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EC number: 202-068-9 | CAS number: 91-44-1
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- no
- Type of assay:
- other: Micronucleus test
Test material
- Reference substance name:
- 7-(diethylamino)-4-methyl-2-benzopyrone
- EC Number:
- 202-068-9
- EC Name:
- 7-(diethylamino)-4-methyl-2-benzopyrone
- Cas Number:
- 91-44-1
- Molecular formula:
- C14H17NO2
- IUPAC Name:
- 7-(diethylamino)-4-methyl-2H-chromen-2-one
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- - Name of the test material as used in report: 4-Methyl-7-diethylamino-cumarin (SWN), Fluoresc. Br. 140
Test animals
- Species:
- rat
- Strain:
- other: CFY
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - Source: Anglia Labaratory Animals, Alconbury, Huntingdon. - Weight at study initiation: Between 57 and 62 grams - Assigned to test groups randomly: yes - Fasting period before study: Overnight - Housing: Five rats per plastic disposable cage. - Diet: "Grain Harvester" Anglia Labaratory Animal Diet, ad libitum - Water: ad libitum - Acclimation period: One week ENVIRONMENTAL CONDITIONS - Temperature (°C): 21 ± 2 - Humidity (%): 50 ± 5 - Air changes (per hr): 20 - Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: Distilled water adjusted to pH 7- Concentration of test material in vehicle: 40, 80 and 160 mg/mL- Amount of vehicle: 0.1 mL/10 g
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:The test substance was received as an off-white coloured powder. It was prepared as a suspension in sterile distilled water, using a Silverson high speed mixer and the pH of each concentration was adjusted to 7.0. Sterile distilled water was used as the negative control and all dosages were administered by intragastric intubation.
- Frequency of treatment:
- Two equal administrations separated by an interval of 24 hours
- Post exposure period:
- Following the last dose, the animals were observed for a further six hours before killing.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 800 mg/kg bw/day
- Remarks:
- Two equal administration of 400 mg/kg bw separated by an interval of 24 hours.
- Dose / conc.:
- 1 600 mg/kg bw/day
- Remarks:
- Two equal administration of 800 mg/kg bw separated by an interval of 24 hours.
- Dose / conc.:
- 3 200 mg/kg bw/day
- Remarks:
- Two equal administration of 1600 mg/kg bw separated by an interval of 24 hours.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Mitomycin C - Route of administration: intraperitoneal injection - Doses / concentrations: 0.1 mL/10 g (7mg/kg) twice.
Examinations
- Tissues and cell types examined:
- Bone marrow smear from the epiphysis of the femur.
- Details of tissue and slide preparation:
- The animals were killed by cervical dislocation and one femur dissected out from each animal. The femur was cleared of tissue and one epiphysis removed. A direct bone marrow smear was made onto a slide containing a drop of calf serum. The slide was cleaned by immersion in methanol for 24 hours and air-dried immediately before use. One smear was made from each femur. The prepared smears were air-dried and fixed in methanol overnight. After fixation, the smears were air-dried and placed in buffered distilled water (pH 6.8) for 10 minutes prior to staining in Giemsa (dilution factor 1 part Giemsa : 9 parts buffered distilled water pH 6.8) for 10 minutes. After rinsing in buffered distilled water (pH 6.8), the slides were air-dried. Prior to mounting in DPX, the slides were defatted by immersion in xylene for 10 minutes.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- After administration of sterile distilled water, the vehicle control, no toxic reactions or mortalities were observed.After administration of the test substance at a total dosage of 800 mg/kg bw/day, no toxic reactions or mortalities were observed.After administration of the test substance at a total dosage of 1600 mg/kg bw/day, no mortalities were observed, but a toxic reaction consisting of slight ataxia and slightly increased lacrimation was observed.After administration of the test substance at a total dosage of 3200 mg/kg bw/day, a toxic reaction consisting of severe ataxia, loss of righting reflex, hypopnoea and increased lacrimation was observed and all animals in the group excreted dark yellow pigmented urine. There was one mortality at this dose level, which died overnight after the administration of the first dose, between 8 and 24 hours. Advanced visceral autolysis prevented any post-mortem examination.After administration of Mitomycin C, the positive control compound, no toxic reactions or mortalities were observed.In this experiment the negative control group gave a mean count of 2.5 micronucleated cells which was within the range for previous unrelated experiments. After administration of the test substance at all dosages, the group mean micronucleated cell counts were comparable with the concurrent control value and within the laboratory standard range for negative controls obtained in previous unrelated experiments.The positive control, Mitomycin C, administered intraperitoneally gave a mean count of 85.9 micronucleated cells per 2000 polychromatic erythrocytes.
Applicant's summary and conclusion
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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