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EC number: 266-026-1 | CAS number: 65996-91-0 The distillate from coal tar having an approximate distillation range of 220°C to 450°C (428°F to 842°F). Composed primarily of three to four membered condensed ring aromatic hydrocarbons and other hydrocarbons.
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 90640-84-9
- Cas Number:
- 90640-84-9
- IUPAC Name:
- 90640-84-9
- Reference substance name:
- Creosote oil, acenaphthene fraction
- EC Number:
- 292-605-3
- EC Name:
- Creosote oil, acenaphthene fraction
- IUPAC Name:
- 292-605-3
- Reference substance name:
- Creosote oil, acenaphthene fraction
- IUPAC Name:
- Creosote oil, acenaphthene fraction
- Details on test material:
- - Name of test material (as cited in study report): Wash oil
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Substance type: organic
- Physical state: liquid
- Stability under test conditions: no measured data; based on chemical structure assumed to be stable
- Storage condition of test material: room temperature, exclusion of light
Constituent 1
Constituent 2
Constituent 3
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
- Age at study initiation: 8 - 10 wks
- Weight at study initiation: 18.1 - 21.9 g
- Housing: macrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3
- Humidity (%): 30 – 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (LLNA)
- Vehicle:
- other: DAE 433
- Concentration:
- mixture of 40% dimethylacetamide, 30% acetone and 30% ethanol
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: emulsion, TS 30 %
- Irritation: no
- Lymph node proliferation response: not examined
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response (on primary proliferation of lymphocytes by incorporation of 3H-methyl thymidine)
Stimulation index (SI) is ≥ 3
Response increases in dose-related manner
Criteria for irritation potential: individual and mean ear weight
TREATMENT PREPARATION AND ADMINISTRATION:
Days 1-3: 25 µL test suspension in DAE 433 , 1x on day 1, 2, and 3
Days 4 and 5: no treatment
Day 6: Injection of 250 μL of phosphate-buffered saline (PBS) containing 7.5 x105 Bq (c. 21 µCi) of 3H-methyl thymidine
into all test and control mice via the tail vein. Five hours later, the animals were killed.
- Positive control substance(s):
- other: DNCB (dinitrochlorbenzene, 0.5% (w/v) solution)
- Statistics:
- 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 [using software Statgraphic ® Centurion (version XV, USA)].
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Concentration = 0.3% / 3% / 30% SI = 1.42 / 4.22 / 5.88 EC3 = 1.82 % Details see Table 2 below
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Concentration / 0.3% / 3% / 30% Group mean / 857 / 2538 / 3534 Details see Table 1 below
Any other information on results incl. tables
Table 1: Individual and mean radioactivity in cell suspensions (Report Table 4)
Activity (DPM, rounded) |
|||||
Animal No. |
NC (1-5) |
PC (6-10) |
30% (11-15) |
3% (16-20) |
0.3% (21-25) |
1 |
599 |
8066 |
2980 |
2659 |
1002 |
2 |
536 |
6900 |
4845 |
1995 |
852 |
3 |
795 |
6625 |
3250 |
2267 |
815 |
4 |
549 |
6332 |
3426 |
3283 |
856 |
5 |
527 |
6804 |
3171 |
2485 |
758 |
Group mean |
601 |
6946 |
3534 |
2538 |
857 |
SI |
1.00 |
11.55 |
5.88 |
4.22 |
1.42 |
NC = vehicle control; PC = positive control
Table 2: Individual and average ear weights (Report Table 5)
Weight of ear biopsies (milligrams) |
|||||
Animal No. |
NC (1-6) |
PC (7-12) |
30% (13-18) |
3% (19-24) |
0.3% (25-30) |
1 |
23.2 |
27.6 |
25.5 |
24.4 |
21.7 |
2 |
24.6 |
38.3 |
23.3 |
23.3 |
22.7 |
3 |
22.0 |
30.4 |
28.1 |
23.7 |
20.4 |
4 |
23.2 |
35.5 |
25.8 |
23.8 |
21.3 |
5 |
22.9 |
29.5 |
26.6 |
24.0 |
21.8 |
Group mean |
23.18 |
32.26* |
25.86* |
23.86* |
21.58 |
SD |
0.93 |
4.16 |
1.75 |
0.37 |
0.83 |
NC = vehicle control; PC = positive control
* statistically significant with p =< 0.05, Mann-Whitney test
Table 3: Summary table (Report Table 6)
Group |
Radioisotope incorporation in lymph nodes (rounded) |
Ear weight |
|
Mean DPM |
SI |
Mean (mg) |
|
NC |
601 |
1.0 |
23.18 |
PC |
6946 |
11.55+ |
32.26* |
30% |
3534 |
5.88+ |
25.86* |
3% |
2538 |
4.22+ |
23.86 |
0.3% |
857 |
1.42 |
21.58 |
Bold figures with + = values >= 3
NC = vehicle control; PC = positive control
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Wash oil considered to exhibit a clear sensitising potential in the LLNA, supported by the fact that a significant stimulatory effect was observed at a low dose (3 %) that failed to produce visible irritation.
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