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Diss Factsheets
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EC number: 610-641-3 | CAS number: 512802-65-2
- 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 oral toxicity study the substance was administered to Wistar rats (5 animals/sex/dose) 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 as expected and no abnormalities found at macroscopic post-mortem examination.The oral LD50 is >2000 mg/kg bw.
In a reliable acute oral 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 dermal 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:
- 12 February 2018 - 05 March 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 2001
- Deviations:
- yes
- Remarks:
- Due to a technician error, the Day 14 body weight for the initial animal treated at a dose level of 2000 mg/kg was not recorded. This deviation was considered not to affect the purpose or integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
- Specific details on test material used for the study:
- Batch: 1023R26015
Purity: 99.7%
Physical state / Appearance: Yellow liquid
Expiry Date: 16 March 2018
Storage Conditions: room temperature in the dark - Species:
- rat
- Strain:
- Wistar
- Remarks:
- ccHan™:WIST
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- The females were nulliparous and non-pregnant. After an acclimatization period of at least 5 days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card. At the start of the study the animals were 8 to 12 weeks of age. The body weight variation did not exceed ± 20% of the mean body weight of any previously treated animals.
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- Sighting test at 300 mg/kg bw.
Main test at 2000 mg/kg bw. - No. of animals per sex per dose:
- Sighting test at 300 mg/kg bw - 1 animal
Main test at 2000 mg/kg bw - 5 animals - Control animals:
- no
- Preliminary study:
- At a dose level of 300 mg/kg bw there was no mortality, no signs of systemic toxicity were noted, the animal showed an expected gain in body weight over the observation period and no abnormalities were noted at necropsy.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the observation period.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 is >2000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study the substance was administered to Wistar rats (5 animals/sex/dose) 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 as expected and no abnormalities found at macroscopic post-mortem examination. The oral LD50 is >2000 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
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 a reliable studies conducted on the substance and a structural analogue, 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.
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