Registration Dossier

Diss Factsheets

Administrative data

Description of key information

In accordance with Annexes VIII and IX of REACH, Column 2, oral is not the most appropriate route of exposure. The registered substance is only handled on secured industrial sites, under strictly controlled conditions, by professional workers equipped with PPE. Therefore, no oral exposure to the registered substance is expected.
The substance Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped is not considered to be toxic via repeated inhalation exposure based on the potential inhalation effects of selected components of the UVCB substance.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: oral
Data waiving:
exposure considerations
Justification for data waiving:
other:
Critical effects observed:
not specified
Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
In accordance with Annexes VIII and IX of REACH, Column 2, oral is not the most appropriate route of exposure. The registered substance is only handled on secured industrial sites, under strictly controlled conditions, by professional workers equipped with PPE. Therefore, no oral exposure to the registered substance is expected.

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: inhalation
Remarks:
other: expert assessment
Type of information:
other: expert assessment
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: An assessment of the potential inhalation toxicity of components of the UVCB substance has been determined using scientific literature available in the public domain.
Qualifier:
no guideline followed
Principles of method if other than guideline:
An assessment of the potential inhalation toxicity of components of the UVCB substance has been determined using scientific literature available in the public domain.
Critical effects observed:
not specified

A number of components of the UVCB substance Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped were identified as having the highest potential to volatilise and therefore to be the most important components when considering exposure to the UVCB via inhalation.

As can be expected, the majority of studies in the scientific literature focus on exposure via the oral route, and where inhalation exposure was investigated it was often at the acute or subacute level. However, a number of studies on chronic inhalation exposure are available. In the case of benzene it was found that effects could be seen after repeated inhalation exposure but at much higher concentrations than that of the benzene measured in the UVCB substance. Some behavioural effects were noted from daily exposure to toluene, and ethyl benzene was found to show some evidence of carcinogenicity in rats and mice, but no in vitro or in vivo mutagenicity.

Owing to the concentrations of the components present in the UVCB, and the expected limited human exposure via inhalation during normal uses of the substance (the registered substance is only handled on secured industrial sites, by professional workers equiped with PPE), it is concluded that the risk of harm via inhalation of Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped is limited.

Conclusions:
The substance Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped is not considered to be toxic via repeated inhalation exposure based on the potential inhalation effects of selected components of the UVCB substance.
Executive summary:

The toxicity of the substance via repeated inhalation exposure was estimated via an investigation of the most volatile components of the substance. Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped is a UVCB and, for the purpose of this assessment of the potential inhalation toxicity via repeated exposure, it has been treated as a complex mixture. The components of the oil have been considered and those with the highest vapour pressure, and therefore considered most likely to volatilise and be inhaled by exposed persons, have been identified. Available literature in the public domain has been investigated to determine the potential influence of these substances in terms of inhalation toxicity.

Chemical composition

The components of Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped can be divided into several groups, each of which will have specific behaviour and effects.

Component Groups to be investigated for repeated inhalation toxicity:

- Paraffins and saturated cyclic hydrocarbons (4.8%)

- Aromatic hydrocarbons in the range C5 to C8 (5%)

- Low olefinic hydrocarbons (15%)

From the above groups, the representative substances shown in the attached document below have been selected for investigation in the assessment based on their concentration and hazard properties.

As can be expected, the majority of studies in the scientific literature focus on exposure via the oral route, and where inhalation exposure was investigated it was often at the acute or subacute level. However, a number of studies on chronic inhalation exposure are available. In the case of benzene it was found that effects could be seen after repeated inhalation exposure but at much higher concentrations than that of the benzene measured in the UVCB substance. Some behavioural effects were noted from daily exposure to toluene, and ethyl benzene was found to show some evidence of carcinogenicity in rats and mice, but no in vitro or in vivo mutagenicity. Owing to the concentrations of the components present in the UVCB, and the expected limited human exposure via inhalation during normal uses of the substance (the registered substance is only handled on secured industrial sites, by professional workers equipped with PPE), it is concluded that the risk of harm via inhalation of Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped is limited.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Repeated dose toxicity: inhalation - local effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: inhalation
Remarks:
other: expert assessment
Type of information:
other: expert assessment
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: An assessment of the potential inhalation toxicity of components of the UVCB substance has been determined using scientific literature available in the public domain.
Qualifier:
no guideline followed
Principles of method if other than guideline:
An assessment of the potential inhalation toxicity of components of the UVCB substance has been determined using scientific literature available in the public domain.
Critical effects observed:
not specified

A number of components of the UVCB substance Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped were identified as having the highest potential to volatilise and therefore to be the most important components when considering exposure to the UVCB via inhalation.

