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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Reference
Name:
Boundary composition (SIP)
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
Boundary composition (SIP)
Reference substance:
Boundary composition (SIP)
Reference substance:
Boundary composition (SIP)
Reference substance:
Boundary composition (SIP)
Reference substance:
Boundary composition (SIP)
Reference substance:
Boundary composition (SIP)
Reference substance:
Boundary composition (SIP)
Reference substance:
Boundary composition (SIP)
Reference substance:
Boundary composition (SIP)
Reference substance:
Boundary composition (SIP)
Reference substance:
Boundary composition (SIP)
Reference substance:
Boundary composition (SIP)
Reference substance:
Boundary composition (SIP)
Reference substance:
Boundary composition (SIP)
Reference substance:
Boundary composition (SIP)
Reference substance:
Boundary composition (SIP)
Reference substance:
Boundary composition (SIP)
Reference substance:
Boundary composition (SIP)
Reference substance:
Boundary composition (SIP)
Reference substance:
Boundary composition (SIP)
Reference substance:
Boundary composition (SIP)
PBT status:
the substance is not PBT / vPvB
Justification:

The notification substance is a UVCB which contains the constituent EC 310 -154 -3 (phenol, dodecyl-, branched) at 1.16%. This substance is a reproductive toxin and classified as Category 1B. At this % within the notification substance, the classification carries through, and hence the notification substance will carry a classification of Category 1 reproductive toxin, H360f (effects on fertility), therefore the substance meets the T criteria.

In the key study (2016 OECD 301B), EC 903-162-9 was shown to undergo biotic and abiotic degradation, but did not fulfil the criteria for ready biodegradability. Due to the test items low water solubility, silica gel was used to enhance the bioavailability to the inoculum, the study was also extended to 60 days to investigate the inherent degradation potential of the test item. A mean total of 62.6% degradation was achieved after 60 days. The average biotic and abiotic cumulative percent biodegradation for EC 903-162-9 were 17.4% and 45.2% respectively. The registration substance showed some inherent biodegradation potential, however complete biodegradation was not achieved in this studies. It is therefore concluded that some organic constituents in the UVCB substance may be P/ vP, therefore the substance as a whole is concluded to be P/vP .

Based on the high log Kow > 10 and the low BCF/BAF values calculated with BCFBAF v3.01 (<= 71 L/kg), the substance is assessed as not bioaccumulative, i.e. not B or vB.

Overall EC 903-162-9 meets the P and T criteria, but not the B criteria, therefore it can be concluded that the substance does not meet the criteria for PBT or vPvB.

The registered composition of the UVCB substance EC 903-162-9 contains approximately 2.5% of base oil. The base oil has not been considered within the PBT assessment for the registration substance, specifically the EPI SUITE estimations for Log Kow and BCF that were used to support the overall PBT assessment. Instead only the relevant detergent species of the registration substance were considered as part of the PBT (vP/vB) assessment. This approach is considered justified for the PBT assessment of EC 903-162-9, as the base oil has its own respective EU REACH registration, within which the PBT status has been adequately assessed. The base oil has been concluded to not meet the PBT or vPvB criteria, as it doesn’t contained any constituents at concentrations of greater than or equal to 0.1% that meet the PBT or vPvB criteria as stipulated in Annex XIII of Regulation (EC) No 1907/2006.As such, the base oil does not impact the PBT (vP/vB) status of the registration substance and it is considered justifiable to exclude it from the PBT (vP/vB) assessment for EC 903-162-9.