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EC number: 306-832-3 | CAS number: 97416-84-7
- 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:
- May 5th, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test conducted according to internationally accepted Guideline and in according to the GLP Principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Principles of method if other than guideline:
- This study design is in agreement with the procedures described in the OECD series on testing and assessment no. 160 – Guidance Document on the bovine corneal opacity and permeability (BCOP) and isolated chicken eye (ICE) test methods: collection of tissues for histological evaluation and collection of data on non-severe irritants.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromo-2-methylpropoxy)benzene]
- EC Number:
- 306-832-3
- EC Name:
- 1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromo-2-methylpropoxy)benzene]
- Cas Number:
- 97416-84-7
- Molecular formula:
- C23H24Br8O2
- IUPAC Name:
- 1,3-dibromo-2-(2,3-dibromo-2-methylpropoxy)-5-{2-[3,5-dibromo-4-(2,3-dibromo-2-methylpropoxy)phenyl]propan-2-yl}benzene
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test system
- Controls:
- yes
- Amount / concentration applied:
- A suspension of the test item at 20 % w/v was prepared in physiological saline, with correction for the displacement due to the volume of the test item. Concentrations were expressed in terms of material as received. The suspension was sonicated and maintained in magnetic agitation until aliquots preparation. Three syringes were filled in with the suspension and maintained at room temperature until use.
- Duration of treatment / exposure:
- 4-hour exposure period
- Observation period (in vivo):
- There was no post-exposure period.
- Number of animals or in vitro replicates:
- n.a.
- Details on study design:
- REPLICANTS: three corneas per Test Item, Negative and Positive control respectively
CONTROLS: positive and negative control
Positive control: 20 % (w/v) Imidazole (Sigma, batch no. 0001422794), in physiological saline (0.9 % NaCl) (Baxter, batch no. 13D0406).
Negative control: Physiological saline (0.9 % NaCl) (Baxter, batch no. 13D0406).
REMOVAL OF TEST SUBSTANCE
- Washing and time after start of exposure:
After exposure, corneas were rinsed thoroughly with complete EMEM with phenol red. For the test item treated group, additional washings were performed and the glass windows of the anterior chambers were removed to allow a more effective removal of the test item from the corneas. A final wash with prewarmed complete EMEM without phenol red was carried out. Finally, the anterior chamber was re-filled with prewarmed complete EMEM without phenol red.
SCORING SYSTEM: in vitro irritacy score (IVIS)
TOOL USED TO ASSESS SCORE: opacitometer
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 4 hours
- Value:
- ca. 0
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- No effects observed under test condition
- Other effects / acceptance of results:
- No relevant increases in opacity or permeability values were recorded after treatment with the test item, when compared to those of negative control.
The calculated in vitro irritancy score (IVIS ) was 0.0.
Negative and positive controls gave the expected results. The test is therefore considered as valid.
Any other information on results incl. tables
Assessment of ocular corrosion/irritation bovine corneal opacity/permeability (BCOP) assay.
Treatment code | Pre-test corna number | Basal opacity | Mean group basal opacity |
N1 | 10 | 0 | 0.00 |
N2 | 6 | 0 | |
N3 | 9 | 0 | |
P1 | 2 | 1 | 0.00 |
P2 | 5 | 0 | |
P3 | 7 | 0 | |
A1 | 1 | 1 | 0.00 |
A2 | 4 | 0 | |
A3 | 8 | 0 |
Mean of basal opacity: 0.00; the mean refers to the total number of selected pre-test corn
The IVIS cut-off values for identifying test chemicals as inducing serious eye damage (UN GHS Category 1) and test chemicals not requiring classification for eye irritation or serious eye damage (UN GHS No Category) are:
- IVIS ≤ 3 –No Classification(UN GHS)
- IVIS > 3; ≤ 55 – No prediction can be made
- IVIS > 55 –Category 1(UN GHS)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Calculated in vitro irritancy score (IVIS ) = 0.0.
No relevant increases in opacity or permeability values were recorded after treatment with the test item, when compared to those of negative control. - Executive summary:
Method
The potential of the test item to cause corrosion/severe irritation by using the Bovine Corneal Opacity and Permeability (BCOP) assay was examined, in agreement with OECD Guideline no. 437 and the Guidance Document OECD series on testing and assessment no. 160.
The test item, a non surfactant powder, was dissolved at 20 % (w/v) in physiological saline and tested on the epithelial surface of three idoneous bovine corneas, for an exposure period of 4 hours.
Observations
The opacity of two of the treated corneas, detected with an opacimeter at the end of the test item exposure period, was 0.0; residual test item was observed on the surface of the third replicate thus the opacity value obtained (18) was not considered reliable. This was confirmed by macroscopic observation, where no alterations of corneas surfaces were noted. After the determination of opacity, the epithelial surface was treated with a 0.5 % solution of sodium fluorescein in DPBS for approximately 90 minutes to investigate alteration in cornea permeability. The mean value of permeability (OD490) of the corneas treated with the test item was 0.0022. The calculated in vitro irritancy score (IVIS) of the test item was 0.0.
Positive and negative controls [a 20 % (w/v) Imidazole solution in physiological saline and physiological saline alone, respectively] were concurrently tested in similar conditions and gave the expected results.
Result
According to the OECD Guideline no. 437, the test item can be classified as Not irritant.
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