As can be expected, the majority of studies in the scientific literature focus on exposure via the oral route, and where inhalation exposure was investigated it was often at the acute or subacute level. However, a number of studies on chronic inhalation exposure are available. In the case of benzene it was found that effects could be seen after repeated inhalation exposure but at much higher concentrations than that of the benzene measured in the UVCB substance. Some behavioural effects were noted from daily exposure to toluene, and ethyl benzene was found to show some evidence of carcinogenicity in rats and mice, but no in vitro or in vivo mutagenicity.

Owing to the concentrations of the components present in the UVCB, and the expected limited human exposure via inhalation during normal uses of the substance (the registered substance is only handled on secured industrial sites, by professional workers equiped with PPE), it is concluded that the risk of harm via inhalation of Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped is limited.

Conclusions:
The substance Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped is not considered to be toxic via repeated inhalation exposure based on the potential inhalation effects of selected components of the UVCB substance.
Executive summary:

The toxicity of the substance via repeated inhalation exposure was estimated via an investigation of the most volatile components of the substance. Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped is a UVCB and, for the purpose of this assessment of the potential inhalation toxicity via repeated exposure, it has been treated as a complex mixture. The components of the oil have been considered and those with the highest vapour pressure, and therefore considered most likely to volatilise and be inhaled by exposed persons, have been identified. Available literature in the public domain has been investigated to determine the potential influence of these substances in terms of inhalation toxicity.

Chemical composition

The components of Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped can be divided into several groups, each of which will have specific behaviour and effects.

Component Groups to be investigated for repeated inhalation toxicity:

- Paraffins and saturated cyclic hydrocarbons (4.8%)

- Aromatic hydrocarbons in the range C5 to C8 (5%)

- Low olefinic hydrocarbons (15%)

From the above groups, the representative substances shown in the attached document below have been selected for investigation in the assessment based on their concentration and hazard properties.

As can be expected, the majority of studies in the scientific literature focus on exposure via the oral route, and where inhalation exposure was investigated it was often at the acute or subacute level. However, a number of studies on chronic inhalation exposure are available. In the case of benzene it was found that effects could be seen after repeated inhalation exposure but at much higher concentrations than that of the benzene measured in the UVCB substance. Some behavioural effects were noted from daily exposure to toluene, and ethyl benzene was found to show some evidence of carcinogenicity in rats and mice, but no in vitro or in vivo mutagenicity. Owing to the concentrations of the components present in the UVCB, and the expected limited human exposure via inhalation during normal uses of the substance (the registered substance is only handled on secured industrial sites, by professional workers equipped with PPE), it is concluded that the risk of harm via inhalation of Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped is limited.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
An assessment of the potential inhalation toxicity of components of the UVCB substance has been determined using scientific literature available in the public domain.

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: dermal
Remarks:
other: expert assessment
Type of information:
other: Expert assessment
Adequacy of study:
key study
Study period:
2016
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: An assessment was conducted based on an examination of the toxicological properties of the components of the UVCB, supported by data from a read-across substance.
Qualifier:
no guideline followed
Principles of method if other than guideline:
An assessment was conducted based on an examination of the toxicological properties of the components of the UVCB, supported by data from a read-across substance.
GLP compliance:
no
Limit test:
no
Dose descriptor:
NOAEL
Effect level:
25 mg/kg bw/day
Based on:
other: expert assessment
Sex:
male/female
Critical effects observed:
not specified

The UVCB substance Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped has been assessed for potential local and systemic effects following a repeated exposure by the dermal route. Public data derived from other light fuel oils have been used, together with an assessment of components known to be present in the UVCB.

According to Feuston et al. (1994), there is a correlation between composition of a gas oil and local and systemic effects following a repeated dermal exposure. They highlighted a correlation between 2-ring aromatic compounds and local dermal effects, while aromatic compounds with 3 rings or more were more associated with systemic toxicity, and no correlation could be determined between toxic effects and the contend of the substances in 1-ring aromatic and nonaromatic compounds. Considering that Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped is mainly composed of 1- and 2-ring aromatics compounds, it is expected to be associated with local effects, while potential systemic effects would be driven by 1-ring aromatic and nonaromatic compounds.

