Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Available data for 4 specific streams within this category [Carbon Black Oil (CAS 64742-90-1), E000014200 (CAS 68475-80-9), Rohnaphthalin-Gemisch (CAS 85117-10-8), Quenchoel (CAS 98072-36-7)], further information included in the Category Summary for Fuel Oils Category (ACC, 2005), and on specific components that are present in some streams (benzene, toluene, ethylbenzene, styrene, biphenyl and anthracene) indicate that Fuel Oils should be considered to be skin irritants. There is some evidence of eye irritation with controlled exposures to liquid test substances although the severity varies widely. Ethylbenzene and biphenyl are also considered to be respiratory irritants. The need for labelling with respect to eye and respiratory irritation is dependent upon available data for the specific stream or the concentration of benzene or biphenyl in the stream.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Non-human information

Skin irritation

The streams E000014200 (CAS 68475-80-9), Rohnaphthalin-Gemisch (CAS 85117-10-8) and Quenchoel (CAS 98072-36-7) have been tested in animal studies and shown to be irritating but not corrosive to rabbit skin, whereas Carbon Black Oil (CAS 64742-90-1) produced only minor effects which showed full recovery and no classification is warranted. Data on the specific components benzene, toluene, ethylbenzene, styrene, biphenyl and anthracene indicate some irritation following dermal contact with effects sufficiently severe to warrant classification.

Eye irritation

Data on the streams Carbon Black Oil (CAS 64742-90-1), E000014200 (CAS 68475-80-9), Rohnaphthalin-Gemisch (CAS 85117-10-8), Quenchoel (CAS 98072-36-7) and on specific components toluene and anthracene indicate that instillation of liquid test substance into the eye may induce some evidence of eye irritation but not of a severity that warrants classification. For benzene, ethylbenzene, styrene and biphenyl the effects are sufficient to warrant classification.

Respiratory irritation

There are no specific data on any of the streams but two component substances (ethylbenzene and biphenyl) are considered to be irritating to the respiratory tract. For ethylbenzene RD50 values of 1432 or 4060 ppm (6215 to 17620 mg/m3) for sensory irritation were determined in different strains of mice (EU, 2008b).

Human information

There is no specific human information concerning skin or eye irritation on any of the streams or on the majority of specific components identified as present in some streams. Specific information of value to the risk assessment is available for benzene and toluene:

Benzene (Classification: EU -Harmful Xi, R36, R38; GHS/CLP - Category 2 H319, Category 2 H315): Liquid benzene on direct contact with the skin may cause erythema and blistering. Skin contact with benzene removes fat from the tissue which may result in the development of a dry, scaly dermatitis if exposure is repeated or prolonged. High concentrations of benzene vapours are irritating to the mucous membranes of the eyes, nose and respiratory tract (EU, 2008a).

Toluene (Classification: EU -Harmful Xi, R38; GHS/CLP - Category 2 H315): No data on skin irritation have been found. The EU RAR (2003a) stated “it is well known that toluene has a degreasing effect on the skin. After repeated exposures, toxic contact dermatitis may develop. ” There are no data from direct exposure of human eyes to liquid toluene. A number of human experimental studies in volunteers have investigated reports of eye “irritation” resulting from exposures to toluene in ambient air. These studies indicate that toluene produces subjective sensations of eye irritation at concentrations ≥ 75 ppm (EU, 2003a). In a recent study, Muttray et al (2005) exposed twenty healthy men to a constant level of 50 ppm toluene. Acute symptoms related to eye irritation were assessed with the Swedish Performance Evaluation System (SPES) self-assessment questionnaire, once before and 3 times during exposure. Values obtained during exposure were related to pre-exposure values. There was no effect of toluene exposure on "irritation to the eye", "watering eyes" or "blurred vision”. 50 ppm (188 mg/m3) toluene is a NOAEC for eye irritation in humans.

References

EU (2008a). European Union Risk Assessment Report for Benzene. EC Joint Research Centre. http: //ecb. jrc. ec. europa. eu/documents/Existing-chemicals/RISK_ASSESSMENT/REPORT/benzenereport063.pdf

EU (2003a). European Union Risk Assessment Report for Toluene. EC Joint Research centre. http://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing-Chemicals/RISK_ASSESSMENT/REPORT/toluenereport032.pdf


Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Data on the streams E000014200 (CAS 68475-80-9), Rohnaphthalin-Gemisch (CAS 85117-10-8) and Quenchoel (CAS 98072-36-7) and on the component substances benzene, toluene, ethylbenzene, styrene, biphenyl and anthracene demonstrate that they are irritating to rabbit skin. Data on one stream (Carbon Black Oil [CAS 64742-90-1]) indicate that it produces only minor evidence of skin irritation. Classification with respect to skin irritation is required for any Fuel Oils streams that have a combined total concentration of irritating components ≥10% (CLP) or ≥20% (DPD). Based on the available irritation data and the likelihood, based on compositional information, that the combined concentrations of irritating components will exceed these cut-offs it is proposed that all Fuel Oils stream are classified as skin irritants as follows: “Irritating to skin” Xi R38 according to Dir 1999/45/EC and “Causes skin irritation” Category 2 H315 according to Reg (EC) 1272/2008.

Information on tested streams (Carbon Black Oil [CAS 64742-90-1], E000014200 [CAS 68475-80-9], Rohnaphthalin-Gemisch [CAS 85117-10-8] and Quenchoel [CAS 98072-36-7]) and on the component substances toluene, naphthalene and anthracene indicate that they are not irritant to the eye and so these streams and streams that only contain these substances will not need to be classified for eye irritating properties.

Benzene, styrene and biphenyl are classified as irritating to the eye. Fuel Oils streams containing ≥10% benzene, styrene, or biphenyl as a total combined concentration should be labelled for eye irritation “Causes serious eye irritation” Category 2 H319 under Reg (EC) 1272/2008. When the total combined concentration of these components is ≥20% or when styrene is ≥12.5%, the stream will need to be labelled “Irritating to eyes” Xi R36 according to Dir 1999/45/EC.

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Biphenyl is classified as irritating to the respiratory tract. Fuel Oils streams containing ≥10% biphenyl should be classified “May cause respiratory irritation” Category 3 H335 under Reg (EC) 1272/2008. When the concentration is ≥20% the stream will need to be classified as “Irritating to respiratory system” Xi R37 according to Dir 1999/45/EC.

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