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Diss Factsheets
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EC number: 201-553-2 | CAS number: 84-69-5
- 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:
- 02 June - 04 June 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study. Available as an unpublished report. Acceptable without restrictions.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for the Testing of Chemicals No. 431 "In Vitro Skin Corrosion: Human Skin Model Test" (adopted 13 April 2004)
- Deviations:
- no
- Principles of method if other than guideline:
- Test method used the EPISKIN™ in vitro Reconstituted Human Epidermis (RHE) Model after treatment periods of 3, 60, and 240 minutes.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Diisobutyl phthalate
- EC Number:
- 201-553-2
- EC Name:
- Diisobutyl phthalate
- Cas Number:
- 84-69-5
- Molecular formula:
- C16H22O4
- IUPAC Name:
- 1,2-bis(2-methylpropyl) benzene-1,2-dicarboxylate
- Details on test material:
- - Name of test material (as cited in study report): Diisobutyl-phthalate
- Physical state: clear colourless liquid
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- Human skin tissue used in in vitro test - EPISKIN Model Kit 0.38 cm2.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 37 °C
Test system
- Type of coverage:
- other: Universal coverage of tissue sample in vitro
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
- Concentration (if solution): Liquid test material used as supplied. - Duration of treatment / exposure:
- 3, 60, and 240 minutes.
- Observation period:
- Assessment of effects required complicated procedure, see below.
- Number of animals:
- Duplicate epidermis samples for each exposure and duration.
- Details on study design:
- PRE-TEST
An assessment of the test material's potential to reduce MTT (a reaction which would have invalidated the main assessment procedure) was first conducted.
50 µL of test material was added to 0.3 mg/mL MTT solution and incubated in the dark for 3 hours. Untreated solution was used as a control. A colur change to blue/purple relative to the control was observed for as this was indicative of a reduction.
MAIN TEST
2.2 mL of assay medium was pipetted into 2 wells fo the second and third columns of a 12-well plate. Tissues were transferred to the second colum.
Duplicate tissues were treated with the test material (50 µL) for the alloted time periods with negative and postive controls being treated with 0.9% w/v NaCl solution and glacial acetic acid respectively.
At the end of the exposure period tissues were removed and rinsed to remove the test material.
Tissues were then transferred to MTT filled wells of the plate and incubated for 3 hours ± 5 minutes at room tempterature then placed onto absorbant paper to dry.Tissues were then examined for MTT staining, and then by total biospy - the epidermis removed from the collagen matrix and both parts placed into 1.5 mL micro tubes containing 850 µL of acidified isopropanol. Tubes were plugged, mixed thoroughly and stored overnight at room temperature to extract formazan crystals out of the MTT-loaded tissues.
After this, tubes were mixed thoroughly on a vortex mixer to produce a homogenous coloured solution. Duplicate 200 µL samples were taken and the optical denisty measured (quantitative viability analysis) at 540 nm using the Anthos 2001 microplate reader.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: OD540
- Value:
- 0.202
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 3 minutes. Reversibility: other: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: OD540
- Value:
- 0.214
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 60 minutes. Reversibility: other: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other:
- Value:
- 0.183
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 240 minutes. Reversibility: other: not applicable. (migrated information)
In vivo
- Irritant / corrosive response data:
- The test material is concluded to be Non-Corrosive to the skin.
Any other information on results incl. tables
The pre-test showed no reduction of MTT by the test material, thus the results of the test are not invalid.
Table 1. Mean OD540 Values and Viabilities for the Negative Control Material, Positive Control Material and Test Material
Material | Exposure Period (minutes) | Mean OD540 of duplicate tissues | Relative mean viability (%) |
Negative Control Material | 240 | 0.099 | Mean viability of negitive control tissues is set to 100% |
Positive Control Material | 240 | 0.018 | 18.2 |
Test Material | 240 | 0.183 | 184.8 |
60 | 0.214 | 216.2 | |
3 | 0.202 | 204 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Non-Corrosive to the skin
- Remarks:
- Criteria used for interpretation of results: not specified
- Conclusions:
- Diisobutyl phthalate is non-corrosive to the skin.
- Executive summary:
In an in vitro assay, treatment of skin tissues with diisobutyl phthalte was not observed to be corrosive. The test was conducted according to standard guidelines and GLP and met the validity criterea.
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