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

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

other: Expert Assessment

Adequacy of study:

key study

Study period:

2021

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: An assessment of the known constituents of the substance was performed to identify those associated with known acute toxicity and STO-SE properties via the inhalation route.

Data source

Reference

Reference Type:

other: Expert Assessment

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The acute toxicity potential and STOT-SE effects of Thermal cracking oil from blends of
rubber, fuel oils and paraffin waxes, steam distillation condensate was evaluated by assessing
the mixture in order to identify the presence of constituents known to be acutely toxic or have
specific target organ effects - single exposure (STOT-SE) via the inhalation route.

GLP compliance:

no

Test type:

other: Expert Assessment

Limit test:

no

Test material

Test material information

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

Effect levels

Dose descriptor:

other: An assessment of the known constituents of the substance was performed to identify those associated with known acute toxicity and STO-SE properties via the inhalation route.

Remarks on result:

other: An assessment of the known constituents of the substance was performed to identify those associated with known acute toxicity and STO-SE properties via the inhalation route.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

It can be concluded that Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate shall be classified as Acute Toxic Category 4
with the Hazard Statement H332: Harmful if inhaled and as STOT-SE Category 3 with the Hazard Statement H336: May cause drowsiness or dizziness.

Executive summary:

The acute toxicity potential and STOT-SE effects of Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate was evaluated by assessing the mixture in order to identify the presence of constituents known to be acutely toxic or have specific target organ effects - single exposure (STOT-SE).

This assessment allowed us to identify 3 constituents (i.e. Ethylbenzene, Styrene and pXylene), classified as Acute Toxic Category 4 via the inhalation route, each present above the 1% cut-off level and 55.33% of other ingredients of unknown toxicity. As such, the equation for the Acute Toxicity Estimate (ATE) Method for classifying a mixture for its acute toxicity when a mixture contains more than 10% of ingredients with unknown toxicity was used.
The calculated ATE of the mixture gave a value of 24.28 mg/ l and was therefore found above the upper limit for Category 4 (20 mg/l). However, since the relevant constituents of the mixture are in a concentration range between ≥ 0.001m - ≤ 20%, we decided to use a worst-case scenario and classify the mixture for Acute Toxicity Category 4 - H332.

Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation
condensate does not contain ingredients classified as STOT-SE Category 1 or 2, however, the mixture does contain above 20% sum of the ingredients classified as STOT-SE category 3 - H336. As such, classification of the mixture as STOT-SE Cat. 3 - H336 is applicable.

It can therefore be concluded that Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate shall be classified as Acute Toxic Category 4 with the Hazard Statement H332: Harmful if inhaled and as STOT-SE Category 3 with the Hazard Statement H336: May cause drowsiness or dizziness.

This assessment was performed using valid available data on all the components of the registered substance, and is considered as sufficient in order to conclude on its classification for acute toxicity via the inhalation route, using the rules laid down in the CLP Regulation. Further testing is not considered required