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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-664-8 | CAS number: 486455-65-6
- 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 median lethal dose of the test material after single oral administration to rats of both sexes, observed over a period of 14 days is:
LD50 (rat): >2000 mg/kg body weight
No acute dermal or inhalation toxicity data is available or required for this level of registration.
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:
- 20 February 2001 - 16 March 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1175 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: HanBrl: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test Animals
Source: RCC Ltd, Biotechnology & Animal Breeding Division, CH-4414, Füllingsdorf / Switzerland
Number of animals per group: 3 males or 3 females
Total number of animals: 3 males and 3 females
Age when treated: Males: 8 weeks; Females: 10 weeks
Identification: By unique cage number and corresponding color-coded spots on the tail.
Acclimatization: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
Husbandry
Room no.: E 16
Conditions: Standard Laboratory Conditions
Air-conditioned with 10-15 air changes per hour and continuously monitored environment with a target range for room temperature of 22 ± 3 °C, and for relative humidity between 30 and 70 % (values above 70 % during cleaning process possible), 12 hours artificial fluorescent light/12 hours dark, music during the light period.
Accommodation: Groups of three per sex in Makrolon type-4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz)
Diet: Pelleted standard Kliba 3433, batch no. 05/00, rat maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst) available ad libitum (except for the overnight fasting period prior to intubation). Results of analyses for contaminants are archived at RCC Ltd, Itingen.
Water: Community tap water from Itingen, available ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen. - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Details on oral exposure:
- Test Item Preparation
The test item was placed into a glass beaker on tared balance MTLR 503-S and the vehicle (polyethylene glycol PEG 300) was added. A weight by volume dilution was prepared using a magnetic stirrer as homogenizer. Homogeneity of the test item in the vehicle was maintained during treatment.
The preparation was made shortly before each dosing.
Dose level was in terms of material as supplied by the sponsor.
Treatment
The animals received a single dose of the test item on a 2000 mg/kg body weight basis by oral gavage following fasting for approximately 16-20 hours but with free access to water. Food was provided again 3 hours after dosing.
Dose / kg body weight: 2000 mg
Application volume / kg body weight: 10 ml
Oral administration was used as this is one possible route of human exposure during manufacture, handling and use of the test item. - Doses:
- 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- Observations
Mortality: Once daily during acclimatization period, one, two, three and five hours after test item administration on test day 1 and twice daily during days 2-15.
Body weights: On test days 1 (pre-administration), 8 and 15.
Clinical signs: Each animal was examined for changes in appearance and behaviour once daily during the acclimatization phase. One, two, three and five hours after test item administration on test day 1, and once daily during days 2-15. All abnormalities were recorded.
Necropsy
At the end of the observation period all animals were sacrificed by intraperitoneal injection of NARCOREN (Rhône Mérieux GmbH, D-88471 Laupheim) at a dose of at least 2.0 ml/kg body weight (equivalent to at least 320 mg sodium pentobarbitone/kg body weight). The animals were examined macroscopically and all abnormalities were recorded. Thereafter, they were discarded. - Statistics:
- No statistical analysis was used.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: No clinic signs were evident during the observation period.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
- Other findings:
- None
- Interpretation of results:
- other: Not classified according to EU criteria
- Conclusions:
- The median lethal dose of the test material after single oral administration to rats of both sexes, observed over a period of 14 days is:
LD50 (rat): greater than 2000 mg/kg body weight - Executive summary:
In an acute oral toxicity study (793631) according to EU Test Method B.1 tris, one group of three male or three female HanBrl: WIST (SPF) rats were treated with the test material at 2000 mg/kg by oral gavage. The test item was suspended in vehicle (polyethylene glycol PEG 300) at a concentration of 0.2g/ml and administered at a volume of 10 ml/kg. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded together with clinical signs at the same time intervals on test day 1 and then twice daily on test days 2-15. Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically.
All animals survived until the end of the study period.
There were no clinical signs noted during observation period.
The body weight of the animals was within the range commonly recorded for this strain and age.
No macroscopic findings were observed at necropsy.
The median lethal dose of the test material after single oral administration to rats of both sexes, observed over a period of 14 days is:
LD50 (rat): greater than 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- 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 study available
Additional information
Acute oral toxicity
In an acute oral toxicity study (793631) according to EU Test Method B.1 tris, one group of three male or three female HanBrl: WIST (SPF) rats were treated with the test material at 2000 mg/kg by oral gavage. The test item was suspended in vehicle (polyethylene glycol PEG 300) at a concentration of 0.2g/ml and administered at a volume of 10 ml/kg. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded together with clinical signs at the same time intervals on test day 1 and then twice daily on test days 2-15. Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically.
All animals survived until the end of the study period.
There were no clinical signs noted during observation period.
The body weight of the animals was within the range commonly recorded for this strain and age.
No macroscopic findings were observed at necropsy.
The median lethal dose of the test material after single oral administration to rats of both sexes, observed over a period of 14 days is:
LD50 (rat): greater than 2000 mg/kg body weight.
Justification for classification or non-classification
No classification based on the result of the acute oral study is required under CLP (1272/2008) as the LD50 was > 2000 mg/kg bw.
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.