Anthracene oil

Endpoint summary

Description of key information

No data is available for anthracene oil (AOL) itself. The structurally related tar oil creosote is used as supporting (source) substance instead. Oral, inhalation, and dermal acute toxicity studies have been carried out with creosote as test material. LD/LC50 values were clearly above 2000 mg/kg bw or 5000 mg/m³, respectively. These results are adopted for the target substance anthracene oil based on the structural similarity of both substances.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

- Name of test material (as cited in study report): Product number 103.206; Rütaleum
- Substance type: creosote type WEI B
- Analytical purity: not applicable (UVCB, distilled coal tar, complex hydrocarbon mixture)
- Storage condition of test material: stable at room temperature under exclusion of UV light

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Age at study initiation: no data
- Weight at study initiation: males: 160 – 201 grams, females: 160 – 231 grams
- Fasting period before study: 16 h
- Housing: 5 rats per cage (Macrolon)
- Diet: ad libitum until 16 h pre-application and continued from 4 h post-application
- Water: ad libitum
- Acclimation period: ≤ 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 50 - 85
- Photoperiod (hrs dark / hrs light): 12 / 12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg

Doses:

3138; 3668; 4184; 5230 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 15 and 45 min, 1, 2 and 3 h, 6 h, 24 and 48 h, 3 and 5 d p.a
- Frequency of weighing: day 0 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Probit analysis according to Finney DY (1971)

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 030 mg/kg bw

Based on:

test mat.

95% CL:

>= 3 642 - <= 4 505

Mortality:

see below "Any other information on results incl. tables"

Clinical signs:

other: Dose-related increase in apathy, discoordination, anormal posture, cyanosis, piloerection, and slightly reduced respiration

Gross pathology:

No particular organ effects reported in deceased and sacrificed animals.
No significant macroscopic abnormalities were found at necropsy.
Residues of test material were found in the gastro-intestinal tract of moribund and deceased animals.

MORTALITY

Dose[mg/kg]	24 h		48 h		3-14 days		Mortality (%)
	Male	female	Male	female	Male	female	Male	female
3138	0/5	0/5	0/5	1/5	0/5	1/5	0	20
3668	0/5	1/5	1/5	2/5	1/5	2/5	20	40
4184	0/5	2/5	2/5	4/5	2/5	4/5	40	80
5230	1/5	4/5	3/5	5/5	4/5	5/5	80	100

The oral LD₅₀ for creosote in rats was 3500 – 4000 mg/kg bw for males and females.

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

but no classification according to EU criteria (CLP regulation)

Conclusions:

Based on the results of this study, the acute oral LC50 for the test substance creosote type WEI B was 4030 mg/kg bw.

Reference 2

Endpoint:

acute toxicity: oral

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 (WEI-Type B, 1987) 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.
The nature of both substances and their constituent are considered to be sufficiently similar that systemic toxic effects after oral application will be effected in a similar way. Therefore, the source substance is suited as supporting substance with regard to acute oral toxicity and data resulting from the source substance can be used for characterising the toxicological properties of the target substance anthracene oil upon oral application.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source material creosote (WEI-Type B, not further specified) 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 %). Detailed analytical information is not available, but a typical creosote composition is assumed. Accumulated concentrations of PAH with two and three rings are estimated to be approx. 40 to 50 % with two-ring aromatics building the larger fraction. Percentage of four- and five-ring PAH is assumed to be < 10 % with benzo[a]pyrene being present in a concentration range around 150 to 300 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 °C 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
Acute toxicity by oral application depends on the uptake characteristics of a substance and on its toxicological properties. Systemic toxic effects will be caused after resorption from the gastrointestinal tract, metabolic activation, and distribution within the body. In the case of complex substances like UVCBs, the overall toxicity will result from the effects caused by the individual components of the substance. If substances are similar, the systemic oral toxicity will be comparable.
The general composition of the source and target substance is similar. 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. Concentration of PAH with carbon frames containing more than three rings may be somewhat higher in creosote. In general, higher molecular weight PAH have a higher toxicity than smaller PAH.
Overall, taking the acute oral toxicity of relevant constituents of the source substance and the target substance into consideration, differences in the PAH composition of both materials are considered not to modify toxic effects of the source and the target material significantly. Toxicokinetic parameters are similar. All PAH have similar metabolic activation pathways and will result in similar final toxicants. Within a range, effects are considered to be comparable. Acute toxic effects observed upon oral application of creosote are assumed to similarly develop from exposure to AOL. For these reasons, it is considered justified to use oral toxicity data of creosote in order to characterise oral toxic effects of 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, WEI-Type B, unspecified_1987;
Reference: Sterner and Chibanguza 1987

