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Diss Factsheets

Administrative data

Description of key information

Anthracene oil is considered to have a skin-sensitising potential, based on a guinea-pig maximisation test conducted with the closely structure-related tar oil creosote.

No experimental data on respiratory sensitisation has been located. From occupational experience over decades, there has been no evidence for this effect in exposed workers.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

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
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.
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
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


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
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)
Positive control results:
see below "Any other information on results ..."
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

Guinea pig maximisation test with the test substance Creosote SNCF:

Result of skin sensitisation test (Challenge)

Number of animals with signs of allergic reactions /
number of animals in group

Negative control

Test group

Positive control (not concurrent)

scored after 24 h

0/10
average score 0.0

17/19
average score 1.2

5/5
average score 2.6

scored after 48 h

0/10
average score 0.0

6/19
average score 0.4

5/5
average score 2.3

*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.

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.
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 source test material creosote (SNFC, WEI-Type B, 1993) consists predominantly of polycyclic aromatic hydrocarbons ranging in size from two up to five fused rings. The target substance anthracene oil (anthracene oil with < 50 ppm benzo[a]pyrene, AOL) is as well composed of a broad range of PAH but predominantly consisting of two to four aromatic rings.
Constituents and properties of both substances are considered to be sufficiently similar that skin sensitising processes upon skin exposure will be similar. Therefore, the source substance is suited as supporting substance with regard to skin sensitising effects and data resulting from the source substance can be used for characterising the skin sensitisation potential of the target substance anthracene oil.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source material creosote (SCNF, WEI-Type B) is a condensation product in the distillation of coal tars that have been obtained in the high temperature carbonisation of bituminous coal. The material is a UVCB substance forming a dark brown oily liquid. It is only partly volatile and consists of a complex mixture of polycyclic aromatic hydrocarbons (PAH) with only minor levels of other components (phenols, N-compounds ≤ 10 %). Accumulated concentrations of PAH with two and three rings are approx. 50 % with two-ring aromatic building the larger fraction. Analytical data for four-ring PAH is incomplete. Taking information from other creosotes into account, it is assumed that accumulated percentage of four- and five-ring PAH is < 10 % with benzo[a]pyrene being present in a concentration of about 160 ppm. The water solubility of creosote is relatively low. It is determined by the solubility properties of its constituents.
The target material anthracene oil (AOL) is a UVCB substance as well produced by the distillation of coal tars extracting the approximate distillation range from ca. 300 °C to 400 °C. 10 % to 95 % of the total product distil over between ca. 300 and 375 °C. The substance is a brown pasty or liquid material consisting of a complex and within limits variable combination of polycyclic aromatic hydrocarbons. The distillation range excludes mostly low molecular aromatic hydrocarbons (especially one-ring and to a lower extent two-ring aromatics) as well as polycyclic aromatic hydrocarbons composed of more than four to five rings depending on the respective boiling points of the individual aromatic substances. Two- and three-ring aromatics amount to about 50 % (typical concentration) with two-ring aromatics forming the smaller fraction. PAH with four and more rings accumulate to about 10 % with pyrene and benzofluorenes representing the highest molecular weight PAH found in AOL. The water solubility of AOL is low being limited by the solubility properties of its constituents.

3. ANALOGUE APPROACH JUSTIFICATION
Skin sensitisation is the result of a process when allergens provoke a cutaneous immune response, which eventually will result in the formation of contact sensitisation. For this purpose, a chemical has to be absorbed into the skin and transformed within the skin into a chemical allergen by forming stable conjugates with macromolecular proteins either due to inherent properties (e.g. functional groups) or after metabolism.
In the skin sensitisation test applied (GMPT), the induction consisted of two test material applications (intradermal injection followed by topical (epicutaneous) application). Insofar, absorption properties of the test material is only of secondary importance, because the test substance is first applied by injection directly into the skin. Therefore, the composition of the test material and the nature of constituents are the major force that drive the induction of skin sensitisation. The overall sensitising potential will result from the combined effects of the individual components present in the test substance. If substances are similar, the sensitising properties will be comparable.
The general composition of the source and target substance is similar (see above). Relevant constituents are two-ring up to four- to five-ring PAH. Two- and three-ring PAH are present in the source substance creosote WEI-Type B and in the target substance anthracene oil in comparable amounts, just the fraction of two-ring aromatics being somewhat higher in creosote and the fraction of three-ring aromatics being somewhat higher in AOL. PAH are chemically rather inert and require metabolic activation to reactive species prior to be conjugated with proteins. Metabolism as well as the nature of reactive metabolites is similar for the range of PAH present in creosote and in AOL. Under this point of view, the sensitising potential of both substances is assumed to be of the same order. In creosote, additional classes of substances are present even though in minor amounts. Phenols and nitrogen-compounds have or can have functional groups that are able to react with proteins forming protein conjugates. This may increase the skin sensitising potential of creosote compared to anthracene oil.
Taking this information into account, it is assessed that the overall skin sensitising effects of both substances are sufficiently similar that data resulting from the source substance creosote can be used as evidence for the target substance anthracene oil. Considering additional, more reactive components in creosote, the use of creosote as supporting (source) substance may even represent a worst case. For these reasons, it is justified to use data on skin sensitising effects of the source material to characterise the skin sensitising potential of the target substance anthracene oil.
Reason / purpose for cross-reference:
read-across source
Principles of method if other than guideline:
Read-across to preceding entry:
Source test material: creosote SNCF, WEI-Type B_1993;
Reference: Clouzeau 1993
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
Remarks on result:
other: the test result of the source substance is adopted for the target substance anthracene oil
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
Remarks on result:
other: the test result of the source substance is adopted for the target substance anthracene oil
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:
erytehma - average score 0.0
Key result
Reading:
2nd reading
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:
erytema -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:
erytema -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 erytema -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 erytema -average score 2.3
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 source 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.
The test results of the source substance creosote SNCF, WEI-Type B are adopted for the target substance anthracene oil.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

No data is available for anthracene oil itself. The data used to characterise the sensitising effects of anthracene oil originate from the closely structure-related tar oil creosote. Due to the similar production process (fractionated distillation of coal tar using overlapping conditions), composition of both substances is similar. Major components are mid-range PAH for both substances (naphthalene to pyrene) with creosote comprising additional five-ring PAH in small amounts. Individual differences in distillation conditions and in starting material may cause gradual variation in qualitative and quantitative composition. But the nature of constituents and the individual components coincide and the percentage of single substances is of the same magnitude. Therefore, the sensitising potential of both materials can be considered to be similar. Hence, creosote is used as supporting (source) substance for characterising the sensitising potential of anthracene oil.

In a guinea pig maximisation test according to OECD TG 406 performed under GLP conditions, the test material creosote showed a skin sensitising potential. A high percentage of animals responded (17 of 19 animals), but at a low-grade intensity (mean score 1.2). 24 hours after the first reading, the number of animals with erythema was reduced to 6 (mean score 0.4). Classification criteria of CLP regulation as Skin Sens. Cat. 1B are met.

For hazard assessment purposes, the skin sensitising effect observed with the source substance creosote are adopted for the target substance anthracene oil.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No experimental data on respiratory sensitisation has been located. From occupational experience over decades, there has been no evidence for this effect in exposed workers.

Justification for classification or non-classification

Based on experimental evidence consistently noted with various tar oils, and although not evident by human experience, anthracene oil should be classified for skin sensitisation. Based on results with the supporting substance creosote (see above), anthracene oil is classified as Skin Sens. Cat. 1B according to classification criteria of Regulation (EC) 1272/2008 (amendment 2nd ATP: Regulation (EU) 286/2011).