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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 935-853-6 | 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 acute oral and the acute dermal median lethal doses (LD50) of the test material in the female Wistar strain rat were estimated to be greater than 2000 mg/kg bodyweight and therefore the submission substance was considered to have no significant acute toxic risk if swallowed and did not meet the criteria for classification according to EU labelling regulations Commission Directive 2001/59/EC for classification and labelling of dangerous substances. The study to determine the toxicity by the inhalation route was not conducted as it was deemed inappropriate as exposure to humans via inhalation is unlikely to occur as the substance does not have a high vapour pressure, and will not be used in a manner likely to produce aerosols, particles or droplets of an inhalable size.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
Additional information
Acute oral toxicity: The study was performed to assess the acute oral toxicity of the test material in the Wistar strain rat. The method was designed to meet the requirements of the OECD Guidelines for Testing of Chemicals No 420 “Acute Oral Toxicity - Fixed Dose Method” (adopted 17 December 2001) and the Method B1 bis Acute Toxicity (Oral) of Commission Regulation (EC) No. 440/2008. Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of undiluted test material at a dose level of 2000 mg/kg bodyweight. At the end of the 14 -day observation period, animals were sacrificed and the LD50 was determined to be >2000 mg/kg.
Acute dermal toxicity: The study was performed to assess the acute dermal toxicity of the test material in the Wistar strain rat. The method was designed to meet the requirements of the OECD Guidelines for the Testing of Chemicals No. 402 “Acute Dermal Toxicity” (adopted 24 February 1987) and Method B3 Acute Toxicity (Dermal) of CommissionRegulation (EC) No. 440/2008. A group of ten animals (five males and five females) was given a single, 24-hour, semi-occluded dermal application of the undiluted test material to intact skin at a dose level of 2000 mg/kg bodyweight.
Signs of dermal irritation noted were well-defined erythema, slight to moderate oedema (on occasions extending ventrally below test site), blanching of the skin, hardened dark brown/black coloured scab, small superficial scattered scabs, scab cracking and scab lifting to reveal glossy skin or bleeding. Adverse reactions prevented accurate evaluation of erythema and oedema from Day 4 until the end of the study on Day 14. The reactions noted at Day 14 were considered to be indicative of dermal corrosion.
However, since both the acute oral and the acute dermal median lethal doses (LD50) of the test material in the female Wistar strain rat were each estimated to be greater than 2000 mg/kg bodyweight the submission substance was considered to have no significant acute toxic risk if swallowed or in contact wit the skin. The submission substance therefore, did not meet the criteria for classification according to EU labelling regulations Commission Directive 2001/59/EC for classification and labelling of dangerous substances.
The above studies have been ranked Reliability 1 according to the scoring system of Klimisch et al. This ranking was deemed appropriate because the study was conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies which do not affect the quality of relevant results.
The study to determine the toxicity by the inhalation route was not conducted as it was deemed inappropriate as exposure to humans via inhalation is unlikely to occur as the substance does not have a high vapour pressure, and will not be used in a manner likely to produce aerosols, particles or droplets of an inhalable size.
Justification for classification or non-classification
The acute oral and the acute dermal median lethal doses (LD50) of the test material in the female Wistar strain rat were each estimated to be greater than 2000 mg/kg bodyweight and therefore the submission substance was considered to have no significant acute toxic risk if swallowed or via skin contact. The submission substance therefore did not meet the criteria for classification as toxic or harmful by oral or dermal route exposure according to EU labelling regulations during the study.
The study to determine the toxicity by the inhalation route was not conducted as it was deemed inappropriate as exposure to humans via inhalation is unlikely to occur as the substance does not have a high vapour pressure, and will not be used in a manner likely to produce aerosols, particles or droplets of an inhalable size.
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.