According to the Lower Olefins and Aromatics REACH Consortium (2010), Benzene, Toluene, Ethyl benzene, and Styrene are expected to drive the toxicological effects of the registered substance following a repeated dermal exposure. However, they are only present at inconsequential, and therefore are not expected to induce significant systemic effects.

Limited information on the toxicity of the other compounds are available regarding the dermal route. Limonene is the identified individual compound present in the most important proportion, and is known to be a skin sensitiser but not for inducing systemic effects following a dermal exposure.

A subchronic toxicity study by dermal route has been performed on rats using the read-across substance Distillates (petroleum), light catalytic crack (API, 2012). Doses of 8, 25, 125, 500 and 1250 mg/kg bw of the substance were applied daily, 5 days a week, for 13 weeks (only 2 weeks for the group dosed at 120 mg/kg bw) with 10 animals/sex/dose. A skin irritation was observed in all the treated groups, with an increasing severity depending on the doses, which is expected considering the findings of Feuston et al. (1994). A significant reduction of bodyweight was observed at 500 mg/kg bw in females and at 125 and 500 mg/kg bw in males. Reduction of haemoglobin and haematocrit was observed at 500 mg/kg bw for both males and females. Reduction of several organs weight (including thymus) and increase of other organs weight (including liver) were observed at 125 and 500 mg/kg bw in males and at 500 mg/kg bw females.

It was therefore concluded that the NOAEL was 25 mg/kg bw for males and females, regarding local and systemic effects.

Considering that Distillates (petroleum), light catalytic cracked contains more 3-ring and more aromatic compounds when compared to the Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped, and that the composition of the registered substance contains a low quantity of substances known to induce systemic effects following a dermal exposure, the NOAEL of 25 mg/kg bw derived for the read-across substance may be considered as conservative, and may be applied to the registered substance.

Conclusions:
Considering the toxicological properties of the components of the registered substance and the information derived from studies performed on a read-across substance, it has been proposed a NOAEL of 25 mg/kg bw for the registered. It has considered to be a conservative value.
Executive summary:

The UVCB substance Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped has been assessed for potential local and systemic effects following a repeated exposure by the dermal route. Public data derived from other light fuel oils have been used, together with an assessment of components known to be present in the UVCB.

This approach was considered as relevant as Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped is only used on secured industrial sites, under controlled conditions, by professional workers equipped with PPE. Therefore, only a limited exposure is expected by dermal route, which does not justify performing animal testing to evaluate the toxicity of the registered following a repeated dermal exposure.

According to Feuston et al. (1994), there is a correlation between composition of a gas oil and local and systemic effects following a repeated dermal exposure. They highlighted a correlation between 2-ring aromatic compounds and local dermal effects, while aromatic compounds with 3 rings or more were more associated with systemic toxicity, and no correlation could be determined between toxic effects and the contend of the substances in 1-ring aromatic and nonaromatic compounds. Considering that Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped is mainly composed of 1- and 2-ring aromatics compounds, it is expected to be associated with local effects, while potential systemic effects would be driven by 1-ring aromatic and nonaromatic compounds.

According to the Lower Olefins and Aromatics REACH Consortium (2010), Benzene, Toluene, Ethyl benzene, and Styrene are expected to drive the toxicological effects of the registered substance following a repeated dermal exposure. However, they are only present at inconsequential concentrations, and therefore are not expected to induce significant systemic effects. Limited information on the toxicity of the other compounds are available regarding the dermal route. Limonene is the identified individual compound present in the most important proportion, and is known to be a skin sensitiser but not for inducing systemic effects following a dermal exposure.

A subchronic toxicity study by dermal route has been performed on rats using the read-across substance Distillates (petroleum), light catalytic cracked (API, 2012). Doses of 8, 25, 125, 500 and 1250 mg/kg bw of the substance were applied daily, 5 days a week, for 13 weeks (only 2 weeks for the group dosed at 120 mg/kg bw) with 10 animals/sex/dose. A skin irritation was observed in all the treated groups, with an increasing severity depending on the doses. A significant reduction of bodyweight was observed at 500 mg/kg bw in females and at 125 and 500 mg/kg bw in males. Reduction of haemoglobin and haematocrit was observed at 500 mg/kg bw for both males and females. Reduction of several organs weight (including thymus) and increase of other organs weight (including liver) were observed at 125 and 500 mg/kg bw in males and at 500 mg/kg bw females.It was therefore concluded that the NOAEL was 25 mg/kg bw for males and females, regarding local and systemic effects.

