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EC number: 402-010-4 | CAS number: 4463-59-6
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1-(2-bromoethoxy)-2-methoxybenzene
- EC Number:
- 402-010-4
- EC Name:
- 1-(2-bromoethoxy)-2-methoxybenzene
- Cas Number:
- 4463-59-6
- Molecular formula:
- C9H11BrO2
- IUPAC Name:
- 1-(2-bromoethoxy)-2-methoxybenzene
- Details on test material:
- - Name of test material (as cited in study report): Carvedilol 5th intermediate (Bromoethoxy-guaiacol)
- Physical state: reddish brown crystalline powder
- Lot/batch No.: 9803
- Expiration date of the lot/batch: June 2001
- Storage condition of test material: at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: TOXI-COOP ZRT. H-1103, Budapest, Cserkesz street 90
- Weight at study initiation: 18.3-21.6 g
- Housing: Type II. Polypropylene/ polycarbonate
- Bedding: Laboratory bedding
- Diet (e.g. ad libitum): ad libitum (Rat/Souris-Elevage E complee diet for rats and mice produced by ssniff Spezialdiaten GmbH )
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 / 12 hours
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25%, 10%, 5%, 2,5%
- No. of animals per dose:
- 4
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 6.5
- Test group / Remarks:
- 25% in AOO
- Parameter:
- SI
- Value:
- 5.9
- Test group / Remarks:
- 10% in AOO
- Parameter:
- SI
- Value:
- 6.4
- Test group / Remarks:
- 5% in AOO
- Parameter:
- SI
- Value:
- 3
- Test group / Remarks:
- 2.5% in AOO
- Cellular proliferation data / Observations:
- The maximum dose selection was performed according to the relevant guidelines and based on results of a formulation evaluation and also results of the Dose Range Finding test (DRF). Based on the formulation evaluation the maximum attainable concentration (based on solubility) was 50 % (w/v) in different vehicles recommended by the relevant guidelines (AOO, DMF, DMSO and MEK). As AOO is the most preferred in the LLNA the test item was formulated with this vehicle.
Significant adverse effect (toxicity, indicated by significantly decreased body weight) was observed in the DRF at test concentrations of 50 % (w/v). Based on the results no obvious indication of a similar effect was considered at lower test concentrations. According to this the test item was examined in the main test at 25 %, 10 %, 5 % and 2.5 % (w/v) concentrations as formulations in AOO.
The LLNA was valid and no confounding effects of irritation interfered with the results. The observed effect on the body weights was considered significant only in case of 1 animal (animal no. 159, 10 % decrease) in the 25 % (w/v) dose group. On the other hand the mean body weight did not decrease significantly in this or in the other dose groups and no other symptoms of a systemic effect were observed in any dose group. It is possible that systemic toxicity interfered with the results at 25 % (w/v) concentration but no significant toxicity was considered at the lower test concentrations. The dose-response is considered to be biologically relevant and corresponds to a dose-response observable when interfering effects (systemic or local) occurs at high treatment concentrations. Other mechanisms (such as immunosuppression) may also result in the lack of a significant dose-response correlation although no experimental evidence of presence of these mechanisms can be obtained from the LLNA.
The test item caused significant lymphoproliferation at all test concentrations. The observed stimulation index values were 6.5, 5.9, 6.4 and 3.0 at treatment concentrations of 25 %, 10 %, 5 % and 2.5% (w/v), respectively. Dose-related response was considered but no significant linear correlation was observed.
According to evaluation criteria of the relevant guidelines [1,2], the significantly increased lymphoproliferation (indicated by an SI ≥ 3) at 2.5 % (w/v) concentration and above and the statistically insignificant but biologically relevant dose-related response are considered evidence that Bromethoxy-qvajacol (CVD 21) is a skin sensitizer.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Under the conditions of the present assay, Bromethoxy-qvajacol (CVD 21) tested at concentrations of 25 %, 10 %, 5 % and 2.5 % (w/v) as formulations (apparently solutions) in a suitable vehicle (AOO) was shown to have skin sensitization potential (skin-sensitizer) in the Local Lymph Node Assay.
According to the effective regulations [5,6] concerning to the classification, labelling and packaging of substances and mixtures the following label elements should be used for the test item:
Risk phrase: R43
Hazard class and category: Skin Sens. 1
Hazard statement: H317 “May cause an allergic skin reaction”
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