Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation concentrate

Endpoint summary

Description of key information

Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate was identified as being Skin Sens. 1; H317 owing to its Limonene content.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation, other

Type of information:

other: Expert assessment

Adequacy of study:

key study

Study period:

11 Feb 2019

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: An assessment was undertaken based on the identification of constituents of the susbtance known to be sensitising to the skin.

Qualifier:

no guideline required

Principles of method if other than guideline:

An assessment of the composition of the substance was performed to identify the presence of molecules known to be skin sensitisers.

GLP compliance:

no

Type of study:

other: Expert assessment

Remarks on result:

other: An assessment was undertaken based on the identification of constituents of the susbtance known to be sensitising to the skin.

Assessment of the constituents outlined amongst the olefins and cyclic olefins, Limonene (CAS 138-86-3 / EC 205-341-0) also known as dipentene. Limonene has a Harmonised Classification as a Skin Sens.1; H3172, meaning that its presence in a mixture at ≥ 1 % would result in the mixture being classified as Skin Sens. 1 in accordance with the CLP Regulation.

Limonene is present in the analysed sample of Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate at ≥ 1 % with a maximum concentration of 15%, and therefore over the threshold concentration for classification as a skin sensitiser.

Furthermore, any C10 olefin constituent present in the substance may be a terpene, whose oxidation products are often associated with skin sensitisation properties. Therefore, based on the understanding that all the constituents with a molecular formula of C10H16 may be terpenes, the substance was further assessed. Suspected terpenes are present in the substance at ≥ 1 %, with a maximum of 10% for any single constituent. However, it cannot be concluded based on the available information that these constituents are oxidisable terpenes. Therefore, although they can be suspected of being skin sensitisers, no conclusion can be reached. No other constituents were found to be classified skin sensitisers or suspected to be skin sensitiser. Since the concentration of constituents within the mixture classified as skin sensitiser is ≥ 1 % in the sample characterised, it can be concluded that Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate shall be classified as Skin Sens. 1; H317 in accordance with Regulation (EC) No 1272/20083.

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

Conclusions:

Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate was identified as being Skin Sens. 1; H317 owing to its Limonene content.

Executive summary:

The skin sensitising potential of Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate was evaluated by assessing the substance to identify the presence of constituents known to be sensitising to the skin. This assessment allowed to identify Limonene as a substance classified as a skin sensitiser (Skin Sens. 1; H317), and present in Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate at concentrations up to 15%. Furthermore, suspected terpenes were found to be present at up to 10% for each constituent, however it was not possible to confirm their identity and properties based on the available information. In accordance with the CLP Regulation, since Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate is including more than 1% of substances classified as skin sensitiser, it shall be classified as Skin Sens. 1 with the Hazard Statement H317: May cause an allergic skin reaction.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Assessment of the constituents outlined amongst the olefins and cyclic olefins, Limonene (CAS 138-86-3 / EC 205-341-0) also known as dipentene. Limonene has a Harmonised Classification as a Skin Sens.1; H3172, meaning that its presence in a mixture at ≥ 1 % would result in the mixture being classified as Skin Sens. 1 in accordance with the CLP Regulation. Limonene is present in the analysed sample of Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate at ≥ 1 % with a maximum concentration of 15%, and therefore over the threshold concentration for classification as a skin sensitiser. Furthermore, any C10 olefin constituent present in the substance may be a terpene, whose oxidation products are often associated with skin sensitisation properties. Therefore, based on the understanding that all the constituents with a molecular formula of C10H16 may be terpenes, the substance was further assessed. Suspected terpenes are present in Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate at ≥ 1 % in total, with a maximum of 10% for any single constituent. However, it cannot be concluded based on the available information that these constituents are oxidisable terpenes. Therefore, although they can be suspected of being skin sensitisers, no conclusion can be reached.

No other constituents were found to be classified skin sensitisers or suspected to be skin sensitiser. Since the concentration of constituents within the mixture classified as skin sensitiser is ≥ 1 % in the sample characterised (with a maximum concentration of 15%), it can be concluded that Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate shall be classified as Skin Sens. 1; H317 in accordance with Regulation (EC) No 1272/20083.

Justification for classification or non-classification

Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate shall be classified as Skin Sens. 1; H317 in accordance with Regulation (EC) No 1272/2008.