Considering that Distillates (petroleum), light catalytic cracked contains more 3-ring and more aromatic compounds when compared to the Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped, and that the composition of the registered substance contains a low quantity of substances known to induce systemic effects following a dermal exposure, the NOAEL of 25 mg/kg bw derived for the read-across substance may be considered as conservative, and may be applied to the registered substance.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
25 mg/kg bw/day
Study duration:
subacute
Species:
other: expert assessment based on data available on different species

Repeated dose toxicity: dermal - local effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: dermal
Remarks:
other: expert assessment
Type of information:
other: Expert assessment
Adequacy of study:
key study
Study period:
2016
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: An assessment was conducted based on an examination of the toxicological properties of the components of the UVCB, supported by data from a read-across substance.
Qualifier:
no guideline followed
Principles of method if other than guideline:
An assessment was conducted based on an examination of the toxicological properties of the components of the UVCB, supported by data from a read-across substance.
GLP compliance:
no
Limit test:
no
Dose descriptor:
NOAEL
Effect level:
25 mg/kg bw/day
Based on:
other: expert assessment
Sex:
male/female
Critical effects observed:
not specified

The UVCB substance Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped has been assessed for potential local and systemic effects following a repeated exposure by the dermal route. Public data derived from other light fuel oils have been used, together with an assessment of components known to be present in the UVCB.

According to Feuston et al. (1994), there is a correlation between composition of a gas oil and local and systemic effects following a repeated dermal exposure. They highlighted a correlation between 2-ring aromatic compounds and local dermal effects, while aromatic compounds with 3 rings or more were more associated with systemic toxicity, and no correlation could be determined between toxic effects and the contend of the substances in 1-ring aromatic and nonaromatic compounds. Considering that Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped is mainly composed of 1- and 2-ring aromatics compounds, it is expected to be associated with local effects, while potential systemic effects would be driven by 1-ring aromatic and nonaromatic compounds.

According to the Lower Olefins and Aromatics REACH Consortium (2010), Benzene, Toluene, Ethyl benzene, and Styrene are expected to drive the toxicological effects of the registered substance following a repeated dermal exposure. However, they are only present at inconsequential, and therefore are not expected to induce significant systemic effects.

Limited information on the toxicity of the other compounds are available regarding the dermal route. Limonene is the identified individual compound present in the most important proportion, and is known to be a skin sensitiser but not for inducing systemic effects following a dermal exposure.

A subchronic toxicity study by dermal route has been performed on rats using the read-across substance Distillates (petroleum), light catalytic crack (API, 2012). Doses of 8, 25, 125, 500 and 1250 mg/kg bw of the substance were applied daily, 5 days a week, for 13 weeks (only 2 weeks for the group dosed at 120 mg/kg bw) with 10 animals/sex/dose. A skin irritation was observed in all the treated groups, with an increasing severity depending on the doses, which is expected considering the findings of Feuston et al. (1994). A significant reduction of bodyweight was observed at 500 mg/kg bw in females and at 125 and 500 mg/kg bw in males. Reduction of haemoglobin and haematocrit was observed at 500 mg/kg bw for both males and females. Reduction of several organs weight (including thymus) and increase of other organs weight (including liver) were observed at 125 and 500 mg/kg bw in males and at 500 mg/kg bw females.

It was therefore concluded that the NOAEL was 25 mg/kg bw for males and females, regarding local and systemic effects.

Considering that Distillates (petroleum), light catalytic cracked contains more 3-ring and more aromatic compounds when compared to the Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped, and that the composition of the registered substance contains a low quantity of substances known to induce systemic effects following a dermal exposure, the NOAEL of 25 mg/kg bw derived for the read-across substance may be considered as conservative, and may be applied to the registered substance.

