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EC number: 700-786-1 | 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Three in vitro genotoxicity studies were conducted with the test substance: OECD 471, OECD 476 and OECD 487, all performed under GLP conditions.
These studies were all negative for genotoxicity (mutagenicity and clastogenicity).
Link to relevant study records
- 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:
- 2003
- Reliability:
- 1 (reliable without restriction)
- 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
- Target gene:
- Salmonella thiphymurium TA1535 --> His G 46 --> additional mutations: rfa uvrB
Salmonella thiphymurium TA100 --> His G 46 --> additional mutations: rfa uvrB pKM 101
Salmonella thiphymurium TA102 --> His G 428 (pAQ1) --> additional mutations: rfa pKM 101
Salmonella thiphymurium TA1537 --> His C 3076 --> additional mutations: rfa uvrB
Salmonella thiphymurium TA98 --> His D 3052 --> additional mutations: rfa uvrB pKM 101 - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix - liver microsomal fraction (S9) of rats
- Test concentrations with justification for top dose:
- Based on the toxicity showed in the preliminary studies the doses were chosen as follows:
1st experiment with and without S9 mix: from 312.5 to 5000µg/plate, idem for TA102 in the 2nd one
2nd experiment: from 156.25 to 2500µg/plate - Vehicle / solvent:
- The tested substance sopholiance was dissolved in DMSO (dimethylsulfoxide).
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Remarks:
- 5 known mutagens tested to check sensitivity
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2-anthramine
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Conclusions:
- The tested substance sopholiance does not show any mutagenic activity in the bacterial reverse mutation test with Salmonella Typhimurium
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2020
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell gene mutation test using the Hprt and xprt genes
- Target gene:
- Mouse lymphoma
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- Lyophilized S-9 mix (MutazymeTM) reconstituted with
purified water to provide a 10% S-9 mix.
Added to the cell cultures at 10% v/v. - Test concentrations with justification for top dose:
- Due to the potentially cytotoxic nature of the
test article, eight concentrations separated by two fold intervals ranging down from
the solubility limit, 10 mM or 2000 μg/mL will be used in the cytotoxicity
Range-Finder. - Vehicle / solvent:
- Vehicle controls will comprise treatments with the chosen
vehicle diluted to the same extent as the test article
solutions.
The preferred vehicles are water or dimethyl sulphoxide
(DMSO). If other vehicles or volumes of the organic
vehicles exceeding 1% (v/v) need to be used, the effects on
mutant frequencies may need to be checked. The choice of
vehicle will be confirmed in the raw data. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- benzo(a)pyrene
- Remarks:
- Untreated Controls Cultures treated with culture medium alone will act as untreated controls (UTC). UTC will be included in this study only if the chosen vehicle is not commonly used in this laboratory (at the discretion of the Study Director).
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- 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
- Conclusions:
- The substance tested did not show any mutagenic result in the test conditions
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2020
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 487 (In vitro Mammalian Cell Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell gene mutation test using the Hprt and xprt genes
- Target gene:
- human peripheral blood lymphocytes
- Species / strain / cell type:
- lymphocytes: human peripheral blood lymphocytes
- Cytokinesis block (if used):
- Cytochalasin B (cytoB) was dissolved in DMSO to a stock concentration of 2 mg/mL. It was used at 6 μg/mL concentration to block cytokinesis.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- In the preliminary toxicity assay (A1), the doses tested ranged from 0.5 to 5000 μg/mL, which was the limit dose for a substance of unknown or variable composition. Cytotoxicity [≥ 55 ± 5% reduction in cytokinesis-blocked proliferation index (CBPI) relative to the vehicle control] was observed at doses ≥ 500 μg/mL in all three exposure groups. At the conclusion of the treatment period, visible precipitate was observed at 5000 μg/mL in all three exposure groups. Based upon these results, the doses chosen for the micronucleus assay ranged from 92.4 to 425 μg/mL for the non-activated 4 and 24-hour exposure groups; and from 132 to 500 μg/mL for the S9-activated 4-hour exposure group.
