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EC number: 249-236-8 | CAS number: 28804-46-8
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Control samples:
- yes, concurrent no treatment
- yes, concurrent positive control
- Amount/concentration applied:
- 20 mg of test item/0.5 cm2
- Duration of treatment / exposure:
- 3 minutes and 60 minutes
- Number of replicates:
- Three replicates were used for both the exposure times
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 106
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 90
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- other: non-corrosive
- Conclusions:
- From the results of this study, under the specified experimental conditions, DPX-C (Di-Cloro-Di-p-Xililene) is concluded to be non-corrosive in in vitro skin corrosion test using reconstructed human epidermis (RHE) tissues.
- Executive summary:
This study was performed to evaluate the non-corrosive and corrosive potential of DPX-C (Di-Cloro-Di-p-Xililene) using reconstructed human epidermis (RHE) tissue in accordance with the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS).
The tissues were exposed to DPX-C (Di-Cloro-Di-p-Xililene) for 3 minutes and 60 minutes at room temperature using three replicates/time point and positive control tissues were exposed for 60 minutes. Two tissue replicates were used for adapted negative control and positive controls (8N KOH) was exposed for 60 minutes, for the treatment of freeze killed tissues (to correct nonspecific MTT reduction). All the treated tissues were incubated at room temperature.
Percent relative viability in the tissues treated with the test item was 106% at 3 minute exposure period and 90% at 60 minute exposure period. Significant reduction in percent cell viability was not observed at any of the exposure period in the treated tissues when compared with the concurrent negative control. Differences between the viability of treated tissues was around 2% i.e. %CV.
All the OD values for the negative control replicates were between 2.292 to 2.591, against guideline requirement of ≥ 0.8 and ≤ 3.0 (the acceptance criteria for SkinEthicTM RHE model). Positive control showed 0.54% cell viability, against guideline requirement of <15%, compared to concurrent negative control, which demonstrate the efficiency of the test system, SkinEthicTM RHE model.
All criteria for a valid study were met as described in the study plan. From the results of this study, under the specified experimental conditions, DPX-C (Di-Cloro-Di-p-Xililene) is concluded to be non-corrosive in in vitro skin corrosion test using reconstructed human epidermis (RHE) tissues.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 16 mg/0.5 cm2 of test item, 16 µL/0.5 cm2 sterile dulbecco’s phosphate buffered saline (DPBS) and 16 µL/0.5 cm2 of 5% sodium dodecyl sulphate (5% aq.) were applied
- Duration of treatment / exposure:
- 42 ± 1 minutes
- Number of replicates:
- Three replicates were used for test item, positive control and negative control
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 98.209
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- other: No Category
- Conclusions:
- Based on the results of this study, an indication of the classification for DPX-C (Di-Cloro-Di-p-Xililene) is as follows:
Globally Harmonized System of Classification and Labelling of Chemicals: No Category. - Executive summary:
This study was performed to evaluate the non-irritant and irritant potential of DPX-C (Di-Cloro-Di-p-Xililene) using reconstructed human epidermis (RHE) tissue in accordance with the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS). The method was followed as per the guideline of the OECD 439 (July 2015).
The tissues were exposed to negative control (Dulbecco’s Phosphate Buffered Saline (DPBS)), positive control (sodium dodecyl sulfate 5% aqueous (SDS)) and DPX-C (Di-Cloro-Di-p-Xililene) in triplicate for 42±1 minutes at room temperature.
Mean cell viability in the tissues treated with the test item was 98.209% at 42 minutes exposure period. Significant reduction in percent cell viability was not observed in the treated tissues when compared with the concurrent negative control.
Optical density values for the negative control replicates were between 1.958 to 2.025, against guideline requirement of ≥0.8 and ≤3.0 (≥ 1.2 as per SkinEthic SOP), blank was between 0.042 to 0.046 which met the guideline requirement i.e. OD< 0.1. Positive control showed a 1.457% cell viability, against the acceptance criteria of <40% for SkinEthic RHE model, compared to concurrent negative control. Variation between the tissue replicates i.e. CV% value was between 0.522 for test item group, 3.500 for positive control and 1.155 for negative control against guideline requirement of ≤ 18%, which demonstrate the efficiency of the test system, SkinEthicTM RHE model. All criteria for a valid study were met as described in the study plan.
Based on the results of this study, an indication of the classification forDPX-C (Di-Cloro-Di-p-Xililene) is as follows:
Globally Harmonized System of Classification and Labelling of Chemicals: No Category
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- Species:
- cattle
- Vehicle:
- other: corn oil
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- One set of corneas were treated with 750 mg (pulverized) of test item (as such). One set of corneas were treated with 750 μL of the prepared test item [20% (w/v) concentration in corn oil]
- Duration of treatment / exposure:
- 4 h ± 5 minutes
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- corneas treated with 750 mg DPX-C (Di-Cloro-Di-p-Xililene)
- Value:
- 0.42
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- corneas treated with 750 mg DPX-C (Di-Cloro-Di-p-Xililene) (suspension) at 20% (w/v)
- Value:
- 0.57
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- other: No Category
- Conclusions:
- Based on the results of this study, an indication of the classification for DPX-C (Di-Cloro-Di-p-Xililene) is as follows:
Classification (OECD 437): No Category. - Executive summary:
This study was conducted to evaluate theocular irritancy of a DPX-C (Di-Cloro-Di-p-Xililene)in compliance with the OECD test guideline forBCOP Test.
InBCOP test, five sets each consisting of three corneas were tested.First set served as vehicle control and was treated with 750 μL normal saline. The second set was treated with 750 mgDPX-C (Di-Cloro-Di-p-Xililene) (pulverized and was applied to the surface of cornea as such)while the third set served aspositive control and was treated with750 μL20% (w/v) imidazole innormal saline. In addition to this one set was treated with corn oil and one set was treated with 750 μLDPX-C (Di-Cloro-Di-p-Xililene) (suspension) at 20% (w/v) concentration in corn oil.Post application the corneas were incubated for approximately 4 h at32 ºC.At the end of the incubation period reading for opacity were taken.
Post opacity reading permeability was measured by applying1 mL of fluorescein sodium solution (5 mg/mL)on to the anterior surface of the cornea and was incubated forapproximately90 min at32 ºC. At the end of the incubation period OD was measured at 490 nm for the fluid collected from the posterior chamber.
The meanIn-VitroIrritatancy Score(IVIS) ofnormal saline (vehicle control), corn oiland750 μL20% (w/v) imidazole innormal saline(positive control)treated corneaswere found to be -0.95, 0.62 and 69.49,respectively,which confirmed the reliability of the test procedure. The IVIS score for the corneas treated with 750 mgDPX-C (Di-Cloro-Di-p-Xililene) and750 μLDPX-C (Di-Cloro-Di-p-Xililene) (suspension) at 20% (w/v) concentration in corn oil were found to be0.42 and 0.57, respectively.
Based on the results of this study, an indication of the classification forDPX-C (Di-Cloro-Di-p-Xililene)is as follows:
Classification (OECD 437): No Category.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
According to the test performed and to the Regulation (EC) n. 1272/2008, Dichloro-p-cyclophane is not classified as irritating to the skin and to the eye.
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