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EC number: 264-727-7 | CAS number: 64194-22-5
- 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:
- 15 April 2013 - 29 April 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.46 (In vitro dermal irritation)
- Deviations:
- yes
- Remarks:
- see below
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 439 (In vitro dermal irritation)
- Deviations:
- no
- Principles of method if other than guideline:
- The study was performed in accordance with study plan with the following deviations from the agreed study plan:
. § Test for direct MTT reduction with the test item: due to a typing error in the study plan, the volume of MTT solution used for the negative control in the preliminary test for direct MTT reduction which is specified in the study plan is incorrect. Indeed, the volume of MTT solution used in this study was 2 mL (as described in CiToxLAB’s SOP) instead of 2.2 mL. This deviation was considered not to have compromised the validity or integrity of the study, - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-methyl-1,5-pentanediyl diacrylate
- EC Number:
- 264-727-7
- EC Name:
- 3-methyl-1,5-pentanediyl diacrylate
- Cas Number:
- 64194-22-5
- Molecular formula:
- C12H18O4
- IUPAC Name:
- 3-methyl-5-(prop-2-enoyloxy)pentyl prop-2-enoate
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: reconstructed human epidermis
- Details on animal used as source of test system:
- EpiskinTM Model Kit (0.38 cm2 tissues) supplied by SkinEthic Laboratories, Lyon, France.
Medium and Incubation T°C: 37°C
Dates of experimental phase: from 23 April 2013 to 29 April 2013 - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- REMOVAL OF TEST SUBSTANCE
- Rinsing: at the end of the treatment period, each tissue was removed from the well of the treatment plate, and rinsed with D-PBS. Rinsing was achieved by gently filling and emptying several times each tissue with D-PBS to gently remove any residual test or control items. Excess D-PBS was removed by blotting the bottom of the tissue culture insert with absorbent paper.
The rinsed tissues were transferred to the second column of 3 wells containing 2 mL of maintenance medium in each well and the plates were incubated at +37°C, 5% CO2 in a humidified incubator for 42 (± 1) hours.
POSITIVE CONTROL
Sodium Dodecyl Sulphate (SDS) at a 5% (w/v) aqueous solution.
NEGATIVE CONTROL
Name: Dulbecco’s Phosphate-Buffered Saline (D-PBS).
SCORING SYSTEM:
- Optical density (OD) was measured at 570 nm:
Relative mean viability (%) = 100 x mean cOD(test item) / mean cOD(negative control)
where:
- mean cOD Negative Control = mean ODNC – mean ODblank
- mean cOD Test Item = mean ODTI – mean ODblank
Interpretation: see below - Control samples:
- yes, concurrent no treatment
- yes, concurrent positive control
- Amount/concentration applied:
- Amount applied per tissue: 10 ± 2 µL
- Duration of treatment / exposure:
- Exposure period of 15 minutes, followed by a rinsing
- Duration of post-treatment incubation (if applicable):
- MTT-loading after a 42h-incubation period following rinsing. Observation of MTT-> formazan transformation by viable cells, after a 3-hour MTT incubation
- Number of replicates:
- Triplicate for each tested substance (test item, negative control, positive control).
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 15 minute exposure (treated)
- Value:
- 6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Preliminary tests
In the preliminary tests, the test item was found not to have direct MTT reducing properties or a colouring potential.
Main test
All acceptance criteria for the negative and positive controls were fulfilled. The study was therefore considered to be valid.
Following a 15 minutes exposure and a 42-hour recovery period, the relative mean viability of the tissues treated with the test item was 6% with a standard deviation of 1%. As the mean viability was < 50% after the MTT reduction, the results met the criteria for an in vitro classification as irritant (R38) to skin.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Under the experimental conditions of this study, the test item is considered to be irritant to skin.
- Executive summary:
The objective of this study was to evaluate the skin irritation potential of the test item using the EpiskinTMreconstructed human epidermis model.
The study design was based upon international guidelines (OECD Guideline No. 439 and Commission Regulation (EC) No. 761/2009, B.46). The study was conducted in compliance with CiToxLAB’s standard operating procedures and the principles of Good Laboratory Practice.
Methods
Preliminary tests were performed to detect the ability of the test item to directly reduce MTT as well as its colouring potential.
Following the preliminary tests, the skin irritation potential of the test item was tested in the main test. The test item and both the negative and positive controls were topically applied on triplicate tissues and incubated at room temperature for 15 (± 1) minutes. At the end of the treatment period, each tissue was rinsed with D-PBS and incubated for 42 (± 1) hours at, 5% CO2 in a humidified incubator. The cell viability was then assessed by means of the colourimetric MTT reduction assay.
Relative viability values were calculated for each tissue and expressed as a percentage of the mean viability of the negative control tissues which was set at 100% (reference viability).
Results
Preliminary tests
In the preliminary tests, the test item was found not to have direct MTT reducing properties or a colouring potential.
Main test
All acceptance criteria for the negative and positive controls were fulfilled. The study was therefore considered to be valid.
Following a 15 minutes exposure and a 42-hour recovery period, the relative mean viability of the tissues treated with the test item was 6% with a standard deviation of 1%. As the mean viability was < 50% after the MTT reduction, the results met the criteria for an in vitro classification as irritant (R38) to skin.
Conclusion
Under the experimental conditions of this study, the test item is considered to be irritant to skin.
According to the results of this study, the classification of the test item should be:
- irritant (R38) (Directive 67/548/EEC) and category 2 (H315) (Regulation (EC) No. 1272/2008).
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