Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

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

Persistence Assessment:

A substance is not considered to be persistent if it can be demonstrated that it has potential to degrade (via photolysis, hydrolysis and/or biodegradation). Mandelic acid was found to be readily biodegradable (according to OECD 301C). Therefore, mandelic acid does not meet the P criterion.

Bioaccumulation Assessment:

Since the log Kow value of mandelic acid (0.5) is below 4.5 the substance is not expected to be bioaccumulative, based on the screening criteria for bioaccumulation, stipulated in the ECHA’s Guidance on information requirements and chemical safety assessment. Therefore, mandelic acid does not meet the screening criteria for Bioaccumulation.

Toxicity Assessment:

Environmental Toxicity:

The substance does not meet the classification for toxic (T) in the environment because the short term data available with aquatic invertebrates and algae present EC values >100 mg/L. Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the test substance is not considered to meet the T criterion.

Thus, mandelic acid is not considered a toxic substance regarding ecotoxicological endpoints.

Human Health Hazards Assessment:

Mandelic acid is not classified as carcinogenic, mutagenic or toxic for reproduction, nor is there any evidence of chronic toxicity according to Regulation (EC) No 1272/2008. Thus, mandelic acid is not considered a toxic substance regarding toxicological endpoints.

Mandelic acid does not meet the T criterion.

Summary and overall conclusions on PBT or vPvB Properties:

According to Annex XIII of the REACH Regulation (EC) No 1907/2006, a PBT substance has to fulfil all three of the criteria for persistence, bioaccumulation and toxicity, as listed in part 1 of Annex XIII, and a vPvB substance has to fulfil all criteria for persistence and bioaccumulation, as listed in part 2 of Annex XIII.

Therefore, on the basis of the relevant data provided and discussed, mandelic acid is not identified as PBT or as a vPvB substance (not P, not B, not T).