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Diss Factsheets
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EC number: 203-593-6 | CAS number: 108-55-4
- 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 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study appears to be well conducted. No evidence that GLP was followed, but likely conducted in the spirit of GLP. Study used an appropriate number fo animals to assess the endpoint.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Doses:
- Males - 500mg, 1000mg, 2000mg, 8000mg
Females - 250 m, 500mg, 1000mg - No. of animals per sex per dose:
- Males
500 mg = 5
1000 mg = 5
2000 mg = 5
8000 mg = 2
Females
250 mg = 5
500 mg = 5
1000 mg = 5 - Control animals:
- no
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 410 mg/kg bw
- 95% CL:
- > 800 - < 2 490
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 540 mg/kg bw
- 95% CL:
- > 360 - < 790
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Female rats appeared to be more sensitive to the effects of the test material. Based on the LD50 value reported for the female rats, the substance meets the criteria for classification as Harmful in the EU.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Standard Acute toxicity methodolgy followed - Rats dosed with test substance and then observed for up to 14 days. However rats were dosed with both test material solution and then an equal volume of water to assess the effect of dilution on the acute toxicity.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Doses:
- Males:
16 ml/kg = 4 g/kg bw
8 ml/kg = 2 g/kg
4 ml/kg = 1 g/kg
2 ml/kg = 0.5 g/kg
1ml/kg = 0.25 g/kg
Females:
4 ml/kg = 1 g/kg
2 ml/kg = 0.5 g/kg
1 ml/kg = 0.25 g/kg - No. of animals per sex per dose:
- Males:
2 animals per dose for the 0.25g/kg dose group, 5 animals per dose for the other dose groups total = 22
Females:
5 animals per dose group. Total = 15 - Control animals:
- no
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 5.66 mL/kg bw
- 95% CL:
- > 3.35 - < 9.55
- Remarks on result:
- other: as 25% w/v in corn oil
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 420 mg/kg bw
- 95% CL:
- > 838 - 2 388
- Remarks on result:
- other: as test substance
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 620 mL/kg bw
- 95% CL:
- > 1 180 - < 2 240
- Remarks on result:
- other: as 25% w/v in corn oil
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 400 mg/kg bw
- 95% CL:
- > 295 - < 560
- Remarks on result:
- other: as test substance
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute toxicity of the test substance does not appear to be moderated by the subsequent dosing of an equal volume of water.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Additional information
Justification for classification or non-classification
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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