Registration Dossier
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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
- 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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study planned
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
Sophorolipids: fermentation products of glucose and fatty acids, C18-unsatd., esters with glycerol with yeast Candida Bombicola, partially hydrolysed
CONSIDERATIONS/JUSTIFICATION FOR THE TESTING PROPOSAL:
In a dose range finding (DRF, non GLP) study for a Reproduction/Developmental Toxicity Screening Study (study name: preliminary prenatal developmental toxicity study in rats) malrotated hindlimbs were observed in one foetus each in one low (100 mg/kg/day) and mid-dose (300 mg/kg/day) female and in three foetuses in two high dose (500 mg/kg/day) females. Rotation of limbs was also present in the Historical Control Data obtained by the Supplier although with a lower incidence, due to the high number of foetuses examined. Further examination is suggested by the test institute in order to evaluate the concern of this finding.
In the subsequently performed OECD 421 (GLP complaint study) these questionable findings could not be clarified, due to the different testing set up. In this study no treatment related findings were noted.
There is no further animal data or historical human data regarding the endpoint reproductive toxicity available. Furthermore, no data on analogue substances are available. There are currently no scientifically validated (Q)SAR or in vitro methods available for this endpoint. Substance-tailored exposure driven testing has not been performed.
None of the given specific adaption possibilities in column 2 of point 8.7 in annex VIII and IX are applicable.
Therefore, to better understand the significance and/or relevance of the findings of the DRF study we deem it necessary to perform a developmental toxicity study (OECD 414, oral, in rats).
Data source
Materials and methods
Test guideline
- Qualifier:
- according to
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- liquid
Test animals
- Species:
- rat
Results and discussion
Applicant's summary and conclusion
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.

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