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Diss Factsheets
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EC number: 904-790-6 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of (24R)-ergost-5-en-3β-ol and stigmast-5-en-3-β-ol and stigmasta-5,22-dien-3-β-ol
- EC Number:
- 904-790-6
- Molecular formula:
- C28H48O; C29H50O; C29H48O
- IUPAC Name:
- Reaction mass of (24R)-ergost-5-en-3β-ol and stigmast-5-en-3-β-ol and stigmasta-5,22-dien-3-β-ol
Constituent 1
- Specific details on test material used for the study:
- Batch no. YH18ZC040304
Expiry date January 2021
Storage conditions Room temperature
In vitro test system
- Test system:
- human skin model
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Duration of treatment / exposure:
- 15 minutes
- Observation period:
- 42 +/- 1 hour recovery period
- Details on study design:
- Before the Main Assay, a preliminary test was carried out to evaluate the compatibility of
the test item with the test system. In a first step, the test item was assayed for the ability of
reducing MTT per se. Light purple solution was noted in the MTT solution at the end of the
incubation period, indicating that the test item could direct interact with MTT. In a second
step, the test item was assayed for the ability of colouring water per se. A white opaque
suspension was observed. This suspension was not dispensable with automatic pipettes,
thus spectrophotometric analysis was not performed. Based on these results, additional
controls were added in the Main Assay.
In the Main Assay, the test item was applied as supplied in three replicates at the treatment
level of 20±2mg/epidermis unit, each measuring 0.38 cm2 (treatment level: 53 µL/cm2).
Positive and negative controls [a 5% (w/v) sodium dodecyl sulphate solution in water and
Dulbecco’s phosphate buffered saline (D-PBS), respectively] were concurrently tested, in
the same number of replicates and test conditions at the treatment level of 20 µL/epidermis
unit. In order to verify if the test item results had to be corrected, the non specific colour
(NSCliving) was evaluated using two alive treated tissues without MTT staining and compared
with the D-PBS control. Moreover, non specific MTT reduction (NSMTT) was evaluated
using two killed tissues and compared with negative control performed with alive tissues.
Since the test item is able both to stain tissue and reduce MTT, to avoid a possible double
correction for colour interference, a third control for Non Specific Colour in killed tissue
(NSCkilled) was performed.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main
- Value:
- 100
- Other effects / acceptance of results:
- Before the Main Assay, a preliminary test was carried out to evaluate the compatibility of
the test item with the test system. In a first step, the test item was assayed for the ability
of reducing MTT per se. A white precipitate was noticed, however no colour change was
observed in the MTT solution at the end of the incubation period, indicating that the test
item could not direct interact with MTT. In a second step, the test item was assayed for the
ability of colouring water per se. A white opaque suspension, was obtained. This suspension
was not dispensable with automatic pipettes, thus spectrophotometric analysis was not
performed. Based on this result, additional controls for colour interference were added in
the Main Assay.
In the Main Assay, the test item was applied as supplied in three replicates at the treatment
level of 20 ± 2 mg/epidermis unit, each measuring 0.38 cm2 (treatment level: 53 mg/cm2).
Positive and negative controls [a 5% (w/v) sodium dodecyl sulphate solution in water and
Dulbecco’s phosphate buffered saline (D-PBS), respectively] were concurrently tested, in
the same number of replicates and test conditions at the treatment level of 20 µL/epidermis
unit. In order to verify if the test item results had to be corrected, the non specific colour
(NSCliving) was evaluated using two alive treated tissues without MTT staining and compared
with the D-PBS control.
Any other information on results incl. tables
In the Main Assay, the negative control gave the expected baseline value (Optical Density values of the three replicates higher than 0.6) and variability [Standard Deviation (SD) of % viability lower or equal to 18], in agreement with the guideline indications. According
to the method, the negative control mean value is considered the baseline value of the
experiment and thus represents 100% of cell viability.
The positive control caused the expected cell death (7% of cell viability when compared to the negative control) and variability (SD of % viability equal to 2.05). Based on the stated criteria (mean viability ≤ 40% and SD of % viability ≤ 18), the assay was regarded as valid.
The NSCliving value was 4%, thus only the OD-blank background subtraction was performed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item did not induce cell death in any replicate, the mean cell viability after the blank
subtraction was 100%, when compared to the negative control. Intra-replicate variability
was acceptable with a SD of % viability value equal to 1.88 (lower than 18, as stated in the
Study Protocol).
Based on the results obtained, the test item Mixture of phytosterols is classified as non-
irritant to the skin (UN GHS No Category).
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