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EC number: - | 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
- Study period:
- From 2010-03-31 to 2010-04-14
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable study report which meets basic scientific principles. 3 animals per group.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted in Jul 2010
- Deviations:
- yes
- Remarks:
- 3 animals per group
- GLP compliance:
- no
- Remarks:
- no more details
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Analytical purity: 100%
- Lot/batch No.: 10SC8156928-2-2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/JNCrlj
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Japan Inc.
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: 19.87 - 25.18 g (range)
- Housing: animals were housed 3 per cage in suspended aluminium cages with stainless steel mesh front and floor, w176 x d302 x h130 mm (Yamato Scientific Co., Ltd., Tokyo, Japan). Cages were exchanged with washed, sterile cages every week.
- Diet: CRF-1 diet (Oriental Yeasy Co., Ltd., Japan), ad libitum
- Water: filtered tap water via an automatic water supply equipment (Labo Engineering Inc.), ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-25
- Humidity (%): 40 - 70
- Air changes (per hr): more than 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 1, 5, 25% (w/v)
- No. of animals per dose:
- 3 females
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: the highest concentration that could be technically used was a 25% suspension in DMSO.
- Irritation: Three mice (1 per dose group) were treated by epidermal application to the dorsal surface of each ear with 1, 5 and 25% concentrations of the test item once daily for 3 consecutive days from Day 0. The ears were assessed for skin irritation on Day 1, 2 and 5. On Day 5, the draining auricular lymph nodes from each ear were excised and weighed. No signs of local irritation was observed in the animals. No treatment-related effects on body weight were noted. The doses applied were selected as the doses to be used in the main study.
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 test substance was considered to be positive for skin sensitisation when the SI ≥ 3.
TREATMENT PREPARATION AND ADMINISTRATION:
25 μL of a 1, 5 and 25% concentration of the test substance in DMSO was applied to the dorsal surface of each ear of each mouse, for 3 consecutive days from Day 0. The control group was treated according to the same protocol with the vehicle alone. Local irritation reactions were assessed on Day 1 and 2. In addition, the body weight was measured on Day 1 and 5. On Day 5, 250 μL phosphate buffered saline (PBS) containing 80 μCi/mL of 3H-methyl thymidine (3H-TdR) was injected into the tail vein of each control and treatment mouse. Five hours later, the animals were sacrificed and the draining auricular lymph node of each ear was excised and pooled.The level of 3H-TdR-incorporation was measured in a β-scintillation counter.
The body weight was determined on Day 0 and 5, prior to the treatment. - Positive control substance(s):
- not specified
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.5
- Test group / Remarks:
- 1%
- Parameter:
- SI
- Value:
- 3.8
- Test group / Remarks:
- 5%
- Parameter:
- SI
- Value:
- 4.1
- Test group / Remarks:
- 25%
- Cellular proliferation data / Observations:
- Irritation was not observed and body weight gains were unaffected in all mice. Higher weights of auricular lymph nodes than vehicle control were observed and SI of 25% and 5% groups were higher than 3.
Any other information on results incl. tables
For the control, 1, 5, and 25% concentration groups, the DPM values per lymph node were 1554, 2314, 5887 and 6346, respectively. As the lymph nodes were pooled, these results were determined by dividing the measured value by the number of lymph nodes pooled.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The simulation index (SI) for the control, 1, 5, and 25% concentration groups was 1.00, 1.5, 3.8 and 4.1, respectively. As the threshold value is 3, the test substance is considered to be a skin sensitiser. The estimated concentration expected to produce a simulation index of 3 (EC3 value) is 3%.
- Executive summary:
Skin sensitization potential of test item was evaluated in mice using the Local Lymph Node Assay (LLNA) using method similar to OECD429. CBA/JNCrljmice (three females/group) received the test substance solution (2 5μL/ear)in DMSO at 25%, 5% or 1% on the dorsal surface of each ear.The highest SI (Stimulation Index) of 4.1 was calculated for 25% group and it was concluded that test item is a skin sensitizer under the conditions of this study and the test item was considered to have an EC3 value of 3%.
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