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Diss Factsheets
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EC number: 272-275-7 | CAS number: 68784-82-7
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 7, 2010 - February 21, 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed in accordance with OECD 423 (2001), EU Method B.1 tris (2008), EPA OPPTS 870.1100 (2002) and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (2001)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- (2002)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): L579
- Physical state: colourless solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation:
Step 1/animals no. 1-3: 170-180 g
Step 2/animals no. 4-6: 153-159 g
- Fasting period before study: 16 to 19 hours
- Housing: the animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 040810)
- Diet: free access to Altromin 1324 maintenance diet for rats and mice (lot no. 1013). Free access again from 4 hrs post dosing.
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10 per hr
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Date of Dose Administration:
Step 1, animals no. 1, 2 and 3: December 22, 2010
Step 2, animals no. 4, 5 and 6: December 29, 2010
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- cotton seed oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.4 g/mL
- Amount of vehicle: 5 mL
- Justification for choice of vehicle: due to its non-toxic characteristics
- Lot/batch no.: Sigma, lot no. MKBB7604, expiry date 30/01/2011
- Purity: not applicable
DOSE VOLUME APPLIED: 5 mL/kg
DOSAGE PREPARATION: the test item was weighed out into a tared plastic vial on a precision balance. Homogeneity was maintained by vortexing. The dosages were made shortly before administration.
CLASS METHOD
- Rationale for the selection of the starting dose: no details provided - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 females twice (6 females in total)
- Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: the animals were weighed on day 1 (prior to the administration), on day 8 (1 week thereafter) and on day 15 (2 weeks thereafter)
- Frequency of observations: a careful clinical examination was made several times on the day of dosing (at least once during the 1st 30 minutes and with special attention given during the 1st 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. According to the OECD Guideline.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortalities occurred
- Mortality:
- - No mortalities occurred
- Clinical signs:
- other: - At 1 hour after administration, slight piloerection was observed in animal #2 and #3 - In animal #1, prone position and slight piloerection was observed at 3 and 4 hours after administration, until day 2 - At 3 and 4 hours after administration, prone po
- Gross pathology:
- - No abnormalities were observed
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an acute oral toxicity study in female rats, conducted in accordance with OECD 423 (2001), EU Method B.1 tris (2008), EPA OPPTS 870.1100 (2002) and according to GLP principles, a LD50 oral of >2000 mg/kg was determined.
- Executive summary:
The acute oral toxicity in female rats has been studied in accordance with OECD 423 (2001), EU Method B.1 tris (2008), EPA OPPTS 870.1100 (2002) and according to GLP principles. The substance was dosed in cotton seed oil at 2 g/kg bw in 6 female rats, in 2 steps. At 1, 3 and 4 hours after administration, slight reduced spontaneous activity, prone position and slight to moderate piloerection was observed in all animals of the 1st group, until day 2. No mortalities occurred. Necropsy did not show any abnormality. The acute oral toxicity (LD50) was determined to be >2000 mg/kg. Based on this result, the substance does not need to be classified for acute toxicity by the oral route.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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