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Diss Factsheets
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EC number: 608-929-9 | CAS number: 33955-44-1
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Principles of method if other than guideline:
- OECD guideline 406 is given in the report, which is probably an error and it is assumed that guideline 429 was followed.
- GLP compliance:
- yes
- Remarks:
- CENTRAL TOXICOLOGY LABORATORY, ALDERLEY PARK MACCLESFIELD, CHESHIRE UK
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1H-benzo[10,5]anthra[2,1,9-def]isoquinoline-1,3(2H)-dione
- EC Number:
- 608-929-9
- Cas Number:
- 33955-44-1
- Molecular formula:
- C22H11NO2
- IUPAC Name:
- 1H-benzo[10,5]anthra[2,1,9-def]isoquinoline-1,3(2H)-dione
- Details on test material:
- - Physical state: Powder
- Stability under test conditions: The stability of the test substance in propylene glycol for the duration of 24 hours was confirmed by analysis. The
stability of the test substance has been confirmed analytically.
- Storage condition of test material: Ambient temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca/Ola/Hsd
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK, Blackthorne, Bicester, Oxon, UK
- Age at study initiation: Young adults
- Weight at study initiation:
- Housing: A maximum of 4 mice was housed per cage, in cages suitable for animais of this strain and weight range
- Diet: RM 1, supplied by Special Diets Services Limnited, Withamn, Essex, UK, available ad libitum.
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Air changes (per hr): A minimum of 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- other: propylene glycol (test substance) and acetone (positive control)
- Concentration:
- 3%, 10% or 30% w/v
- No. of animals per dose:
- 4
- Details on study design:
- MAIN STUDY
- Criteria used to consider a positive response: The criterion for a positive response is that one or more concentrations of the test substance should elicit a 3-fold or greater increase in isotope incorporation relative to the vehicle control group.
TREATMENT PREPARATION AND ADMINISTRATION:
Approximately 25 µl of a 3%, 10% or 30% w/v preparation of the test substance in propylene glycol was applied, using a variable volume micro-pipette, to the dorsal surface of each ear. A vehicle control group was similarly treated using propylene glycol alone. The procedure was repeated daily for 3 consecutive days. A concurrent naive control group was not treated with the test substance or the vehicle.
Three days after the third application, all the animals were injected, via the tail vein, with approximately 250µl of phosphate buffered saline (PBS) containing approximately 20 µCi of a 2.0 Ci/mmol specific activity 3 H-methyl thymidine. Approximately 5 hours later, the animals were humanely killed by inhalation of halothane vapour followed by cervical dislocation. The draining auricular lymph nodes were removed from each animal and, together with the nodes from the other animals in the group, were placed in a container of PBS.
A single cell suspension was prepared by mechanical disaggregation of lymph nodes through a 200-mesh stainless steel gauze. The cell suspensions were then washed three times by centrifugation with approximately 10 ml of PBS. Approximately 3ml of 5% w/v trichloroacetic acid (TCA) was added and, after overnight precipitation at 4°C, the samples were pelleted by centrifugation and the supernatant was discarded. The cells were then resuspended in approximately 1ml of TCA.
The lymph node suspensions were transferred to scintillation vials and 10ml of scintillant (Optiphase) was added prior to 13-scintillation counting using a Packard Tri-Carb 2500TR Liquid Scintillation Counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see below
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see below
Any other information on results incl. tables
SKIN SENSITISATION POTENTIAL - TEST SUBSTANCE
Test item concentration | number of lymph nodes | Disintegrations per minute (dpm) | DPM/lymph node (x10-2) | Test control ratio |
Naive control | 8 | 4753 | 5.94 | N/A |
vehicle control | 8 | 4082 | 5.1 | N/A |
3 % (w/v) | 8 | 4318 | 5.4 | 1.06 |
10 % (w/v) | 8 | 4024 | 5.03 | 0.99 |
30 % (w/v) | 8 | 5321 | 7.4 | 1.45 |
SKIN SENSITISATION POTENTIAL OF THE POSITIVE CONTROL SUBSTANCE
concentration of hexyleinnamaldehyde | number of lymph nodes | Disintegrations per minute (dpm) | DPM/lymph node (x10-2) | Test control ratio |
Naive control | 8 | 2438 | 3.05 | N/A |
vehicle control | 8 | 2881 | 3.6 | N/A |
1 % (w/v) | 8 | 5975 | 7.47 | 2.08 |
3 % (w/v) | 8 | 16126 | 20.16 | 5.6 |
10 % (w/v) | 8 | 28732 | 35.92 | 9.98 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In conclusion, the test article is unlikely to be a moderate or strong skin sensitiser under the conditions of the test.
- Executive summary:
The test article was assessed for its skin sensitisation potential using the mouse Local Lymph Node Assay. The test substance was applied as 3%, 10% or 30% w/v preparations in propylene glyco1. The test substance did not have the capacity to cause skin sensitisation when applied as 3%, 10% or 30% w/v preparations in propylene glycol. In a positive control study, hexylcinnamaldehyde was shown to have the capacity to cause skin sensitisation when applied as 3% or 10% w/v preparations in acetone, confirming the validity of the protocol used for this study. In conclusion, the test substance is unlikely to be a moderate or strong skin sensitiser under the conditions of this test.
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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