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Diss Factsheets
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EC number: 210-088-4 | CAS number: 605-50-5
- 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 / corrosion, other
- Remarks:
- EPISKIN
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7th June 2010 - 14th June 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline 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:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Principles of method if other than guideline:
- OECD Guideline For The Testing of Chemicals (2009), Draft proposal for a new guideline: In Vitro Skin Irritation: Human Skin Model Test. Year 2009. EPISKIN three dimensional human skin model.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Diisopentyl phthalate
- EC Number:
- 210-088-4
- EC Name:
- Diisopentyl phthalate
- Cas Number:
- 605-50-5
- Molecular formula:
- C18H26O4
- IUPAC Name:
- diisopentyl phthalate
- Details on test material:
- - Name of test material (as cited in study report): Diisoamyl phthalate
- Physical state: colourless to slightly yellow clear liquid
- Analytical purity: 99.98%
- Purity test date: Not reported
- Lot/batch No.: 7920-1-1
- Expiration date of the lot/batch: 12 August 2012
- Storage condition of test material: Ca. room temperature (+20°C) in the dark
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used:The EPISKIN Skin Irritation Test-42 hours
- Date of initiation of testing: 8th June 2010
TEMPERATURE USED FOR TEST SYSTEM
The tissues were removed from the agar and placed into wells of 12 well plates containing
2 ml pre-warmed maintenance medium per well. The tissues were incubated for a minimum
of 24 hours at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air.
REMOVAL OF TEST MATERIAL AND CONTROLS
After 15 ± 0.5 minutes, each tissue was rinsed with 25 ml sterile Dulbeccos Phosphate
Buffered Saline (DPBS) to remove residual test substance.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
It is possible that a test substance may reduce MTT, resulting in the production of a
blue/purple colour without any involvement of cellular mitochondrial dehydrogenase. Since
the test substance is rinsed off the tissue before the MTT assay, this is usually avoided.
However, it is possible that small amounts of test substance may be present after washing or
be released through the tissue into the MTT medium. If the mixture with the test substance
turned blue/purple after approximately 3 hour incubation at 37 ±2ºC in 5% CO2 in air, MTT
reduction may have occurred.
The MTT reducing capability of the test substance, Diisoamyl Phthalate, was investigated by
mixing approximately 10 Fl of the test substance with 2 ml of 0.3 mg/ml MTT solution in
duplicate. A control of 10 Fl of purified water, mixed with 2 ml of 0.3 mg/ml MTT solution
was also included in duplicate.
NUMBER OF REPLICATE TISSUES: Triplicate tissues.
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if [complete, e.g. the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.] - Control samples:
- yes, concurrent positive control
- Amount/concentration applied:
- 10 μl
- Duration of treatment / exposure:
- Triplicate tissues were dosed for 15 ± 0.5 minutes with the test substance.
- Duration of post-treatment incubation (if applicable):
- 42 hours.
- Number of replicates:
- 3
Test system
- Type of coverage:
- other:
- Preparation of test site:
- other: n/a
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 15+/-0.5 minutes
- Observation period:
- Not applicable
- Number of animals:
- Not applicable
- Details on study design:
- See any other information below.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 104.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 74.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 104.4
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean
- Value:
- 94.6
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Negative control
The mean absorbance of the triplicate negative control values was 0.711 which was above the minimum acceptance value of 0.6. The standard deviation of the % viability was 13.8 which was below the maximum acceptance value of 18.
Positive control
The percentage mean viability of the positive control was 12.0 ± 1.7 of the negative control. These were below the maximum acceptance values of 30% viability and SD of 18.
Test substance
It was concluded that the test substance, Diisoamyl Phthalate, with a mean tissue viability of 94.6 ± 17.3%, was predicted as non-irritant to the skin.
In vivo
- Irritant / corrosive response data:
- Not Applicable
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- It was concluded that the test substance, diisopentyl phthalate, with a mean tissue viability of 94.6 ± 17.3%, was predicted as a non-irritant to the skin.
- Executive summary:
The objective of this test was to assess the skin irritation potential, in vitro, of the test ubstance, Diisoamyl Phthalate.
The test substance was applied to EPISKIN human epidermis skin constructs. The constructs consisted of normal, human-derived epidermal keratinocytes, which had been cultured to form a multilayered, highly differentiated model of the human epidermis with a functional multilayered stratum corneum. The cell viability of the multi layers was determined by mitochondrial dehydrogenase activity. The prediction model uses the percentage viability values (compared to negative control viability) to identify irritant and non-irritant substances.
The test substance, Diisoamyl Phthalate, elicited a mean tissue viability of 94.6% and was predicted as non-irritant.
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