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EC number: 700-548-7 | CAS number: 56138-10-4
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08-09-2011 to 07-10-2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP. All relevant validity criteria were met.
- Justification for type of information:
- Information as to the availability of the in vivo study is provided in 'attached justification'.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- (2E)-2-methyl-3-(4-methylphenyl)prop-2-en-1-ol
- EC Number:
- 700-548-7
- Cas Number:
- 56138-10-4
- Molecular formula:
- C11H14O
- IUPAC Name:
- (2E)-2-methyl-3-(4-methylphenyl)prop-2-en-1-ol
- Details on test material:
- - Physical state: Waxy solid at temperature < 23°C and liquid at temperature > 23°C
- Storage condition of test material: In refrigerator (2-8°C) in the dark under nitrogen
- Other: white waxy solid at temperature < 23°C and clear colourless liquid at temperature > 23°C
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI (Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: 8 - 9 weeks (nulliparous and non-pregnant)
- Weight at study initiation: 142 - 195 g; Body weight variation did not exceed +/- 20% of the sex mean.
- Fasting period before study: Overnight and until 3-4 hours after administration of the test substance.
- Housing: Group housing of 3 animals per cage containing sterilized sawdust as bedding material and paper as cage-enrichment.
- Water: ad libitum
- Acclimation period: At least five (5) days under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0 (actual: 19.0 to 22.6°C)
- Humidity (%): 40 to 70 (actual: 44 – 82%)
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 hours light/dark
IN-LIFE DATES: 08-09-2011 to 07-10-2011
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Identity: Polyethylene glycol 400
- Concentration in vehicle: The concentration of the test item in vehicle was varied to allow constant dosage volume in terms of mL/kg body weight.
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: The vehicle was selected based on trial formulations performed.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION (if unusual): The formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Since the test substance was in a fluid state at the time of weighing, it was not heated.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the absence of data suggesting the test material was toxic, 2000 mg/kg was chosen as the starting dose. The toxicity of the test substance was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups. - Doses:
- 300 mg/lg and 2000 mg/kg
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Mortality/Viability: Twice daily; Bodyweights: Days 1 (pre-administration), 8 and 15; Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15. The signs were graded according to fixed scales and the time of onset, degree and duration were recorded.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 2000 mg/kg bw: there was 2/6 mortalities (2/3 in the second group.
300 mg/kg bw: there was no mortalities. - Clinical signs:
- other: 2000 mg/kg bw: Lethargy, flat and/or hunched posture, piloerection, slow breathing, uncoordinated movements, dark eye and/or watery discharge from the eyes were noted in all animals between Days 1 and 6. One animal showed scales and scabs on the snout dur
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the oral LD50 established to be > 300 and < 2000 mg/kg bw in female Wistar rats. According to OECD TG 423 the LD50 cut-off value was considered to be 2000 mg/kg bw.
- Executive summary:
The study was performed according to OECD TG 423 and EU Method B1 tris Acute Toxicity, US EPA OPPTS 870.1100 and Japanese JMAFF guidelines and in accordance with GLP to assess the acute oral toxicity of the test item following a single oral administration in the female Wistar strain rat by the acute class method. The test item was administered by oral gavage in a PEG 400 vehicle to two sequential groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15). There was two mortalities in the second group. Lethargy, flat and/or hunched posture, piloerection, slow breathing, uncoordinated movements, dark eye and/or watery discharge from the eyes were noted in all animals between Days 1 and 6. In addition one animal showed scales and scabs on the snout during the observation period. A second dose level was then employed at 300 mg/kg bodyweight. All animals showed hunched posture and one animal showed piloerection on Day 1. No further effects were subsequently seen. The body weight gain shown by survivors over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination of the animals at any dose level. The oral LD50 value of the test substance in Wistar rats was established to be > 300 and < 2000 mg/kg body weight. According to the OECD TG 423 test guideline, the LD50 cut-off value was considered to be 2000 mg/kg body weight.
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