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EC number: 262-114-9 | CAS number: 60239-68-1
- 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
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 April 05, 2017 to April 07, 2017
- 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)
- Test system:
- human skin model
- Remarks:
- artificial three-dimensional model of human skin
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- This test method provides an in vitro procedure that, depending on information requirements, may allow determining the cytotoxic potency and skin irritancy of test substances as a stand-alone replacement test within a testing strategy, in a weight of evidence approach.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Three tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined by using the MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue) reduction assay and expressed as relative percentage of viability of the negative control-treated tissues.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The test substance was applied as liquid test substance topically undiluted to the model skin surface.
- Duration of treatment / exposure:
- 60 min
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- cells
- Run / experiment:
- MTT test (mean viablility compared to the negative control - %)
- Value:
- 6.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: prediction of irritation
- Other effects / acceptance of results:
- - The mean viability of cells exposed to the test substance was 6.5% of the negative controls and, hence, was below the cut-off percentage cell viability value that distinguishes irritant from non-irritant test substances of ≤50%. The test substance was considered to be cytotoxic and predicted to be irritant to skin in accordance with UN GHS category 1 or 2 (H314 or H315).
- The mean optical density (OD) of 3 negative control tissues was 1.314 and was well within the acceptable range of ≥ 1.0 to ≤ 2.5. The viability of cells treated with the positive reference substance, 5% SDS, was 6.9% of the negative control and fulfilled the acceptance criterion of ≤20%.
- The standard deviation of all triplicates determined was below the limit of acceptance of 18%. Hence, all acceptance criteria were fulfilled. - Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Under the study conditions, the test substance was predicted to be a skin irritant.
- Executive summary:
A study was conducted to determine the in vitro skin irritation potential of the test substance, C11-unsatd. DEA, according to OECD Guideline 439 and EU Method B.46 (three-dimensional reconstructed human epidermis model EpiDermTM), in compliance with GLP. The test substance was applied for 60 min in liquid form topically, undiluted, to the model skin surface (3 replicates). This was followed by a 42 h post incubation period. The optical density (OD) was determined by using the MTT reduction assay and expressed as relative percentage of viability of the negative control-treated tissues. The mean viability of cells exposed to the test substance was 6.5% of the negative controls and, hence, was below the cut-off percentage cell viability value that distinguishes irritant from non-irritant test substances of ≤50%. The test substance was considered to be cytotoxic and predicted to be irritant to skin in accordance with UN GHS classification. The mean optical density (OD) of 3 negative control tissues was 1.314 and well within the acceptable range of ≥1.0 to ≤2.5. The viability of cells treated with the positive reference substance, 5% SDS, was 6.9% of the negative control and fulfilled the acceptance criterion of ≤ 20%. The standard deviation of all triplicates determined was below the limit of acceptance of 18%. Hence, all acceptance criteria were fulfilled. Under the study conditions, the test substance was predicted to be a skin irritant (Spruth, 2017).
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From May 22, 2017 to May 31, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Remarks:
- three-dimensional model of human skin EpiDerm
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Model used: EpiDerm™ (EPI-200-SCT, Lot no. 25815) MatTek In Vitro Life Science Laboratories, Bratislava, Slovak Republic.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 50 μL of the supplied test substance were applied to the skin model with a surface area of 0.63 cm2 to uniformly cover the skin surface.
- Duration of treatment / exposure:
- The test substance and the reference substance were applied to the skin model surface at two exposure periods of 3 minutes or 1 hour.
- Number of replicates:
- Two tissues were used for each treatment and concurrent control groups.
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 88.9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 h
- Value:
- 32
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The mean optical density (OD) of the negative control of 2 tissues was 1.304 (3 min exposure) or 1.472 (1 h exposure) and therefore well within the acceptable range of ≥ 0.8 to ≤ 2.8. The viability of cells treated with the positive control 8 N KOH was 5.3 or 4.4% (3 min or 1 h exposure, respectively) of the negative control and, hence well below the 15% cut-off value at the 1 h exposure. The difference of viability between the two tissue replicates (at 20 – 100% viability) was below the limit of acceptance of 30%. Hence, all acceptance criteria were fulfilled.
