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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 941-809-7 | 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
Description of key information
- In an in vitro skin irritation study performed in accordance with OECD draft proposal for a new guideline “In vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method”, GLP, Reliability 1, the test substance showed a mean relative tissue viability of 113.2 % and was considered as not irritating to skin.
- In an ex vivo eye irritation guideline study (bovine corneal opacity and permeability assay) according to OECD 437, GLP, Reliability 1, the mean in vitro irritation score was 32.3 ± 5.8. According to the guideline, no prediction can be made using this value.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-05-04 to 2010-05-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- according to an OECD draft guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for the testing of chemicals draft proposal for a new guideline In vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method
- Deviations:
- yes
- Remarks:
- re-spreading of sodium dodecyl sulphate was avoided.
- GLP compliance:
- yes
- Test system:
- human skin model
- Remarks:
- EPISKIN reconstructed human epidermis
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- skin obtained from plastic surgery from multiple donors
- Details on animal used as source of test system:
- not applicable
- Justification for test system used:
- The Episkin® Skin Irritation Test is accepted as a reliable and relevant stand-alone replacement test for in vivo skin irritation testing. This test uses a reconstructed human epidermis model which consists of normal human epidermal keratinocytes and therefore represents in vitro the target organ of the species of interest and closely mimics the biochemical and physiological properties of the upper parts of the human, i.e. the epidermis. An ECVAM-validated protocol was followed.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN® reconstructed human epidermis
- Tissue batch number: 10-EKIN-016
- Production date: 2010-05-04
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 10x, 2.5 mL PBS
- Observable damage in the tissue due to washing: not reported
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL, freshly prepared
- Incubation time: 3 h
- Wavelength: 570 mnm
- spectrophotometer: BMG Labtech PC Logiciel BMG Optima Mars V2.00
NUMBER OF REPLICATE TISSUES: 3
SCORING SYSTEM
A test compound was classified as irritant if tissue viability was equal or below 50 %.
A test compound was classified as non-irritant if tissue viability was above 50 %.
For further details, please see section "any other information on materials and methods incl. tables". - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Amount of test item applied: 10 µL, neat
For further details, please see section "any other information on materials and methods incl. tables". - Duration of treatment / exposure:
- 15 minutes, observation period 42 h
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- TEST ITEM (mean of 3 replicates)
- Value:
- ca. 113.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- positive control (mean of 3 replicates)
- Value:
- ca. 29
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Remarks on result:
- positive indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- negative control (mean of 3 replicates)
- Value:
- 100
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: not reported
- Direct MTT reduction: no
- Colour interference with MTT: no
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating in the in vitro skin irritation test under the experimental conditions described in this report.
- Executive summary:
In an in vitro skin irritation study performed in accordance with OECD draft proposal for a new guideline “In vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method”, the test substance “Sophorolipids: fermentation products of glucose and fatty acids, C18-unsatd., esters with glycerol with yeast Candida Bombicola, partially hydrolysed” was applied neat to reconstructed human epidermis for an exposure period of 15 minutes. The number of replicate tissues was three. After 15 minutes exposure the tissues were washed with phosphate buffered saline. Subsequently the tissue constructs were incubated for 42 h at 37 °C. Afterwards, tissues were placed in MTT working solution and incubated at 37 °C, 5 % CO2, for approximately 3 h. MTT was reduced by viable cells into blue formazan crystals which were extracted and transferred for 570-nm optical density reading in duplicate. Relative cell viability for each test compound was calculated as the OD570 ratio to negative control.
The positive (5 % SDS) and negative (PBS) control gave responses that were within the acceptance criteria and as such demonstrated the validity of the study.
The relative mean tissue viability obtained after 15 minutes treatment with the test substance compared to the negative control tissues was 113.2 %. Since the mean relative tissue viability for the test substance was above 50 %, the test substance “Sophorolipids: fermentation products of glucose and fatty acids, C18-unsatd., esters with glycerol with yeast Candida Bombicola, partially hydrolysed” is identified to be not irritating.
