Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 479-940-2 | CAS number: 613246-75-6
- 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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-03-07 to 2005-06-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- July 17th 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- July 31st 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- no
- Details on sampling:
- NA
- Vehicle:
- yes
- Details on test solutions:
- On each day of the test the "water accommodated fraction" (WAF) was prepared. This was done by weighing the nominal load of 100 mg/L, adding the corresponding amount of dilution water and stirring slowly for 24 h. The solution was left to stand for about 15 min. Then the lower phase was used for the test. Controls were treated similarly. A thin oily layer was formed on the water surface.
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebrafish
- Strain: Hamilton Buchanan
- Source: Weiler´s Pet´s best, Turmstr. 6, 67433 Neustadt, Germany
- Age at study initiation: sexually immature young fish
- Length at study initiation: 2 ± 1 cm
- Feeding during test: no
ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions: same as test conditions
- Type and amount of food: warm-water food, daphnia, artemisia, tubifex or ground liver
- Feeding frequency: 3 times/day
- Health during acclimation: no mortality observed. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- no
- Hardness:
- 94.3 mg CaCO3/L
- Test temperature:
- 22 - 23°C
- pH:
- 7.9 - 8.2
- Dissolved oxygen:
- > 7.9 mg/L or 92% throughout the test.
- Salinity:
- NA
- Nominal and measured concentrations:
- Nominal concentration: 100 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: glass aquaria
- Material, size, headspace, fill volume: maximal volume 10L
- Aeration: accomplished with glass tubes, frequency of bubbles 1/s
- Renewal rate of test solution (frequency/flow rate): Medium renewal every 24±1 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 7
- No. of vessels per control (vehicle): 7
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: good quality drinking water
- Total organic carbon: 0.82 mg/L
- Pesticides: < 0.1 µg/L
- Chlorine: 12.5 mg/L
- Conductivity: 249 µS/cm
- Culture medium different from test medium: no
- Interval of water quality measurement: yearly
OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: 12/12 hours using neon tubes
TEST CONCENTRATIONS
- test concentration: 100 mg/L
Range finding study
- Test concentration: 100 mg/L
- Results used to determine the conditions for the definitive study: As the test item is poorly water soluble, an oily film was observed already on the surface of the stock solution and on the treatment as well. The fish did not show any abnormal behaviour or mortality caused by this effect. But the concentration of the test item in the treatment is not reproducible. Therefore the experiment was repeated, but the WAF was prepared by stirring over 24 hours. The lower phase was used. - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 24 h
- Dose descriptor:
- LL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 48 h
- Dose descriptor:
- LL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 72 h
- Dose descriptor:
- LL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 24 h
- Dose descriptor:
- LL100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 48 h
- Dose descriptor:
- LL100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 72 h
- Dose descriptor:
- LL100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LL100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 24 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 48 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 72 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- As no analytical method exists for the test item and because of the immediate hydrolysis of the test item, the hydrolysis product 2,2-Dimethyl-3-laureoyloxy-propanal should have initially been analysed. But this product is not stable as well. The soluble part is too little to be determined as TOC. Therefore no analytical determination of the test item in the test solutions was possible and the biological results were based on the nominal concentrations.
Because of immediate hydrolysis, no water solubility could be determined. The calculated value (following EPA-Calculation) is much smaller than 1mg/L. The water solubility of the product of hydrolysis is below 1 mg/L. Therefore it can be stated that the tested concentration is definitely above the limit of water solubility and thus the worst case was tested. - Results with reference substance (positive control):
- Not applicable
- Validity criteria fulfilled:
- yes
- Remarks:
- No mortality occurred in the control. The concentration of dissolved oxygen stayed above 7.9 mg/L or 92 % throughout the test (100 % at 101300 Pa equals 8.57 mg/L, following DIN 38408 part 22).
- Conclusions:
- Sika Härter LJ was tested for acute toxicity to freshwater fish in a 96h-semi-static test according to EU method C.1. The test item showed no mortality up to a nominal concentration of 100 mg/L revealing a LC50 of greater than 100 mg/L and a NOEC of 100 mg/L.
- Executive summary:
Sika Härter LJ was assessed in a GLP-compliant short-term toxicity to fish study, according to OECD guideline 203 and EU method C.1. Two experiments were performed. For the first experiment a stock emulsion containing 1000 mg/L in dilution water was prepared on each day of the test. This emulsion was used to prepare the test solution containing 100 mg/L. Three fish were exposed to the test item for 96 hours in a semi-static test system with a medium renewal every 24 hours. No mortality was observed, either in the treatment or the control. None of the fish showed any signs of morbidity at the end of the test. The pH and the oxygen value of the water were normal. The test item is poorly water soluble and an oily film was observed on the surface of the stock emulsion as well as on the treatment solution. Thus, the concentration of the test item in the treatment was not reproducible.
In the second experiment, for each medium renewal the “water-accommodated fraction” (WAF) was prepared by weighing of the nominal load 100 mg/L, adding the corresponding amount of dilution water and stirring slowly for 24 hours instead of shaking. The resulting solution was left to stand for 15 minutes, then the lower phase was taken for the test. Seven fish were exposed to the test item for 96 hours in a semi-static test system with medium renewal every 24 hours. No mortality was observed in the treatment and the control. None of the fish showed any signs of morbidity at the end of the test. The pH and the oxygen value of the water were normal. As no analytical method exists for the test item and because of the immediate hydrolysis of the test item, the hydrolysis product 2,2-Dimethyl-3-laureoyloxy-propanal should have initially been analysed. But this product is not stable as well. The soluble part is too little to be determined as TOC (as has been demonstrated in the respective studies “toxicity against alga and daphnia”). Therefore no analytical determination of the test item in the test solutions was possible and the biological results were based on the nominal concentrations.
The test item showed no mortality up to a nominal concentration of 100 mg/L. Therefore the 96 h LC 50 was determined to be greater than 100 mg/L and the 96 h NOEC was determined to be 100 mg/L.
Because of the immediate hydrolysis, no water solubility could be determined. The calculated value (following EPA-Calculation) is much smaller than 1 mg/L. The water solubility of the product of hydrolysis is below 1 mg/L. Therefore it can be stated that the tested concentration is definitely above the limit of water solubility and thus the “worst case” was tested.
Reference
Description of key information
Sika Hardener LJ was tested for acute toxicity to freshwater fish in a 96h-semi-static test according to EU method C.1. The test item showed no mortality up to a nominal concentration of 100 mg/L revealing a LC50 of greater than 100 mg/L and a NOEC of 100 mg/L.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Dose descriptor:
- LC50
- Effect concentration:
- > 100 mg/L
Additional information
Sika Hardener LJ was assessed in a short-term toxicity to fish study, according to OECD guideline 203 and EU method C.1. Young zebrafish were exposed to the test item in a semi-static test for 96 h at a nominal concentration of 100 mg/L. The test item showed no mortality up to a nominal concentration of 100 mg/L. Therefore the 96 h LC 50 was determined to be greater than 100 mg/L and the 96 h NOEC was determined to be 100 mg/L.
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.