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EC number: 310-231-1 | CAS number: 140203-21-0 The distillate from the fractional distillation of high-temperature coal tar having an approximate distillation range of 280°C to 450°C (536°F to 842°F). Composed primarily of tri- and polynuclear aromatic 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
Endpoint summary
Administrative data
Description of key information
The target compound, Distillates (coal tar), high-temperature, heavy oils (EC no. 310-231-1; CAS no. 140203-21-0) is considered to be a skin sensitiser, based on a BaP content of 1 - 1.5 %. BaP was shown to be a potent sensitiser in an assay using guinea pigs (Old et al. 1963).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- with reproducible test method
- Qualifier:
- no guideline available
- Version / remarks:
- year of study 1963
- Principles of method if other than guideline:
- Delayed hypersensitivity/contact sensitisation: Intradermal injection of the agents into the foot pad for induction in the presence of Freund´s adjuvant, followed by topical/epidermal challenge
(method according to: Gell PG and Benacerraf B J. Exp. Med. 113, 571 (1961) - GLP compliance:
- no
- Type of study:
- intracutaneous test
- Justification for non-LLNA method:
- LLNA test method not available at time of the study
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 3,4-benzpyrene (BP)
- Analytical purity: "highly purified" (acc. to report) - Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Route:
- intradermal
- Vehicle:
- other: emulsion in complete Freund´s adjuvant with saline
- Concentration / amount:
- 125 µg into each front foot pad, total 250 µg
- Day(s)/duration:
- exposure period 2 - 3 wks
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: acetone-olive oil mixture (not further specified)
- Concentration / amount:
- 0.001 %
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- epicutaneous, open
- Vehicle:
- other: acetone-olive oil mixture (not further specified)
- Concentration / amount:
- 0.01 %
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- not specified
- No.:
- #3
- Route:
- epicutaneous, open
- Vehicle:
- other: acetone-olive oil mixture (not further specified)
- Concentration / amount:
- 0.1 %
- Day(s)/duration:
- 24
- Adequacy of challenge:
- not specified
- No.:
- #4
- Route:
- epicutaneous, open
- Vehicle:
- other: acetone-olive oil mixture (not further specified)
- Concentration / amount:
- 1 %
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 6, 16, and 10 were used for 3-methylcholanthrene (MC), BaP and 9,10-dimethyl-1,2-benzanthracene (DMBA), respectively
- Details on study design:
- RANGE FINDING TESTS: no data
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 i.d.
- Exposure period: 2 - 3 weeks
- Test groups: 4
- Control group: 1
- Site: each foot pad
- Frequency of applications: 1x
- Concentrations: 250 µg (125 µg/0.1 mL into each front foot pad)
- Auxiliary agent: emulsion in complete Freund´s adjuvant with saline
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 - 3 weeks after induction
- Exposure period: 24 h
- Test groups: 4
- Control group: 1
- Site: ventral or dorsal shaved skin
- Concentrations: 0.001, 0.01, 0.1,and 1 % (one drop each applied)
- Evaluation (hr after challenge): 24
OTHER:
- Scoring system
according to Gell PG and Benacerraf B J. Exp. Med. 113, 571 (1961): from +++ to 0
- Challenge controls:
- PAH known to be contact sensitisers in this test system: MC and DMBA
- Positive control substance(s):
- yes
- Remarks:
- 3- methylcolanthrene (MC) and 9,1-dimethyl-1,2-benzanthracene (DMBA)
- Positive control results:
- MC +++ (>= 0.1 %); DMBA +++ (1 %).
Dose-related intensity of the responses - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.001%
- Clinical observations:
- contact reactivity with score +
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- score + indicates the onset of a sensitising effect
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.01%
- Clinical observations:
- contact reactivity with score ++
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- score ++ shows a moderate sensitising response
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- Clinical observations:
- contact reactivity with score +++
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- score +++ demonstrates a clear sensitising response
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- Clinical observations:
- contact reactivity with score +++
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- no application of substance during challenge
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- reponse - to +- (negative to slight erythema)
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- negative response on challenge
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Remarks:
- dose related intensity of the response with regard to the test substance concentration during challenge
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The target compound, Distillates (coal tar), high-temperature, heavy oils (EC no. 310-231-1; CAS no. 140203-21-0) as well as the read-across (source) compound, pitch (coal tar) [CAS No. 65996-93-2] are coal tar-borne UVCB substances consisting of a complex mixture of polycyclic aromatic hydrocarbons (PAH), predominantly of condensed four to five-ring aromatic ring systems which form a matrix that is practically insoluble in water. The GC-analytical profiles are very similar, and hence will be the physico-chemical and toxicological properties of these structure-related fractions. It is expected that the mammalian systemic and local toxicity of the target compound will not be higher than that of the read-across compound, pitch (coal tar).
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The read-across (source) compound, pitch (coal tar) [CTPht], as heavy coal-tar distillate, shows a very similar PAH-profile: This is due to the fact that the considered coal-tar pitch is the high-molecular, "heavy" RESIDUE of a sequential fractionation procedure of coal tar with the temperature increasing, among others under vacuum distillation. On the other hand, the target compound is the high-termperature re-distillate of a high-molecular, heat-treated coal-tar fraction. This is expressed also in the respective fractions of total analysable GC-volatiles which amount to approx. 10% in coal-tar pich, while the GC volatiles of the target compound sum up to a comparable percentage of 13%.
3. ANALOGUE APPROACH JUSTIFICATION
In both cases, 1% or above account for BaP, which is an experimental skin sensitiser (see Old et al. 1963). Based on this finding and taking account of the classification criteria for this endpoint, Distillates (coal tar), high-temperature, heavy oils (EC no. 310-231-1; CAS no. 140203-21-0) has to be classified as a skin sensitiser the same way as CTPht. - Reason / purpose for cross-reference:
- read-across source
- Principles of method if other than guideline:
- Read-across to the preceding entry:
Source substance: benzo[a]pyrene (benzo[def]chrysene), generic (commercial product);
Reference: Old LJ et al. 1993; WHO 1998; ATSDR 1995 - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.001 %
- Clinical observations:
- contact reactivity with score +
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- score + indicates the onset of a sensitising effect / test result is adopted for the target substance CTPht
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.01 %
- Clinical observations:
- contact reactivity with score ++
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- score ++ shows a moderate sensitising response / test result is adopted for the target substance CTPht
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 %
- Clinical observations:
- contact reactivity with score +++
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- score +++ demonstrates a clear sensitising response / test result is adopted for the target substance CTPht
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- Clinical observations:
- contact reactivity with score +++
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- test result is adopted for the target substance CTPht
Referenceopen allclose all
There was a dose-related increase in the intensity of the delayed contact reactivity. There was also cross-reactivity with MC and DMBA as challenging agent and BaP with previous inducer. The intensity of the response was dose-related but primarily expressed at the higher challenge doses, i.e. weaker than with BaP as challenger.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Skin Sensitisation
No data is available on sensitising effects of the target compound, Distillates (coal tar), high-temperature, heavy oils (EC no. 310-231-1; CAS no. 140203-21-0).
benzo[a]pyrene [BaP] is used as supporting substance to characterise the sensitising potential in analogy to CTPht.
Based on a the content of >1% of BaP, a strong experimental sensitiser, Distillates (coal tar), high-temperature, heavy oils (EC no. 310-231-1; CAS no. 140203-21-0) is classified as sensitising Cat. 1 by the registrant.
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