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EC number: 204-373-2 | CAS number: 120-14-9
- 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
Acute oral toxicity: OECD TG 401: 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:
- The study was conducted in August 1974.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Reliability 2 is assigned because although the study was conducted similar to the current OECD TG 401, the guideline is not referenced and the study is non-GLP. However, this did not influence the reliability of the results.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals
- Weight at study initiation: 235-287 g
- Fasting period before study: 16-20 hours
- Housing: 5/cage in suspended wire mesh cages. Bedding was placed beneath the cages.
- Diet: fresh Purina Rat Chow (Diet #5012), ad libitum, except 16-20 hours prior to dosing
- Water: ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- The following doses were used in the study: 1310, 1640, 2050, 2560 and 5000 mg/kg bw.
- No. of animals per sex per dose:
- 10 males/dose
- Control animals:
- no
- Details on study design:
- - Frequency of observations: Animals were observed 3-4 hours post dosing and once daily thereafter for 14 days for mortality, toxicity and pharmacological effects.
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, toxicity and pharmacological effects. - Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 1 840 - < 2 160
- Mortality:
- The following numbers of animals died during the study, at the doses of:
- 1310 mg/kg bw: 0/10
- 1640 mg/kg bw: 4/10 (2 on day 1 and 2 on day 2)
- 2050 mg/kg bw: 6/10
- 2560 mg/kg bw: 9/10
- 5000 mg/kg bw: 10/10. - Clinical signs:
- other: Lethargy was noted in rats at the 3 higher doses.
- Other findings:
- No other findings were noted.
- Interpretation of results:
- other: Classified as Acute Category 4
- Remarks:
- According to EU CLP 1272/2008 and its amendments.
- Conclusions:
- Acute oral toxicity was performed equivalent to the guideline OECD TG 401. The acute oral LD50 for the substance in male rats was determined to be 2000 mg/kg bw. Based on the results of this study, in accordance with EU CLP 1272/2008 criteria, the test substance needs to be classified as Category 4. The test substance needs to be classified according to GHS criteria as Category 4 as well.
- Executive summary:
An acute oral toxicity study was performed according to the guideline OECD TG 401. Ten male rats were administered the substance at dose levels of: 1310, 1640, 2050, 2560 and 5000 mg/kg bw. No rat died at the dose of 1310 mg/kg bw, four died at 1640 mg/kg bw, six at 2050 mg/kg bw, nine at 2560 mg/kg bw and ten at 2000 mg/kg bw. The clinical signs observed was lethargy at 3 higher doses. The acute oral LD50 for the substance in male rats was determined to be 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Additional information
An acute oral toxicity study was performed according to the guideline OECD TG 401. Ten male rats were administered the substance at dose levels of:1310, 1640, 2050, 2560 and 5000 mg/kg bw. No rat died at the dose of 1310 mg/kg bw, four died at 1640 mg/kg bw, six at 2050 mg/kg bw, nine at 2560 mg/kg bw and ten at 2000 mg/kg bw. The clinical signs observed was lethargy at 3 higher doses.The acute oral LD50 for the substance in male rats was determined to be 2000 mg/kg bw.
Justification for classification or non-classification
According to the criteria outlined in EU CLP 1272/2008/EC (and its amendments), the substance needs to be classified as acute toxic by the oral route Category 4.
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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