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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- The sensitizing capacity of the given test chemical on rodents.
- Author:
- HAUSEN AND Berger
- Year:
- 1 989
- Bibliographic source:
- Contact Dermatitis
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Modified FCA method and Guinea pig maximization test
- Principles of method if other than guideline:
- Modified FCA method and Guinea pig maximization test was performed to evaluate the dermal sensitization potential of the test chemical
- GLP compliance:
- not specified
- Type of study:
- other: Modified FCA method and Guinea pig maximization test
- Justification for non-LLNA method:
- not specified
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
- Details on test material:
- - Name of test material (as cited in study report): 7-DIETHYLAMINO-4-METHYLCOUMARIN
- Molecular formula: C14H17NO2
- Molecular weight : 231.2933 g/mol
- Substance type:Organic
- Physical state:Solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbrigjht white strain
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: No data available
- Age at study initiation: No Data available
- Weight at study initiation:280-350 g
- Housing: animals were kept 3 to a cage
- Diet (e.g. ad libitum):altromin ad libitum
- Water (e.g. ad libitum): water ad libitum
- Acclimation period: No Data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22-24⁰C
- Humidity (%):50-55%
- Air changes (per hr): No Data available
- Photoperiod (hrs dark / hrs light): Under artificial illumination for 10 hours a day
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: FCA and saline
- Concentration / amount:
- 15 mg
- Day(s)/duration:
- 5th and 9th day
- Adequacy of induction:
- not specified
Challenge
- No.:
- #10
- Route:
- epicutaneous, open
- Vehicle:
- other: Acetone
- Concentration / amount:
- 0.05ml
- Adequacy of challenge:
- other: subirritent concentration.
- No. of animals per dose:
- Induction route-10
Challenge route-10 - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 8
- Exposure period:9 days
- Test groups: 10 guinea pigs
- Control group: 10 guinea pigs
- Site: Intradermal induction -Intraderma injection of 6x0.10-0.15 ml of emulsion were applied.The emulsion was applied in a semicircular arc on clipped and shaved shoulder area (4Х6 cm) from left to right.
- Frequency of applications: repeated on 5th and 9th days
- Duration: 9 days
- Concentrations: 15 mg in 4 ml FCA
B. CHALLENGE EXPOSURE
- No. of exposures: multiple times
- Day(s) of challenge: 11 days after induction, animals were challenged.
- Exposure period:5 mins
- Test groups: 10 guinea pigs
- Control group: 10 guinea pigs
- Site: clipped and shaved skin of the right flank of treated animals.
- Concentrations:0.05ml
- Evaluation (hr after challenge): after 24, 48 and 72 hr. - Challenge controls:
- No data available.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- other: Mean
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.05ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Non sensitizer
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Sensitizer |
Challenged with |
Concentration |
24 hour |
48 hour |
72 hour |
24 hour |
48 hour |
72 hour |
||||||||||||||||||||||||||||||
|
|
|
|
|
|
0 |
0 |
0 |
The mean response was computed as the quotient of the sum of the observed reactions and the number of the treated animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitising
- Conclusions:
- No sensitization effects were observed after 72 hours post challenge exposure. Hence, the test chemical can be considered as non -sensitizing to the female guinea pigs.
- Executive summary:
Modified FCA method and Guinea pig maximization test was performed to evaluate the dermal sensitization potential of the test chemical. 20 female Pirbright White guinea pigs were used for the study.
.In the induction phase, the test compound was dissolved in FCA, 15 mg in 4 ml physiological saline and an emulsion was prepared by mixing the material by mean of a 5ml syringe, until emulsification was completed. The intradermal injections of 6 X 0.10-0.15 ml of this emulsion was applied in a semi circle arc on clipped and shaved shoulder from left to right in such a way that whole quantity of emulsion was used up for 10 animals. This procedure was repeated on 5thand 9thday, leaving a gap of 2-3 cm between the rows of injection. After induction phase of 11 days, animals were challenged by applying 0.05ml of test chemical in a sub irritant concentration, with further dilution to the clipped and shaved skin of the right flank of the treated animals, allowing 5 mins for drying. Control animals were also used. Mean Observations were made after 24, 48 and 72 hours.
No sensitization effects were observed after 72 hours post challenge exposure. Hence, the test chemical can be considered as non -sensitizing to the female guinea pigs.
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