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EC number: 700-071-4 | CAS number: 932742-30-8
- 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:
- adverse effect observed (sensitising)
- Additional information:
The skin sensitisation potential of SIKA Hardener LI was tested in a Local Lymph Node Assay (LLNA) according to EU method B.42 and OECD guideline 429. Vehicle compatibility was verified in a preliminary test with Acetone: Olive oil 4:1 mixture (AOO), in which the test item was completely miscible. A preliminary irritation toxicity test was performed with the test item at concentrations of 100 % (the undiluted test item) and 50 % (%w/v) in the selected vehicle. In the main assay sixteen female CBNCa Ola Hsd mice were allocated to four groups of four animals each: three groups received the appropriate formulation of SIKA Hardener LI at concentrations of 100 %, 50 % or 25 %, and the negative control group concurrently received the vehicle (AOO) only. Each concentration was applied on the external surface of ears (25 µL/ear) for three consecutive days (Day 1, 2 and 3). There was no treatment on days 4, 5 and 6. On day 6, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine. Obtained values were used to calculate stimulation indices (SI).
No mortality or systemic clinical signs were observed during the study. No treatment related effect on the body weights was observed. No signs of irritation or other cutaneous effect were observed in any of the treated groups. A significant lymphoproliferative response (SI > 3) was noted for SIKA Hardener LI at all tested concentrations. The stimulation index values (SI) were 6.2, 4.8 and 4.1 at concentrations of 100 %, 50 % and 25 %, respectively. The stimulation index values obtained were compatible with the conventional biological dose-response. An EC3 value was extrapolated from the data according to Annex IV of the Updated ICCVAM-Recommended Protocol. A value of 8.4 % was extrapolated from the raw data. The result of the latest reliability check was used to demonstrate the appropriate performance of the assay in according to test guidelines. The result with the positive control substance a-Hexylcinnamaldehyde (HCA) confirmed the validity of the LLNA. Under the conditions of the presented assay SIKA Hardener LI revealed sensitisation potential (sensitiser).
Migrated from Short description of key information:
The skin sensitisation potential of SIKA Hardener LI was tested in a Local Lymph Node Assay (LLNA) according to EU method B.42 and OECD guideline 429. Under the conditions of the presented assay SIKA Hardener LI revealed sensitisation potential (sensitiser).
Justification for selection of skin sensitisation endpoint:
only one study available
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results of the presented LLNA study, SIKA Hardener LI was classified and labled as R43 (may cause sensitisation by skin contact) and Skin Sensitiser cat. 1B (H317: may cause an allergic skin reaction) according to Directive 67/548/EEC (DSD) and to Regulation (EC) No 1272/2008 (CLP), respectively.
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