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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Reference
Name:
Galata composition
Type of composition:
boundary composition of the substance
State / form:
liquid
> 80 - <= 100 % (w/w)
Reference substance:
Composition 1
Reference substance:
Composition 1
This impurity is considered relevant for the classification and labelling of the substance
PBT status:
the substance is not PBT / vPvB
Justification:

See Chapter 8 of attached CSR

Persistence

DBTL is classified as not readily biodegradable. In the hydrolysis study it underwent rapid initial hydrolysis but then appeared to enter into an equilibrium with DBT mono-laurate. It is therefore concluded that DBTL satisfies the persistence criteria.

Bioaccumulation

DBTL has a LogKow of 4.44, which is <4.5 indicating a low risk of bioaccumulation. In an aquatic bioaccumulation study BCFs of 30.9, 813, 138 and 53.6 were obtained in muscle, liver, kidney and vertebrae respectively. These are below 2000 and thus DBTL can be considered not to satisfy the bioaccumulation criterion.

Toxicity

No chronic data are available. All the acute endpoints (EC/LC50s) are >0.1 mg/L. No NOEC was obtained in the algal study (also considered a long term end point). Based on the environmental data DBTL is not considered to satisfy the T criteria.

However, DBTL is classified as a category 2 mutagen and as category 1B for toxicity for reproduction. DBTL is therefore considered to satisfy the T criteria.

DBTL is classified as P and T.

DBTL is not classified as B

Likely routes of exposure:

As the substance has not been found to meet the PBT or vPvB criteria, no emission characterisation is required