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EC number: 701-230-0 | CAS number: -
- 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:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted April 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Reaction products of butane-1,4-diol and 1-chloro-2,3-epoxypropane, esters with acrylic acid
- EC Number:
- 701-230-0
- Cas Number:
- 52408-42-1
- Molecular formula:
- C16H26O8
- IUPAC Name:
- Reaction products of butane-1,4-diol and 1-chloro-2,3-epoxypropane, esters with acrylic acid
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: B & K Universal Ltd, Hull, UK and Charles River UK Limited
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 15 - 23g
- Housing: single in suspended solid-floor polypropylene cages
- Diet (e.g. ad libitum): certified rat and mouse diet (code 5LF2) ad lib.
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%):30 - 70%
- Air changes (per hr): app. 15
- Photoperiod (hrs dark / hrs light): 12h/12h
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5%, 10%, 25% (v/v)
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- concentrations: 25%, 50%, 100% (1 animal per dose)
- Irritation: redness between the ears at 25%
- signs of toxicity only noted at 50%: hunched posture, lethargy, piloerection, ptosis and laboured respiration
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: at least one concentration of the test material must results in a threefold or greater increase in 3HTdR incorporation compared to contral values.
TREATMENT PREPARATION AND ADMINISTRATION:
The mice were treated by daily application of 25µl per ear (50µl total) of the appropriate concentration of the test material for three consecutive days. The test material formulation was administered using an automatie micropipette and spread over the dorsal surface of the ear using the tip of the pipette. Five days following the first topical application of the test material all mice were injected via the tail vein with 250µl of phosphate buffered saline (PBS) containing 3H-methyl thymidine. Five hours later, the mice were killed by carbon dioxide asphyxiation and the auricular lymph nodes were excised and pooled per experimental group. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- sensitizing (SI = 5.07) at 50%
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 4.28
- Remarks on result:
- other: 5%
- Parameter:
- SI
- Value:
- 4.14
- Remarks on result:
- other: 10%
- Parameter:
- SI
- Value:
- 7.32
- Remarks on result:
- other: 25%
- Cellular proliferation data / Observations:
- DPM :
vehicle: 8868.46
5%: 37933.26
10%: 36740.79
25%: 64912.78
Any other information on results incl. tables
No signs of systemic toxicity were observed. The body weight increased as expected.
Moderate redness was noted between the ears in animals treated with 10% and 25% of the test substance.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The test material was considered a sensitizer under the conditions of the test at all concentrations tested (5%, 10%, 25%). Signs for irritation were only observed at the two highest concentrations.
- Executive summary:
A local lymph node assay in the mouse was performed on butane-1,4-diylbis(oxy-2-hydroxypropane-3,1-diyl) bisacrylate to assess the skin sensitization potential of the substance in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The study was performed according to the OECD guideline 429 (2002).
Following a preliminary screening test, three groups, each of four animals, were treated with 50 µl (25 µl per ear) of the test material as a solution in acetone/olive oil 4:1 at concentrations of 5%, 10% and 25%. A further group of 4 animals was treated with acetone/olive oil 4:1 alone.
The stimulation index expressed as the mean incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are of 4.28, 4.14 and 7.32 respectively. All the SI were higher than 3, indicating positive results. In conclusion, the test material was considered to be a sensitizer under the conditions of the test.
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