverse mutation in Salmonella typhimurium or Escherichia coli in the absence or presence of S9 metabolism, under the reported experimental conditions.
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