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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 247-368-0 | CAS number: 25956-17-6
- 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
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity:
The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the given test chemical. The LD50 value is >10000 mg/kg bw. The study concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.
Acute Inhalation Toxicity:
The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 1.67E-021 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.
Acute Dermal toxicity:
The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The LD50 value is >10000 mg/kg bw. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from publication.
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Acute oral toxicity study of the given test chemical was performed in rat.
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Fasting period before study: The animals were fasted for 3-4 hours prior to dosing.
- Housing: Following dosing, the animals were housed in metal cages suspended above the droppings.
- Diet (e.g. ad libitum): Food, ad libitum.
- Water (e.g. ad libitum): Water, ad libitum. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10% W/V solution - Doses:
- 215, 464, 1000, 2150, 4640, and 10000 mg/kg bw
- No. of animals per sex per dose:
- Six groups of five male and five female
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made immediately following dosing, at 1, 4, 24, 48 hours and once daily thereafter up to 14 days.
- Necropsy of survivors performed: yes, following the observation period, the animals were weighed, sacrificed by cerebral concussion and necropsied. - Statistics:
- not specified
- Preliminary study:
- not specified
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths at any dose level tested.
- Clinical signs:
- other: Clinical observations were normal with the exception of red colored feces in both sexes at all dose levels and red-colored urine at the three highest dose levels in the female animals.
- Gross pathology:
- not specified
- Other findings:
- not specified
- Interpretation of results:
- other: Not classified
- Conclusions:
- Acute oral toxicity dose (LD50) value was considered to be >10000 mg/kg bw, when male and female Sprague-Dawley albino rats were treated with the given test chemical via oral gavage route.
- Executive summary:
Acute oral toxicity study was conducted by using the given test chemical in male and female Sprague-Dawley albino rats at the dose concentrations of 215, 464, 1000, 2150, 4640, and 10000 mg/kg bw. Six groups of five male and five female Sprague-Dawley rats each were administered the test substance in a 10% weight/volume solution. The animals were fasted for 3-4 hours prior to dosing. Following dosing, the animals were housed in metal cages suspended above the droppings. Food and water were available ad libitum. Observations were made immediately following dosing, at 1, 4, 24, 48 hours and once daily thereafter up to 14 days. Following the observation period, the animals were weighed, sacrificed by cerebral concussion and necropsied. There were no deaths at any dose level tested. Clinical observations were normal with the exception of red colored feces in both sexes at all dose levels and red-colored urine at the three highest dose levels in the female animals. Under the condition of the study, the LD50 value was considered to be >10000 mg/kg bw, when male and female Sprague-Dawley albino rats were treated with the given test chemical via oral gavage route.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 000 mg/kg bw
- Quality of whole database:
- Data is Klimisch 2 and from publication.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Quality of whole database:
- Waiver
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from Publication.
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Acute dermal toxicity study of the given test chemical was performed in rabbit.
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not specified
- Type of coverage:
- other: Dermal
- Vehicle:
- not specified
- Details on dermal exposure:
- not specified
- Duration of exposure:
- not specified
- Doses:
- 10000 mg/kg bw
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Details on study design:
- not specified
- Statistics:
- not specified
- Preliminary study:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed at 10000 mg/kg bw in treated animals.
- Clinical signs:
- other: not specified
- Gross pathology:
- not specified
- Other findings:
- not specified
- Interpretation of results:
- other: Not classified
- Conclusions:
- Acute dermal toxicity dose (LD50) value was considered to be >10000 mg/kg bw, when rabbits were treated with the given test chemical by dermal application.
- Executive summary:
Acute dermal toxicity study was conducted by using the given test chemical in rabbits at the dose concentration of 10000 mg/kg bw.
Animals were observed for mortality. No mortality was observed at 10000 mg/kg bw in treated animals.
Hence, the LD50 value was considered to be >10000 mg/kg bw, when rabbits were treated with the given test chemical by dermal application.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 000 mg/kg bw
- Quality of whole database:
- Data is Klimisch 2 and from publication.
