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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 614-598-1 | CAS number: 68553-12-8
- 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
In a reliable acute toxicity study the substance was administered to Sprague Dawley rats (5 animals/sex/dose) by oral gavage at a dose level of 2000 mg/kg bw (single administration). The oral LD50 is >2000 mg/kg bw. In a second reliable acute oral toxicity study the substance was administered to rats (5 animals/sex/dose) by oral gavage at a dose level of 10000 mg/kg bw (single administration). The LD50 is 10000 mg/kg bw.
In a reliable acute toxicity study a structurally similar substance was administered to Sprague Dawley rats (6 animals) by oral gavage at a dose level of 2000 mg/kg bw (single administration). The oral LD50 is >2500 mg/kg bw.
In a reliable acute toxicity study a structurally similar substance was administered to Sprague Dawley rats (5 animals/sex) by semi-occluded dermal application for 24 hours at a dose level of 2000 mg/kg bw (single administration). The dermal LD50 is >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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Read-across to K1 study therefore K2 is the maximum Klimisch value.
- Justification for type of information:
- Read-across approach - see read-across justification in section 13.
- Reason / purpose for cross-reference:
- read-across source
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths
- Clinical signs:
- other: No signs of systemic toxicity
- Gross pathology:
- No abnormalities were noted at necropsy
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 for the substance was > 2500 mg/kg (2000 mg/kg).
- Executive summary:
In an acute toxicity study the substance was administered to Sprague Dawley rats (6 animals) by oral gavage at a dose level of 2000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was comparable with the control animals and no abnormalities found at macroscopic post-mortem examination. The LD50 is >2500 mg/kg bw as concluded by the study facilitator.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 March 1998 - 21 April 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 24 February 1997
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Five/sex
- Control animals:
- no
- Preliminary study:
- One male and one female rat was administered the substance via oral gavage at a dose of 2000 mg/kg bw. There were no clinical toxicity or mortality. Based on this inforamtion a dose of 2000 mg/kg bw was chosen for the main study.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One female was found dead two days after dosing.
- Clinical signs:
- other: No signs of systemic toxicity (except for the dead female) was observed.
- Gross pathology:
- Abnormalities noted at necropsy of the dead female included haemorrhagic lungs, dark liver, pale spleen, dark kidneys, pale gastric mucosa and gaseous distension of the stomach and large intestines. No abnormalities were noted of the animals terminated at the end of the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 is >2000 mg/kg bw.
- Executive summary:
In an acute toxicity study the substance was administered to Sprague Dawley rats (5 animals/sex/dose) by oral gavage at a dose level of 2000 mg/kg bw (single administration). One female was found dead two days after dosing. Abnormalities noted at necropsy of the dead female included haemorrhagic lungs, dark liver, pale spleen, dark kidneys, pale gastric mucosa and gaseous distension of the stomach and large intestines. This was attributed to misadministration. No abnormalities were noted of the other animals terminated at the end of the study. There were no other signs of clinical toxicity, mean body weight gain was as expected. The oral LD50 is >2000 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 October 1986 - 21 October 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- May 12th, 1981
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: boron: HISW (SPF TNO)
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 10000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex/dose
- Control animals:
- no
- Preliminary study:
- A preliminary study was conducted but the details of this were not included in the study report.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities.
- Clinical signs:
- other: One after administration, the animals displayed slightly rough coat, later also slight squatting, and 3 animals had diarrhea. After 24 hours, all animals were free from symptoms of intoxication.
- Gross pathology:
- No abnormalities found at macroscopic post-mortem examination.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 is 10000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study the substance was administered to rats (5 animals/sex/dose) by oral gavage at a dose level of 10000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was as expected and no abnormalities were found at macroscopic post-mortem examination. The LD50 is 10000 mg/kg bw.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Sufficient to address requirements.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Read-across to K1 study therefore K2 is the maximum Klimisch value.
- Justification for type of information:
- Read-across approach - see read-across justification in section 13.
- Reason / purpose for cross-reference:
- read-across source
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 24 hour
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex
- Control animals:
- no
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No Mortality
- Clinical signs:
- other: No systemic toxicity observed
- Gross pathology:
- No abnormalities were reported at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 of the substance was found to be > 2000 mg/kg body weight.
- Executive summary:
In an acute toxicity study the substance was administered to Sprague Dawley rats (5 animals/sex) by semi-occluded dermal application for 24 hours at a dose level of 2000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was comparable with the control animals and no abnormalities found at macroscopic post-mortem examination. The LD50 is >2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Sufficient to address requirements.
Additional information
Justification for classification or non-classification
Based on the findings of reliable oral and dermal toxicity study conducted on the substance, classification of the substance is not justified.
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.