Anthracene oil

Endpoint summary

Description of key information

Anthracene oil is irritating to skin but not irritating to the eye, based on animal testing of the closely structure-related tar oil creosote. For respiration, no experimental data has been located. Occupational experience gave no evidence of respiratory irritation at ambient temperature due to low vapour concentrations, 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

Reference 1

Endpoint:

skin irritation: in vivo

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 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

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: Batch No.4460 A 93
- Storage condition of test material: Stable at room temperature under exclusion of UV light

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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): no data
- 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

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritation parameter:

edema score

Basis:

animal #3

Time point:

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:

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:

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:

Category 2 (irritant) based on GHS criteria

Remarks:

According EU criterial (CLP regulation) Skin Irrit. 2

Conclusions:

Under the conditions of the test, the test material, creosote SNCF, WEI-Type B, is irritating to the skin of rabbits. EU criteria for classification as skin irritant Category 2 are met.

Reference 2

Endpoint:

skin irritation: in vivo

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 (BaP), 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 dermal irritation processes upon contact with skin will be similar. Therefore, the source substance is suited as supporting substance with regard to skin-irritating effects and data resulting from the source substance can be used for characterising the skin-irritating 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
Upon contact with skin, source and target material (creosote and anthracene oil)) may develop skin-irritating effects. These will be caused by active components present in the oily materials. These components are similar for both substances (various PAH, see above).
Two- and three-ring PAH are present in the source substance creosote 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. The source material will contain a broader range of PAH with carbon frames containing more than three rings and the concentration of these PAH may differ to some degree between both substances.
In skin irritation studies, the test material is applied as pure substance to the skin. Insofar, the applied dose of individual substances is very high and individual concentrations are considered to be secondary as long as they are in the same order of magnitude.
Taking this information into account (the range of components is quite similar in both substances and the concentrations of the components are roughly of the same order), it is assessed that the overall irritating 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. For these reasons, it is justified to use data on skin-irritating effects of the source material to characterise the skin-irritating 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

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: the test result of the source substance is adopted for the target substance anthracene oil

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: the test result of the source substance is adopted for the target substance anthracene oil

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: the test result of the source substance is adopted for the target substance anthracene oil

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

other: the test result of the source substance is adopted for the target substance anthracene oil

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

other: the test result of the source substance is adopted for the target substance anthracene oil

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.7

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

other: the test result of the source substance is adopted for the target substance anthracene oil

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Remarks:

According EU criterial (CLP regulation) Skin Irrit. 2

Conclusions:

Under the conditions of the test, the test material, creosote SNCF, WEI-Type B, is irritating to the skin of rabbits.

Taking into account the similarity of the test material and the target substance (similar constituents, source, type of liquid), the result of the skin irritation test of the source substance creosote is adopted for the target substance anthracene oil. EU criteria for classification of anthracene oil as skin irritant Category 2 are met.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

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 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

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:

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): no data
- 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.

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: (no effects were observed in any of the test animals)

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: (no effects were observed in any of the test animals)

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0.4

Max. score:

3

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: (two animals with a mean score of 0.667 each)

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0.2

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: (one animal with a mean score of 0.667)

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:

GHS criteria not met

Remarks:

as well as EU criteria according to CLP regulation

Conclusions:

All individual effect scores (mean score from gradings at 24, 48, and 72 hours after test material instillation) remained below cut-off limits for classification: cornea < 1, iris < 1, redness < 2, oedema < 2 .
Under the conditions of the test, the test material creosote SNCF, WEI-Type B is not irritating to the eyes of rabbits.

Reference 2

Endpoint:

eye irritation: in vivo

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 eye irritation processes upon eye exposure will be similar. Therefore, the source substance is suited as supporting substance with regard to eye-irritating effects and data resulting from the source substance can be used for characterising the eye-irritating 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 (< 50 ppm BaP, 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
Upon contact with eyes, source and target material (creosote and anthracene oil) may develop irritating effects. These will be caused by active components present in the oily materials. These components are similar for both substances (various PAH, see above).
Two- and three-ring PAH are present in the source substance creosote 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. The source material will contain a broader range of PAH with carbon frames containing more than three rings and the concentration of these PAH may differ to some degree between both substances. The exact concentrations of individual components are considered to be of minor importance with regard to eye irritating effects as long as they fall in the same range.
Taking this information into account (the range of components is quite similar in both substances and the concentrations of the components are roughly of the same order), it is assessed that the overall irritating 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. For these reasons, it is justified to use data on eye-irritating effects of the source material to characterise the eye-irritating 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

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: (the test result of the source substance is adopted for the target substance anthracene oil)

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: (the test result of the source substance is adopted for the target substance anthracene oil)

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0.4

Max. score:

3

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: (two animals with a mean score of 0.666 each

Remarks:

the test result of the source substance is adopted for the target substance anthracene oil)

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0.24

Reversibility:

fully reversible

Remarks on result:

other: (one animal with a mean score of 0.666

Remarks:

the test result of the source substance is adopted for the target substance anthracene oil)

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.

Interpretation of results:

GHS criteria not met

Remarks:

as well as EU criteria according to CLP regulation

Conclusions:

Taking into account the similarity of the test material and the target substance (similar constituents, source, type of liquid), the result of the eye irritation test of the source sustance creosote is adopted for the target substance anthracene oil. EU criteria for classification of anthracene oil as eye irritant according to CLP regulation are not met.

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. The data used to characterise the irritating 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 irritating potential of both materials can be considered to be similar. Hence, creosote is used as supporting substance for characterising the skin and eye irritating potential of anthracene oil.

Skin and eye irritation studies with the test material creosote were performed under GLP conditions according to OECD TG 404 and 405. Irritating effects observed on skin exceeded CLP criteria. They were fully reversible within 7 days. In the eye irritation study, no effects on cornea and iris were observed (score 0), while conjunctivae and chemosis scores were very low (0.4 and 0.2 respectively, mean of three animals).

For hazard assessment purposes, the irritating effects observed with the source substance creosote are adopted for the target substance anthracene oil.

Justification for classification or non-classification

Anthracene oil (< 50 ppm BaP, AOL) 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.

Eye irritation observed in the study with creosote was very low (see above). CLP classification criteria are not met.