Conclusions:
Considering the toxicological properties of the components of the registered substance and the information derived from studies performed on a read-across substance, it has been proposed a NOAEL of 25 mg/kg bw for the registered. It has considered to be a conservative value.
Executive summary:

The UVCB substance Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped has been assessed for potential local and systemic effects following a repeated exposure by the dermal route. Public data derived from other light fuel oils have been used, together with an assessment of components known to be present in the UVCB.

This approach was considered as relevant as Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped is only used on secured industrial sites, under controlled conditions, by professional workers equipped with PPE. Therefore, only a limited exposure is expected by dermal route, which does not justify performing animal testing to evaluate the toxicity of the registered following a repeated dermal exposure.

According to Feuston et al. (1994), there is a correlation between composition of a gas oil and local and systemic effects following a repeated dermal exposure. They highlighted a correlation between 2-ring aromatic compounds and local dermal effects, while aromatic compounds with 3 rings or more were more associated with systemic toxicity, and no correlation could be determined between toxic effects and the contend of the substances in 1-ring aromatic and nonaromatic compounds. Considering that Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped is mainly composed of 1- and 2-ring aromatics compounds, it is expected to be associated with local effects, while potential systemic effects would be driven by 1-ring aromatic and nonaromatic compounds.

According to the Lower Olefins and Aromatics REACH Consortium (2010), Benzene, Toluene, Ethyl benzene, and Styrene are expected to drive the toxicological effects of the registered substance following a repeated dermal exposure. However, they are only present at inconsequential concentrations, and therefore are not expected to induce significant systemic effects. Limited information on the toxicity of the other compounds are available regarding the dermal route. Limonene is the identified individual compound present in the most important proportion, and is known to be a skin sensitiser but not for inducing systemic effects following a dermal exposure.

A subchronic toxicity study by dermal route has been performed on rats using the read-across substance Distillates (petroleum), light catalytic cracked (API, 2012). Doses of 8, 25, 125, 500 and 1250 mg/kg bw of the substance were applied daily, 5 days a week, for 13 weeks (only 2 weeks for the group dosed at 120 mg/kg bw) with 10 animals/sex/dose. A skin irritation was observed in all the treated groups, with an increasing severity depending on the doses. A significant reduction of bodyweight was observed at 500 mg/kg bw in females and at 125 and 500 mg/kg bw in males. Reduction of haemoglobin and haematocrit was observed at 500 mg/kg bw for both males and females. Reduction of several organs weight (including thymus) and increase of other organs weight (including liver) were observed at 125 and 500 mg/kg bw in males and at 500 mg/kg bw females.It was therefore concluded that the NOAEL was 25 mg/kg bw for males and females, regarding local and systemic effects.

Considering that Distillates (petroleum), light catalytic cracked contains more 3-ring and more aromatic compounds when compared to the Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped, and that the composition of the registered substance contains a low quantity of substances known to induce systemic effects following a dermal exposure, the NOAEL of 25 mg/kg bw derived for the read-across substance may be considered as conservative, and may be applied to the registered substance.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
0.14 mg/cm²
Study duration:
subacute
Species:
other: expert assessment based on data available on different species

Additional information

The toxicity of the substance via repeated inhalation exposure was estimated via an investigation of the most volatile components of the substance. Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped is a UVCB and, for the purpose of this assessment of the potential inhalation toxicity via repeated exposure, it has been treated as a complex mixture. The components of the oil have been considered and those with the highest vapour pressure, and therefore considered most likely to volatilise and be inhaled by exposed persons, have been identified. Available literature in the public domain has been investigated to determine the potential influence of these substances in terms of inhalation toxicity.

The components of Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped can be divided into several groups, each of which will have specific behaviour and effects.

Component Groups to be investigated for repeated inhalation toxicity:

- Paraffins and saturated cyclic hydrocarbons (4.8%)

- Aromatic hydrocarbons in the range C5 to C8 (5%)

- Low olefinic hydrocarbons (15%)

From the above groups, the representative substances shown in the attached document below have been selected for investigation in the assessment based on their concentration and hazard properties.