Reference
Experiment validation
The results of the MTT assay for negative and positive controls are shown in Table 1. Optical density for negative control (PBS) was above 0.6 and the standard deviation value of the percentage of viability was lower than 18 %. The tissue viability for the positive control (5 % SDS) was below 40 %, with the standard deviation value lower than 18 %. Therefore, the acceptance criteria were met for this experiment.
MTT-interaction
No interaction with MTT: no risk of false negatives.
The coloring potential of test-substances
There was no change to the colour of the tissues and no perturbation the OD measurement.
Tissue viability
For each treated tissue, the tissue viability was expressed as a percentage of the mean negative control. The tissue viability data obtained with the MTT assay for test substances are presented in Table 1. In every case, the relative viabilities of tissues exposed to test substances were above 50 % for neat concentration.
Table 1: summary results and classification
Substance |
OD mean |
OD s.d |
Viability mean (%) |
Viability s.d |
Classification |
Negative control (PBS) |
0.866 |
0.070 |
100.0 |
8.1 |
Non-irritant |
Positive control (SDS 5%) |
0.251 |
0.008 |
29.0 |
1.0 |
irritant |
Test item |
0.980 |
0.072 |
113.2 |
8.3 |
Non-irritant |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-11-29 to 2010-11-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- 7 September 2009
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- - Source: slaughterhouse, not specified
- Calf eyes were excised as soon as possible after slaughter. Care was taken to avoid damaging the cornea during the enucleation procedure. Eyes were collected in a plastic container containing 1 L of sterile Hanks's Balanced Salt Solution (HBSS). Medium storage and transportation of eyes to the laboratory was performed at room temperature. The eyes were used within 3 hours after slaughter. - Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.75 mL
- Concentration: 10 % solution of test item prepared in 0.9 % sodium chloride
For further details, please refer to section "any other information on materials and methods incl. tables". - Duration of treatment / exposure:
- 10 ± 1 minutes
- Observation period (in vivo):
- 120 (+/-) 10 minutes
- Number of animals or in vitro replicates:
- triplicates
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): at least three times(until the medium was clear with approximately 4 ml of EMEM solution
- Time after start of exposure: 130 minutes
For further details, please refer to section "any other information on materials and methods incl. tables". - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean of 3 replicates
- Value:
- ca. 32.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: no abnormalities.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for solvent control: yes
- Acceptance criteria met for positive control: yes - Interpretation of results:
- other: Expert judgement: not Category 1
- Conclusions:
- The eye irritancy potential of the test substance was investigated in the bovine corneal opacity and permeability assay. The following mean in vitro irritation score was calculated: 32.3 ± 5.8. No prediction can be made regarding the classification of the test substance to the evaluation criteria. For precautionary reasons, the test substance is classified as Category 2.
- Executive summary:
In an ex vivo eye irritation guideline study (bovine corneal opacity and permeability assay) according to OECD 437 under GLP conditions, 0.75 mL of a 10 % solution of “Sophorolipids: fermentation products of glucose and fatty acids, C18-unsatd., esters with glycerol with yeast Candida Bombicola, partially hydrolysed” in physiological saline was applied on corneas for 10 min at 32 °C. The test was performed in triplicates.
Physiological saline was used as negative control, N,N-dimethylformamide as positive control. Both controls confirmed the validity of the study.
In this study, the mean in vitro irritation score was 32.3 ± 5.8. According to the guideline, no prediction can be made using this value. For precautionary measures, “Sophorolipids: fermentation products of glucose and fatty acids, C18-unsatd., esters with glycerol with yeast Candida Bombicola, partially hydrolysed” is classified voluntarily as irritating to eyes (GHS Category 2).
Reference
RESULTS
For each exposure condition, three corneas were visually inspected and showed no abnormalities. Three corneas were treated with 0.9 % sodium chloride as solvent/vehicle control. The IVIS of 0.9 % sodium chloride was -0.2 ± 0.4 (-0.6 to 0.2) with a mean opacity value of -0.2 ± 0.4 (-0.6 to 0.2) and a mean permeability value of 0.001 ± 0.001 (0.001 to 0.002).
