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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- other: OECD 437. 7 September 2009, OECD Guideline for the Testing of Chemicals: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants.
- Deviations:
- no
- Principles of method if other than guideline:
- Bovine Corneal Opacity and Permeability Test: An In Vitro Assay of Ocular Irritancy. Fundamental and Applied Toxicology 18: 442-449, 1992.
- 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 (Diisopentyl phthalate)
- Substance type: organic
- Physical state: colorless to slightly yellow liquid
- Analytical purity: 99.98%
- Lot/batch No.: 7920-1-1
- Expiration date of the lot/batch: August 12, 2012
- Stability under test conditions: not reported
- Storage condition of test material: at room temperature (ca. 20°C), in the dark
Constituent 1
Test animals / tissue source
- Species:
- other: in vitro assay on bovine ocular tissue
- Strain:
- other: n/a
- Details on test animals or tissues and environmental conditions:
- Source
The bovine eyes, supplied by a reputable Abattoir, were excised by an abattoir employee and collected as soon after slaughter as possible (excised at 13.00 hours, 15 June 2010).
Instructions were given to avoid damaging the corneas during excision. Excised eyes were maintained and transported to the laboratory, at ambient temperature, in sufficient HBSS, containing 1% (v/v) penicillin/streptomycin solution, to cover all the eyes in the receptacle.
The eyes were used within 4 hours of slaughter (incubation of mounted corneas commenced at 15.22 hours, 15 June 2010).
Preparation of Corneas
All eyes were carefully examined, macroscopically, for defects (opacity, scratches, pigmentation, cuts, etc.) and those exhibiting defects were discarded. The tissue surrounding the eyeball was carefully pulled away and the cornea dissected leaving approximately 2 to 3 mm of sclera present around the cornea. The isolated corneas were stored in a petri dish containing HBSS plus 1% penicillin/streptomycin solution until all the corneas had been dissected. Once all the corneas had been dissected, they were rinsed in fresh HBSS plus 1% penicillin/streptomycin solution prior to mounting.
The corneas were mounted in the cornea holders with the endothelial side against the O-ring of the posterior half of the holder. Each cornea was gently flattened over the O-ring and holder surface with a wetted, gloved finger to expel any air. The anterior half of the holder was then positioned on top of the cornea and secured with screws. Both compartments of the holder were filled with cMEM, using a syringe. The posterior compartment was always filled first to return the cornea to its natural shape. Care was taken to ensure no air bubbles were present within the holders.
The holders were then plugged and incubated, in an upright position, for 60 minutes ± 5 minutes at 32°C ± 1°C in a waterbath. The waterbath temperature remained within the limits of 32°C ± 1°C throughout the experiment.
At the end of the 60 minute incubation period, the medium was removed from both the anterior and posterior compartments using a pipette tip attached to a vacuum pump. The compartments were refilled with fresh cMEM. Again care was taken to ensure no air bubbles were present within the holders. The posterior compartment was then plugged and the basal opacity measurements performed.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: excised corneas employed for testing
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume) 0.75 mL
- Concentration : undiluted - Duration of treatment / exposure:
- Applied once, allowed to remain in contact with the cornea for 10 mins, then washed off with MEM seven times to ensure complete removal of test material.
- Observation period (in vivo):
- Following washing to remove the test material the anterior compartment holding the cornea was then filled with cMEM taking care to ensure no air bubbleswere present in the compartment. Once all the air bubbles had been removed, the anterior compartment was re-plugged and the holders returned to the waterbath and incubated, in an upright position, for two hours ± 10 minutes at 32°C ± 1°C.
Following completion of the two hour incubation period, the medium was removed from both compartments and replaced with fresh cMEM. The posterior compartment was re-plugged and the opacity of each cornea measured and recorded. The opacity values obtained at this stage were used in calculating the final In Vitro Irritancy Score.
Throughout the assay the corneas were examined for opaque spots or other irregularities. - Number of animals or in vitro replicates:
- Not applicable as excised corneas only employed for testing.
- Details on study design:
- Control corneas were treated with the positive control (ethanol) in exactly the same manner as for the test corneas.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- -0.4
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Diisoamyl Phthalate |
-0.333 ± 0.577 |
-0.003± 0.016 |
-0.4 ± 0.3 |
Non Corrosive/ |
Ethanol |
21.000 ± 3.000 |
1.625 ± 0.074 |
45.4 ± 4.0 |
Non Corrosive/ Non Severe |
09% saline |
0.000 ± 1.000 |
0.021 ± 0.011 |
N/A |
N/A |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the referred classification criteria the test article Diisopentyl phthalate is classified as non corrosive/non severe eye irritant
- Executive summary:
The Bovine Corneal Opacity and Permeability Assay (BCOP) was performed to assess the ocular irritancy potential in vitro of the test substance. Ethanol was tested in parallel as a positive control.
The assay uses isolated bovine corneas as a means of assessing the ocular corrosivity or severe irritancy potential of test substances in vitro. The isolated corneas were obtained as a by-product of the meat production industry. Two endpoints, corneal opacity and permeability, were measured and combined to give an In Vitro Irritancy Score which can be used to classify and rank test substances as potential eye irritants according to OECD guideline 437 (OECD 437).
The test substance, Diisoamyl Phthalate, elicited an In Vitro Irritancy Score of -0.4 ± 0.3 and was predicted to be a non corrosive/non severe eye irritant.
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