- Conclusions:
- Under the study conditions, the test substance was determiend to be non-corrosive to the skin.
- Executive summary:
A study was conducted to determine the skin corrosion potential of the test substance, C11-unsatd. DEA (90.6% active), according to OECD Guideline 431 and EU Method B.40-tris using an artificial three-dimensional model of human skin, in compliance with GLP. Two tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined by using the MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, thiazolyl blue) reduction assay and expressed as relative percentage of viability of the negative control-treated tissues. 50 μL of the supplied test substance were applied to the skin model with a surface area of 0.63 cm2 to uniformly cover the skin surface. Sterile deionised water was used as the negative control. 8 N KOH was used as the positive reference substance. The test substance and the reference substance were applied to the skin model surface at two exposure periods of 3 min or 1 h. All the acceptance criteria for the test were fulfilled. In comparison to the negative controls, the mean viability of cells exposed to the test substance was 88.9% after a 3 min exposure period and 32.0% after a 1 hour exposure and hence, both values were above the cut-off percentage cell viability distinguishing corrosive from non-corrosive test substances (≥50 and ≥15%, respectively). Under the study conditions, the test substance was determiend to be non-corrosive to the skin (Spruth, 2017).
Referenceopen allclose all
None.
None.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- October 31, 1986 to November 25, 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- KL2 due to RA
- Justification for type of information:
- Refer to the section 13 for details on the category justification.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- other: Kleinrusse chbb
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- 4 males
- Source: HM/Fa. Thomae, Germany
- Average bodyweight at test start: 2,630 g - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.01 ml (low volume method)
- Duration of treatment / exposure:
- Single treatment
- Observation period (in vivo):
- 21 d
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- 0.01 mL test substance carefully applied in undiluted form into the lower lid of the right eye of the test animals. The other eye remained untreated. After 1, 6, 24, 48 and 72 h, then 7, 10, 14, 17 and 21 d, eyes were analysed for reaction based on the Draize appraisal method (J.H. Draize, Appraisal of the safety of chemicals in foods, drugs and cosmetics. Ass. of Food and Drug Officials of the US, pp 49-52 (1959)).
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1.25
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.25
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 2.58
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1.17
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 2.92
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- On the cornea, slight to moderate opacity was observed in all treated eyes. The reaction was irreversible. Irreversible effects were also noted in the iris of one animal. Finally, all animals presented moderate to severe redness, chemosis, and/or exudation (sometimes infiltrated with blood) of the conjunctivae, which did not entirely disappear by the end of the 21 d observation period.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the study conditions, the test substance was highly irritating to the rabbit eye.
- Executive summary:
A study was performed to assess the eye irritation potential of read across substance, C12-18 and C18-unsatd. DEA (>95% active), according to OECD Guideline 405 and EU Method B.5, in compliance with GLP. Four rabbits received 0.01 mL of an undiluted solution in one eye. The other eye remained untreated. After 1, 6, 24, 48 and 72 h, then 7, 10, 14, 17 and 21 d, eyes were analysed for reaction based on the Draize scoring method. On the cornea, slight to moderate opacity was observed in all treated eyes. The reaction was irreversible. Irreversible effects were also noted in the iris of one animal. Finally, all animals presented moderate to severe redness, chemosis, and/or exudation (sometimes infiltrated with blood) of the conjunctivae, which did not entirely disappear by the end of the 21 d observation period. Under the study conditions, the test substance was highly irritating to the rabbit eye (Kästner, 1987). Based on the result of the read across study, the test substance is also expected to have similar eye irritation potential.
