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Diss Factsheets
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EC number: 946-342-2 | CAS number: -
- 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:
- 5 April 2016 - 25 April 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- An assessment of acute toxicity is required to fulfil REACH Annex VII information requirements. The acute oral toxicity study was conducted according to OECD TG 423, GLP and is considered reliable without restriction (Klimisch 1).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Methyl 2-[[(Z)-(2,4-dimethylcyclohex-3-en-1-ylidene)methyl]amino]benzoate
- Molecular formula:
- C17H21NO2
- IUPAC Name:
- Methyl 2-[[(Z)-(2,4-dimethylcyclohex-3-en-1-ylidene)methyl]amino]benzoate
- Reference substance name:
- Methyl 2-[[(E)-(2,4-dimethylcyclohex-3-en-1-ylidene)methyl]amino]benzoate
- Molecular formula:
- C17H21NO2
- IUPAC Name:
- Methyl 2-[[(E)-(2,4-dimethylcyclohex-3-en-1-ylidene)methyl]amino]benzoate
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Species, strain: Sprague-Dawley (Crl:CD(SD)), SPF
- Age at study initiation: 8 weeks
- Weight at study initiation: 179.9-190.2 g
- Fasting period before study: Approximately 16 hours
- Housing: Housed individually in stainless wire mesh cages (260 x 350 x 210 mm)
- Diet (e.g. ad libitum): Pelleted rodent chow, ad libitum
- Water (e.g. ad libitum): Public tap water in Cheongju-si was filtered and irradiated by ultraviolet light and provided ad libitum.
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1−23.2°C
- Humidity (%): 45.1−54.2%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle, 150-300 Lux
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 500 mg/mL
- Lot/batch no. (if required): MKBV2080V
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION (if unusual): The test item was weighed into a bottle and a small amount of corn oil was added. The test item was dissolved using a vortex mixer. Corn oil was gradually added to yield the desired concentration.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Due to the low expected toxicity of the test substance, based on information supplied by the sponsor, a starting dose of 5,000 mg/kg was administered in one animal for this study (Step 1). - Doses:
- 5000 mg/kg bodyweight
- No. of animals per sex per dose:
- 1 for Step 1, 2 for Step 2
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for mortality, general condition and clinical signs (type, severity, time of onset and recovery) at 30 minutes after dosing and at 1, 2, 4 and 6 hours after dosing on Day 0 and once daily thereafter for 14 days (Day 1−Day 14). The body weight was recorded prior to dosing on Day 0 and on Days 1, 3, 7 and on the day of necropsy, Day 14.
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs and body weight - Statistics:
- Statistical analysis was not performed. Mean scores and values are determined.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- All animals at 5,000 mg/kg survived the duration of the study. There were no effects on mortality.
- Clinical signs:
- other: Chromaturia (abnormal colour of the urine) were observed in all animals at 6 hours after dosing at 5,000 mg/kg. Chromaturia, compound-coloured stool, decrease in locomotor activity, decrease of faecal volume, mucous stool, soiled perineal region and/or ab
- Gross pathology:
- No abnormal morphological findings were observed in any animal at 5,000 mg/kg.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study conducted according to OECD TG 423, GLP and considered reliable without restriction (Klimisch 1), the LD50 (cut-off) was determined to be ≥ 5,000 mg/kg bw.
- Executive summary:
The acute oral toxicity of the test item was determined by the Acute Toxic Class Method in female Sprague-Dawley rats. Three animals were administered a single oral dose of 5000 mg/kg body weight (bw) by intubation. Mortality, clinical signs of toxicity and body weight were observed for 14 days following administration. Mortality was not observed at any tested dose level, and the LD50 was expected to be >5000 mg/kg bw. Effects considered to be test substance related included chromaturia, compound-colored stool, decrease in locomotor activity, decrease of fecal volume, mucous stool, soiled perineal region, abnormal gait, suppression of body weight gain and/or decreased bodyweights on Days 1 and 2.
This study is considered to be reliable without restrictions (Klimisch 1) as it was GLP-compliant and was performed according to OECD guideline 423. There is no evidence of a relevant intrinsic acute oral toxicity requiring classification or substance specific risk mitigation measures (RMM).
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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