Registration Dossier
Registration Dossier
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EC number: 204-110-1 | CAS number: 115-83-3
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT assessment for pentaerythritol tetrastearate (CAS 115-83-3) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).
Persistency assessment
Pentaerythritol tetrastearate is considered to be readily biodegradable. A degradation rate of 66.4 - 76 % was determined in studies according to OECD 301. Thus, the substance does not meet the screening criterion for persistence and is not considered to be P or vP.
Bioaccumulation
Pentaerythritol tetrastearate is readily biodegradable and therefore it is considered to be not P and vP. Therefore, no B-assessment was carried out since it is only required if the substance fulfills the P or vP criteria, according to the guideline (Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment, 2017).
Toxicity
For Pentaerythritol tetrastearate the available acute effect concentrations are > 0.1 mg/L (fish, aquatic invertebrates, algae) and the chronic effect concentration (daphnia, algae) is ≥ 0.01 mg/L. The substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B) or toxic for reproduction (category 1A, 1B or 2) according to Regulation (EC) No 1272/2008. In addition, the substance shows no specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation (EC) No 1272/2008. The substance is readily biodegradable indicating no persistence. Therefore, the criteria set out in Annex X of Regulation (EC) No 1907/2006 are not met and the test substance is not considered to meet the T criterion.
Conclusion
In conclusion, the substance is not PBT/vPvB.
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