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EC number: 807-621-3 | CAS number: 1428450-95-6
- 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
Endpoint summary
Administrative data
Description of key information
A LLNA was performed to determine the skin sensitizing potemtial of W630.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 Aug 2011 - 13 Sept 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted in 2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Swiss Federal Office of Public Health, Bern, Switzerland
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Kent, United Kingdom
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: 15.8 - 22.2 g
- Housing: The animals were housed in groups in Makrolon Type-II cages with standard softwood bedding.
- Diet: Pelleted standard Harlan Teklad 2914C rodent maintenance diet, ad libitum
- Water: Community tap water from Itingen/Switzerland, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- dimethylformamide
- Concentration:
- 1, 2.5, 5, 10 and 25 % (w/v)
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: A solubility experiment was performed with concentrations of 75, 50, 25 and 10 % test substance and the solvents acetone/olive oil (4:1 v/v), dimethylformamide, methyl ethyl ketone, propylene glycol, dimethyl sulfoxide, ethanol 70 % and ethanol 30 %. The highest concentration which can be technically used is 25 % (w/w) in dimethylformamide.
- Irritation and lymph node proliferation response: To determine the highest non-irritant test concentration, a pre-test was performed. Two mice were treated with concentrations of 10 % and 25 % (w/v) each in dimethylformamide on three consecutive days. In the pre-test, clinical signs were recorded within approximately 1 hour and 24 ± 4 hours after each application as well as on the day corresponding to the day of lymph node preparation. Additionally, ear thickness measurements were performed pre-dose, approximately 48 hours after the first application as well as on the day corresponding to the day of lymph node preparation. No signs of irritation or systemic toxicity were observed at any reading time point and the ear thickness did not change from the pre-dose value.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: ³H-methyl thymidine incorporation determined by β-scintillation
- Criteria used to consider a positive response: The exposure to at least one concentration of the test substance resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the S.I. and the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
Each test group of mice was treated by topical application of 25 µL of the test substance to the dorsal surface of each ear lobe once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle as vehicle control group.
Five days after the first topical application, all mice were administered 250 µL of phosphate-buffered saline (PBS) containing 81.82 µCi/mL 3HTdR by intravenous injection via the tail vein. Approximately five hours after treatment with 3HTdR, all mice were euthanized.
The draining lymph nodes were rapidly excised and pooled in PBS for each experimental group (8 lymph nodes per group). Single cell suspensions of pooled lymph node cells were prepared by gentle mechanical disaggregation through a gauze (200 µm mesh size) and transferred in centrifugation vials. After washing twice with PBS, the lymph node cells were resuspended in 5 % trichloroacetic acid and incubated at approximately 5 °C for at least 18 hours for precipitation of macromolecules. The supernatant was removed by centrifugation. The precipitates were then resuspended in 1 mL 5 % trichloroacetic acid and transferred to glass scintillation vials with scintillation liquid and thoroughly mixed. The level of 3HTdR incorporation was measured on a β-scintillation counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- For the body weight mean values and standard deviations were calculated.
- Positive control results:
- The positive control substance (hexyl cinnamic aldehyde) induced SI values of 1.8, 1.6 and 8.4 at 5, 10 and 25 %, thus meeting the reliability criteria for the local lymph node assay (SI ≥ 3).
- Parameter:
- SI
- Value:
- 0
- Test group / Remarks:
- Group 1 (0 % Test item)
- Parameter:
- SI
- Value:
- 1.5
- Test group / Remarks:
- Group 2 (1 % Test item)
- Parameter:
- SI
- Value:
- 2
- Test group / Remarks:
- Group 3 (2.5 % Test item)
- Parameter:
- SI
- Value:
- 2.9
- Test group / Remarks:
- Group 4 (5 % Test item)
- Remarks on result:
- other: used for calculation of EC3 value
- Parameter:
- SI
- Value:
- 3.5
- Test group / Remarks:
- Group 5 (10 % Test item)
- Remarks on result:
- other: used for calculation of EC3 value
- Parameter:
- SI
- Value:
- 3.8
- Test group / Remarks:
- Group 6 (25 % Test item)
- Key result
- Parameter:
- EC3
- Value:
- 5.8
- Test group / Remarks:
- Calculated from SI values of group 4 and 5.
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- CLP: Skin sens 1B, H317
- Executive summary:
In order to study the possible contact allergenic potential of W630 (Sample ID: 25130), five groups of four female mice each were treated daily with the test item at concentrations of 1%, 2.5%, 5%, 10% and 25% (w/v) in DMF 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 DMF 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.
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 reported in the following table. The estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the test results, the test item W630 (Sample ID: 25130) shows an allergenic potential when tested up to the concentration of 25% (w/v) in DMF.
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