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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 April 2000 - 24 April 2000
- 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 dermal toxicity study was conducted according to OECD TG 402, GLP and is considered reliable without restriction (Klimisch 1).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute 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:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Species, Strain: Sprague-Dawley CD (Crl:CD (SD) IGS BR)
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: Males - 200-218 g. Females - 201-221 g
- Housing: Suspended polypropylene cages furnished with woodflakes
- Diet: Rat and Mouse Expanded Diet No.1, ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back and flanks
- % coverage: 10
- Type of wrap if used: Surgical gauze semi-occluded with a piece of self-adhensive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: Wiped with cotton wool moistened with arachis oil BP
- Time after start of exposure: 24 hours
TEST MATERIAL
- Concentration: 2000 mg/kg bodyweight - Duration of exposure:
- 24 hour exposure, with a 14-day observation period
- Doses:
- 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0.5, 1, 2 and 4 hours after dosing, then once daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: Mortality, clinical signs, dermal reactions, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No deaths
- Clinical signs:
- other: No clinical signs of toxicity were noted during the study.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- No signs of dermal Irritation were noted during the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item was determined to be > 2000 mg/kg bodyweight.
- Executive summary:
The acute dermal toxicity of the test item was determined in a limit test with male and female Sprague-Dawley rat. The backs and flanks of the animals were shorn and the test material was applied unchanged at a dosage of 2000 mg/kg bodyweight. The treatment sites were semi-occluded and rats were exposed to the test item for 24 hours. Mortality, clinical signs of toxicity, dermal reactions and body weight were observed for 14 days following treatment. There were no mortalities observed, therefore the LD50 was determined to be > 2000 mg/kg bodyweight. No signs of dermal irritation, clinical signs of toxicity or abnormal bodyweight changes were observed throughout the study duration. This study is considered to be reliable without restrictions (Klimisch 1) as it was GLP-compliant and was performed according to OECD guideline 402.
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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