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EC number: 254-100-6 | CAS number: 38720-66-0
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 31 JUL 2002 to 14 AUG 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 429)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Remarks:
- ; Remark: it is mentioned that the study is based also on OECD TG406
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- according to Swiss legislation of Good Laboratory Practice
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione
- EC Number:
- 254-100-6
- EC Name:
- Dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione
- Cas Number:
- 38720-66-0
- Molecular formula:
- C20H10Cl2N2O2
- IUPAC Name:
- 1,8-dichloro-5,7,12,14-tetrahydro-5,12-diazapentacene-7,14-dione; 1,9-dichloro-5,7,12,14-tetrahydro-5,12-diazapentacene-7,14-dione; 2,9-dichloro-5,7,12,14-tetrahydro-5,12-diazapentacene-7,14-dione
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands, Horst, The Netherlands
- Age at study initiation: 7-12 weeks (beginning of acclimatisation)
- Weight at study initiation: 17.3-21.3 g (beginning of acclimatisation)
- Housing: 4 per cage, Makrolon type -3 cages
- Diet (ad libitum): Pelleted standard Kliba 3433, batch no. 34/02 mouse maintenance diet (Provimi Kliba AG, Kaiseraugst, Switzerland)
- Water (ad libitum): tap water
- Acclimation period: from 31 JUL 2002 to 6 AUG 2002, under test conditions after health examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 1, 5, 10%
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Irritation: To determine the highest non-irritant and technically applicable test item concentration, a non-GLP pretest was performed in 2 mice with concentrations of 1 %, 2 . 5 %, 5 % and 1 0% (w/v) (pretest excluded from Statement of Compliance).
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response:
The proliferative response of lymph node cells is expressed as the number of radioactive disintegrations per minute per Iymph node (DPM/NODE) and as the ratio of 3HTdR into lymph node cells of test Iymph nodes relative to that recorded for control lymph nodes (STIMULATION INDEX). Before DPM/NODE values were determined, mean scintillation¬background DPM was subtracted from test and control raw data.
A test item is regarded as a sensitizer in the LLNA if the following criteria are fulfilled:
First, that exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the STIMULATION INDEX.
Second, that the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear lobe (left and right) with different test item concentrations of 1 %, 5 % and 10 °/0 (w/v) in acetone:olive oil, 4:1 (v/v). The application volume, 25 µl, was spread over the entire dorsal surface (diameter 8 mm) of each ear lobe once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals). A hair dryer was used to dry the ear's surface as quickly as possible to avoid loss of test item applied.
Five days after the first topical application, all mice were administered with 250 µI of79.87 pCi/ml3H-methyl thymidine (3HTdR, equal to 20.0 µCi3HTdR) by intravenous injection via a tail vein.
Approximately five hours after treatment with3HTdR all mice were euthanized byintraperitoneal injection of VETANARCOL at a dose of at least 2 ml/kg body weight (equivalent to 324 mg sodium pentobarbitone/kg body weight).
The draining lymph nodes were rapidly excised and pooled for each experimental group (8 nodes per group). Single cell suspensions (phosphate buffered saline) of pooled lymphnode cells were prepared by gentle mechanical disaggregation through stainless steel gauze (200 pm mesh size). After washing three times with phosphate buffered saline (approx.10 ml) the lymph node cells were resuspended in 5 % trichloroacetic acid (approx. 3 ml) and incubated at approximately +4 °C overnight for precipitation of macromolecules. The precipitates were then resuspended in 5 % trichloroacetic acid (1 ml) and transferred to glass scintillation vials with 10 ml of 'Ultima Gold' scintillation liquid and thoroughly mixed.
The level of3HTdR incorporation was then measured on a ß-scintillation counter. Similarly, background3HTdR levels were also measured in two ml-aliquots of 5 % trichloroacetic acid.The ß-scintillation counter expresses3HTdR incorporation as the number of radioactive disintegrations per minute (DPM).
TREATMENT PREPARATION AND ADMINISTRATION: The preparations were made shortly before each dosing. The test item was placed into a volumetric flask an a tared Mettler balance and the vehicle (acetone:olive oil, 4:1 (v/v)) was quantitatively added. The weight/volume dilutions were prepared individually using a magnetic stirrer as homogenizer. Homogeneity of the test item in the vehicle was maintained during treatment with the magnetic stirrer. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- no data
Results and discussion
- Positive control results:
- Stimulation indices of 2.9, 2.6 and 7.1 were determined with the positive control substance at concentrations of 5 %, 10 % and 25 % (w/v) in acetone:olive oil, 4:1 (v/v). Alpha-hexylcinnamaldehyde showed an allergenic potency when tested at concentration of 25 % (w/v). Based on these results a EC3 value of 11.3% (w/v) was calculated.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 1%: 2.4 5%: 2.0 10%: 1.6
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Background: 7, 8 (duplicate) control: 1593 (1585 without background) 1%: 3735 (3727 without background) 5%: 3178 (3170 without background) 10%: 2567 (2559 without background)
Any other information on results incl. tables
No deaths occurred during the study period.
No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period.
The body weight of the animals, recorded at the start of acclimatization period and prior to necropsy, was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this LLNA-assay the test item was not sensitising.
- Executive summary:
Three groups of four female CBA mice each were treated with the test item at concentrations of 1 %, 5 % and 10 % (w/v) in acetone:olive oil, 4:1 (v/v) by topical application to the dorsum of each ear lobe (left and right) on three consecutive days. A control group of four mice was treated with the vehicle (acetone:olive oil, 4:1 (v/v)) only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular Iymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes which were washed subsequently and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a ß-scintillation counter.
No test item-related clinical signs were observed. All treated animals survived the scheduled study period. In this study stimulation indices (S.I.) of 2.4, 2.0 and 1.6 were determined with the test item at concentrations of 1%, 5 % and 10 % (w/v) in acetone:olive oil, 4:1 (v/v).
Based on these criteria, the test item was found to be non sensitizing. Therefore no classification is required according to Regulation (EC) No 1272/2008.
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