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EC number: 943-175-7 | 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 a study according to OECD guideline 423, GLP, Reliability 2, the LD50 of Rhamnolipids: fermentation products of glucose with Pseudomonas bacteria in the female ratswas estimated as being greater than 2000 mg/kg bw).
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:
- key study
- Study period:
- 2016-09-19 to 2016-11-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 27 December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI (Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9-11 weeks
- Weight at study initiation: step 1: 165-169g; step 2: 165-174g
- Fasting period before study: 16-19 hrs
- Housing: The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): ad libitum, standard chow (Altromin 1324)
- Water (e.g. ad libitum): ad libitum; tap water , sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10 x /h
- Photoperiod (hrs dark / hrs light): 12 h light/12 h dark
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: The vehicle was chosen due to its non-toxic characteristics.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The starting dose was selected to be 2000 mg/kg body weight. No compound-related mortality was recorded for any animal of step 1 or 2. Based on these results and according to the acute toxic class method regime no further testing was required. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Step 1: 3 animals and step 2: 3 animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weighing was performed on day 1, 8 and 15, observations of clinical signs were performed once daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy - Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- no mortality occurred
- Clinical signs:
- other: No specific findings during the whole observation period.
- Gross pathology:
- No specific gross pathological changes were recorded for any animal.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The present study was performed in order to determine the LD50 of Rhamnolipids. No premature deaths occurred and no adverse effects were observed during cage side observations and final gross necropsy. Thus, Rhamnolipids is not classified according to GHS criteria.
- Executive summary:
In an acute oral toxicity study according to OECD Guideline 423 (2001) and EU method B.1 tris (2008), groups of fasted, 9-11 weeks old female Wistar rats (2 steps, 3 animals per step) were given a single oral dose of Rhamnolipid (88.1% a.i.) in sterile water at a doses of 2000 mg/kg bw and observed for 14 days.
The test item showed no mortality and no other acute oral toxicity characteristics after a single dose administration. No specific clinical sings were observed during the whole observation period. None of the animals showed weight loss during the observation period. No specific gross pathological changes were recorded for any animal.
According to the guideline, the LD50 cut-off(rat) is >5000 mg/kg bw
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read across, QSAR studies)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the criteria laid down in CLP regulation, the substance Rhamnolipids: fermentation products of glucose with Pseudomonas bacteria is not classified for acute toxicology.
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