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EC number: 241-734-3 | CAS number: 17741-63-8
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 8,18-dichloro-5,15-diethyl-5,15-dihydrodiindolo[3,2-b:3',2'-m]triphenodioxazine
- EC Number:
- 228-767-9
- EC Name:
- 8,18-dichloro-5,15-diethyl-5,15-dihydrodiindolo[3,2-b:3',2'-m]triphenodioxazine
- Cas Number:
- 6358-30-1
- Molecular formula:
- C34H22Cl2N4O2
- IUPAC Name:
- 8,18-dichloro-5,15-diethyl-5,15-dihydrocarbazolo[3',2':5,6][1,4]oxazino[2,3-b]indolo[2,3-i]phenoxazine
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 B.V. Postbus 6174 NL - 5960 AD Horst / The Netherlands
- Age at study initiation: 8-12 weeks
- Housing: single
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22+/-3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 7.5, 15, 30 %
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
To determine the highest non-irrltant test concentration or the highest technically
applicable concentration, a non-GLP pretest was performed in two mice (pre-test
excluded from Statement of Compllance ). The data showed that the highest test item
concentration, whlch could be technically used, was a 30 % suspension in acetone:olive
oil, 4:1 (v/v). Also in other vehicles tested (DMSO, DMF) a higher concentration could not
be suspended. At the 30 % suspension the treated mause did not show any signs of
systemic toxicity. Due to the intense violet colour of the test item local Irritation reactions
such as ear redness couid not be detected. No swelling of the ears was observed.
The test ltem in the main study was assayed at three consecutive concentrations 7,5, 15,
and 30 %).The top dose rs the highest technically achievable concentration whflst avoiding
systemic toxicity and excessive local irritation. No severe irritant effects were tolerated
choosing the lest concentrations.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response:
A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled:
• First, that. exposure to at least one concentration of the test item resulted in an incorporat1on of 3HTdR at least 3-fold or greater than that that recorded in control mice as indicated by the stimulation index
- Second, that the data are compatlble with a conventional dose response although
allowance must be made (especially at high topical concentrations) for either local
toxicity or immunologlcal suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
Topical Application
Each test group of mice was treated by topical (epidermal) application to the dorsal
surface of each ear lobe (left and rlght) with different test item concentratons of 7.5, 15 and
30 % (w/v) in acetone:olive oil, (v/v). The application volume, 25 ul was spread over the
entire dorsal surface (0 "'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 ral~ydht vehicle alone
(control animals). A halr dryer was used to dry the ear's surface as quickly as possible to
avoid loss of test ltem applied.
Administration of 3H-Methyl Thymidine
3HMmethyl thymidine (3HTdR) was purchased from Amersham International (Amersham
product code no" TRA 310; specific actlvity, 2 Ci/mmol; concentration, 1 mCi/ml).
Five days after the first topical application, all mice were admlnistered wlth 250 μI of
78A pCi/ml 3HTdR (corresponds to 19.6 μCi 3HTdR per mouse) by intravenous injection
via a tail vein.
Observations
In addition to the sensitising reactions the followlng observatlons and data were recorded
during the test and observation period:
Mortality / Vlabillty Daily from acclimatisation start to the termination of
in-life phase.
Body weights
Clinical signs (local I systemlc)
Prior to the first application and prior to necropsy.
Daily from accllmatisation start to the termlnation of
in-Hfe phase. Especially the treatment sites were
observed carefully. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body welght tables.
A statistical analysis was conducted for assessment of the dose-response relationship,
and the EC3 value was calculated according to the equatlon
EC3 = (a-c) [(3-d)/(b-d}] + c
where EC3 is the estlmated concentration of the test item required to produce a 3-fold
increase in draining lymph node cell proliferative activity; (a, b} and (c, d) are respectively
the co-ordinates of the two pair of data lying immediately above and below the SJ. value of
3 on the local lymph node assay dose response plot
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- >= 0.5 - <= 0.7
- Test group / Remarks:
- 7.5%, 15%, 30%
- Remarks on result:
- other: 7.5% 0.5 15% 0.7 30% 0.6
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- >= 4 287 - <= 5 001.7
- Test group / Remarks:
- 7.5%,15%, 30%
- Remarks on result:
- other: 7.5% 4362.4 15% 4287.0 30% 5001.7
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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