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EC number: 700-453-0 | CAS number: 59802-05-0
- 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
- Study period:
- 02.09.2016 - 01.11.2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,4-Benzenedicarboxylic acid, 1,4-diisononyl ester
- EC Number:
- 700-453-0
- Cas Number:
- 59802-05-0
- Molecular formula:
- C26H42O4
- IUPAC Name:
- 1,4-Benzenedicarboxylic acid, 1,4-diisononyl ester
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- cattle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL - Duration of treatment / exposure:
- The incubation time lasted ten minutes.
- Duration of post- treatment incubation (in vitro):
- two hours
- Number of animals or in vitro replicates:
- 3 corneae per groups
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
Freshly isolated bovine eyes of at least 9 month old donor cattle were collected from the
abattoir. Excess tissue was removed from the excised eyes. The isolated eyes were
transported to the laboratory in HBSS at ambient temperature. The corneae were isolated on the same day after delivery of the eyes and were directly used in the BCOP test.The cornea was carefully removed from the eye using scalpel and rounded scissors. A rim of about 2 mm of tissue (sclera) was left for stability and handling of the isolated cornea.
QUALITY CHECK OF THE ISOLATED CORNEAS
All eyes were carefully examined macroscopically for defects. Those presenting defects such as vascularization, pigmentation, opacity and scratches were discarded.
NUMBER OF REPLICATES
3
NEGATIVE CONTROL USED
Saline (0.9% NaCl in deionised water)
POSITIVE CONTROL USED
2-Ethoxyethanol (purity: 99%)
APPLICATION DOSE AND EXPOSURE TIME
The anterior compartment received the test item or negative or positive control at a volume of 0.75 mL on the surface of the corneae. The corneae were incubated in a horizontal position at 32 ± 1 °C in the water-bath.
The incubation time lasted ten minutes.
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
After the test item or control items, respectively, were rinsed off from the application side
with saline, fresh cMEM was added into the anterior compartment.
- Number of washing steps after exposure period: once
- POST-EXPOSURE INCUBATION:
Then the corneae were incubated at 32 ± 1 °C for further two hours in a vertical position, followed by a second opacity reading (t130).
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity:The opacitometer determines changes in the light transmission passing through the corneae, and displays a numerical opacity value.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of [UV/VIS spectrophotometry] (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
≤ 3 No Category (according to GHS)
> 3; ≤ 55 No prediction can be made
> 55 Serious eye damage according to CLP/EPA/GHS (Cat 1)
DECISION CRITERIA:
The test will be acceptable if
• the positive control gives an IVIS that falls within two standard deviations of the
current historical mean (updated every three months), and if
• the negative control responses result in opacity and permeability values that are less
than the established upper limits for background opacity and permeability values for
bovine corneae treated with the respective negative control.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- ca. 0.43
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item Benzol-1,4-dicarbonsäure-diisononylester was tested undiluted. Relative to the
negative control, the test item Benzol-1,4-dicarbonsäure-diisononylester did not cause an
increase of the corneal opacity or permeability. The calculated mean IVIS was 0.43
(threshold for serious eye damage: IVIS ≥ 55). According to OECD 437 the test item is not
categorized.
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