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Diss Factsheets
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EC number: 943-540-0 | 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
GLP compliant acute oral toxicity study performed according to the OECD 420 test guideline.
GLP compliant acute oral toxicity studies performed according to non-OECD test method.
GLP compliant acute dermal toxicity study performed according to the OECD 402 test guideline.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
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
Additional information
Acute Oral Toxicity in the Rat
Key Study
Introduction
The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat, using the OECD 420 test method.
Methods
Following a sighting test at a dose level of 2000 mg/kg, a further group of four fasted females was given a single oral dose of test item, unchanged, at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
Results
Mortality. No deaths.
Clinical Observations. There were no signs of systemic toxicity.
Body Weight. All animals showed expected gains in body weight.
Necropsy. No abnormalities were noted at necropsy
Conclusion
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was considered to be greater than 2000 mg/kg body weight.
Supporting Studies
The test substance was dosed undiluted at 5.0 g/kg by oral gavage to 5 male and 5 female albino rats that had been fasted overnight. 1 male and 2 female rats died on each of Day 1 and Day2. The remaining 4 animals (3 males and 1 female) survived until the end of the observation period. The test substance was determined to have an acute oral LD50 of less than 5.0 g/kg.
In a supporting study the test substance was dosed undiluted at 2.0 g/kg by oral gavage to 5 male and 5 female albino rats that had been fasted overnight. There were no premature mortalities recoded during the 14 -day observation period. The test substance was determined to have an acute oral LD50 of greater than 2.0 g/kg.
Acute inhalation toxicity
According to REACH Annex VIII, Section 8.5, Column 2, information on acute toxicity shall be provided for at least one other route in addition to the oral route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. The substance is a liquid with a vapour pressure of 0.013 Pa at 25°C and, based on evaluation of the life cycle of the substance, it is expected that exposure inhalation exposure will be low. The most likely route of exposure for workers and consumers is considered to be the dermal route and testing for acute toxicity via the inhalation route is not required.
Acute Dermal Toxicity in the rat.
Introduction. The study was performed to assess the acute dermal toxicity of the test item in the Wistar strain rat. The method was designed to be compatible with the following:
OECD Guidelines for the Testing of Chemicals No. 402 “Acute Dermal Toxicity” (adopted 24 February 1987)
Method B3 Acute Toxicity (Dermal) of CommissionRegulation (EC) No. 440/2008
Method. Initially, two animals (one male and one female) were given a single, 24 hour, semi‑occluded dermal application of the undiluted test item to intact skin at a dose level of 2000 mg/kg bodyweight. Based on the results of the initial test, a further group of eight animals (four males and four females) was similarly treated. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Mortality. There were no deaths.
Clinical Observations. There were no signs of systemic toxicity.
Dermal Irritation. Signs of dermal irritation noted at test sites of females included very slight erythema, very slight edema, hemorrhage of the dermal capilliaries, crust formation, glossy skin and small superficial scabs. There were no signs of dermal irritation in the males.
Bodyweight. All animals showed expected gains in body weight.
Necropsy. No abnormalities were noted at necropsy.
Conclusion. The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
Justification for selection of acute toxicity – oral endpoint
Klimisch grade 1, GLP compliant study performed according to OECD 420 test method.
Justification for selection of acute toxicity – dermal endpoint
Klimisch grade 1, GLP compliant study performed according to OECD 402 test method.
Justification for classification or non-classification
The oral LD50 is greater than 2000 mg/kg, therefore no classification is warranted under CLP.
The dermal LD50 is greater than 2000 mg/kg, therefore no classification is warranted under 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.
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