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 030 mg/kg bw

Based on:

test mat.

95% CL:

>= 3 642 - <= 4 505

Remarks on result:

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

Conclusions:

Based on the result of the source study, the acute oral LC50 for the test substance creosote type WEI B is 4030 mg/kg bw.
The test result of the source substance creosote is adopted for the target substance anthracene oil.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 030 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: inhalation

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 403 (Acute Inhalation Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

- Name of test material (as cited in study report): Creosote; North American P1/P13 Creosote; North American Creosote Composite Test Material P1/P13
- Composition of test material, percentage of components: see under Test material information

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Crl:CD® BR VAF/Plus®

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Portage, Michigan, USA
- Age at study initiation: 53 – 75 days
- Weight at study initiation: males: 234 – 283 g, females: 192 – 216 g

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

air

Mass median aerodynamic diameter (MMAD):

>= 1.3 - <= 3.4 µm

Geometric standard deviation (GSD):

>= 1.65 - <= 1.98

Details on inhalation exposure:

MMAD ± GSD [µm]:
5000 mg/m³: 3.4 ± 1.89 (2.5 % of particles ≤ 1 µm diameter)
600 mg/m³: 1.3 ± 1.64 (29 % of particles ≤ 1 µm diameter)

Analytical verification of test atmosphere concentrations:

yes

Remarks:

GC-FID after sampling (9 key aromatics quantified (approx. 50 % of creosote), then result extrapolated to total creosote by using a factor of 1.64)

Duration of exposure:

4 h

Concentrations:

600, 5000 mg/m³ (analytical)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Key result

Sex:

male/female

Dose descriptor:

LC0

Effect level:

5 000 mg/m³ air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: concentration in air was determined gravimetrically

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5 000 mg/m³ air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: highest concentration tested

Mortality:

No deaths occurred at maximum dose.

Clinical signs:

other: 5000 mg/m³: Directly after exposure, 9/10 animals with reduced activity. Three males and one female showed increased salivation. During the 14-day post-exposure period, five males and four females exhibited decreased activity. 600

Body weight:

5000 and 600 mg/m³: bw gain depressed, persisted for 14 days post exposure.

Gross pathology:

No significant macroscopic abnormalities were found at necropsy.

Table A6_1-1.               Table for Acute Toxicity (inhalation)
Dose[mg/m^3air]	Toxicological results*	Duration of clinical signs	Time of death	Mortality (%)	Particles£5mm (%)
males
600	0/2/5	4h – 14d	-	-	99
5000	0/5/5	4h – 14d	-	-	53
LC50value > 5000 mg/m^3air (aerosol)
females
600	0/0/5	4h – 14d	-	-	99
5000	0/4/5	4h – 14d	-	-	53
LC50value > 5000 mg/m^3air (aerosol)

*number of dead animals / number of animals with clinical signs of toxicity / total number of animals

Interpretation of results:

GHS criteria not met

Remarks:

as well as EU criteria according to CLP regulation

Conclusions:

Based on the results of this study, the four-hour inhalation LC50 for Creosote P1/P13 was greater than 5000 mg/m³.

