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EC number: 296-575-2 | CAS number: 92797-39-2 Substance obtained by acidic, alkaline, or enzymatic hydrolysis of milk composed primarily of amino acids, peptides, and proteins. It may contain impurities consisting chiefly of carbohydrates and lipids along with smaller quantities of miscellaneous organic substances of biological origin.
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Protein hydrolyzates, milk
- EC Number:
- 296-575-2
- EC Name:
- Protein hydrolyzates, milk
- Cas Number:
- 92797-39-2
- IUPAC Name:
- Protein hydrolyzates, milk
- Test material form:
- solid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- human three dimensional epidermal model (EPISKIN Small model (EPISKIN-SMTM)
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from multiple donors
- Source strain:
- other: SkinEthic Laboratories, Lyon, France
- Details on animal used as source of test system:
- Epi-200-Kit Lot No.: 16858 Kit B
- Justification for test system used:
- In the interest of sound science and animal welfare, a sequential testing strategy is recommended to minimize the need of in vivo testing. One of the validated in vitro skin irritation tests is the EPISKIN test, which is recommended in international guidelines (e.g. OECD and EC).
- Vehicle:
- other: DPBS
- Control samples:
- yes, concurrent vehicle
- Amount/concentration applied:
- Each approximately 26 - 28 mg of the test item were applied to triplicate tissues, wetted
with 50 μL DPBS, and spread to match the surface of the tissues.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: mean realtive absorbance
- Value:
- 89
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions
reported, the test item YOGURTENE 20 CQ (PFR) U/A - 6099943 is not irritant to skin. - Executive summary:
This in vitro study was performed to assess the irritation potential of YOGURTENE 20 CQ
(PFR) U/A - 6099943 by means of the Human Skin Model Test.
Three tissues of the human skin model EpiDerm™ were treated with the test item, the
negative or the positive control for 60 minutes.
26 – 28 mg of the test item were applied to each tissue, wetted with 50 μL of DPBS, and
spread to match the tissue size.
30 μL of either the negative control (DPBS) or the positive control (5% Sodium lauryl
sulfate) were applied to each tissue.
After treatment with the negative control the absorbance values were well in the required
range of the acceptability criterion of mean OD ≥ 1.0 and ≤ 2.5 for the 60 minutes
treatment interval, thus assuring the quality of the tissues.
Treatment with the positive control induced a sufficient decrease in the relative
absorbance as compared to the negative control for the 60 minutes treatment interval,
and thus assuring the validity of the test system.
After treatment with the test item YOGURTENE 20 CQ (PFR) U/A - 6099943 the mean
relative absorbance value decreased to 89.0% compared to the relative absorbance value
of the negative control. This value is above the threshold for irritancy of ≤ 50%. Therefore,
the test item is not considered to possess an irritant potential.
In conclusion, it can be stated that in this study and under the experimental conditions
reported, the test item YOGURTENE 20 CQ (PFR) U/A - 6099943 is not irritant to skin.
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