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EC number: 201-325-2 | CAS number: 81-11-8
- 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
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A QSAR program calculated a positive sensitisation potential of the test substance. The LLNA study however did not indicate a potential for sensitisation.
The sensitising potential of the test substance was evaluated according to an experimental study according to OECD Guideline 429 using the radioactive Murine Local Lymph Node Assay.
Groups of 5 female CBA/J mice each were treated with 10%, 25% and 50% w/w preparations of the test substance in 1% aqueous Pluronic® or with the vehicle alone. The study used 3 test groups and 1 control group. Each test animal was applied with 25 μL per ear of the respective test-substance preparation to the dorsum of both ears for three consecutive days. The control group was treated with 25 μL per ear of the vehicle alone.
Three days after the last application the mice were injected intravenously with 20 μCi of 3Hthymidine in 250 μL of sterile saline into a tail vein. About 5 hours after the 3H-thymidine injection, the mice were sacrificed and the auricular lymph nodes were removed. Lymph node response was evaluated by measuring the cellular content and 3H-thymidine incorporation (indicator of cell proliferation) as well as the weight of each animal’s pooled lymph nodes.
Moreover, a defined area with a diameter of 0.8 cm was punched out of the apical part of each ear and for each animal the weight of the pooled punches was determined in order to obtain an indication of possible skin irritation.No signs of systemic toxicity were noticed.
When applied as 10%, 25% and 50% preparations in 1% aqueous Pluronic®, the test substance induced an increase in the auricular lymph node cell counts below 1.5 fold of the control value (= stimulation index (SI) ≥ 1.5) without concentration dependence. There was a slight increase in lymph node weights without concentration dependence, as well.
Concomitantly, the 25% concentration caused a borderline increase of 3H-thymidine incorporation into the cells above the cut off stimulation index of 3. The 50% and 10% concentration failed to reach the cut-off value (no increase above the stimulation index of 3).However, increases in cell counts, 3H-thymidine incorporation and lymph node weights were statistically significant at all concentrations without concentration dependence. The 50% test-substance preparation caused a statistically significant increase in ear weights. No relevant increases in ear weights were observed at the concentrations 10% and 25%.
As the SI for 3H-thymidine incorporation at the 25% concentration lies at the border of biological relevance, whereas the increase of cell counts was not biologically relevant and because there was no concentration response relation, the 3H-thymidine incorporation is not considered to indicate a skin sensitization reaction.
Thus it is concluded that the test substance does not show a skin sensitizing effect in the Murine Local Lymph Node Assay under the test conditions chosen.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available (further information necessary)
Justification for classification or non-classification
The LLNA study indicated absence of a sensitisation potential. Therefore the substance is not classified for this endpoint in accordance to the CLP Regulation (EC) No 1272/2008.
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.
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