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EC number: 204-133-7 | CAS number: 116-26-7
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in 2015 at recognised contract research organisation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 2,3-dihydro-2,2,6-trimethylbenzaldehyde
- EC Number:
- 204-133-7
- EC Name:
- 2,3-dihydro-2,2,6-trimethylbenzaldehyde
- Cas Number:
- 116-26-7
- Molecular formula:
- C10H14O
- IUPAC Name:
- 2,6,6-trimethylcyclohexa-1,3-diene-1-carbaldehyde
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI rats
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Doses:
- 2000 mg/kg body weight (bw) (Group 1)
300 mg/kg bw (Group 2 and Group 3) - No. of animals per sex per dose:
- Three groups of three female rats_ single oral treatment
- Control animals:
- yes
- Details on study design:
- The single-dose oral toxicity of SAFRANAL was performed according to the acute toxic class method in Crl:WI rats.
Three groups of three female rats were treated with the test item at a dose level of 2000 mg/kg body weight (bw) (Group 1) or at a dose level of 300 mg/kg bw (Group 2 and Group 3).
A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. The food was available again 3 hours after the treatment. The test item was administered formulated in Poly(ethylene glycol) 400 (PEG 400) at a concentration of 200 mg/mL or 30 mg/mL and at a dose volume of 10 mL/kg bw.
Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. Since all animals died, a new group (Group 2) was treated at a dose level of 300 mg/kg bw. No mortality was observed in this group, therefore a confirmatory group (Group 3) was tested at the same dose level according to the Regulatory Guidelines.
Clinical observations were performed at 5 and 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter (or at the time points listed above, until the time point closest to the death of the animal). Body weights were measured on Day -1, and Day 0, and in surviving animals on Day 7 and Day 14 before the necropsy or at death. All animals were subjected to a necropsy and macroscopic examination. - Statistics:
- no statistics required as to following top-down method
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All rats died at a dose level of 2000 mg/kg bw on Day 1 or on Day 3.
The test item did not cause mortality at a dose level of 300 mg/kg bw. - Clinical signs:
- other: At a dose level of 2000 mg/kg bw on Day 0-2 the following clinical signs were recorded: decreased activity (slight) excessive digging irritability hunched back incoordination (slight to severe) continuous tremors increased salivation (slight) piloerection
- Gross pathology:
- At a dose level of 2000 mg/kg bw, the gastric glandular mucosa was dark red (2/3) or in the stomach yellow, liquid material was present (1/3), and was considered to be associated with administration of the test item. In the collapsed lungs of the three found dead rats, diffuse, dark red discoloration could be observed and regarded as agonal or post mortem.
In the rats at the dose level of 300 mg/kg bw, no external or internal findings were recorded at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item SAFRANAL was found to be between 300 and 2000 mg/kg bw in female Crl:WI rats.
- Executive summary:
STUDY DESIGN
The single-dose oral toxicity of SAFRANAL was performed according to the acute toxic class method in Crl:WI rats.
Three groups of three female rats were treated with the test item at a dose level of 2000 mg/kg body weight (bw) (Group 1) or at a dose level of 300 mg/kg bw (Group 2 and Group 3).
A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. The food was available again 3 hours after the treatment. The test item was administered formulated in Poly(ethylene glycol) 400 (PEG 400) at a concentration of 200 mg/mL or 30 mg/mL and at a dose volume of 10 mL/kg bw.
Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. Since all animals died, a new group (Group 2) was treated at a dose level of 300 mg/kg bw. No mortality was observed in this group, therefore a confirmatory group (Group 3) was tested at the same dose level according to the Regulatory Guidelines.
Clinical observations were performed at 5 and 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter (or at the time points listed above, until the time point closest to the death of the animal). Body weights were measured on Day -1, and Day 0, and in surviving animals on Day 7 and Day 14 before the necropsy or at death. All animals were subjected to a necropsy and macroscopic examination.
RESULTS
Mortality
All rats died at a dose level of 2000 mg/kg bw on Day 1 or on Day 3. The test item did not cause mortality at a dose level of 300 mg/kg bw.
Clinical Observations
At a dose level of 2000 mg/kg bw on Day 0-2 the following clinical signs were recorded:
decreased activity (slight), excessive digging, irritability, hunched back, incoordination (slight to severe), continuous tremors, increased salivation (slight), piloerection and red discoloration on both fore-paws, both hind-paws and on the tail in 3 of 3 rats and red discoloration on both pinna in 2 of 3 rats.
The rats dosed to 300 mg test item/kg bw showed the following clinical signs on Day 0:
irritability, excessive digging, piloerection, hunched back, red discoloration on both fore-paws, both hind-paws and on both pinna in 6 of 6 rats, increased salivation (slight) in 4 of 6 rats, incoordination (slight) in 3 of 6 rats and red discoloration on the tail in 1 of 6 rat.
Each rat of this dose level was symptom-free from Day 1 at the latest.
Body Weight and Body Weight Gain
Body weight gains of SAFRANAL-treated surviving animals showed no indication of a test item-related effect during the study.
Macroscopic Findings
At a dose level of 2000 mg/kg bw, the gastric glandular mucosa was dark red (2/3) or in the stomach yellow, liquid material was present (1/3), and was considered to be associated with administration of the test item. In the collapsed lungs of the three found dead rats, diffuse, dark red discoloration could be observed and regarded as agonal or post mortem.
In the rats at the dose level of 300 mg/kg bw, no external or internal findings were recorded at necropsy.
CONCLUSION
Under the conditions of this study, the acute oral LD50 value of the test item SAFRANAL was found to be between 300 and 2000 mg/kg bw in female Crl:WI rats.
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