Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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.

Data source

Reference
Reference Type:
other: Expert Assessment
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
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

Test material

Constituent 1
Reference substance name:
1,4-xylene; ethylbenzene; toluene
EC Number:
942-492-8
IUPAC Name:
1,4-xylene; ethylbenzene; toluene
Test material form:
liquid

Results and discussion

Test results
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.

Applicant's summary and conclusion

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.