- Vehicle / solvent:
- DMSO
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- vinblastine
- other: water
- Evaluation criteria:
- Evaluation of Test Results
The test substance was considered to have induced a positive response if:
• at least one of the test concentrations exhibited a statistically significant increase when compared with the concurrent negative control (p ≤ 0.05), and
BioReliance Study No. AG19AR.348REACH.BTL 15
• the increase was concentration-related (p ≤ 0.05), and
• results were outside the 95% control limit of the historical negative control data.
The test substance was considered to have induced a clear negative response if none of the criteria for a positive response were met. - Statistics:
- Statistical analysis was performed using the Fisher's exact test (p ≤ 0.05) for a pairwise comparison of the percentage of micronucleated cells in each treatment group with that of the vehicle control. The Cochran-Armitage trend test was used to assess dose-responsiveness.
- Key result
- Species / strain:
- lymphocytes: human peripheral blood lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Conclusions:
- These results indicate Sophorolipids was negative for the induction of micronuclei in the presence and absence of the exogenous metabolic activation system.
- Executive summary:
The test substance, Sophorolipids, was tested to evaluate the potential to induce micronuclei in human peripheral blood lymphocytes (HPBL) in both the absence and presence of an exogenous metabolic activation system. HPBL were treated for 4 hours in the absence and presence of S9, and for 24 hours in the absence of S9. Dimethyl sulfoxide (DMSO) was used as the vehicle.
In the preliminary toxicity assay (A1), the doses tested ranged from 0.5 to 5000 μg/mL, which was the limit dose for a substance of unknown or variable composition. Cytotoxicity [≥ 55 ± 5% reduction in cytokinesis-blocked proliferation index (CBPI) relative to the vehicle control] was observed at doses ≥ 500 μg/mL in all three exposure groups. At the conclusion of the treatment period, visible precipitate was observed at 5000 μg/mL in all three exposure groups. Based upon these results, the doses chosen for the micronucleus assay ranged from 92.4 to 425 μg/mL for the non-activated 4 and 24-hour exposure groups; and from 132 to 500 μg/mL for the S9-activated 4-hour exposure group.
In the initial micronucleus assay (B1), cytotoxicity (≥ 55 ± 5% reduction in CBPI relative to the vehicle control) was observed at doses ≥ 222 μg/mL in the non-activated 4-hour exposure group and at doses ≥ 361 μg/mL in the S9-activated 4-hour exposure group. At the conclusion of the treatment period, visible precipitate was not observed at any dose in any of the exposure groups. In the non-activated 24-hour exposure group, due to lack of requisite cytotoxicity, the micronucleus assay was repeated at doses ranging from 59 to 200 μg/mL.
In the repeat assay (B2), cytotoxicity (≥ 55 ± 5% reduction in CBPI relative to the vehicle control) was observed at doses ≥ 162 μg/mL in the non-activated 24-hour exposure group. At the conclusion of the treatment period, visible precipitate was not observed at any dose.
The doses selected for evaluation of micronuclei were 92.4, 132, and 261 μg/mL for the non-activated 4-hour exposure group; 132, 261, and 425 μg/mL for the S9-activated 4-hour exposure group; and 59, 131, and 162 μg/mL for the non-activated 24-hour exposure group.
In the non-activated 4 and 24-hour exposure groups, neither statistically significant nor dose-dependent increases in micronuclei induction were observed at any dose (p > 0.05; Fisher’s Exact and Cochran-Armitage tests). The results were within the 95% control limit of the historical negative control data.
In the S9-activated 4-hour exposure group, no statistically significant increases in micronuclei induction were observed at any dose (p > 0.05; Fisher’s Exact test). The results were within the 95% control limit of the historical negative control data. However, the Cochran-Armitage test was positive for a dose response increase (p ≤ 0.05). Since the increased induction of micronuclei was not significant and was within the 95% control limit of the historical negative control data, it was considered not biologically relevant.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Given the lack of genotoxic effects of the test substance in the three in vitro assays, no classification for mutagenicity is warranted.
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