Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Based on the available information it can be concluded that the substance fulfills the P criterion, but not the B/vB nor the T criteria, and hence can not be assessed as PBT or vPvB.

Persistence

While the registered substance was not readily biodegradable in the OECD 301B test, it did show 45% degradation in 28 days.  It is assessed as P but not vP.  

BIOWIN modeling of a representative structure of the registered substance shows the following results:

•       BIOWIN6 (MITI non-linear model): 0.6479

•       BIOWIN3 (ultimate survey model): 2.7198 (weeks-months)

•       Ready biodegradability prediction: No

These values indicate that the registered substance may be potentially P but not vP.

This is further borne out by Fugacity Level 3 modelling (EPI Suite v4.00-4.11) of a representative structure of the TS, which shows that it is expected to partition preferentially into soil (82.5 %) and then water (17.5 %), with estimated half-lives of 75 and 37.5 days respectively, which are both below the respective Annex XIII criteria of 120 and 40 days respectively.  The use of multi-media modelling is allowed in ECHA guidance on PBT/vPvB assessment (Chapter R.11: PBT/vPvB assessment, v3.0 (June 2017).

Bioaccumulation

Two log Kow studies have been conducted on Alkenes, C15-18 α-, sulfurized conducted according to OECD 117. In the first study, the log Kow was determined to be >9.4; the highest log Kow of reference standards (1-phenyltridecane) established by HPLC at the time. In the second study, 1-phenyltetradecane was also used as a reference standard, and has a log Kow of 10. The log Kow was determined to be greater than this reference standard. Therefore, the log Kow of Alkenes, C15-18 α-, sulfurized was established as >10. ECHA Chapter R.11: PBT/vPvB assessment states: "The aquatic BCF of a substance is probably lower than 2000 if the calculated log Kow is higher than 10”. On this basis, the BCF of Alkenes, C15-18 α-, sulfurized is considered to be <2000.

ECHA Chapter R.11: PBT/vPvB assessment states “From one study of a diverse set of substances it appeared that for compounds with a DMAXaver larger than 1.7 nm the BCF value will be less than 2000”. DMAXaver for representative structures, with the exception of one structure, were >1.7 nm. Therefore, it can be considered that, based on molecular diameter, they will not bioaccumulate. The other structure has a DMAXaver value of 1.6 nm. This is very slightly below the threshold. However, it should be noted that this is not an ‘absolute’ limit, and therefore, it is considered that bioaccumulation of this structure is unlikely.

However, further investigation was conducted using QSARs. QSARs indicate that all of the representative structures are not bioaccumulative (BCFs <10 L/kg).

The toxicity data are also experimental indicators for hinderance of uptake of this substance. A range mammalian toxicity studies have been performed, crucially, including an OECD 408 90-day oral toxicity study in rodents. In all studies, no effects were seen at the maximum dose tested (1000 mg/kg bw/day). This lack of effects is indicative of very low uptake of the test substance. Therefore, it can be concluded that bioaccumulation is unlikely to occur.

Therefore, the substance is not considered B or vB.

Toxicity

A chronic fish study in fathead minnow (Pimephales promelas) in accordance with OECD 210, "Fish, Early-Life Stage Toxicity Test”. Over the duration of the test there were no significant mortalities or sub-lethal effects of exposure resulting from the exposure of the early-life stages of fathead minnow (Pimephales promelas) larvae up to a test concentration of 100 mg/L loading rate WAF. A 33-day EL10 of >100 mg/L WAF was determined.

A chronic invertebrate study was performed with Daphnia magna in accordance with OECD 211, "Daphnia magna Reproduction Test". Due to the low aqueous solubility and complex nature of the test item, the test medium was prepared as a Water Accommodated Fraction (WAF). A 21-day EL10 of >100 mg/L was established.

Therefore, the test substance is not T based on EC10/NOEC values >0.01 mg/L.

There was no evidence of toxicity at all three trophic levels was observed in short-term aquatic studies up to 100 mg/L, i.e. E(L)L50s are > 100mg/L.

The substance is not classified with regard carcinogenicity (category 1 or 2), mutagenicity (category 1 or 2) or toxicity to reproduction (category 1, 2 or 3) according to Directive 67/548/EEC or carcinogenicity (category 1A or 1B), germ cell mutagenicity (category 1A or 1B) or toxicity to reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008.

There is no evidence of chronic toxicity, as identified by the classifications T, R48 or Xn, R48 according to Directive 67/548/EEC or specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008.

Therefore, the substance is not considered T.