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EC number: 814-113-5 | CAS number: 253454-23-8
- 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
Acute oral toxicity: LD50 > 5000 mg/kg bw (OECD TG 401).
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:
- 14 June 1984 - 28 June 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reliability has been presented as 2 because similar to OECD Guideline protocol has been follo wed but not GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Section 1500.3 - Federal Hazardoes Substances Act Regulations - 16 CFR
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA (USDA licensed animal dealer)
- Females (if applicable) nulliparous and non-pregnant: not indicated
- Age at study initiation: not indicated
- Weight at study initiation: average body weight of males: 261 g; average weight of females: 214 g
- Fasting period before study: yes, overnight
- Housing: stainless steel cages with elevated wire mesh flooring; 5 rats/cage by sex
- Diet: ad libitum, Wayne Lab-Blox
- Water: ad libitum tap water
- Acclimation period: yes, duration of acclimation period not specified
ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 18.3 - 22.8
- Humidity (%): 45 - 55
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 14 June 1984 To: 28 June 1984 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 5 g/kg bw
- Doses:
- One fixed dose: 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: frequently on the day of dosage and twice per day thereafter (morning and afternoon)
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the animals died during the study.
- Clinical signs:
- No abnormal behaviour or adverse clinical signs were observed. All animals appeared normal throughout the 14 day observation period.
- Body weight:
- Average bodyweights at the end of the 14 day observation period: 350 g for males; 244 g for females. All animals showed normal bodyweight gain during the study.
- Gross pathology:
- No gross abnormalities were noted for the animals necropsied at the conclusion of the study.
- Interpretation of results:
- other: Not acute harmful
- Remarks:
- According to EU CLP (EC No. 1272/2008 and its amendments).
- Conclusions:
- The acute oral toxicity test with the substance showed an LD50 of >5000 mg/kg bw.
- Executive summary:
The acute oral toxicity of the substance was determined in a similar to OECDTG 401 study: 10 rats (5 males and 5 females) were administered with the substance at a dose level of 5000 mg/kg bw by oral gavage. No animal died during the study and all animals appeared normal throughout the 14 day observation period. Following necropsy, there were no gross abnormalities found in any of the animals. Based on the results in this study, the acute oral LD50 for the substance in male and female rats was determined to be >5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The acute oral toxicity result is of sufficient quality and adequate for this dossier.
Additional information
Acute oral:
The acute oral toxicity of the substance was determined in a similar to OECDTG 401 study: 10 rats (5 males and 5 females) were administered with the substance at a dose level of 5000 mg/kg bw by oral gavage. No animal died during the study and all animals appeared normal throughout the 14 day observation period. Following necropsy, there were no gross abnormalities found in any of the animals. Based on the results in this study, the acute oral LD50 for the substance in male and female rats was determined to be >5000 mg/kg bw.
Justification for classification or non-classification
The substance does not need to be classified for acute oral toxicity according to EU CLP (EC No. 1272/2008 and its amendments).
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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