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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
Endpoint summary
Administrative data
Description of key information
- In the publication by Ikeda et al. (1986), the LD50 of Sophorolipid C16-18 unsatd. lactone was determined in 10 fasted male mice per dose group and calculated to be 12500 mg/kg based on test material. This LD50 refers to the lactone form of the target UVCB substance.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- no information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- 7 days observation
- GLP compliance:
- no
- Test type:
- standard acute method
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Shizuoka Prefecture Agricultural Cooperative Association for Laboratory Animals
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 25-29 g
- Fasting period before study: yes, 16-18 hours before the administration
- Housing: polycarbonate cages with wood chip floor covering and 5 animals per cage
- Diet: solid feed (CE-2, CLEA Japan, Inc.) ad libitum
- Water: tap water ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2 °C
- Humidity (%): 55 ± 10 %,
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): not reported - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 37.5 w/v suspension
- Amount of vehicle (if gavage): not specified - Doses:
- 7230, 8680, 10420, 12500 and 15000 mg/kg bw
- No. of animals per sex per dose:
- 10 males per dose level
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes - Statistics:
- LD50 value was calculated with the Litchfield and Wilcoxon method using the mortality rate.
- Preliminary study:
- not applicable
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 12 500 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 11 060 - <= 14 130
- Mortality:
- At the highest dose level of 15000 mg/kg bw, all 10 animals died in between 1 day after administration.
At the dose level of 12500 mg/kg bw, 5 animals died in between 1 day after administration.
At the dose level of 10420 mg/kg bw, 1 animal died in between 1 day after administration.
No other deaths were reported in the 7-day observation period. - Clinical signs:
- other: reduced locomotion, sedation, hyperventilation, weakness of the extremities, loose stool, diarrhoea, piloerection
- Gross pathology:
- Individuals which had died showed hyperemia or mild bleeding from the pyloric region of the stomach to the small intestine. No specific abnormalities could be found in the surviving individuals.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 of the test item in male mice was determined to be 12500 mg/kg bw.
- Executive summary:
The publication by Ikeda et al. (1986) reports the determination of the LD50 value of Sophorolipid in its lactone form. The study has not been conducted according to an OECD guideline, but generally meets the principle for determination of acute oral toxicity and has been described in sufficient detail. The study is therefore considered as acceptable for classification purposes.
In this study, 10 fasted male mice per dose group were administered the test item p.o. via gavage. The dose groups were 7230, 8680, 10420, 12500 and 15000 mg/kg bw. The animals were observed for 7 days. Necropsy was conducted after death or in all surviving animals after the observation period. Clinical signs were reduced locomotion, sedation, hyperventilation, weakness of the extremities, loose stool, diarrhoea and piloerection.
The LD50 of Sophorolipid, lactone form, was calculated to be 12500 mg/kg based on test material. However, the percentage of active ingredient in the test item is not reported. The test item is described as a semi-solid colloid which may indicate rather high content of active ingredient. Taking into account that the Sophorolipid raw material after filtration and decanting is a solution consisting of approximately 50-60 % Sophorolipids mainly in the lactone form, the LD50 would here still be in a range that does not need classification.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The toxicological profile for systemic endpoints is expected to be similar for target substance Sophorolipids: fermentation products of glucose and fatty acids, C18-unsatd., esters with glycerol with yeast Candida Bombicola, partially hydrolysed when compared to the source substance. Read-across is expected to be reliable including the data on acute oral toxicity, sensitization and gene toxicity in vitro.
For detailed information, please see the justification for read-across in chapter 13. - Reason / purpose for cross-reference:
- read-across source
- Test type:
- standard acute method
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 7230, 8680, 10420, 12500 and 15000 mg/kg bw
- No. of animals per sex per dose:
- 10 males per dose level
- Control animals:
- no
- Statistics:
- LD50 value was calculated with the Litchfield and Wilcoxon method using the mortality rate.
