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EC number: 242-440-8 | CAS number: 18599-22-9
- 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:
- weight of evidence
- Study period:
- 19 February 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
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)
- Version / remarks:
- 9 October 2017
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-bromo-3,3,4,4-tetrafluorobut-1-ene
- EC Number:
- 242-440-8
- EC Name:
- 4-bromo-3,3,4,4-tetrafluorobut-1-ene
- Cas Number:
- 18599-22-9
- Molecular formula:
- C4H3BrF4
- IUPAC Name:
- 4-bromo-3,3,4,4-tetrafluorobut-1-ene
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- other:
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Neat
- Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 2 hours
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- -0.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks:
- Yes: 52.1
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 1
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- Yes: 0.7
- Positive controls validity:
- valid
- Remarks:
- Yes: 32.3
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- 1
- Value:
- -0.007
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- Yes: 0.011
- Positive controls validity:
- valid
- Remarks:
- Yes: 1.315
Any other information on results incl. tables
Table 1 summarizes the results of the BCOP assay. The followng prediction models were used to evaluate the ocular irritancy potential as described by Sina et al. (1995)[2] for non-regulatory purposes or as described in OECD TG437 (2017).
The prediction model according to Sina et. al based on a wide range of materials (note: While this classification system provides a good initial guide to interpretation of these in vitro data, these specific ranges may not be applicable to all classes of materials or other exposure times. Whenever possible, results should be compared to "benchmark" materials tested under similar exposure conditons.):
In Vitro Score | Sina et al Prediction |
≤ 25 | Mild irritant |
> 25 ; ≤ 55 | Moderate irritant |
> 55 | Severe irritant |
Prediction model outlined in OECD TG 437:
In Vitro Irritation Score (IVIS) | UN GHS |
≤ 3 | No Category |
> 3; ≤ 55 | No prediction can be made* |
> 55 | Category 1 |
*- Additional testing would be required for a definitive classification of ocular irritation potential according to GHS
The BCOP assay was accepted when the positive control (ethanol) produced an In Vitro Score that fell within two standard deviations of the historical mean. The current acceptance range for ethanol is 37.9-63.4.
[2] Sina, J.F., Galer, D.M., Sussman, R.G., Gautheron, P.D., Sargent, E.V., Leong, B., Shah, P.V., Curren, R.D., and Miller, K. (1995) A collaborative evaluation of seven alternatives to the Draize eye irritation test using pharmaceutical intermediates. Fundamental and Applied Toxicology 26:20-31.
Applicant's summary and conclusion
- Interpretation of results:
- other: No Category
- Conclusions:
- According to the current OECD test guideline 437 (OECD TG 437) the test substance is predicted to not require classification or labeling for ocular irritation according to the Globally Harmonized System (GHS No Category).
- Executive summary:
The Bovine Corneal Opacity and Permeability Assay (BCOP) was used to assess the potential ocular irritancy of the test substance, BTFB, also referred to as 4-Bromo-3,3,4,4-tetrafluorobut-1-ene (CAS 18599-22-9). Bovine corneas, obtained as a byproduct from freshly slaughtered animals, were mounted in special holders and exposed to the test substance for 10 minutes + 2 hrs post exposure period. The test substance was tested neat. An In Vitro Score was determined for the test substance based on the induction of opacity and permeability (to fluorescein) in the isolated bovine corneas. The In Vitro Score obtained for the test substance was -0.1. The test substance would be classified as a mild irritant according to the classification system established by Sina Scale (i.e. In Vitro Score ≤ 25). According to the OECD test guideline 437 (OECD TG 437) the test substance is predicted to not require classification or labeling for ocular irritation according to the Globally Harmonized System (GHS No Category).
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