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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
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 and epicutaneous
Vehicle:
petrolatum
Concentration / amount:
see below "Any other information on materials..."
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
see below "Any other information on materials..."
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: one
- Day(s) of challenge: Day 21
- Exposure period: 24 h
- Test groups: test substance 100 %
- Control group: petrolatum
- Site: posterior side
- Concentrations: undiluted
- Evaluation: 24h + 48h 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 "Remarks on results..."
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100 %
No. with + reactions:
17
Total no. in group:
19
Clinical observations:
average score: 1.2
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 17.0. Total no. in groups: 19.0. Clinical observations: average score: 1.2.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100 %
No. with + reactions:
6
Total no. in group:
19
Clinical observations:
average score 0.4
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 6.0. Total no. in groups: 19.0. Clinical observations: average score 0.4.

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 skinafter 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 (≥1and ≥3) at both 24 and 48 h after treatment.
Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of the test, the test substance, Creosote SNF, showed a skin sensitising potential in guinea pigs. A high percentage of animals responded, but at a low-grade intensity.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:
Migrated from Short description of key information:
Anthracene oil is considered to have a skin-sensitising potential, based on a guinea-pig maximisation test conducted with a closely structure-related tar oil.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No data is available for anthracene oil itself. Data obtained for skin sensitisation originate from the closely 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). 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 skin sensitising potential of both materials can be considered to be similar. Hence, creosote is used as supporting substance for the skin sensitising effect of anthracene oil.


Migrated from Short description of key 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 the skin-sensitising potential. Based on results with the supporting substance creosote (see above), anthracene oil <50 ppm BaP is to be classified as Skin Sens. Cat. 1B according to classification criteria of Regulation (EC) 1272/2008 (amendment 2nd ATP: Regulation (EU) 286/2011).