Reference 2

Endpoint:

acute toxicity: inhalation

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 (US type P1/P13) consists predominantly of polycyclic aromatic hydrocarbons (PAH) 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.
The nature of both substances and their constituents are considered to be sufficiently similar that systemic toxic effects observed following acute inhalation exposure to aerosols are equivalent. Therefore, the source substance is suited as supporting substance with regard to acute inhalation toxicity and data resulting from the source substance can be used for characterising the acute systemic toxicological properties of the target substance anthracene oil upon aerosolic inhalation exposure.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source material creosote (US type P1/P13) 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 with no or only a minimal content of other components (phenols). Two- and three-ring aromatics amount to about 40 % (typical concentration) with two-ring aromatics forming the smaller fraction. PAH with four and more rings accumulate to about 14 %. Five-ring PAH are only present in low concentration (below 0.3 %). 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 °C 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 weight 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
Composition of both substances is somewhat different creosote having a broader spectrum of PAH with a higher concentration of two-ring and a smaller concentration of three-ring PAH compared to AOL. The amount of four-ring PAH is similar for both substances but creosote contains a broader range of five-ring PAH (low concentrations). Basically, the same PAH are present in both substances and their consistency is quite similar.
Upon aerolisation, components of both substances will be transferred into the respiratory air and are after inhalation available for uptake into and distribution within the body. Besides formation of aerosol droplets, constituents of both substances will vaporise. Smaller molecules tend to vaporise more easily and tend to remain distributed in air for a longer period of time compared to larger molecules. Thus, it can be assumed that the fraction of two-ring PAH is increased in aerosols (vapour phase) compared to the liquid state of the substances. Still, concentration of two-ring PAH will be higher in aerosols of creosote compared to AOL, while concentration of three-ring PAH will be lower.
Considering the acute toxicity of two- and three-ring PAH, moderate differences in the concentration of constituents in the aerosols (vapour and droplets) of both substances are considered to be of minor importance to the overall acute toxic effects caused by the substances after inhalation. The similar composition of both substances and the acute toxicity of the individual components in combination with the high LC50 value of the source substance provide further evidence that classification of the target substance can be based in a weight of evidence approach on the LC50 value obtained with the source substance. For these reasons, it is considered justified to use data on the aerosolic inhalation toxicity of the source material to characterise the acute toxic effects of the target substance anthracene oil by inhalation.

Reason / purpose for cross-reference:

read-across source

Principles of method if other than guideline:

Read-across to preceding entry:
Source test material: US Creosote P1/P13;
Reference: Hilaski 1993

Key result

Sex:

male/female

Dose descriptor:

LC0

Effect level:

5 000 mg/m³ air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: concentration in air was determined gravimetrically

Remarks:

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

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5 000 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: highest concentration tested

Remarks:

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

Conclusions:

Based on the results of the source study, the four-hour inhalation LC50 for Creosote P1/P13 was greater than 5000 mg/m³.
This result is adopted for the target substance anthracene oil.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

5 000 mg/m³ air

Acute toxicity: via dermal route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

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:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa Crédo, 69210 L´Arbresle, France
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: males: 258 ± 11 g, females: 222 ± 5 g
- Fasting period before study: none
- Housing: polycarbonte cage, 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: ≥ 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): approx. 13
- Photoperiod (hrs dark / hrs light): 12 / 12

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 30 - 35 cm²
- % coverage: about 10 % of the animals´ total surface
- Type of wrap if used: gauze and bandage semiocclusive

TEST MATERIAL
- Amount applied (volume or weight with unit): 1.91 mL/kg bw

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 0, 5, 8, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

not applicable

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: limit test

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: limit test

Mortality:

none

Clinical signs:

other: No particular findings

Gross pathology:

No local reactions at the site of application; no abnormalities observed following macroscopic examination of organs

Other findings:

none

Interpretation of results:

GHS criteria not met

Remarks:

as well as EU criteria according to CLP regulation

Conclusions:

Based on the results of this study, the acute dermal LC50 (exposure period 24 h) of the test substance creosote SNCF, WEI-Type B was > 2000 mg/kg bw.

