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Diss Factsheets
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EC number: 927-957-5 | 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
- Study period:
- From August 07, 2017 to August 11, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Addition product of dehydrated castor oil, linseed oil and maleic anhydride
- EC Number:
- 927-957-5
- Molecular formula:
- UVCB - not applicable
- IUPAC Name:
- Addition product of dehydrated castor oil, linseed oil and maleic anhydride
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Batch No.: WD0066442; Purity: 100 %; Appearance: homogeneous amber liquid
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiDermTM tissues
- Source species:
- other: human-derived epidermal keratinocytes
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other:
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The test system is a commercially available EpiDermTM-Kit, procured by MatTek. The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers representing main lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell culture inserts.
Origin:
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava.
Designation of the kit: EPI-200-SIT - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- One plate was used as negative control; each tissue was treated with 30 μL DPBS buffer, a nylon mesh was added in order to ensure sufficient contact with the tissue surface. One plate was used as positive control; each tissue was treated with 30 μL 5% SDS solution, a nylon mesh was added in order to ensure sufficient contact with the tissue surface.
One plate was used for treatment with the test substance:
For each plate, 3 tissues were used. The tissues were wetted with 25 μL DPBS buffer before applying the test substance and spreading it to match the tissue size.
The following amounts were applied to the tissues:
Replicate 1: 26.6 mg
Replicate 2: 26.2 mg
Replicate 3: 26.7 mg
Tissues were dosed in 1-minute-intervals. After dosing the last tissue, all plates were transferred into the incubator for 35 minutes at 37 ± 1°C and 5.0 ± 0.5% CO2. 1 hour after the first application, the inserts were removed from the plates using sterile forceps and rinsed immediately in 1-minute-intervals. After rinsing, each tissue was blotted with sterile cellulose tissue and then transferred into a new 6-well-plate with fresh assay medium (0.9 mL). Then, the tissues were set in the incubator for 23 hours 30 minutes at 37 ± 1°C and 5.0 ± 0.5% CO2.
Medium Renewal
After post-incubation, the tissues were removed from the incubator and shaken for 5 minutes (120 rpm). 0.9 mL assay medium were filled in the lower row of the 6-wellplate. Then the inserts were transferred into the lower row of the 6-well-plate and set into the incubator for 19 hours 5 minutes for post-incubation at 37 ± 1 °C and 5.0 ± 0.5% CO2. - Duration of treatment / exposure:
- 1 hour
- Duration of post-treatment incubation (if applicable):
- 23 hours and 30 minutes
- Number of replicates:
- 3 replicates
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 72.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Results:
% Tissue viability (tissue 1): 71.5 %
% Tissue viability (tissue 2): 73.1 %
% Tissue viability (tissue 3): 72.6 %
% Tissue viability (mean) 72.4 %
Tissue Viability
The photometric absorbance of the negative controls is considered as 100%. For each replicate of test substance and positive control, tissue viability is calculated as % photometric absorbance compared with the mean of the negative controls:
% Tissue Viability = (OD replicate test substance resp. positive control x 100%) / OD negative controls
Acceptance of the results:
- The test substance is considered as non-irritant to skin.
- After the treatment, the relative absorbance values were reduced to 99.4%. This value is above the threshold for skin irritation (50%).
- The optical density of the negative control was well within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8.
- The positive control has met the acceptance criterion too, demonstrating the validity of the test system.
- Variation within replicates was within the accepted range for negative control, positive control and test substance (required: ≤ 18%).
Validity:
- OD of negative control: 1.6 (Required: ≥ 0.8 and ≤ 2.8)
- % Tissue viability of positive control SDS: 2.2% (Required: ≤ 20 % of negative control)
- SD of mean viability of the tissue replicates (≤18 %):
9.7% (negative control)
0.2% (positive control)
0.8% (test substance)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- non-irritant
- Conclusions:
- Under the study conditions, after the treatment with the test substance, the mean value of relative tissue viability was reduced to 72.4%. This value is above the threshold for skin irritation potential (50%). Therefore, the test substance is considered non-irritant to skin in the Reconstructed human Epidermis (RhE) test method.
- Executive summary:
A study was conducted to determine the skin irritation potential of the test substance using the Reconstructed Human Epidermis (RHE) Test Method according to OECD Guideline 439 and EU Method B.46, in compliance with GLP. One valid experiment was performed. Three tissues of the human skin model EpiDermTM were treated with the test substance for 60 minutes. The test substance was applied directly to each tissue and spread to match the tissue size (0.63 cm2). DPBS-buffer was used as negative control and 5% SDS solution was used as positive control. After treatment with the negative control, the absorbance values with a mean OD of 1.6, were within the required acceptability criterion of 0.8≤ mean OD ≤2.8. The positive control showed clear irritating effects. The mean value of relative tissue viability was reduced to 2.2%. The variation within the tissue replicates of negative control, positive control and test substance was acceptable (required: ≤ 18%). Under the study conditions, after the treatment with the test substance, the mean value of relative tissue viability was reduced to 72.4%. This value is above the threshold for skin irritation potential (50%). Therefore, the test substance is considered non-irritant to skin in the Reconstructed human Epidermis (RhE) test method (Andres, 2017).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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