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EC number: 923-725-2 | 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

Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD guideline 402 (adopted 1987)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- (Harlan Laboratories Ltd)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- (2S)-2-amino-3-hydroxybutanoic acid
- EC Number:
- 923-725-2
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- (2S)-2-amino-3-hydroxybutanoic acid
- Details on test material:
- - Name of test material (as cited in study report): Biofert Plusz
Details are presented in "Confidential details on test material"
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories Ltd.
- Age at study initiation: 9 (males) or 11 weeks (females)
- Weight at study initiation: 245-258 g (males) and 190-205 g (females)
- Housing: individually
- certified diet ad libitum
- tap water ad libitum
- Acclimation period: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
according to guideline
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 10% of the total body surface (one day before treatment, the backs of the animals were clipped with an electric clipper; re-shaved on test days 6, 9 and 13)
- % coverage: semi-occlusive dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h
- Washing: dressing was removed and the skin was washed up with lukewarm tap water and dried with disposable paper toweis
TEST MATERIAL
undiluted test substance - Duration of exposure:
- 24 h
- Doses:
- 7.12 mL of the liquid Biofert Plusz corresponding to 2000 mg/kg bw dry mass
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations (clinical signs including local effects): Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalities were reeorded.
- Frequency of weighing: On test days 1 (prior to administration), 8 and 15.
- Necropsy: yes, at termination (day 15)
- Other examinations performed: no - Statistics:
- not used
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- other: dry mass
- Remarks on result:
- other: dose corresponds to 7.12 mL/kg bw of the liquid test substance; no clinical signs, no relevant effects on body weight, no findings at necropsy
- Mortality:
- no mortality
- Clinical signs:
- other: No clinical signs observed during the course of the study.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
- Other findings:
- no
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- In male and female Wistar rats the dermal LD50 is > 2000 mg/kg bw (related to dry mass).
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