Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 266-024-0 | CAS number: 65996-89-6 The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700°C (1292°F)) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons. May contain minor amounts of phenolic compounds and aromatic nitrogen bases.
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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)
- Principles of method if other than guideline:
- Determination of test concentration-related stimulation indices (SI) and the effective concentration (EC) inducing a stimulation index (SI) of 3.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- 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: 19.4 - 21.8 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 - 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: dispersion/emulsion- Irritation: yes
- Lymph node proliferation response: not examinedMAIN
STUDYANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response (on primary proliferation of lymphocytes by incorporation of 3H-methyl thymidine), Simulation index (SI) is ≥ 3, and response increases in dose-related mannerCriteria 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)].
- Key result
- Parameter:
- EC3
- Remarks:
- [%]
- Value:
- < 0.3
- Test group / Remarks:
- estimated
- Remarks on result:
- other: concluded to be not irritating based on ear effect
- Key result
- Parameter:
- SI
- Value:
- 7.36
- Test group / Remarks:
- 0.3% test material in vehicle
- Remarks on result:
- other: not irritating based on ear effect
- Key result
- Parameter:
- SI
- Value:
- 13.52
- Test group / Remarks:
- 3% test material in vehicle
- Key result
- Parameter:
- SI
- Value:
- 19.44
- Test group / Remarks:
- 30% test material in vehicle
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- neg. control (vehicle)
- Parameter:
- SI
- Value:
- 16.94
- Test group / Remarks:
- pos. control
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA / SI DETERMINATION
see "Any other information on results"
EC3 CALCULATION
In this case, no reasonable calculation based on the algorithm below is possible, because there is no highest concentration that fails to produce an SI of 3: The SI for all test concentrations are significantly above 3. Hence the estimated EC is << 0.3%.
Base algorithm:
EC3 = c + [(3 -Sc)/(Sa-Sc)] * (a-c) with a = the lowest concentration giving stimulation SI >3; Sa = the actual stimulation index caused by a; c = the highest concentration failing to produce a stimulation index of 3; Sc = the actual stimulation index caused by c. (Note: The vehicle control data (at SI = 1) should not be used for the c and Sc.)
References:
Kimber, I.; Basketter, D.A.; Berthold, K.; Butler, M., et al. 2001:Skin sensitization testing in potency and risk assessment. Toxicol. Sciences, 59, 198 - 208 (p. 203)
Basketter et al. 1999:A comparison of statistical approaches to the derivation of EC3 values from local lymph node assay dose responses. Journal of Applied Toxicology, 19, 261–266 - Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- Coal tar considered to exhibit a sensitising potential, supported by the fact that a significant stimulatory effect was observed at a low dose that failed to produce visible irritation. The EC3 (Effective Concentration inducing a Stimulation Index SI of 3) is distinctly below 0.3%, hence significantly below the cut-off concentration of 2% for classification of category 1A skin sensitiser.
Reference
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 |
348 |
3414 |
4134 |
2755 |
1969 |
2 |
256 |
5547 |
6021 |
3491 |
1834 |
3 |
213 |
4808 |
5040 |
3536 |
1615 |
4 |
196 |
3278 |
4154 |
3467 |
2004 |
5 |
174 |
3045 |
3712 |
2793 |
1309 |
Group mean |
237 |
4018 |
4613 |
3208 |
1746 |
SI |
1.00 |
16.94 |
19.44 |
13.52 |
7.36 |
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 |
21.8 |
32.9 |
37.7 |
25.0 |
23.0 |
2 |
22.4 |
34.2 |
32.1 |
26.2 |
22.3 |
3 |
21.9 |
38.5 |
34.0 |
25.5 |
22.8 |
4 |
22.1 |
26.9 |
36.2 |
24.5 |
23.3 |
5 |
23.1 |
32.6 |
34.1 |
25.5 |
22.2 |
Group mean |
22.26 |
33.02* |
34.82* |
25.34* |
22.72 |
SD |
0.52 |
4.16 |
2.17 |
0.63 |
0.47 |
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 |
238 |
1.0 |
22.26 |
PC |
4018 |
16.94+ |
33.02 |
30% |
4612 |
19.44+ |
34.82 |
3% |
3208 |
13.52+ |
25.34 |
0.3% |
1746 |
7.36+ |
22.72 |
Bold figures with + = values >= 3
NC = vehicle control; PC = positive control
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Coal tar showed a sensitising potential in the LLNA screening test (Local Lymph Node Assay, OECD 429): There was an increase in the test parameter (Stimulation Index SI) significantly above 3 (SI = 7.4) at a non-irritating dose of 0.3 %, followed by a dose-related increase in cellular stimulation (incorporation of 3H-methyl thymidine in lymphocytes) accompanied by increasing irritation (ear weight).
Justification for classification or non-classification
Coal tar induced a significant stimulatory effect on lymph nodes in mouse at a low dose that failed to produce visible irritation, thus indicating a sensitising potential. The EC3 is distinctly below 0.3%, hence significantly below the cut-off concentration of 2% for classification of category 1A skin sensitiser.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.