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EC number: 415-450-7 | CAS number: 126213-50-1
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27.1.-9.2.2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was carried out in accordance with internationally valid GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): 3,4-Ethylenedioxythiophene
- Comercial name. EDOT
- Substance type: pure organic substance
- Physical state: liquid near colourless to pale yellow
- Analytical purity: > 99%
- Lot/batch No.: 091201
- Expiration date of the lot/batch: 21.1.2011
- Storage condition of test material: Keep in dark at room temperature. Stored in amber glass bottles under the argon atmosphere. Minimalize time for handling with substance without protective argon atmosphere as possible. Maximal time without protective atmosphere is 30 min.
- pH: approximately 4 (by contact of application form with universal indicator pH strip moistened with water, strip producer Lach-Ner, s.r.o. (Neratovice)
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic, RČH CZ 21760118
- Age at study initiation: 8 to 10 weeks (at start of dosing)
- Weight at study initiation: 19.4 to 22.2 g (at start of dosing)
- Housing: group-wise five in macrolon cages with sterilized softwood shavings.
- Diet (e.g. ad libitum): Pelleted standard diet for experimental animals ad libitum. Microbiological control and content of nutrients was performed according SOP No. 75
- Water (e.g. ad libitum): Drinking tap water ad libitum. Water quality corresponded to Ministerial Decree No. 252/2004 Czech Coll. of Law
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3oC, permanently monitored
- Humidity (%): 30 – 70 %, permanently monitored
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle: 6am-6pm/6pm-6am
STUDY TIME SCHEDULE
Animal arrival/ start of acclimatization: 21. 01.2010
Pilot experiment: 27.- 30. 01. 2010
Main study:
First day of administration: 03.02.2010
End of treatment period: 05.02.2010
Application of radionuclide and necropsy: 08.02.2010
Study design: in vivo (LLNA)
- Vehicle:
- other: DAE 433 - mixture of 40% dimethylacetamide, 30% acetone and 30% ethanol
- Concentration:
- 30% (v/v) 300 µL/mL
3% (v/v) 30 µL/mL
0.3% (v/v) 3 µL/mL - No. of animals per dose:
- 5 animals
- Details on study design:
- RANGE FINDING TESTS:
- The highest test-substance concentration of 30% was administered to three animals to assess possible systemic toxicity. During the pilot experiment, clinical symptoms of systemic toxicity were observed (decreased sensory reactivity on acoustic stimuli, increased sensory reactivity on acoustic stimuli). No macroscopic changes (after necropsy) were found in all three animals.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Animals were subjected to a clinical examination (health check) shortly after arrival. Study animals were randomly allocated to the dose groups manually and assigned animal numbers.
EVALUATION OF RESULTS
Stimulation index
The SI is obtained by dividing the pooled radioactive incorporation for each treatment group by the incorporation of the pooled vehicle control group; this yields a mean SI. The response towards the test substance is considered positive, if the stimulation index (SI) is ≥ 3, and the response increases in dose-related manner (dose-response relationship). The response is considered negative, if the stimulation index (SI) is < 3 without the dose–response relationship. The response is considered ambiguous if the stimulation index is < 3, but the response increases in dose-related manner (dose–response relationship), and eventually statistical significance is observed.
Ear weight – irritation effect
If after treatment with the test substance a statistically significant increase of ear weight together with clear concentration dependence of the effect is recorded, the inflammatory effect is considered as irritation induced by the test substance.
TREATMENT PREPARATION AND ADMINISTRATION:
Dosage volume: 25 μL / ear / animal
Preparation for administration: All emulsions were prepared by suspending an appropriate amount of 3,4-Ethylenedioxythiophene in the vehicle to obtain a concentration of 30%, 3% or 0.3% (v/v). The emulsions were prepared before the start of application by mixing on magnetic stirrer and were still being mixed during application.
