Registration Dossier

Diss Factsheets

Administrative data

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.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
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.

Test material

Constituent 1
Reference substance name:
Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped
EC Number:
941-627-8
Molecular formula:
Not Applicable
IUPAC Name:
Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped
Constituent 2
Reference substance name:
Not assigned
IUPAC Name:
Not assigned
Test material form:
other: Liquid
Details on test material:
Name: Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam-stripped

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.