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EC number: 240-385-4 | CAS number: 16294-75-0
- 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:
- weight of evidence
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Current Guideline study according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 14H-anthra[2,1,9-mna]thioxanthen-14-one
- EC Number:
- 240-385-4
- EC Name:
- 14H-anthra[2,1,9-mna]thioxanthen-14-one
- Cas Number:
- 16294-75-0
- Molecular formula:
- C23H12OS
- IUPAC Name:
- 8-thiahexacyclo[10.10.2.0²,⁷.0⁹,²³.0¹³,¹⁸.0²⁰,²⁴]tetracosa-1(23),2,4,6,9,11,13,15,17,20(24),21-undecaen-19-one
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: 6-8 weeks
- Weight at study initiation: 20,2 +/- 1,2 g
- Housing: individual
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: yes
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)
- Remarks:
- in a repeat experiment: propylene glycol
- Concentration:
- 0-5-10-25 %
- No. of animals per dose:
- 4
- Details on study design:
- ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: Si >/= 3 and positie dose/response relation
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 5, 10 and 25% (w/v) in acetone:olive oil, 4:1 (v/v) in the main experiment, and 25% (w/v) in propylene glycol in the repeat experiment. The application volume, 25 μl, was spread over the entire dorsal surface (∅ ∼ 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.
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Tables below
Any other information on results incl. tables
Table 1 Result from Experiment 1
Group/Test item conc. (%) |
DPM |
DPM - Background |
Number of LN |
DPM per LN |
Stimulation Index (SI) |
Back ground 1 |
0 |
|
|
|
|
Back ground 2 |
2,4 |
|
|
|
|
Aceton/Olive oil |
3059,2 |
3058 |
8 |
382,3 |
1 |
5% |
14134 |
14130 |
8 |
1766,6 |
4,6 |
10 |
13366 |
13365 |
8 |
1670,6 |
4,4 |
25 |
11291 |
11289 |
8 |
1411,2 |
3,7 |
Table 1 Result from Experiment 2
Group/Test item conc. (%) |
DPM |
DPM - Background |
Number of LN |
DPM per LN |
Stimulation Index (SI) |
Back ground 1 |
34,5 |
|
|
|
|
Back ground 2 |
34,1 |
|
|
|
|
Propylene glycol |
2360,5 |
2326,2 |
8 |
290,8 |
1 |
25 |
9412,3 |
9378 |
8 |
1172,3 |
4,0 |
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- As the stimulation index was above 3 in all tested concentrations the test material is regarded as a sensitiser under the conditions of the LLNA.
- Executive summary:
In the study the test item dissolved in acetone:olive oil, 4:1 (v/v) in the main experiment and in propylene glycol in the repeat experiment was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed using test item concentrations of 5, 10 and 25% in the main experiment and 25% in the repeat experiment.
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.
In this study Stimulation Indices (S.I.) of 4.6, 4.4 and 3.7 were determined with the test item at concentrations of 5, 10 and 25% (w/v) in acetone:olive oil, 4:1 (v/v), respectively.
In the repeat experiment a Stimulation Index of 4.0 was determined with the test item at a concentration of 25% (w/v) in propylene glycol.
An EC3 value could not be calculated since the S.I. was above 3 even at the lowest tested concentration of 5 % (w/v).
The test item was found to be a skin sensitiser under the described conditions.
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