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

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Waived based on the availablility of an expert assessment for in vivo genotoxicity.

Link to relevant study records

Reference

Reference 1

Endpoint:

in vitro cytogenicity / micronucleus study

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Reference 2

Endpoint:

in vitro gene mutation study in mammalian cells

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Reference 3

Endpoint:

in vitro gene mutation study in bacteria

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (positive)

Genetic toxicity in vivo

Link to relevant study records

Reference

Endpoint:

genetic toxicity in vivo, other

Type of information:

other: Expert assessment

Adequacy of study:

key study

Study period:

18 March 2019

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: An assessment of the known mutagenic properties of the constituents of the substance was performed.

Qualifier:

no guideline required

Principles of method if other than guideline:

An assessment of the constituents was performed to identify whose associated to known mutagenic properties.In line with Regulation (EC) No 1272/2008, when data are existing on the constituents of a substance, it may be possible to use a mixture-based approach to conclude on its classification.

GLP compliance:

no

Type of assay:

other: Expert assessment

Key result

Sex:

male/female

Genotoxicity:

positive

Toxicity:

not specified

Vehicle controls validity:

not applicable

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Remarks on result:

other:

Remarks:

Benzene constituent associated to known mutagenic properties and classified as a category 1B mutagen, and present in the substance at concentrations up to 10%. therefore is may be concluded that the substance shall be classified as Muta. 1B; H340 in accordance with the CLP Regulation.

Conclusions:

Following an expert assessment of the consituents of Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate, it shall be classified as Muta. 1B; H340 in accordance with the CLP Regulation.

Executive summary:

The mutagenic 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 Benzene which has a harmonised classification, classified as Muta. 1B; H3403 in accordance with the CLP Regulation and present in Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate at concentrations up to 10%. In accordance with the CLP Regulation, since Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate is including ≥0.1% of substances classified as Muta.1B, it shall be classified as Muta. 1B; H340 with the Hazard Statement: May cause genetic defects.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (positive)

Justification for classification or non-classification

Following an expert assessment of the consituents of Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate, it shall be classified as Muta. 1B; H340 in accordance with the CLP Regulation.