Hydrocarbon waxes (petroleum), oxidized, Me esters

PBT assessment

PBT assessment: overall result

Reference

Name:

Hydrocarbon waxes (petroleum), oxidized, Me esters

Type of composition:

legal entity composition of the substance

State / form:

solid: bulk

Reference substance:

Hydrocarbon waxes (petroleum), oxidized, Me esters

Reference substance:

Hydrocarbon waxes (petroleum), oxidized, Me esters

Reference substance:

Hydrocarbon waxes (petroleum), oxidized, Me esters

Reference substance:

Hydrocarbon waxes (petroleum), oxidized, Me esters

Reference substance:

Hydrocarbon waxes (petroleum), oxidized, Me esters

Reference substance:

Hydrocarbon waxes (petroleum), oxidized, Me esters

Reference substance:

Hydrocarbon waxes (petroleum), oxidized, Me esters

PBT status:

the substance is not PBT / vPvB

Justification:

The test item is a very complex mixture of oxidized species derived from a paraffinic (straight-chain) hydrocarbon slack wax and individual components cannot be isolated in pure form. The product contains only carbon, hydrogen, and oxygen (functional groups include alcohols, carboxylic acids, their condensed esters, and other oxidation products like aldehydes and ketones). There are no aromatic species present. The different chemical classes present in the registered substance contain a fairly broad molecular weight distribution and the substance is a UVCB primarily due to the variation in molecular weight of the constituent esters. The slack wax is itself a UVCB and is predominately composed of linear straight chain hydrocarbons from C18 to C35 in chain length. The oxidized material shows a much broader molecular weight range with carbon numbers from about 5 to 65. The acidic species in the oxidized hydrocarbon are then esterified with methanol. However, the functional groups present in the product (fatty acids, fatty acid methyl esters, fatty esters, and unreacted paraffinic hydrocarbon wax) are not expected to have a significantly different PBT profile. Additionally, since all alkyl groups are derived from a linear chain, they are expected to have a similar PBT profile.In line with ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment, application of the ‘whole substance’ approach is therefore considered suitable.

Persistence

Potentially P or vP

The test item attained only 49 % biodegradation after 28 days (OECD 301B and EU Method C.4-C) and is a complex mixture for which investigation of hydrolysis via OECD 111 and EU Method C.7 is not suitable because solubility is low even in strong organic solvents and no analytical method was available to support the hydrolysis test at low concentration in water. In accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (Version 3.0; June 2017), the substance is considered to be potentially persistent or very persistent.

Bioaccumulation

 

Not B or vB

Log Kow was determined to be > 10.0 using the HPLC method (OECD 117 and EU Method A.8). The substance is not expected to bioaccumulate because, in accordance with ECHA Guidance on information requirements and chemical safety assessment Chapter R11: PBT/vPvB assessment (Version 3.0; November 2017), a decreasing relationship between BCF and Log Kow is observed at high Log Kow (> 6) and the aquatic BCF of a substance is likely to be < 2000 if the Log10 Kow value is higher than 10.

Toxicity

 

Potentially T

Based on available evidence, and in accordance with Regulation (EC) No. 1272/2008, the substance does not meet the criteria for classification as a carcinogen (category 1A or 1B), germ cell mutagen (category 1A or 1B) or reproductive toxin (category 1A, 1B or 2). Furthermore, there is no evidence of chronic toxicity and the substance does not meet the criteria for classification for specific target organ toxicity (STOT RE 1 or STOT RE 2). Results from short-term tests on three trophic levels provide no evidence of environmental toxicity long-term testing is considered to be unnecessary because the Chemical Safety Assessment gives no cause for concern. Nevertheless, the available acute data are considered screening information and cannot be used to definitively conclude not T even though the substance is not classified as environmentally hazardous (see ECHA guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment; Version 3.0, June 2017).

Likely routes of exposure:

Human exposure via the dermal route plus release to the environment via waste water.