Application: The volume of the dose was constant for all groups of animals - 25 L of the appropriate dilution to the dorsum of each ear once a day morning for 3 consecutive days. The application was performed very slowly by micropipette to avoid losses caused by draining from the ear. - Positive control substance(s):
- other: DNCB (dinitrochlorbenzene)
- Statistics:
- For statistical calculations the software Statgraphic ® Centurion (version XV, USA) was used. At first the global comparison of all three values of the concentration groups with vehicle control is performed by applying the non-parametric Kruskal-Wallis test, and then the non-parametric two-group Mann-Whitney rank test (probability level 0.05) was applied to all two-group comparisons.
Results and discussion
- Positive control results:
- The positive control substance DNCB produced a positive LLNA response at an exposure level expected to give an increase in the Stimulation Index SI of ≥ 3 over the negative control group, which was consistent with the expected mode of action of a contact allergen. The positive control also elicited a reaction pattern with a statistically significant increase in ear weight. These results demonstrate that the method performed under the conditions of our laboratory had sufficient sensitivity.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- The SI for the test groups treated with the test substance was decreased in dose-related manner. At the highest dose level, the SI was 1.60, at the middle dose level the SI was 1.66, and at the lowest dose level, the mean SI was 2.87. The stimulation indexes of all test groups were below the threshold.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: See table No.6
Any other information on results incl. tables
Table 6. Summary table
Group |
Radioisotope incorporation |
Ear weight |
|
Mean DPM |
SI |
Mean (mg) |
|
NC |
237.26 |
1.00 |
22.26 |
PC |
4018.42 |
16.94+ |
33.02 |
30% |
378.59 |
1.60 |
21.54 |
3% |
394.58 |
1.66 |
22.66 |
0.3% |
680.99 |
2.87 |
22.04 |
Notes:
Bold figures with cross = values ≥ 3
NC – Negative control group
PC – Positive control group
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the given test conditions, the test substance, 3,4-Ethylenedioxythiophene, elicited negative response in LLNA test.
- Executive summary:
The test substance, 3,4-Ethylenedioxythiophene, was tested for the assessment of skin sensitisation potential with the murine local lymph node assay. This study is a part of the test substance health hazard evaluation.
The Local Lymph Node Assay (LLNA) with radionuclides was used. The testing was conducted according to the EU Method B.42, Skin sensitization: Local Lymph Node Assay, Council Regulation (EC) No. 440/2008, published in O.J. L142, 2008.
In this study the contact allergenic potential of 3,4-Ethylenedioxythiophene was evaluated after topical application to female BALB/c mice. Five mice per group were exposed by test and control substances on the dorsum of both ears once a day during 3 consecutive days. Primary proliferation of lymphocytes in the lymph node draining the site of application was evaluated by using radioactive labelling. The ratio of the proliferation in treated groups to that in vehicle controls, termed the Stimulation Index (SI), was determined. Statistical evaluation of ear weight was performed for elimination of potentially false positive findings with certain skin irritants.
Concentrations: positive control DNCB (dinitrochlorobenzene): 0.5% (w/v) and 3,4-Ethylenedioxythiophene: 30%, 3%, 0.3% (v/v) in the solvent mixture, DAE 433.
The animals exposed to the test substance at all dose levels showed no pathological skin reactions. Symptoms of systemic toxicity were observed at the highest dose level throughout the experiment (decreased response on stimuli, apathy, piloerection, reduction of body weights by 7.51% from Day 1 to Day 6,) and at the middle dose level (piloerection, decreased response on stimuli). The positive control substance DNCB elicited a reaction pattern with statistically significant increase in ear weight and cell proliferation, the Stimulation Index reaching 16.94, which was consistent with its expected mode of action as a contact allergen.
The comparison of the Stimulation Indexes between the treated groups and the control group revealed that the test substance 3,4-Ethylenedioxythiophene did not cause a significant increase in radioisotope incorporation into the DNA of proliferating lymphocytes.
In conclusion, at the given experimental conditions the result of LLNA study with test substance 3,4-Ethylenedioxythiophene was negative.
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