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EC number: 928-726-1 | CAS number: 1179913-28-0
- 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 February 23, 2016 to March 11, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
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:
- Reaction product of oxiran-2-ylmethyl 2,2,3,5-tetramethylhexanoate with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:1)
- Molecular formula:
- Not applicable (UVCB constituent)
- IUPAC Name:
- Reaction product of oxiran-2-ylmethyl 2,2,3,5-tetramethylhexanoate with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:1)
- Reference substance name:
- Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:2)
- Molecular formula:
- Not applicable (UVCB constituent)
- IUPAC Name:
- Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:2)
- Reference substance name:
- Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:1)
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:1)
- Reference substance name:
- Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:3)
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Reaction product of 4,4'-Methylendiphenyldiglycidylether (BADGE) with linseed oil fatty acids (including majorly linolenic acid, linoleic acid and oleic acid) (1:3)
- Reference substance name:
- High Mw components based on linseed oil fatty acids
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- High Mw components based on linseed oil fatty acids
- Reference substance name:
- Sum of unassigned components
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Sum of unassigned components
- Test material form:
- liquid
- Details on test material:
- UVCB
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
- Specific details on test material used for the study:
- Batch no.: #210162718
Composition: reaction products of linseed-oil fatty acids, 4,4'Methylendiphenyldiglycidylether with neodecanoic fatty acid, oxiranylmethylester
Purity: 100 % as per definition of UVCB
Appearance: brown liquid
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on animal used as source of test system:
- Commercially available EpiDermTM-Kit (from MatTek In Vitro Life Science Laboratories, Bratislava). 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 arranged in patterns analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell cultures inserts.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The test consists of a topical exposure of the neat test substance to a human reconstructed epidermis model followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of MTT 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromide, present in cell mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The percentage reduction of cell viability in comparison of untreated negative controls is used to predict skin irritation potential.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 30 µL of undissolved test substance
- Duration of treatment / exposure:
- 60 min
- Duration of post-treatment incubation (if applicable):
- ca. 42h30. Following this post-incubation period, the MTT test was performed
- Number of replicates:
- 3 tissues, 2 replicates
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- % formazan production
- Run / experiment:
- MMT test (relative absorbance value)
- Value:
- 98.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- After treatment with the negative control, the absorbance values were within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 2.0. The positive control showed clear irritating effects. Relative absorbance was reduced to 3.2% (requirement: < 20%). Variation within tissues was acceptable (requirement: ≤18%). After the treatment with the test substance, the relative absorbance values were reduced to 98.5%. This value is well above the threshold for irritation potential (50%).
Any other information on results incl. tables
The first experiment was not valid, because one validity criterion of the negative control was not fulfilled. The standard deviation within the tissue replicates was too high. These data are not reported, but kept together with the raw data in the GLP archive of the test facility. The second experiment was valid.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Remarks:
- does not require classification
- Conclusions:
- Under the study conditions, the test substance was considered not to be irritant to the skin in the Human Skin Model Test.
- Executive summary:
A study was conducted to determine the in vitro skin irritiation potential of the test substance according to OECD Guideline 439 and EU Method B.46 (Reconstructed Human Epidermis Test Method), in compliance with GLP. Three tissues were exposed for 60 min to 30 µL of undissolved test substance. After a post-incubation period of ca. 42h 30 min, the MTT test was performed. Indeed, cell viability was measured by dehydrogenase conversion of MTT, present in cell mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The percentage reduction of cell viability in comparison of untreated negative controls was used to predict skin irritation potential. After treatment with the negative control (DPBS-buffer), the absorbance values were within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 2.0. The positive control (sodium dodecyl sulphate) showed clear irritating effects. Relative absorbance was reduced to 3.2% (requirement: ≤18 %). After the treatment with the test substance, the relative absorbance values were reduced to 98.5%. This value is well above the threshold for irritation potential (50%). Based on the results obtained, the experiment was considered valid. Under the study conditions, the test substance was considered not to be irritant to the skin (Andres, 2016).
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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