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EC number: 293-426-3 | CAS number: 91079-38-8
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A well documented GLP study according to OECD guideline
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
There is number of unifying considerations justifying the similarity between the two substances:
- Similarity of synthesis: the two substances are obtained by an acidic alkaline or enzymatic hydrolysis of protein.
- Similarity of use: the two substances are used in industrial and biotechnological applications as a supplement to cell culture, food for aquatic organisms and animals.
- Similarity of toxicokinetic behavior: the two substances are composed primarily of amino acids which are completely metabolized. Once ingested the two substances follow the same ways of absorption, distribution, metabolism and elimination.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See attached read across justification document)
3. ANALOGUE APPROACH JUSTIFICATION
The read-across substance, as compared to the target substance, is more soluble (1,896 g/L and 8.82 – 28.96 g/L, respectively) and thus provides a conservative read-across due to increased bioavailability.
4. DATA MATRIX
See attached justification document.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A well documented GLP study according to OECD guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000 mg/Kg bw
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the results obtained in the study and according to the Globally Harmonized System (GHS), the test item is classified as Category 5/No classified.
Under the system currently used in the European Union (Directive 2004/73/EC, Annex 2B) and the criteria published in the Official Journal of the European Communities 6 August 2001 (Directive 2001/59/EC, Annex VI), we conclude that the product MOSCA TRAP is considered "NOT CLASSIFIED", so there is no need to assign risk notation. Hence, based on the read across from this supporting substance, peptone beef are considered as well "NOT CLASSIFIED".
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 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
Test material
- Reference substance name:
- Peptones, beef
- EC Number:
- 293-426-3
- EC Name:
- Peptones, beef
- Cas Number:
- 91079-38-8
- Molecular formula:
- The substance is an UVCB. The molecular formula as well as the molecular weight are not defined.
- IUPAC Name:
- Peptones, beef
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000 mg/Kg bw
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the results obtained in the study and according to the Globally Harmonized System (GHS), the test item is classified as Category 5/Not classified.
Under the system currently used in the European Union (Directive 2004/73/EC, Annex 2B) and the criteria published in the Official Journal of the European Communities 6 August 2001 (Directive 2001/59/EC, Annex VI), we conclude that the product MOSCA TRAP is considered "NOT CLASSIFIED", so there is no need to assign risk notation. Hence, based on the read across from this supporting substance, peptone casein are considered as well "NOT CLASSIFIED".
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