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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 289-296-2 | CAS number: 87061-04-9
- 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
Key study:- Ianamoto (1999), Acute toxicity oral (OECD 420): LD50 > 2000 mg/kg bw (male/female rats)
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:
- 28th May to 22nd June 1999 for males, 2nd July to 28th July for females
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted in 1999 in accordance with OECD guideline 420 although not in accordance with GLP. The batch number (807007) and purity (100%) are both noted in the report. A statement of authentication is also provided in the report in lieu of a more formal Quality Assurance procedure. The study is well reported with regards to both the methodology and results. One animal died during the study but no explanation attributing the cause of death is made within the report. There were no abnormalities detected upon necropsy. Due to the lack of observed effects this deviation is not considered to affect the reliability of the study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 7 weeks old
- Weight at study initiation: 215-252 g for males and 171-195 g for females
- Fasting period before study: Overnight (18 to 20 hours)
- Housing: Group caged by sex, 2 or 3 animals in each cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 25 days for males, 10 days for females
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 30-70 %
- Air changes (per hr): Approximately 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark - Route of administration:
- oral: gavage
- Vehicle:
- soya oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle: 1 mL/100 g bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 males and 5 females dosed with the test material
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: The animals were observed at least once daily, the animals were weighed prior to dosing and on days 7 and 15
- Necropsy of survivors performed: Yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occcurred in the males dosed with the test material. One female was found dead on day 2.
- Clinical signs:
- other: There were no treatment related clinical signs.
- Gross pathology:
- There were treatment related necropsy findings. No abnormaltities of the abdominal and thoracic cavities were observed. No abnormalities were observed in animals sacrificed at the end of the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the test, the LD50 of the test material was found to be greater than 2000 mg/kg bw in male and female Wistar rats.
- Executive summary:
In a study conducted to OECD 420, the acute oral toxicity of the test material was investigated in male and female Wistar rats using a limit dose of 2000 mg/kg bw. Only one mortatlity was noted during the course of the study, and no treatment related changes were apparent. Under the conditions of the test, the LD50 of the test material was determined to be greater than 2000 mg/kg bw.
Reference
Table 1: Results
Sex |
Dose (mg/kg) |
Number of Rats |
Age and Weight (g) at Dosing |
Mortality |
Male |
2000 |
6 |
7 weeks old, 215-252 g |
0/6 |
0 (control) |
1 |
0/1 |
||
Female |
2000 |
5 |
7 weeks old, 171-195 g |
1/5 |
0 (control) |
1 |
0/1 |
||
Combined |
2000 |
11 |
7 weeks old, 171-252 g |
1/11 |
0 (control) |
2 |
0/2 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The key study has been assigned a reliability score of 1 in accordance with the criteria of Klimisch (1997) while a supporting study, performed to a methodology similar or equivalent to OECD 401, was assigned a reliability score of 2. Overall, the quality of the database is good.
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
ORAL
In the key study, conducted to OECD 420, the acute oral toxicity of the test material was investigated in male and female Wistar rats using a limit dose of 2000 mg/kg bw. Only one mortality was noted during the course of the study, and no treatment related changes were apparent. Under the conditions of the test, the LD50 of the test material was determined to be greater than 2000 mg/kg bw.
Supporting information is available in the form of a study, conducted to a method that is similar to the now redundant OECD 401 guideline. The test material was dosed using varying volumes by oral gavage. Under the conditions of the test, the test material was found to have a combined LD50 of 5700 mg/kg bw and an LD50 of 5800 and 5600 mg/kg bw in males and females respectively.
Justification for selection of acute toxicity – oral endpoint
The study was conducted in accordance with the standardised guideline OECD 420; although no information relating to the GLP status was provided in the reporting of the study, quality assurances were reported by the laboratory. In line with the criteria for assessing data quality as described in Klimisch (1997), the study was assigned a reliability score of 1, and considered reliable and adequate for assessment.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for acute toxicity by the oral route as no signs of toxicity were noted during the course of the studies.
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.