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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
Naugalube APAN
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
Naugalube APAN
Reference substance:
Naugalube APAN
Reference substance:
Naugalube APAN
Reference substance:
Naugalube APAN
Reference substance:
Naugalube APAN
Reference substance:
Naugalube APAN
Reference substance:
Naugalube APAN
PBT status:
the substance is not PBT / vPvB
Justification:

Assessment of PBT / vPvB properties has been conducted in accordance with the guidance provided in Annex XIII of Regulation 1907/2006 (as amended by Commission Regulation No 253-2011 of 15 March 2011). The substance is not considered to be a PBT or a vPvB substance.

Persistence

The substance displays properties that indicate persistency within the environment, based on low ready biodegradability (3% degradation in 28 days). Due to the extremely low water solubility and the half-life for hydrolysis being determined to be > 1 year when tested at pH concentrations of 4,7 and 9. This information indicates that biotic degradation would not be its primary route of degradation for this substance.

As such, based on the information available, the substance fulfils the requirements of Annex XIII, Para 1.1 based on evaluation of available data, and can be considered to be “P” based in this data.

 

Bioaccumulation

There are currently no specific studies evaluating the bioaccumulation of the substance in aquatic/sedimented environments. The partition coefficient for the substance has however been experimentally determined for the substance. The substance attained a log Kow of 4.11 which according to the ECHA guidance “Part C: PBT/vPvB assessment” Table C.4-1: Screening information for Persistence, Bioaccumulation, and Toxicity indicates that the substance” is below the limit which a substance is characterised as potentially bioaccumulative (4.5).

Therefore the substances is not considered to meet the criteria for “b” based on this data.

 

Toxicity

Based on the available information from the ecotoxicity studies, the substance does not meet the toxic criterion as the EC50 and NOEC provided are above 0.1 mg/L. However the substance has been classified as STOT RE 1, H372 due to the effects noted at between 150 mg/kg/day relating to adverse effects noted in the liver. Based on this, the substance meets the Toxic criterion.

 

The substance meets the criteria for Persistence and Toxicity on the basis that the substance is not readily biodegradable and is classified as STOT RE 1 with effects. There are no studies investigating to bioacummulative potential of the substance, however utilising the partition coefficient value in accordance with the screening criteria in “Part C: PBT/vPvB assessment”, the substance presumed to be not bioaccumulative.

Therefore, as the substances does not fulfil all P, B and T criterion, the substance cannot be classified as a PBT substance.