Registration Dossier

Administrative data

Description of key information

Anthracene oil is irritating to skin but not irritating to the eye, based on animal testing of closely structure-related tar oils. For respiration, no experimental data has been located. Occupational experience gave no evidence of respiratory irritation due to low  vapour at ambient temperature, but exposure to vapours at elevated temperatures may produce irritating effects on the respiratory tract.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
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
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 2.8 ±0.1 kg
- Housing: polystyrene cage, 1 animal/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >= 5 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +-3
- Humidity (%): 50 +-20
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
9 and 12 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm2
- Type of wrap if used: bandage semiocclusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water-moistened gauze
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scale with grades 1 to 4 for severity of erythema and oedema
Data evaluation: According to directive 91/325/EEC: irritating = score >= 2 in 2/3 animals for >= 24 h for erythema or oedema
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
average over time
Time point:
other: 24, 48, 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
average over time
Time point:
other: 24, 48, 72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
average over time
Time point:
other: 24, 48, 72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
average over time
Time point:
other: 24, 48, 72 h
Score:
3.3
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
average over time
Time point:
other: 24, 48, 72 h
Score:
3.3
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
average over time
Time point:
other: 24, 48, 72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 h
Score:
2.2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 h
Score:
3.1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritant / corrosive response data:
Mean scores per animal were 2 or distinctly higher at any time point until 72 h with mean scores over time >2 for erythema (2/3 animals) or >3 for oedema (3/3 animals).
Other effects:
Skin dryness prevailed between day 4 and 11 in 2 animals.

Table for skin irritation study

Score (average of three animals investigated)

time

Erythema

Edema

Average Draize scores
(0 to maximum 4)

60 min

2.3

4.0

24 h

2.7

4.0

48 h

2.3

3.3

72 h

1.7

2.0

Average score

24h, 48h, 72h

2.2

3.1

Reversibility: *

c

c

Time for reversibility in all animals (score 0)

7 d

6 d

*   c :    completely reversible
  n c :    not completely reversible
     n :    not reversible

Interpretation of results:
irritating
Remarks:
Migrated information
Conclusions:
Under the conditions of the test, the test material, creosote SNCF, is irritating to the skin of rabbits.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
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
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 2.8 ±0.1 kg
- Housing: polystyren cage, 1 animal/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >= 5 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +-3
- Humidity (%): 50 +-20
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:
not rinsed
Observation period (in vivo):
1, 24, 48, 72 h post-instillation
Number of animals or in vitro replicates:
3 (male)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure:


SCORING SYSTEM: Numeric Draize scale:
Grades 0 to 3 for severity of redness of conjunctivae as well as lacrimation,
grades 0 - 4 for oedema and corneal effects,
grades 0 - 2 for iris effects.
EVALUATION: according to EU classification system

Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 h
Score:
0.2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
3 animals
Time point:
other: 24, 48, 72 h
Score:
0.4
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
Very slight chemosis (score 1 in one animal only) and slight (score 1) to moderate (score 2) redness of the conjunctivae between 1 and 48 h, the moderate effect in one animal after 24 h. No effect on the iris and cornea.
Other effects:
none
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
All individual effects scores over time remained below cut-off limits for classification: cornea < 2, iris < 1, redness < 2.5, oedema < 2.
Under the conditions of the test, the test material, Creosote SNCF, is not irritating to the eyes of rabbits.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No data is available for anthracene oil itself. Data obtained for irritation 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 irritating potential of both materials can be considered to be similar. Hence, creosote is used as supporting substance for irritating effects of anthracene oil.


Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Anthracene oil < 50 ppm BaP is classified as skin irritating Cat. 2 based on results obtained with the supporting substance creosote (see above). Classification criteria of Regulation (EC) 1272/2008 were exceeded in this test.