Three corneas were selected for treatment with the positive control 100 % N,N-dimethylformamide. Treatment resulted in a mean IVIS of 100.5 ± 9.9. The corrected mean value of the opacity was 81.9 ± 6.0, ranging from 76.4 to 88.3. The corrected mean value of the permeability was 1.240 ± 0.340, ranging from 0.890 to 1.570. Before starting the permeability test, the dye solution sodium fluorescein was checked for its quality. The dye solution is valid for use, if a dilution of the stock solution containing 10 µg/mL gave the correct concentration on the calibration curve (acceptable range OD490: 1.75 ± 0.2). The average concentration of 2 measurements calculated by the spectrophotometer was 1.7797 µg/mL (OD 1.7692 and OD 1.7902) and thus valid for use. This means that the test conditions were optimal to determine the irritating potential of test item.
Three corneas were selected for treatment with the test item. Treatment resulted in a mean IVIS of 32.3 ± 5.8 after 10 minutes treatment, ranging from 28.2 to 38.9. The net value of the opacity score ranged from 2.6 to 4.4, the mean value was 3.8 ± 1.0. The mean corrected permeability value of the corneas was 1.900 ± 0.372, ranging from 1.583 to 2.310.
Treatment | Mean opacity | Mean permeability | Mean in vitro irritation score |
Negative control | 0.2 (+/-) 0.4 | 0.001 (+/-) 0.001 | - 0.2 (+/-) 0.4 |
Positive control | 81.9 (+/-) 6.0 | 1.240 (+/-) 0.340 | 100.5 (+/-) 9.9 |
Test substance | 3.8 (+/-) 1.0 | 1.9 (+/-) 0.372 | 32.3 (+/-) 5.8 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In an in vitro skin irritation study performed in accordance with OECD draft proposal for a new guideline “In vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method”, the test substance “Sophorolipids: fermentation products of glucose and fatty acids, C18-unsatd., esters with glycerol with yeast Candida Bombicola, partially hydrolysed” was applied neat to reconstructed human epidermis for an exposure period of 15 minutes. The number of replicate tissues was three. After 15 minutes exposure the tissues were washed with phosphate buffered saline. Subsequently the tissue constructs were incubated for 42 h at 37 °C. Afterwards, tissues were placed in MTT working solution and incubated at 37 °C, 5 % CO2, for approximately 3 h. MTT was reduced by viable cells into blue formazan crystals which were extracted and transferred for 570-nm optical density reading in duplicate. Relative cell viability for each test compound was calculated as the OD570 ratio to negative control.
The positive (5 % SDS) and negative (PBS) control gave responses that were within the acceptance criteria and as such demonstrated the validity of the study.
The relative mean tissue viability obtained after 15 minutes treatment with the test substance compared to the negative control tissues was 113.2 %. Since the mean relative tissue viability for the test substance was above 50 %, the test substance “Sophorolipids: fermentation products of glucose and fatty acids, C18-unsatd., esters with glycerol with yeast Candida Bombicola, partially hydrolysed” is identified to be not irritating.
Eye irritation
In an ex vivo eye irritation guideline study (bovine corneal opacity and permeability assay) according to OECD 437 under GLP conditions, 0.75 mL of a 10 % solution of “Sophorolipids: fermentation products of glucose and fatty acids, C18-unsatd., esters with glycerol with yeast Candida Bombicola, partially hydrolysed” in physiological saline was applied on corneas for 10 min at 32 °C. The test was performed in triplicates.
Physiological saline was used as negative control, N,N-dimethylformamide as positive control. Both controls confirmed the validity of the study.
In this study, the mean in vitro irritation score was 32.3±5.8. According to the guideline, no prediction can be made using this value. For precautionary measures, potassium hexafluorophosphate is classified voluntarily as irritating to eyes (GHS Category 2).
Justification for classification or non-classification
Justification for classification as "irritating to eyes": Study data do not allow a prediction. For precautionary measures, the test substance “Sophorolipids: fermentation products of glucose and fatty acids, C18-unsatd., esters with glycerol with yeast Candida Bombicola, partially hydrolysed” is classified voluntarily as irritating to eyes (GHS Category 2).
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.