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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
A repeated toxicity oral study with the test item SIKA Hardener LI was performed according to OECD guideline 408. The derived no observed adverse effect level (NOAEL) was 300 mg/kg bw/day.
Testing via inhalation and dermal routes was waived, according to the REACH Regulation (EC) No 1907/2006/EEC, Annex VIII, 8.6.1.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- GLP and OECD Guideline study
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity: oral
A 90-day oral (gavage) toxicity study was performed with SIKA Hardener LI in male and female Hsd.Brl.Han: Wistar according to OECD Gudeline 408. The test item was administered orally to the test animals (n=15 animals/sex in the control and high dose groups, n= 10 animals/sex in the low and middle dose groups) once a day at 0 (vehicle control), 1000, 300 and 100 mg/kg bw/day doses corresponding to concentrations of 200 mg/mL, 60 mg/mL and 20 mg/mL, applied in a dose volume of 5 mL/kg bw for 90 days. 5 animals/sex in the control and high dose groups were observed without administration for four weeks (recovery observations). Polyethylene glycol 400 was used as vehicle. Animals were observed for mortality twice a day in the course of the study. Daily general clinical observations and weekly detailed clinical observations were performed. A functional observation battery was conducted in the last week of treatment. The body weight and food consumption were measured and evaluated weekly. Clinical pathology examinations (including hematology and clinical chemistry) and gross pathology were conducted one day after the last treatment and at the end of the recovery period. The absolute and relative weights of selected organs were determined. Full histopathology was performed on the preserved organs or tissues of the animals of the control and high dose groups including recovery groups. Thymus showing macroscopic changes was examined histologically in one male animal of 300 mg/kg bw/day group. SIKA Hardener LI caused salivation (male and female), changes in white blood cell count (females) and in spleen weight (females) at 1000 mg/kg bw/day in Hsd.Brl.Han: Wistar rats after the consecutive 90-day oral (gavage) administration. At 300 mg/kg bw/day, salivation was observed in some male and female animals during the treatment period. Slight changes in the white blood cell count and spleen weight relative to body weight in female animals were judged to be toxicologically not relevant. At 100 mg/kg bw/day, there was no test item related effect. Based on these observations the No Observed Adverse Effect Level (NOAEL) was determined as follows: NOAEL: 1000 mg/kg bw/day for male animals; NOAEL: 300 mg/kg bw/day for female animals.
Additionally, a second repeated dose toxicity study (supporting study) is available: A 28-day oral (gavage) toxicity study was performed with SIKA Hardener LI in male and female CRL:(WI) BR Wistar rats according to EC method B.7 and OECD guideline 407. Dose levels administered in this study were selected based on data obtained during a 14-day dose-range-finding toxicity study. The test item was administered to control and treatment groups (n= 5 animals per group and sex) at doses of 0, 50, 350 and 1000 mg/kg bw/day doses levels, at a 4 mL/kg bw in PEG 400. Stability and homogeneity of test item in the vehicle was confirmed. Administration of SIKA Hardener LI did not lead to any toxicologically adverse effects at dose levels of 50, 350 or 1000 mg/kg bw/day. There were no changes in the animal clinical condition, body weight or food consumption. No treatment related effects noted in clinical pathology (haematology, coagulation and clinical chemistry). There were no macroscopic or microscopic findings, or changes in the organ weights. In conclusion, under the conditions of this study, the no observed effect level (NOEL) for SIKA Hardener LI was 1000 mg/kg bw/day (limit dose).
Repeated dose toxicity: dermal
Repeated dose toxicity testing via the dermal route was waived, according to the REACH Regulation (EC) No 1907/2006, Annex VIII, 8.6.1.
Repeated dose toxicity: inhalation
Repeated dose toxicity testing via inhalation was waived, according to the REACH Regulation (EC) No 1907/2006, Annex VIII, 8.6.1.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
only one subchronic study available
Justification for classification or non-classification
Based on a chronic repeated oral toxicity study, test item SIKA Hardener LI was not classified and labelled according to Directive 67/548/EEC (DSD) and to Regulation (EC) No 1272/2008 (CLP).
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.