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EC number: 608-605-7 | CAS number: 313482-99-4
- 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
Acute oral toxicity: LD50 > 2000 mg/kg bw (OECD 423; GLP)
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:
- 2002-12-02 to 2003-03-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 1996-03-22
- Deviations:
- yes
- Remarks:
- rationale for the selection of the starting dose is missing
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the freezer protected from light, under nitrogen - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 9 weeks old
- Weight at study initiation: males: 311 ± 12 g; females: 204 ± 3 g
- Fasting period before study: food was withheld overnight (for a maximum of 20 hours) prior to dosing until 3-4 hours after administration of the test substance.
- Housing: group housing of 3 animals/sex/cage in Macrolon cages (type IV; height 18
cm.) containing purified sawdust as bedding material (SAWI, Jelu Werk, Rosenberg, Germany).
- Diet (ad libitum): standard pelleted laboratory animal die! (from Allromin (code VRF 1 ), Lage, Germany)
- Water (ad libitum): tap-water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 3°C
- Relative humidity: 30 - 70%
- Air changes: approx. 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- DOSAGE PREPARATION:
The formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. The formulations were heated to 50°C and allowed to cool down until 36 - 38 °C prior to dosing.
VEHICLE
- Justification for choice of vehicle: the vehicle was selected based on trial formulations performed at the laboratory.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 males / 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
a) Mortality/Viability: twice daily
b) Body weights: days 1 (pre-administration), 8 and 15
c) Clinical signs: at periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15. The symptoms were graded according to fixed scales and the time of onset, degree and duration were recorded:
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored (1 ).
- Necropsy of survivors performed: yes, at the end of the observation period, all animals were sacrificed and subjected to necropsy. - Statistics:
- No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).
- Preliminary study:
- not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- Hunched posture, uncoordinated movements, paresis, paresis of the forelegs, piloerection, chromodacryorrhoea and/or ptosis were noted among the females between days 1 and 3.
Lethargy was noted in one female on day 7.
Uncoordinated movements, abnormal gait and/or abnormal posture (of forelegs and hindlegs) were noted among the males belween days 1 and 5. - Body weight:
- The body weight gain shown by the animals over the study period was considered to be similar to !hat expected of normal untreated animals of the same age and strain.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 (female rats) > 2000 mg/kg bw
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is not acutely toxic via the oral route.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
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
Acute oral toxicity
One reliable study described in van Huygevoort (2003; OECD 423 (1996); GLP) is considered to be reliable without restrictions and is used as key study for this endpoint. The LD50 was determined to be greater than 2000 mg/kg bw.
Justification for classification or non-classification
Acute oral toxicity
The substance is not acutely toxic via the oral route based on an acute oral toxicity test (OECD 423) and does not require classification according to Regulation (EC) No 1272/2008 and subsequent adaptations.
Specific target organ toxicant (STOT) - single exposure: oral
Reversible or irreversible adverse health effects were not observed immediately or after exposure in an acute oral toxicity test (OECD 423). Thus, the classification criteria as specific target organ toxicant (STOT) – single exposure, oral are not met and the substance does not require classification according to Regulation (EC) No 1272/2008 and subsequent adaptations.
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