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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 258-296-4 | CAS number: 53018-24-9
- 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, Edwards (1985)
Under the conditions of the study the acute oral LD50 of the test material was between 2.0 and 5.0 mL/kg bodyweight (equivalent to between 2020 and 5050 mg/kg when taking the density of the test material as 1.01 as detailed in the study report).
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
- Study period:
- 23 April 1985 to 30 April 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Groups of mice were orally intubated at 3 dose levels using graded volumes of the test material. Animals were observed for up to 7 days after intubation. All animals dying were autopsied. All survivors were killed and examined post mortem after 7 days.
The study was conducted in accordance with S.O.P. No 195. - GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- mouse
- Strain:
- not specified
- Remarks:
- White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4-5 weeks old
- Weight at study initiation: 21 - 27 g
- Fasting period before study: 4 hours prior to dosing
- Housing: the animals were housed individually
- Diet: ad libitum commercial pelleted diet after treatment
- Water: ad libitum after treatment - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10.0 mL/kg
DOSAGE PREPARATION: the test material was dosed undiluted
DOSES
- The most relevant dose-level for the class of the test material was selected (5.0 mL/kg), and three male and three female animals are dosed at this level. Two groups of one male and one female were dosed above (10.0 mL/kg) and below (2.0 mL/kg) this level. - Doses:
- 2.0, 5.0 and 10.0 mL/kg
- No. of animals per sex per dose:
- 2.0 and 10.0 mL/kg: 1 animal per sex
5.0 mL/kg: 3 animals per sex - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days (any animal dying during this period was autopsied)
- Necropsy of survivors performed: yes
- Other examinations performed: yes, surviving animals were weighed before termination - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 - < 5 mL/kg bw
- Based on:
- test mat.
- Mortality:
- The mice dosed at 10.0 and 5.0 mL/kg were found dead after 18 hours.
- Clinical signs:
- - The mice dosed at 10.0 mL/kg were somnolent and showing signs of stress and laboured breathing within 30 minutes after treatment. The mice became semi-comatose after 1 hour, comatose after 2 hours and were found dead after 18 hours.
- The mice dosed at 5.0 mL/kg showed similar symptoms and were found dead after 18 hours.
- The female mouse dosed at 2.0 mL/kg was showing signs of stress and was ataxic after 2 hours, but recovered within 18 hours. The male mouse dosed at this level appeared unaffected by treatment. - Gross pathology:
- - Autopsy of the mice that died revealed slight irritation of the small intestines and pale liver and kidneys.
- The surviving mice gained weight during the 7-day observation period and presented a normal appearance at autopsy. - Conclusions:
- Under the conditions of this study the acute oral LD50 of the test material was between 2.0 and 5.0 mL/kg bodyweight.
- Executive summary:
The acute oral toxicity of the test material was investigated with male and female mice.
During the study groups of mice were orally intubated at 3 dose levels using graded volumes of the test material. Animals were observed for up to 7 days after intubation. All animals dying were autopsied. All survivors were killed and examined post mortem after 7 days.
The most relevant dose-level for the class of the test material was selected (5.0 mL/kg), and three male and three female animals are dosed at this level. Two groups of one male and one female were dosed above (10.0 mL/kg) and below (2.0 mL/kg) this level.
The mice dosed at 10.0 mL/kg were somnolent and showing signs of stress and laboured breathing within 30 minutes after treatment. The mice became semi-comatose after 1 hour, comatose after 2 hours and were found dead after 18 hours. The mice dosed at 5.0 mL/kg showed similar symptoms and were found dead after 18 hours. The female mouse dosed at 2.0 mL/kg was showing signs of stress and was ataxic after 2 hours, but recovered within 18 hours. The male mouse dosed at this level appeared unaffected by treatment.
Autopsy of the mice that died revealed slight irritation of the small intestines and pale liver and kidneys. The surviving mice gained weight during the 7-day observation period and presented a normal appearance at autopsy.
Under the conditions of this study the acute oral LD50 of the test material was between 2.0 and 5.0 mL/kg bodyweight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Additional information
Acute Oral Toxicity, Edwards (1985)
The acute oral toxicity of the test material was investigated with male and female mice. The study was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997).
During the study Groups of mice were orally intubated at 3 dose levels using graded volumes of the test material. Animals were observed for up to 7 days after intubation. All animals dying were autopsied. All survivors were killed and examined post mortem after 7 days.
The most relevant dose-level for the class of the test material was selected (5.0 mL/kg), and three male and three female animals are dosed at this level. Two groups of one male and one female were dosed above (10.0 mL/kg) and below (2.0 mL/kg) this level.
The mice dosed at 10.0 mL/kg were somnolent and showing signs of stress and laboured breathing within 30 minutes after treatment. The mice became semi-comatose after 1 hour, comatose after 2 hours and were found dead after 18 hours. The mice dosed at 5.0 mL/kg showed similar symptoms and were found dead after 18 hours. The female mouse dosed at 2.0 mL/kg was showing signs of stress and was ataxic after 2 hours, but recovered within 18 hours. The male mouse dosed at this level appeared unaffected by treatment.
Autopsy of the mice that died revealed slight irritation of the small intestines and pale liver and kidneys. The surviving mice gained weight during the 7-day observation period and presented a normal appearance at autopsy.
Under the conditions of the study the acute oral LD50 of the test material was between 2.0 and 5.0 mL/kg bodyweight (equivalent to between 2020 and 5050 mg/kg when taking the density of the test material as 1.01 as detailed in the study report).
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance does not require classification with respect to acute oral toxicity.
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.