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EC number: 453-080-8 | CAS number: 154858-16-9
- 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
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:
- 2004-02-17 to 2004-03-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented guideline conform, scientific GLP report
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH; Gartenstrasse 27; D-33178 Borchen, Germany
- Age at study initiation: 6-10 Weeks
- Weight at study initiation: 195g ± 8.9 g
- Fasting period before study:
- Housing:
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: yes, at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3°C
- Humidity (%): 50 ±20%
- Air changes (per hr): n.a.
- Photoperiod: 12 hrs dark/12hrs light
IN-LIFE DATES: From: 2004-02-17 To: 2004-03-02 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 300 and 2000 mg/kg body weight
- No. of animals per sex per dose:
- 2000 mg/kg body weight: 3 (start dose)
300 mg/kg body weight: 6 - Control animals:
- no
- Details on study design:
- The prepared test substance was administered by gavage to fasted animals at the stated dosage.
The observation period following treatment lasted for 14 days.
Symptoms and lethality were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays
only once.
During this time the animals were weighed weekly.
Animals found dead were dissected as soon as possible and examined for macroscopically visible changes.
At the end of the observation period surviving animals were killed by carbon dioxide asphyxiation, dissected and
also examined for macroscopically visible changes - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- discriminating dose
- Effect level:
- > 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: According to OECD guideline 423 the LD50 cut-off value is 500 mg/kg body weight.
- Mortality:
- at 300 mg/kg body weight: 2/6
at 2000 mg/kg body weight: 3/3 - Clinical signs:
- other: At 2000 mg/kg bw The following clinical signs were observed in the female animals starting between 10 and 30 minutes after the administration of the test substance: squatting posture, stilted, uncoordinated and ataxic gait, forward crawling, prone positi
- Gross pathology:
- At 2000 mg/kg bw:
Necropsy of one decedent animal revealed diffuse reddening in mucous membranes of stomach and small intestine. Another decedent animal revealed additionally orange discolored lungs, small intestines filled with green mucous as well as stomach filled with gas.
At 300 mg/kg bw:
Necropsy of the decedent animals revealed orange discolored lungs, as well as diffuse reddening of mucous membranes in stomach and small intestine. One decedent animal showed additional small intestines filled with green mucous and stomach filled with gas.
The animals killed at the end of the observation period showed no macroscopically visible changes. - Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results obtained in this study with female rats the median lethal dose value (LD50) of the test substance lies between 300 and 2000 mg/kg body weight.
The LD50 cut-off value is 500 mg/kg body weight according to OECD guideline 423. - Executive summary:
In order to determine the acute oral toxicity of the test substance an acute oral toxicity test according to OECD Guideline 423 was performed in female rats. The solid test substance was solved in water and applied once by oral intubation. Observation period was 14 days. The starting dose of 2000 mg/kg body weight was choosen for 3 animals. Due to mortality seen in all 3 animals of that dose level within 1 to 4 hours after treatment, 300 mg/kg body weight was choosen for the next level. Two rats out of 6 rats of this dose group were found dead (i.e. at day 3 and day 6).
The acute oral toxicity testing of the test substance in the female rat yielded the following median lethal dose (LDso):
300< LD50 < 2000 mg/kg body weight. According to OECD guideline 423 the LD50 cut-off value is 500 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 500 mg/kg bw
- Quality of whole database:
- Reliable without restrictions.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In order to determine the acute oral toxicity of the test substance an acute oral toxicity test according to OECD Guideline 423 was performed in female rats. The solid test substance was solved in water and applied once by oral intubation. Observation period was 14 days. The starting dose of 2000 mg/kg body weight was choosen for 3 animals. Due to mortality seen in all 3 animals of that dose level within 1 to 4 hours after treatment, 300 mg/kg body weight was choosen for the next level. Two rats out of 6 rats of this dose group were found dead (i.e. at day 3 and day 6).
Based on the results obtained in this study with female rats the median lethal dose value (LD50) of the test substance lies between 300 and 2000 mg/kg body weight.
The LD50 cut-off value is 500 mg/kg body weight according to OECD guideline 423.
Justification for selection of acute toxicity – oral endpoint
Well documented guideline conform, scientific GLP report
Justification for classification or non-classification
According to Regulation No. 1272/2008 of the European Parliament and of the Council of Dec.2008 the test substance has to be classified for Acute toxicity 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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