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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Reference
Name:
Sakura Salicylate
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

P and vP criterion

Sakura Salicylate was found to be readily biodegradable in a GLP study according to OECD TG 301C.

Therefore, the substance is nor P and not vP.

B and vB criterion

The log Kow of Sakura Salicylate was determined to be 3.25 in a GLP study according to OECD TG 117 (HPLC method).

Furthermore, the log Koa is calculated to be ca. 4.3 by means of the EPISuite module KOAWIN using the log Kow of 3.25 and a Henry's law constant of 233 Pa·m3/mole. As the log Koa is <5, the substance is considered to be not potentially bioaccumulative in air-breathing organisms.

Therefore, the substance is not B and not vB.

T criterion

Sakura Salicylate is not classified for Carcinogenicity category 1A, 1B, for Mutagenicity 1A, 1B, or toxic for Reproductive toxicity 1A, 1B or 2 and not classified for STOT RE 1 or 2 according to EC Regulation 1272/2008. Long-term NOEC/EC10 data are available only from a study with algae. As however algae are not found to be the most sensitive species, at this point no conclusion on the T properties of the substance can be drawn.

Overall conclusion

The substance is not PBT/vPvB based on the P/vP and B/vB criteria alone.