Registration Dossier
Registration Dossier
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EC number: 201-039-8 | CAS number: 77-58-7
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Galata composition
- Type of composition:
- boundary composition of the substance
- State / form:
- liquid
- > 80 - <= 100 % (w/w)
- Reference substance:
- Galata composition
- Reference substance:
- Galata composition
- 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
Reference
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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