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EC number: 218-076-0 | CAS number: 2049-95-8
- 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:
- From 11 May to 06 June 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ICCVAM: Current status of in vitro test methods for identifying ocular corrosives and severe irritants: The Bovine Corneal Opacity and Permeability (BCOP ) Test Method, March 2006
- Deviations:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- tert-pentylbenzene
- EC Number:
- 218-076-0
- EC Name:
- tert-pentylbenzene
- Cas Number:
- 2049-95-8
- Molecular formula:
- C11H16
- IUPAC Name:
- (2-methylbutan-2-yl)benzene
- Details on test material:
- - Analytical purity: 97.4%
- Impurities: Cumene: 0.7%, Heptylbenzene (C13H18): 0.6%, Nonylbenzene (C15H22): 0.6%
- Lot/batch No.: Tank BV1112 du 18 avril 2007.
Constituent 1
Test animals / tissue source
- Species:
- other: Bovine eyes
- Details on test animals or tissues and environmental conditions:
- TEST SYSTEM
- Test system: Bovine eyes from young cattle were obtained from the slaughterhouse
- Source: Vitelco, 's Hertogenbosch, The Netherlands
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 32 +/- 1°C
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µl of the control or test substance was introduced onto the epithelium of the cornea. - Duration of treatment / exposure:
- The Corneas were incubated for 10 +/- 1 minutes.
- Number of animals or in vitro replicates:
- Three corneas were selected at random for each treatment group.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the incubation the control or test substance was removed and the epithelium was washed at least three times with cMEM (Eagle's Minimum Essential Medium).
SCORING SYSTEM: Opacity determinations were performed on the corneas using a opacitometer. The change in opacity for each individual cornea (including the negative control) was calculated by subtracting the initial opacity reading from the final post-treatment reading. Following the final opacity measurement, permeability of the cornea was evaluated. The mean opacity and mean permeability values were used for each treatment group to calculate an in vitro score. If this in-vitro score ranges between 0-3 the test substance is non-irritant. If the in-vitro score is >80 the test substance is very severe irritant.
Results and discussion
In vitro
Results
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 10 minutes (topical application)
- Value:
- ca. 1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- See Table 1. The in vitro irritancy scores of the corneas treated with Tertiary-amylbenzene ranged from 0.2 to 1.7 with a mean of 1.0. Since all in vitr scores were less than 3.1 Tertiary-amylbenzene was considered non-irritant.
Based on the results obtained with the negative and positive control, it can be concluded that the test conditions were adequate and the test system functioned properly.
Any other information on results incl. tables
Table 1: Summary of opacity, permeability and in vitro scores
Treatment |
Mean opacity |
Mean permeability |
Mean in vitro score |
Negative control |
0 |
-0.001 |
0.0 |
Positive control |
87 |
6.170 |
179 |
Tertiary-amylbenzene |
0 |
0.046 |
1.0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions of this study, Tertiary-amylbenzene is non irritant in the Bovine Corneal Opacity and Permeability according to EU criteria.
- Executive summary:
Screening for the eye irritancy potential of Tertiary-amylbenzene using the Bovine Corneal Opacity and Permeability test (BCOP test) was performed. The possible ocular irritancy of Tertiary-amylbenzene was tested through topical application for 10 minutes. The test substance was applied undiluted (750 µL) directly on top of the corneas.
The mean in vitro irritancy score obtained with the negative control was less than 3.1 indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (10% w/v Benzalkonium chloride) was within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
The in vitro irritancy scores of the corneas treated with Teritiary-amylbenzene ranged from 0.2 to 1.7 with a mean of 1.0. Since all in vitro irritancy scores were less than 3.1, Tertiary-amylbenzene was considered non-irritant.
Under the test conditions of this study, it is concluded that this test is valid and that Tertiary-amylbenzene is non-irritant in the Bovine Corneal Opacity and Permeability according to EU criteria.
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