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EC number: 955-731-6 | 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
No substance specific data on acute toxicity is available. Therefore, data from a suitable read-across partner was used . For details and justification of read-across please refer to the report attached in section 13 of IUCLID.
In a publication from Ikeda et al. (1986) an LD50 of Sophorolipid (C16-C18), was calculated to be 10500 mg/kg.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- For details and justification of read-across please refer to the report attached in section 13 of IUCLID.
- Reason / purpose for cross-reference:
- read-across source
- 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: 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 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.
This information is used in a read-across approach in the assessment of the target substance. For justification of read-across please refer to the attached read-across report (see IUCLID section 13).
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The substance described by Ikeda et al. (1986), polyoxypropylene (12) [2'-0-beta-D-glucopyranosyl-beta-D-glucopyranosyl) oxy-] fatty acid ester-], is a glycolipide derivative and an acetylated form of the sophorolipids. The underlying generic structure of the main component of the target substance is identical to the source substance. Therefore, it is expected that these substances have similar physicochemical properties, and thus, there should be no sinificant differences in the absorption into the body and in the toxicity profile between source and target substance.
- Reason / purpose for cross-reference:
- read-across source
- Preliminary study:
- not applicable
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 12 000 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 9 850 - <= 14 650
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 10 500 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 9 380 - <= 11 760
- Mortality:
- see in box "Any other information on results incl. tables".
- Clinical signs:
- other:
- 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 mice was determined to be 10500 mg/kg bw (female mice).
- Executive summary:
The publication by Ikeda et al. (1986) reports the determination of the LD50 value of Sophorolipid (C16-C18). In this study, 10 fasted male and female mice per dose group were administered the test item (37.% w/v) p.o. via gavage at following doses:
Male mice: 6960, 9210, 12170, 16100, 21290 mg/kg bw
Female mice: 6960, 8000, 9210, 10590, 12170, 14000 mg/kg bwThe animals were observed for 7 days. Necropsy was conducted after death or in all surviving animals after the observation period. Clinical signs were decreased locomotor activity, sedation, hyperventilation, weakness of limbs, loose stool, diarrhea, and rising hair. 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.
The LD50 of Sophorolipid (C16-C18) was calculated to be 10500 mg/kg (female mice).
This information is used in a read-across approach in the assessment of the target substance.
The substance described by Ikeda et al. (1986), polyoxypropylene (12) [2'-0-beta-D-glucopyranosyl-beta-D-glucopyranosyl) oxy-] fatty acid ester-], is a glycolipide derivative and an acetylated form of the sophorolipids. The underlying generic structure of the main component of the target substance is identical to the source substance. Therefore, it is expected that these substances have similar physicochemical properties, and there should be no significant differences in the absorption into the body and in the toxicity profile between source and target substance.
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 male mice and LD50 after oral installation of the test item.
Male |
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] |
6960 |
0 |
0 |
0 |
0 |
12000 (9850-14650) |
9120 |
0 |
3 |
0 |
30 |
|
12170 |
2 |
1 |
0 |
30 |
|
16100 |
7 |
2 |
0 |
90 |
|
21290 |
9 |
1 |
0 |
100 |
Table 2: Deaths of femalemice and LD50 after oral installation of the test item.
Female |
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] |
6960 |
0 |
0 |
0 |
0 |
10500 (9380-11760) |
8000 |
2 |
0 |
0 |
20 |
|
9210 |
3 |
1 |
0 |
40 |
|
10590 |
0 |
2 |
0 |
20 |
|
12170 |
4 |
3 |
0 |
70 |
|
14000 |
6 |
44 |
0 |
100 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 500 mg/kg bw
- Quality of whole database:
- similar to guideline study
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 800 mg/kg bw
- Quality of whole database:
- low; route of administration is subcutanous injection
Additional information
The publication by Ikeda et al. (1986) reports the determination of the LD50 value of Sophorolipid in its lactone form and for Sophorolipid (C16-C18).
In the study conducted with Sophorolipid, lactone form, 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.
For Sophorolipid (C16-C18) following doses were used:
Male mice: 6960, 9210, 12170, 16100, 21290 mg/kg bw
Female mice: 6960, 8000, 9210, 10590, 12170, 14000 mg/kg bw
Clinical signs were decreased locomotor activity, sedation, hyperventilation, weakness of limbs, loose stool, diarrhea, and rising hair. 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.
The LD50 of Sophorolipid (C16-C18) was calculated to be 10500 mg/kg bw (female mice).
Justification for classification or non-classification
The available data are reliable and suitable for classification purposes under Regulation 1272/2008. The substance is not considered to be classified for acute oral toxicity under Regulation (EC) No. 1272/2008.
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.
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