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EC number: 244-320-0 | CAS number: 21295-57-8
- 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:
- 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 6-(cyclohexylamino)-3-methyl-3H-dibenz[f,ij]isoquinoline-2,7-dione
- EC Number:
- 244-320-0
- EC Name:
- 6-(cyclohexylamino)-3-methyl-3H-dibenz[f,ij]isoquinoline-2,7-dione
- Cas Number:
- 21295-57-8
- Molecular formula:
- C23H22N2O2
- IUPAC Name:
- 10-(cyclohexylamino)-14-methyl-14-azatetracyclo[7.7.1.0²,⁷.0¹³,¹⁷]heptadeca-1(16),2,4,6,9,11,13(17)-heptaene-8,15-dione
- Test material form:
- solid
- Details on test material:
- Purity: 94.2%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Janvier Labs SAS, Le Genest St. Isle, 53941 Saint Berthevin Cedex, France
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 11 weeks
- Weight at study initiation: 230 - 245 g
- Fasting period before study: overnight
- Housing: groups of one to five rats
- Historical data: available
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days prior to start of dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 45-65%
- Air changes (per hr): at least 8 per hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2020-02-10 To: 2020-02-26
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: stability in vehicle given
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: a severe toxicity which may necessitate humane euthanasia was not expected at 2000 mg/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 1 female for the pre-test
4 females for the main study - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations and inspections for morbidity / mortality were performed at least three times within the first six hours after application (i.e., 30 minutes and 1 hour, 2 hours and 4 hours after dosing), thereafter at least once daily for 14 days. Body weights were recorded on Day 0 (prior to dosing), Day 7, and 14.
- Necropsy of survivors performed: yes - Statistics:
- not needed
Results and discussion
- Preliminary study:
- In the sighting test with one female and a single dose of 2000 mg/kg bw
Effect levels
- Sex:
- female
- Dose descriptor:
- discriminating dose
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: Hunched posture, stained faeces (dark red), decreased activity, fur stained by test item, piloerection, partially closed eyes, abdominal tension, secretion of Haderian glands, and nervousness were noted in all treated females, starting at about 4 hour aft
- Gross pathology:
- Macroscopic examination at study termination on Day 14 revealed red to pink fur, congestion of the genitalia, enlarged heart, slightly blue coloured pharynx, slightly blue coloured front teeth of the lower jaw.
- Other findings:
- Stained fur was observed throughout the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The registered substance was tested in a single dose of 2000 mg/kg bw in an acute oral toxicity study in female Wistar rats following OECD TG 420. There were no deaths during the study. As clinical signs hunched posture, stained faeces (dark red), decreased activity, fur stained by test item, piloerection, partially closed eyes, abdominal tension, secretion of Haderian glands, and nervousness were noted in the first two days after dosing. The animal showed expected gains in body weight over the observation period. The acute median lethal oral dose (LD50) to rats of Macrolex Fluoreszenzrot 4B was demonstrated in this study to be greater than 2000 mg/kg body weight.
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