Reference
None.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
A study was conducted to determine the skin corrosion potential of the test substance, C11-unsatd. DEA (90.6% active), according to OECD Guideline 431 and EU Method B.40-tris using an artificial three-dimensional model of human skin, in compliance with GLP. Two tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined by using the MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, thiazolyl blue) reduction assay and expressed as relative percentage of viability of the negative control-treated tissues. 50 μL of the supplied test substance were applied to the skin model with a surface area of 0.63 cm2 to uniformly cover the skin surface. Sterile deionised water was used as the negative control. 8 N KOH was used as the positive reference substance. The test substance and the reference substance were applied to the skin model surface at two exposure periods of 3 min or 1 h. All the acceptance criteria for the test were fulfilled. In comparison to the negative controls, the mean viability of cells exposed to the test substance was 88.9% after a 3 min exposure period and 32.0% after a 1 hour exposure and hence, both values were above the cut-off percentage cell viability distinguishing corrosive from non-corrosive test substances (≥50 and ≥15%, respectively). Under the study conditions, the test substance was determiend to be non-corrosive to the skin (Spruth, 2017).
A study was conducted to determine the in vitro skin irritation potential of the test substance, C11-unsatd. DEA, according to OECD Guideline 439 and EU Method B.46 (three-dimensional reconstructed human epidermis model EpiDermTM), in compliance with GLP. The test substance was applied for 60 min in liquid form topically, undiluted, to the model skin surface (3 replicates). This was followed by a 42 h post incubation period. The optical density (OD) was determined by using the MTT reduction assay and expressed as relative percentage of viability of the negative control-treated tissues. The mean viability of cells exposed to the test substance was 6.5% of the negative controls and, hence, was below the cut-off percentage cell viability value that distinguishes irritant from non-irritant test substances of ≤50%. The test substance was considered to be cytotoxic and predicted to be irritant to skin in accordance with UN GHS classification. The mean optical density (OD) of 3 negative control tissues was 1.314 and well within the acceptable range of ≥1.0 to ≤2.5. The viability of cells treated with the positive reference substance, 5% SDS, was 6.9% of the negative control and fulfilled the acceptance criterion of ≤ 20%. The standard deviation of all triplicates determined was below the limit of acceptance of 18%. Hence, all acceptance criteria were fulfilled. Under the study conditions, the test substance was predicted to be a skin irritant (Spruth, 2017).
Eye irritation
A study was performed to assess the eye irritation potential of read across substance, C12-18 and C18-unsatd. DEA (>95% active), according to OECD Guideline 405 and EU Method B.5, in compliance with GLP. Four rabbits received 0.01 mL of an undiluted solution in one eye. The other eye remained untreated. After 1, 6, 24, 48 and 72 h, then 7, 10, 14, 17 and 21 d, eyes were analysed for reaction based on the Draize scoring method. On the cornea, slight to moderate opacity was observed in all treated eyes. The reaction was irreversible. Irreversible effects were also noted in the iris of one animal. Finally, all animals presented moderate to severe redness, chemosis, and/or exudation (sometimes infiltrated with blood) of the conjunctivae, which did not entirely disappear by the end of the 21 d observation period. Under the study conditions, the test substance was highly irritating to the rabbit eye (Kästner, 1987). Based on the result of the read across study, the test substance is also expected to have similar eye irritation potential.
Justification for classification or non-classification
Skin
Based on the results of the in vitro skin corrosion (OECD 431) and skin irritation (OECD 439) study conducted with C11-unsatd. DEA, the substance warrants classification Skin Irrit. 2 - H315 (causes skin irritation) according to CLP (EC 1272/2008) criteria.
Eye
The key in vivo eye irritation study with the read-across substance with C12-18 and C18-unsatd. DEA suggests that the test substance is highly irritating to eyes, with irreversible eye effects in one animal. Since the effects seen in this study were severe, C11-unsatd. DEA was classified as Eye Damage 1 - H318 (causes serious eye damage) according to CLP (EC 1272/2008) criteria.
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