Reference 2

Endpoint:

acute toxicity: dermal

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.
The nature of the matrix and constituents of both substances are considered to be sufficiently similar that dermal absorption and subsequent systemic toxic effects will proceed in a similar way. Therefore, the source substance is suited as supporting substance with regard to acute dermal toxicity and data resulting from the source substance can be used for characterising the toxicological properties of the target substance anthracene oil upon dermal application.

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 1-ring and to a lower extent 2-ring aromatics) as well as polycyclic aromatic hydrocarbons composed of more than 4 to 5 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
Acute toxicity by dermal application depends on the uptake characteristics of a substance and on its toxicological properties. Uptake is determined by absorption and penetration through skin. In the case of complex substances like UVCBs, this process will depend mainly on substance properties (type and concentration of components, effects of the substance matrix). If substances are similar (similar constituents, similar matrix), the systemic dermal toxicity will be comparable.
Two- and three-ring PAH are present in the source substance creosote SNCF, 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. Concentration of PAH with carbon frames containing more than three rings may be somewhat higher in creosote but distinct data are not reported for the source substance. Higher molecular weight PAH have a higher toxicity than smaller PAH, but on the other hand dermal absorption and penetration will be reduced compared to lower molecular weight PAH.
The actual concentration of individual constituent is considered to be secondary, because upon dermal application of both oily substances, the individual components will be highly overdosed with regard to skin absorption/penetration. The effect of the substance matrix is assessed to be in favour of creosote, as data support a more liquid consistency (lower viscosity) of creosote.
Taking the combined information into account, it is assessed that the overall dermal toxicity of both substances is sufficiently similar that data resulting from the source substance creosote can be used as supporting evidence for the target substance anthracene oil. Regarding the substance matrix, creosote may even be a worst case (slightly better release of constituents). For these reasons, it is considered justified to use data on acute dermal toxicity of the source material to characterise acute dermal toxic effects of the target substance anthracene oil.

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

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: limit test

Remarks:

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

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: limit test

Remarks:

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

Conclusions:

Based on the results of the source study, the acute dermal LC50 (exposure period 24 h) for the test substance creosote SNCF, WEI-Type B is > 2000 mg/kg bw.
The test result of the source study is adopted for the target substance anthracene oil.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

No data is available for anthracene oil itself. The data uses to characterise the acute toxicity of anthracene oil originate from acute toxicity studies with the closely structure-related tar oil creosote. Due to the similar production process (fractionated distillation of coal tar using overlapping conditions), the composition of both substances is quite 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 composition of both substances is similar. Hence, creosote is used as supporting substance to characterise the acute toxicity of anthracene oil. A more detailed justification is included in the respective read-across endpoint study records.

The acute toxicity studies with creosote as test material were performed according to the respective OECD test guidelines under GLP conditions. In the oral study, four graduate test concentrations were applied by gavage resulting in a LC50 value of 4030 mg/kg bw/day. In the inhalation study, two test concentration were used with the high concentration being the limit concentration. The dermal study was performed as limit tests. In both tests, no mortality was observed at the limit dose (5000 mg/m³ air (analytical) and 2000 mg/kg bw/day, respectively), demonstrating that the LC/LD50 values were clearly above the limit dose.

Anthracene oil is expected to show no or only a low acute oral or dermal toxicity based on results obtained with the closely related source substance creosote. No acute intoxication is expected from inhalation exposure, given the low vapour pressure of anthracene oil. Acute toxicity after exposure to aerosols is also expected to be low based on the aerosolic inhalation LC50 value of creosote.

For hazard assessment purposes, the LD/LC50 values of the source substance creosote are adopted for the target substance anthracene oil.

Justification for classification or non-classification

Based on experimental evidence, no classification required (LD/LC50 values clearly above classification criteria).