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EC number: 700-772-5 | CAS number: 1190961-28-4
- 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
- Study period:
- Between 29 November and 13 December 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in accordance with recognised guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1,6-bis({2,2-bis[(undecyloxy)methyl]butyl}) hexanedioate
- EC Number:
- 700-772-5
- Cas Number:
- 1190961-28-4
- Molecular formula:
- N/A - too complex
- IUPAC Name:
- 1,6-bis({2,2-bis[(undecyloxy)methyl]butyl}) hexanedioate
- Test material form:
- other: Liquid
- Details on test material:
- - Physical state: Amber liquid
- Expiration date of the lot/batch: June 17, 2012
- Storage condition of test material: At room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Strain: CBA/Ca (CBA/CaOlaHsd)
- Source: Harlan Laboratories B.V., Netherlands
- Age at study initiation: 9-11 weeks
- Weight at study initiation: 15.1 – 22.3 g
- Housing: Group housing in Makrolon Type-II cages with standard softwood bedding.
- Diet (e.g. ad libitum): Pelleted standard Kliba 3433 mouse maintenance diet (Provimi Kliba AG, 4303 Kaiseraugst/Switzerland), available ad libitum.
- Water (e.g. ad libitum): Community tap water from Itingen/Switzerland, available ad libitum.
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10 - 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light/dark cycle
IN-LIFE DATES: No data available
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- CONCS: 20%, 50%, and 100% w/v
- No. of animals per dose:
- 4 mice per dose.
- Details on study design:
- TREATMENT PREPARATION AND ADMINISTRATION:
RANGE FINDING TESTS:
- Compound solubility: the vehicle was based on trail formulations. Homogeneity was obtained to visually acceptable levels.
- Irritation: At a 100% test substance concentration no local irritation was noted. The highest test substance concentration selected for the main study was a 100% concentration because it is pipettable liquid.
- Lymph node proliferation response: Expressed as the number of radioactive disintegrations per minute per lymph nodes from each individual animal and as the ration of ^3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index).
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: The test material will be regarded as a sensitiser if at least one concentration of the test material results in a threefold or greater increase in ^3HTdR incorporation compared to control values.
TREATMENT PREPARATION AND ADMINISTRATION:
The dorsal surface of both ears was epidermally treated (25 µl/ear). The concentrations were mixed thoroughly using a vortex mixer immediately prior to dosing. The application was repeated on days 2 and 3. On day 6 an injection of 250 µl phosphate buffered saline (PBS) containing 20 µCi of 3H-methyl thymidine (3H-TdR) was made into the tail vein of each experimental mouse. Five hours later, the draining Auricular lymph node of each ear was excised into PBS. The nodes were pooled for each animal in approximately 10mL PBS. A single cell suspension of lymph node cells (LNC) was prepared in PBS by gentle separation through stainless steel gauze. LNC were washed twice with an excess of PBS by centifugation at 4C. To precipitate the DNA, the LNC were exposed to 5% trichloroacetic acid (TCA) at 4 C during the night. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Result:
PositiveConcentration v/v in acetone/olive oil 4:1 = 25 %
Stimulation Index: 7.4
Result: Positive
Concentration v/v in acetone/olive oil 4:1 = 10 %
Stimulation Index: 1.9
Result: Negative
Concentration v/v in acetone/olive oil 4:1 = 5 %
Stimulation Index: 1.1
Result: Negative
EC3 = 13.0%
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 20%
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Concentration Mean dpm/animal vehicle control: 1706 20%: 1660 50%: 3101 100%: 4814
- Key result
- Parameter:
- SI
- Value:
- 1.8
- Test group / Remarks:
- 50%
- Key result
- Parameter:
- SI
- Value:
- 2.8
- Test group / Remarks:
- 100%
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- The test material was considered to be a non-sensitiser under the conditions of the test.
- Executive summary:
Method
In order to study the possible contact allergenic potential of the test substance, three groups of four female mice each were treated daily with the test item at concentrations of 20%, 50% (w/v) in acetone:olive oil (4:1 v/v) and 100% by topical application to the dorsum of each ear lobe for three consecutive days. A control group of four female mice was treated with the vehicle acetone:olive oil (4:1 v/v) only.
Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine, 3HTdR). Approximately five hours after intravenous injection, the mice were sacrificed; the draining auricular lymph nodes were excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3HTdR measured in a β-scintillation counter.
Results
All treated animals survived the scheduled study period. Neither clinical signs on the ears of the animals nor systemic findings were observed during the study period.
The results obtained Stimulation Index (S.I.) are 1.0, 1.8 and 2.8 for test item concentration 20%, 50% and 100%, respectively.
Conclusion
The test item was not a skin sensitizer in this assay.
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