Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:
PBT status:
the substance is not PBT / vPvB
Justification:

Persistence assessment:

Test method according to OECD 301F. GLP study. The substance achieved 75.3 % biodegradation in 28 days, it was considered as readily biodegradable.

The substance is not fulfilling the criteria for P/vP.

Bioaccumulation assessment:

The estimated log Kow for representative structures of the UVCB substance are all below 4.5

Conclusion on B / vB properties: The substance is notfulfilling the criteria for Biaccumulable (B)

Toxicity assessment:

There is no long-term toxicity study available with fish or aquatic invertebrates.

Toxicity to aquatic algae: No Effect Loading Rate (72h) = 100 mg/L loading rate WAF (basis for effect: growth rate) (read-across, test method according to OECD 201. GLP study).

The substance is not classified as CMR.

The substance is not classified for STOT-RE.

Toxicity to fish: Test method according to OECD 203. GLP study.Based on the read-across approach, the 96-Hour LL50(Lethal Loading rate) of the substance was > 100 mg/L loading rate WAF and the 96h-NOELR = 100 mg/L loading rate WAF.

Toxicity fo aquatic invertebrates: Test method according to OECD 202. GLP study. Based on the read-across from an analogue substance, the 48 h-EC50 is greater than 100 mg/L loading rate WAF and the 48h-NOELR is 100 mg/L loading rate WAF.

Conclusion on T properties: The substance is notfulfilling the criteria for Toxicity (T).

CONCLUSION:

Fatty acids, C14 -22, ethylene esters, bisulfited, sodium salts is not a PBT or vPvB substance.