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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
Endpoint summary
Administrative data
Description of key information
Based on the in vitro study results, the test substance is not considered to be irritating to skin and eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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)
- 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 - 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
- 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%).
- 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).
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 01, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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 - Species:
- cattle
- Strain:
- other: Bos primigenius Taurus
- Details on test animals or tissues and environmental conditions:
- Bovine corneas were used. They were collected from slaughtered cattle (from Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany, on the day of the test) which were between 12 and 60 months old.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 µL (the “closed chamber-method” was used in this study, for liquid substances)
- Duration of treatment / exposure:
- 10 min at 32 ± 1 °C
- Duration of post- treatment incubation (in vitro):
- 2 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The test substance was brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 h and whose opacity had been measured. The test substance was incubated on the cornea for 10 min at 32 ± 1 °C. After removal of the test substance and 2 h post-incubation, opacity and permeability values were measured
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- cornea opacity and permeability
- Value:
- 0.44
- 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:
- Physiological sodium chloride solution was used as negative control and showed no irritating effect on the cornea and the calculated IVIS (in vitro irritancy score) was -0.79. Dimethylformamide (DMF) undiluted was used as positive control and induced serious eye damage on the cornea and fell within two standard deviations of the current historical mean. The calculated IVIS (in vitro irritancy score) was 96.29.
Under the conditions of this study, the test substance showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) was 0.44. According to OECD Guideline no. 437, a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage. - Interpretation of results:
- other: CLP criteria not met
- Remarks:
- does not require classification
- Conclusions:
- Under the study conditions, the test substance was not irritating to bovine eye (BCOP test).
- Executive summary:
A study was conducted to determine the in vitro eye irritation potential of the test substance according to OECD Guideline 437 and EU Method B.47 (BCOP test), in complinace with GLP. Bovine eyes were exposed to 750 µL undiluted test substance for 10 min (in triplicates). After removal of the test substance and 2 h post-incubation, opacity and permeability values were measured and reported as the in vitro irritancy score (IVIS). Physiological sodium chloride solution was used as negative control and dimethylformamide (DMF) undiluted as positive control. Physiological sodium chloride solution showed no irritating effect on the cornea and the calculated IVIS was -0.79. DMF induced serious eye damage on the cornea and fell within two standard deviations of the current historical mean. The calculated IVIS was 96.29. The test substance showed no effects on the cornea of the bovine eye. The calculated IVIS was 0.44. All validity criteria were met. Under the study conditions, the test substance was not irritating to bovine eye (Andres, 2016).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In vitro skin irritation/corrosion:
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 irritating to the skin (Andres, 2016).
In vitro eye irritation:
A study was conducted to determine the in vitro eye irritation potential of the test substance according to OECD Guideline 437 and EU Method B.47 (BCOP test), in complinace with GLP. Bovine eyes were exposed to 750 µL undiluted test substance for 10 min (in triplicates). After removal of the test substance and 2 h post-incubation, opacity and permeability values were measured and reported as the in vitro irritancy score (IVIS). Physiological sodium chloride solution was used as negative control and dimethylformamide (DMF) undiluted as positive control. Physiological sodium chloride solution showed no irritating effect on the cornea and the calculated IVIS was -0.79. DMF induced serious eye damage on the cornea and fell within two standard deviations of the current historical mean. The calculated IVIS was 96.29. The test substance showed no effects on the cornea of the bovine eye. The calculated IVIS was 0.44. All validity criteria were met. Under the study conditions, the test substance was not irritating to bovine eye (Andres, 2016).
Justification for classification or non-classification
Based on the results of in vitro studies, the test substance does not need to be classified for skin and eye irritation according to CLP criteria (EC 1272/2008).
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