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Diss Factsheets
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EC number: 485-270-1 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 Apr 2007 (Date of Project Protocol) - 09 Jul 2007 (Date of Report)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted 24 April 2002
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Test material form:
- liquid: viscous
- Details on test material:
- Colour: Light yellow
Constituent 1
- Specific details on test material used for the study:
- Storage conditions: at room temperature
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- CBA/Ca01aHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HArlan Winkelmann GmbH, D-33178 Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: 6-12 weeks
- Weight at study initiation: 16 - 19g
- Housing: The animal were kept in groups in Macrolon-cages on Altromin saw fiber bedding
- Diet: ad libitum, Altromin 1324 maintenance diet for rat and mice (TPF)
- Water: free access to tap water
- Acclimation period: adequate acclimatisation period (at least 5 days)
- Indication of any skin lesions: Proir to the application and once a day thereafter all animals were observed in order to detect special clinical signs or reactions to treatment.
ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C
- Humidity: 55±10%
- Air changes: at least 10x / hour
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (LLNA)
- Vehicle:
- other: AOO (3+1 (v/v) Acetone/ Olive Oil)
- Remarks:
- Vehicle served as negative control.
- Concentration:
- 25%, 50%, 100%
- No. of animals per dose:
- 5
- Details on study design:
- The preparations were made immediately prior to each dosing.
TREATMENT PREPARATION AND ADMINISTRATION
Topical applicaiton: Each mouse was treated by topical application of 25µL of the selected solution to the entire dorsal surface of each ear.
Topical applications were performed once daily over three consecutive days.
Administration of ³H-methyl thymidine: Five days after the first topical application treatment all mice were dosed with 20µCi ³H-methyl thymidine by intravenous injection (tail vein) of 250µL of ³H-methyl thymidine, diluted to a working concentration of 80µCi/mL.
Preparation of cell suspension: Approcimately 5 Hours after ³H-methyl thymidine-injection all mice were sacrificed. The draining "auricular lymph nodes" were excised, individually pooled for each animal (2 lymph nodes per animal) and collected in PBS. A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through polyamide gauze (200 mesh size). After washing the gauze with PBS the cell suspension was pelleted in a centrifuge. The supernatant was discarded and the pellets were resuspended with PBS. This washing procedure was repeated.
After the final wash each pellet was resuspended in approx. 1 mL 5% TCA at approx. 4°C overnight for precipitation of macromolecules. Each precipitate was once washed again, resuspended in 1 mL 5% TCA and 10 mL scintillation fluid was added. Then this solution was transferred into scintillation vials.
Determination of incorporated ³H-methyl thymidine: The ³H-methyl thymidine - incorporation was measured in a ß-counter and expressed as the number of disintegrations per minute (DPM). Similarly, background ³H-methyl thymidine levels were also measured (5% TCA). Determination of radioactivity was performed individually for each animal.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 14.6
- Test group / Remarks:
- at a concentration of 25%
- Parameter:
- SI
- Value:
- 21.6
- Test group / Remarks:
- at a concentration of 50%
- Parameter:
- SI
- Value:
- 19.1
- Test group / Remarks:
- at a concentration of 100%
- Cellular proliferation data / Observations:
- The average DPM was 871.6 for the controls and 12772.2, 18786.2 and 16639.6 for the animals tested at 25%, 50% and 100%, respectively.
Any other information on results incl. tables
Weight development of all animals was within the expected range, which includes a weight loss of up 2 g throughout the study.
At the daily clinical observations the animals did not show any visible clinical symptoms.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The skin sensitising properties of the substance were assessed in an LLNA, performed according to OECD/EC guidelines and GLP principles. All three tested concentrations of the test item exceeded the stimulation index of 3, therefore the substance was concluded to be a skin sensitiser.
The potency of the substance could not be determined, as no dose response relationship was found and extrapolation to derive an EC3 value was thus not possible. However, taking into account the high SI values found, it is highly likely the substance is a strong sensitiser (cat. 1A).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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