Additional information
Acute oral toxicity:
In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats and mice for the given test chemical. The studies are summarized as below –
The reported study was conducted to determine acute oral toxicity dose by using the given test chemical in male and female Sprague-Dawley albino rats at the dose concentrations of 215, 464, 1000, 2150, 4640, and 10000 mg/kg bw. Six groups of five male and five female Sprague-Dawley rats each were administered the test substance in a 10% weight/volume solution. The animals were fasted for 3-4 hours prior to dosing. Following dosing, the animals were housed in metal cages suspended above the droppings. Food and water were available ad libitum. Observations were made immediately following dosing, at 1, 4, 24, 48 hours and once daily thereafter up to 14 days. Following the observation period, the animals were weighed, sacrificed by cerebral concussion and necropsied. There were no deaths at any dose level tested. Clinical observations were normal with the exception of red colored feces in both sexes at all dose levels and red-colored urine at the three highest dose levels in the female animals. Under the condition of the study, the LD50 value was considered to be >10000 mg/kg bw, when male and female Sprague-Dawley albino rats were treated with the given test chemical via oral gavage route.
The above study is supported with another study for the given test chemical. The acute oral toxicity study was conducted in four to five mice at the dose concentration of 2000 mg/kg bw. The given test chemical was dissolved in saline and administered via oral route. Animals were observed for mortality. There were no deaths observed at 2000 mg/kg bw. Hence, the LD50 value was considered to be >2000 mg/kg bw, when four to five mice were treated with the given test chemical via oral route.
These studies are supported with the data available in study report and the acute oral toxicity study was designed and conducted as per OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method) for the test chemical in Sprague Dawley rats. Initially, 3 female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, 3 female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality after the dosing. No mortality was observed at 300 mg/kg dose group, hence additional 3 female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg resulted in diarrhoea (reddish colour stools) in all animals with onset at 2 hours and no mortality after the dosing. As no mortality were observed at 24 hours after the dosing, hence additional 3 female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - II). Administration of the test item at 2000 mg/kg resulted in diarrhoea (reddish colour stools) in all animals with onset at 2 hours and no mortality after the dosing. All animals from 300 mg/kg and 2000 mg/kg dose groups survived through the study period of 14 days. Staining of the stool is attributed to the reddish colour of the test item. Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg and 2000 mg/kg dose groups. Under the condition of the study, the acute oral LD50 of test chemical was >2000 mg/kg body weight. Thus, it was concluded that the acute toxicity study of test chemical, when administered via oral route in Sprague Dawley rats falls into the “Category Not classified” criteria of CLP.
All the above studies are further supported with the data available in study report for the given test chemical and conducted in Sprague Dawley rats. Initially, 3 female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, 3 female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality after the dosing. No mortality was observed at 300 mg/kg dose group, hence additional 3 female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. As no mortality were observed at 24 hours after the dosing, hence additional 3 female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - II). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg and 2000 mg/kg dose groups. It was concluded that the acute oral median lethal dose (LD50) of test chemical, when administered to Sprague Dawley rats was considered to be >2000 mg/kg body weight and falls into the “Category Not classified” criteria of CLP.
Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.
Acute Inhalation Toxicity:
The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 1.67E-021 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.
Acute Dermal Toxicity:
In different studies, the given test chemical has been investigated for acute dermal toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats and rabbits for test chemical. The studies are summarized as below -
The reported study was conducted to determine acute dermal toxicity dose by using the given test chemical in rabbits at the dose concentration of 10000 mg/kg bw. Animals were observed for mortality. No mortality was observed at 10000 mg/kg bw in treated animals. Hence, the LD50 value was considered to be >10000 mg/kg bw, when rabbits were treated with the given test chemical by dermal application.
The above study is supported with the data available in study report and conducted by using the given test chemical in Sprague Dawley rats. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was considered to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute dermal toxicant. CLP Classification: “Not classified”.
These studies are supported with the data mentioned in report for the given test chemical. The study was designed and conducted to determine the acute dermal toxicity dose tested in Sprague Dawley rats. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not exhibit acute toxicity by the dermal route.
All the above studies are further supported with the data available in study report and the study was designed and conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not exhibit acute toxicity by the dermal route.
Thus, based on the above summarised studies for test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.
Justification for classification or non-classification
Based on the above studies for the test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute oral and acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral and acute dermal toxicity. For acute inhalation toxicity waiver was added so, not possible to classify.
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.