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EC number: 292-602-7 | CAS number: 90640-80-5 A complex combination of polycyclic aromatic hydrocarbons obtained from coal tar having an approximate distillation range of 300°C to 400°C (572°F to 752°F). Composed primarily of phenanthrene, anthracene and carbazole
- 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The non-LLNA test (GPMT) was performed quite some time before the Local Lymph Node Assay was developed and evaluated, and a test guideline for the LLNA method was available. The results of the presentl GPMT can be used to assess the skin sensitisation potential of the registration substance.
Test material
- Reference substance name:
- Creosote
- EC Number:
- 232-287-5
- EC Name:
- Creosote
- Cas Number:
- 8001-58-9
- Molecular formula:
- not applicable
- IUPAC Name:
- Creosote
- Test material form:
- liquid
- Details on test material:
- - Test material quality: Creosote Type WEI B (Grade B)
- Substance type: organic
- Analytical purity: not applicable (UVCB substance, distilled coal tar, complex hydrocarbon mixture)
- Impurities (identity and concentrations): not applicable
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Creosote SNCF
- Type of test material: Creosote Type WEI B (Grade B)
- Analytical purity: not applicable (UVCB, distilled coal tar, complex hydrocarbon mixture)
- Impurities (identity and concentrations): not applicable
- Source and lot/batch No.of test material: SNCF, batch no. 4460 A 93
- Storage condition of test material: Stable at room temperature under exclusion of UV light
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Centre d´Elevage Lebeau, 78950 Gambais, France
- Age at study initiation: no data
- Weight at study initiation: Males: 395 ± 22 g, females: 407 ± 24 g
- Housing: polycarbonate cages, 1 animal/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- petrolatum
- Concentration / amount:
- 10 %
- Day(s)/duration:
- day 0 of treatment
- Route:
- intradermal
- Vehicle:
- other: test substance in 25 % FA
- Concentration / amount:
- 5 %
- Day(s)/duration:
- day 0 of treatment
- Route:
- epicutaneous, open
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL test substance
- Day(s)/duration:
- day 7 of treatment
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL test substance
- Day(s)/duration:
- day 21 of treatment
- No. of animals per dose:
- 10 animals (5m/5f) untreated control; 20 animals (10m/10f) test article
- Details on study design:
- RANGE FINDING TESTS: yes
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Test groups: see below "Any other information on materials..."
- Site: anterior side
- Duration: 24 d
- Concentrations: 1st induction: 10 % in petrolatum; 2nd induction: undiluted test article
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 21
- Exposure period: 24 h
- Test groups: test substance 100 %
- Control group: petrolatum
- Site: posterior side
- Concentrations: undiluted
- Evaluation: 24 h and 48 h after termination of challenge exposure - Positive control substance(s):
- yes
- Remarks:
- 5 female animals positive control (1-Chloro-2,4-dinitrobenzene = DNCB) (not concurrent)
Results and discussion
- Positive control results:
- see below "Any other information on results ..."
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% (neat substance, on the right)
- No. with + reactions:
- 17
- Total no. in group:
- 19
- Clinical observations:
- erythema; average score 1.2
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% (neat substance, on the right)
- No. with + reactions:
- 6
- Total no. in group:
- 19
- Clinical observations:
- slight erythema; average score 0.4
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0 (vehicle only, on the left)
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- erythema - average score 0.0
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0 (vehicle only, on the left)
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- erythema - average score 0.0
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- erythema - average score 0.0
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- erythema - average score 0.0
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 and 0.5%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- distinct erythema - average score 2.6
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1 and 0.5%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- distinct erythema - average score 2.3
Any other information on results incl. tables
Guinea pig maximisation test with the test substance Creosote SNCF:
Result of skin sensitisation test (Challenge) |
|||
Number of animals with signs of allergic reactions / |
|||
Negative control |
Test group |
Positive control (not concurrent) |
|
scored after 24 h |
0/10 |
17/19 |
5/5 |
scored after 48 h |
0/10 |
6/19 |
5/5 |
*Scoring system: Draize grading
0 = no reaction; 1 = slight erythema; 2 = well visible erythema; 3 = moderate erythema; 4 = strong erythema
A spontaneous death occurred in one female animal on day 9 with no relation to the treatment.After challenge with the test article, there was a brownish discolouration at the site of application and, additionally, dryness of the skin after 48 h p.a.
Discolouration but no dryness is also reported for the not-induced control group.
The induced animals showed slight to well defined erythema (definition see table below):
· 24 h after challenge exposure: 5/19 score 2, 12/19 score 1 and 2/19 score 0 and
· 48 h after challenge exposure: 1/19 score 2, 5/19 score 1, and 13/19 score 0.
All animals treated with DNCB (positive controls) exhibited positive dose-related scores (≥ 1 and ≥ 3) at both 24 and 48h after treatment.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Remarks:
- as well as EU criteria according to CLP regulation
- Conclusions:
- Under the conditions of the test, the test substance creosote SNCF, WEI-Type B showed a skin sensitising potential in guinea pigs. A high percentage of animals responded, but at a low-grade intensity.
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