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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 300-504-3 | CAS number: 93941-05-0
- 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
Oral
The acute oral LD50 of the test material was determined to be > 2000 mg/kg bw.
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:
- 2009-Nov-18
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- GLP compliance:
- no
- Remarks:
- Testing was performed outside the EU to meet non-EU regulatory requirements
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 5 male and 5 female Sprague-Dawley rats about 5 weeks old were obtained from the supplier. The rat quarantined for 2 weeks and acclimated to the condition of the animal room for at least 5 days prior to the test.
Environmental conditions:
Temperature: 22±4°C
Relative humidity: 40-70%
Light cycle: 12 hours light/dark - Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000 mg/ kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- Limit test: The test article was administered to the rats by oral gavage with gastric tube at a dose of 2,000 mg/kg bw. Individual body weight of the treated rats was measured on day 1, day 8 and day 15.
After dosing of the test article, all treated rats were observed individually 2 a day by veterinarian for a total of 14 days.
During the observation period, the mortality of the rats, toxic reaction after dosing, time of onset and length of period were recorded. Any found dead or moribund rats in the interim would be examined by gross necropsy. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- After application of the test article, all treated rats survived till the end of the study. The body weight of the rats was increased normally during the observation period and the result of the gross necropsy examination showed that there were no significant gross lesions founded.
According to the above findings, the median lethal dose (LD50) of the substance was greater than 2,000 mg/kg under the condition designed for this study. - Executive summary:
This study was conducted to investigate the acute oral toxicity of the substance (Specimen no. 90077902). 5 males and 5 females Sprague-Dawley rats in the study were housed in Yang-Ming University Laboratory Animal Quarters. The test article was administered to the rats by oral gavage at a dose of 2,000 mg/kg bw. After application of the test article, the rats were observed for mortality and sign of toxicity for 14 days. Results showed all treated rats survived till the end of the study. The body weight of the rats was increased normally during the observation period. At the end of the study, all treated rats were subjected to gross necropsy, and the examination showed that there were no significant gross lesions founded.
According to the findings of the study, the median lethal dose (LD50) of the substance was more than 2,000 mg/kg bw under the condition designed for this study.
Reference
All the treated rats survived till the end of the study.
All the survival rats were subjected to gross necropsy examination on day 15. Results indicated that there were no significant gross lesions founded.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- 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
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
Based on Column 2 of the table given in REACH Annex VIII, the study on acute inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected, based on vapour pressure and/or the likelihood of an exposure to aerosols, particles or droplets.
Since the melting point of the substance is above 300 °C, the vapour pressure of the substance is considered to be very low. Furthermore, the substance is imported into the EU in a formulated form as a dust-free powder or as a granulate. The inhalation route of exposure is therefore considered to be unlikely and hence it is considered justified to omit an acute inhalation toxicity study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of REACH Annex VIII, an acute dermal toxicity study does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation).
Two available acute oral toxicity studies with the substance provide LD50 values of greater than 2000 mg/kg bw. Hence the substance is not classified as hazardous by the oral route. Additionally, no effects were noted in the key in vivo skin irritation or skin sensitisation studies.
It is therefore considered justified to omit the acute dermal toxicity study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral
5 males and 5 females Sprague-Dawley rats in the study were housed in Yang-Ming University Laboratory Animal Quarters. The test article was administered to the rats by oral gavage at a dose of 2,000 mg/kg bw. After application of the test article, the rats were observed for mortality and sign of toxicity for 14 days. Results showed all treated rats survived till the end of the study. The body weight of the rats was increased normally during the observation period. At the end of the study, all treated rats were subjected to gross necropsy, and the examination showed that there were no significant gross lesions founded.
According to the findings of the study, the median lethal dose (LD50) of the substance was more than 2,000 mg/kg bw under the condition designed for this study.
Inhalation
Based on Column 2 of the table given in REACH Annex VIII, the study on acute inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected, based on vapour pressure and/or the likelihood of an exposure to aerosols, particles or droplets.
Since the melting point of the substance is above 300 °C, the vapour pressure of the substance is considered to be very low. Furthermore, the substance is imported into the EU in a formulated form as a dust-free powder or as a granulate. The inhalation route of exposure is therefore considered to be unlikely and hence it is considered justified to omit an acute inhalation toxicity study.
Dermal
In accordance with column 2 of REACH Annex VIII, an acute dermal toxicity study does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation).
Two available acute oral toxicity studies with the substance provide LD50 values of greater than 2000 mg/kg bw. Hence the substance is not classified as hazardous by the oral route. Additionally, no effects were noted in the key in vivo skin irritation or skin sensitisation studies.
It is therefore considered justified to omit the acute dermal toxicity study.
Justification for classification or non-classification
The acute oral toxicity of the substance shows LD50 of greater than 2000 mg/kg bw.
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 toxicity via the oral route.
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.