As can be expected, the majority of studies in the scientific literature focus on exposure via the oral route, and where inhalation exposure was investigated it was often at the acute or subacute level. However, a number of studies on chronic inhalation exposure are available. In the case of benzene it was found that effects could be seen after repeated inhalation exposure but at much higher concentrations than that of the benzene measured in the UVCB substance. Some behavioural effects were noted from daily exposure to toluene, and ethyl benzene was found to show some evidence of carcinogenicity in rats and mice, but no in vitro or in vivo mutagenicity. Owing to the concentrations of the components present in the UVCB, and the expected limited human exposure via inhalation during normal uses of the substance (i.e. the substance is added to the fuel tanks of ships), it is concluded that the risk of harm via inhalation of Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped is limited.

The UVCB substance Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped has been assessed for potential local and systemic effects following a repeated exposure by the dermal route. Public data derived from other light fuel oils have been used, together with an assessment of components known to be present in the UVCB.

This approach was considered as relevant as Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped is only used on secured industrial sites, under controlled conditions, by professional workers equipped with PPE. Therefore, only a limited exposure is expected by dermal route, which does not justify performing animal testing to evaluate the toxicity of the registered following a repeated dermal exposure.

According to Feuston et al. (1994), there is a correlation between composition of a gas oil and local and systemic effects following a repeated dermal exposure. They highlighted a correlation between 2-ring aromatic compounds and local dermal effects, while aromatic compounds with 3 rings or more were more associated with systemic toxicity, and no correlation could be determined between toxic effects and the contend of the substances in 1-ring aromatic and nonaromatic compounds. Considering that Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped is mainly composed of 1- and 2-ring aromatics compounds (70%), it is expected to be associated with local effects, while potential systemic effects would be driven by 1-ring aromatic and nonaromatic compounds.

According to the Lower Olefins and Aromatics REACH Consortium (2010), Benzene, Toluene, Ethyl benzene, and Styrene are expected to drive the toxicological effects of the registered substance following a repeated dermal exposure, which, based on the toxicological profile of these compounds, would be expected as targeting primarily the central nervous system, the hematopoietic system, the liver, and the lungs, with a possible increase of the frequency of cancer. However, they are only present at respectively 18 ppm, 0.60%, 0.60%, and 0.50%, and therefore are not expected to induce significant systemic effects. Limited information on the toxicity of the other compounds are available regarding the dermal route. Limonene is the identified individual compound present in the most important proportion (8.4%), and is known to be a skin sensitiser but not for inducing systemic effects following a dermal exposure.

A subchronic toxicity study by dermal route has been performed on rats using the read-across substance Distillates (petroleum), light catalytic cracked (API, 2012). A skin irritation was observed in all the treated groups, with an increasing severity depending on the doses. A significant reduction of bodyweight was observed at 500 mg/kg bw in females and at 125 and 500 mg/kg bw in males. Reduction of haemoglobin and haematocrit was observed at 500 mg/kg bw for both males and females. Reduction of several organs weight (including thymus) and increase of other organs weight (including liver) were observed at 125 and 500 mg/kg bw in males and at 500 mg/kg bw females.It was therefore concluded that the NOAEL was 25 mg/kg bw for males and females, regarding local and systemic effects.

Considering that Distillates (petroleum), light catalytic cracked contains more 3-ring and more aromatic compounds when compared to the Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped, and that the composition of the registered substance contains a low quantity of substances known to induce systemic effects following a dermal exposure, the NOAEL of 25 mg/kg bw derived for the read-across substance may be considered as conservative, and may be applied to the registered substance.


Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
An assessment of the potential inhalation toxicity of components of the UVCB substance has been determined using scientific literature available in the public domain.

Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
An assessment of the potential inhalation toxicity of components of the UVCB substance has been determined using scientific literature available in the public domain.

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
An assessment was conducted based on an examination of the toxicological properties of the components of the UVCB, supported by data from a read-across substance.

Justification for selection of repeated dose toxicity dermal - local effects endpoint:
An assessment was conducted based on an examination of the toxicological properties of the components of the UVCB, supported by data from a read-across substance.

Justification for classification or non-classification

There are limited repeat dose toxicity data on any of the specific streams identified for this category. However, there are substantial data on the repeated dose toxicity of a number of specific components present in some streams i.e. benzene, toluene, ethylbenzene and styrene which demonstrate significant target organ toxicity in order to classify the substance as STOT RE. 2; H373. This approach is considered as conservative as there is a low percentage of Toluene and Napthalene in the registered substance.

Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen, which justify the classification of the registered substance as STOT SE. 3; H336. This approach is considered as conservative as there is a low percentage of Toluene in the registered substance.