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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 944-290-5 | 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
Endpoint summary
Administrative data
Description of key information
The oral toxicity study with 2 test groups of each 3 female rats administered with 2000 mg/kg bw of the test substance showed no mortality, clinical signs and pathological findings. The median lethal dose of rats after oral administration therefore is above 2000 mg/kg bw. The study on dermal toxicity in rats with a dose of 2000 mg/kg bw of the test substance revealed an LD50 of above 2000 mg/kg bw. In both male and female rats different stages of erythema, edema, scaling and incrustations were observed but disappeared before day 10 after application of the test substance.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
Acute Toxic Class method (Bioassay 2015)
In an acute oral toxicity study performed according to OECD guideline 401, 2000 mg/kg of the undiluted test item were administered by gavage to two test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females).
2000 mg/kg (first and second test group):
- No mortality occurred.
- No clinical signs were observed in the animals.
- The mean body weight of the surviving animals increased within the normal range throughout the study period with three exceptions (one in the first test group and two in the second test group). In three females body weights increased within the normal range during the first week, but the animals revealed a stagnation of body weight during the second week. This effect is observed occasionally in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth.
- There were no macroscopic pathological findings in the surviving animals sacrificed at the end of the observation period.
The acute oral LD50 was determined to be above 2000 mg/kg bw.
Acute dermal toxicity study (Bioassay 2015)
In an acute dermal toxicity study (Limit Test) according to OECD guideline 402, young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the undiluted test item to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10 % of the total body surface area. The animals were observed for 14 days.
- No mortality occurred.
- No signs of systemic toxicity were observed.
- The following test item-related local effects were recorded during the course of the study, local effects occurred within the first 10 days after administration:
- Very slight to moderate erythema (grade 1 to 3)
- Very slight to moderate edema (grade 1 to 3)
- Incrustations
- Scaling
- The mean body weight of the male animals increased within the normal range throughout the study period. The body weight of the female animals increased within the normal range throughout the study period with one exception. One animal lost weight during the first week, probably due to the bandage procedure, but body weights were within the normal range during the second week.
- No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.
Accordingly, the acute dermal median lethal dose (LD50) was determined to be above 2000 mg/kg bw.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No mortality occurred at the limit dose of 2000 mg/kg bw. As a result the substance does not need to be classified and labelled for acute toxicity (oral, dermal) under 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.
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.