- Preliminary study:
- not applicable
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 12 500 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 11 060 - <= 14 130
- Mortality:
- At the highest dose level of 15000 mg/kg bw, all 10 animals died in between 1 day after administration.
At the dose level of 12500 mg/kg bw, 5 animals died in between 1 day after administration.
At the dose level of 10420 mg/kg bw, 1 animal died in between 1 day after administration.
No other deaths were reported in the 7-day observation period. - Clinical signs:
- other: reduced locomotion, sedation, hyperventilation, weakness of the extremities, loose stool, diarrhoea, piloerection
- Gross pathology:
- Individuals which had died showed hyperemia or mild bleeding from the pyloric region of the stomach to the small intestine. No specific abnormalities could be found in the surviving individuals.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 of the test item in male mice was determined to be 12500 mg/kg bw.
Referenceopen allclose all
Table 1: Deaths of mice and LD50 after oral installation of the test item.
|
Number of dead animals during observation period (day) |
|
|||
Dose level [mg/kg bw] |
0-1 |
2-4 |
5-7 |
Lethality [%] |
LD50 and 95 % CL [mg/kg bw] |
7230 |
0 |
0 |
0 |
0 |
12500 (11060 – 14130) |
8680 |
0 |
0 |
0 |
0 |
|
10420 |
1 |
0 |
0 |
10 |
|
12500 |
5 |
0 |
0 |
50 |
|
15000 |
10 |
0 |
0 |
100 |
Table 1: Deaths of mice and LD50 after oral installation of the test item.
|
Number of dead animals during observation period (day) |
|
|||
Dose level [mg/kg bw] |
0-1 |
2-4 |
5-7 |
Lethality [%] |
LD50 and 95 % CL [mg/kg bw] |
7230 |
0 |
0 |
0 |
0 |
12500 (11060 – 14130) |
8680 |
0 |
0 |
0 |
0 |
|
10420 |
1 |
0 |
0 |
10 |
|
12500 |
5 |
0 |
0 |
50 |
|
15000 |
10 |
0 |
0 |
100 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Acute oral toxicity values are derived from a read-across approach based on a scientific publication.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a read-across approach, the acute oral LD50 was determined from a scientific publication.
The toxicological profile for systemic endpoints is expected to be similar for target substance Sophorolipids: fermentation products of glucose and fatty acids, C18-unsatd., esters with glycerol with yeast Candida Bombicola when compared to the source substances. Read-across is expected to be reliable including the data on acute oral toxicity, sensitization and gene toxicity in vitro.
Scientific publication by Ikeda et al. (1986):
The publication by Ikeda et al. (1986) reports the determination of the LD50 value of Sophorolipid in its lactone form. The study has not been conducted according to an OECD guideline, but generally meets the accepted scientific principle for determination of acute oral toxicity and has been described in sufficient detail. The study is therefore considered as acceptable for classification purposes.
In this study, 10 fasted male mice per dose group were administered the test item p.o. via gavage. The dose groups were 7230, 8680, 10420, 12500 and 15000 mg/kg bw. The animals were observed for 7 days. Necropsy was conducted after death or in all surviving animals after the observation period. Clinical signs were reduced locomotion, sedation, hyperventilation, weakness of the extremities, loose stool, diarrhoea and piloerection.
The LD50 of Sophorolipid, lactone form, was calculated to be 12500 mg/kg based on test material. However, the percentage of active ingredient in the test item is not reported. The test item is described as a semi-solid colloid which may indicate rather high content of active ingredient. Taking into account that the Sophorolipid raw material after filtration and decanting is a solution consisting of approximately 50-60 % Sophorolipids mainly in the lactone form, the LD50 would here still be in a range that does not need classification.
Overall, in this read-across approach, the LD50 of the test item was determined to be > 2000 mg/kg bw based on active ingredient.
There are no studies available on acute toxicity via dermal or inhalation route.
Justification for classification or non-classification
The acute oral toxicity of the test item is > 2000 mg/kg bw based on active ingredient and therefore, GHS criteria for acute oral toxicity are not met.
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