Distillates (coal tar), high-temperature, heavy oils

Endpoint summary

Description of key information

No particular irritation to skin and eye was noted in experimental standard studies with the read-across source, coal-tar pitch (CTPht). The same holds for the target compound, Distillates (coal tar), high-temperature, heavy oils (EC no. 310-231-1; CAS no. 140203-21-0), based on the similarity of composition.

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:

other: Directive 83/467/EEC

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

Electrode binder [CAS No. 65996-93-2]
- Name of test material (as cited in study report): 101.110
- Physical state: solid, black powder

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, Bremerförde/Germany
- Age at study initiation: no data
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: cage, single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >= 7 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +-2 °C
- Humidity (%): 50 - 86 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Type of coverage:

occlusive

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 g

Duration of treatment / exposure:

4 hour(s)

Observation period:

readings: 1 h, 24, 48, and 72 h after removal of the cover

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- skin intact and scarified

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

SCORING SYSTEM: according to Draize

Irritation parameter:

other: erythema and edema score

Basis:

animal: 1 to 6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

both on the intact and scarified skin

Irritant / corrosive response data:

There was no skin reaction over the observation time of 72 h (score 0 for all parameters).

Interpretation of results:

GHS criteria not 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 target compound, Distillates (coal tar), high-temperature, heavy oils (EC no. 310-231-1; CAS no. 140203-21-0) as well as the read-across (source) compound, pitch (coal tar) [CAS No. 65996-93-2] are coal tar-borne UVCB substances consisting of a complex mixture of polycyclic aromatic hydrocarbons (PAH), predominantly of condensed four to five-ring aromatic ring systems which form a matrix that is practically insoluble in water. The GC-analytical profiles are very similar, and hence will be the physico-chemical and toxicological properties of these structure-related fractions. It is expected that the mammalian systemic and local toxicity of the target compound will not be higher than that of the read-across compound, pitch (coal tar).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The read-across (source) compound, pitch (coal tar), as heavy coal-tar distillate, shows a very similar PAH-profile: This is due to the fact that the considered coal-tar pitch is the high-molecular, "heavy" RESIDUE of a sequential fractionation procedure of coal tar with the temperature increasing, among others under vacuum distillation. On the other hand, the target compound is the high-termperature re-distillate of a high-molecular, heat-treated coal-tar fraction. This is expressed also in the respective fractions of total analysable GC-volatiles which amount to approx. 10% in coal-tar pich, while the GC volatiles of the target compound sum up to a comparable percentage of 13%.

3. ANALOGUE APPROACH JUSTIFICATION
By far the major part of the highly condensed matrix of Distillates (coal tar), high-temperature, heavy oils (EC no. 310-231-1; CAS no. 140203-21-0) is supposed to be biologically unavailable, as is pitch (coal tar ), the read-across source. This means, both mammalian toxicological profiles are supposed to closely overlap.

Reason / purpose for cross-reference:

read-across source

Principles of method if other than guideline:

Read-across to preceding entry:
Source test material: Pitch (coal tar), high temperature [CAS no. 65996-93-2]
Reference: Sterner/IBR 1987_skin irritation

Irritation parameter:

other: erythema and edema score

Basis:

animal: 1 to 6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

both on the intact and scarified skin

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not 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:

other: Directive 83/467/EEC.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

Electrode binder [CAS No. 65996-93-2]
- Name of test material (as cited in study report): 101.110
- Physical state: solid, black powder

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, Bremerförde/Germany
- Age at study initiation: no data
- Weight at study initiation: 2.4 - 2.6 kg
- Housing: cage, single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >= 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +-2 °C
- Humidity (%): 50 - 86 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Observation period (in vivo):

1, 24, 48, and 72 h post-application

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no, eye not rinsed

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: fluorescein after 24 and 72 h

Irritation parameter:

conjunctivae score

Basis:

animal: #1 - #5

Time point:

other: 1 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 24 h

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

other: 1 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 24 h

Irritation parameter:

chemosis score

Basis:

animal: #1, #3, #4

Time point:

other: 1 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 24 h

Irritation parameter:

chemosis score

Basis:

animal: #2, #5, #6

Time point:

other: 1 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 24 h

Irritant / corrosive response data:

No irritation effects after 24 h (scores 0)

Interpretation of results:

GHS criteria not met

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 target compound, Distillates (coal tar), high-temperature, heavy oils (EC no. 310-231-1; CAS no. 140203-21-0) as well as the read-across (source) compound, pitch (coal tar) [CAS No. 65996-93-2] are coal tar-borne UVCB substances consisting of a complex mixture of polycyclic aromatic hydrocarbons (PAH), predominantly of condensed four to five-ring aromatic ring systems which form a matrix that is practically insoluble in water. The GC-analytical profiles are very similar, and hence will be the physico-chemical and toxicological properties of these structure-related fractions. It is expected that the mammalian systemic and local toxicity of the target compound will not be higher than that of the read-across compound, pitch (coal tar).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The read-across (source) compound, pitch (coal tar), as heavy coal-tar distillate, shows a very similar PAH-profile: This is due to the fact that the considered coal-tar pitch is the high-molecular, "heavy" RESIDUE of a sequential fractionation procedure of coal tar with the temperature increasing, among others under vacuum distillation. On the other hand, the target compound is the high-termperature re-distillate of a high-molecular, heat-treated coal-tar fraction. This is expressed also in the respective fractions of total analysable GC-volatiles which amount to approx. 10% in coal-tar pich, while the GC volatiles of the target compound sum up to a comparable percentage of 13%.

3. ANALOGUE APPROACH JUSTIFICATION
By far the major part of the highly condensed matrix of Distillates (coal tar), high-temperature, heavy oils (EC no. 310-231-1; CAS no. 140203-21-0) is supposed to be biologically unavailable, as is pitch (coal tar ), the read-across source. This means, both mammalian toxicological profiles are supposed to closely overlap.

Reason / purpose for cross-reference:

read-across source

Principles of method if other than guideline:

Read-across to preceding entry:
Source test material: Pitch (coal tar), high temperature [CAS no. 65996-93-2]
Reference: Sterner/IBR 1987_eye irritation

Irritation parameter:

conjunctivae score

Basis:

animal: #1 - #5

Time point:

other: 1 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 24 h

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

other: 1 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 24 h

Irritation parameter:

chemosis score

Basis:

animal: #1 - #5

Time point:

other: 1 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 24 h

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

other: 1 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 24 h

Irritant / corrosive response data:

No irritation effects after 24 h (scores 0)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No particular irritation to skin and eye was noted in experimental standard studies.

However, in the presence of UV-light (UVA), photo-induced human skin irritation was observed under working and experimental conditions (Crow et al. 1961). Human exposure to pitch (identity not specified) within a working environment under bright sunlight resulted in skin irritation. In addition, the same pitch experimentally applied on the skin of human volunteers as chloroform solution caused pronounced skin irritation after radiation with UV-light (UVA). The composition of the pitch utilised may be somewhat different from the registration substance due to differences in production conditions and distillation temperature. Basic constituents and consequentially basic effects will be the same for both substances. Thus, it is justified to use this study (Crow et al. 1961) to indicate possible irritation effects of the target compound under UV-light irradiation.

Justification for classification or non-classification

No irritating effects have been observed after exposure to pitch, coal tar, high-temp., the read-across substance, under standard test conditions. Hence, classification for irritation/corrosion is not required for Distillates (coal tar), high-temperature, heavy oils (EC no. 310-231-1; CAS no. 140203-21-0).

Potential UV-light induced skin irritating effects (see above) are not taken into account for classification, as conditions causing this effect do not correlate to standard test procedures.