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PBT assessment

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PBT assessment: overall result

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

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, and a vPvB substance has to fulfil all criteria for persistence and bioaccumulation. Stearic acid (CAS 57-11-4) is not identified as PBT nor as vPvB substance on the basis of the relevant data provided and discussed.

PBT/vPvB criteria and justification

Persistence (P) 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). Several studies using standardized OECD, EU- and ISO test guidelines are available for fatty acids that could all demonstrate the ready biodegradability of the substance within 28 days. Therefore, stearic acid (CAS 57-11-4) do not meet the Persistent (P) or very Persistent (vP) criteria.

Bioaccumulation (B) Assessment:

The BCF value obtained for whole organisms after exposure to the fatty acid analogue substance C12 fatty acid sodium laurate is below the bioaccumulation criterion of BCF > 2000 set in Annex XIII of REACH Regulation (EC) No 1907/2006. In addition fatty acids rapid metabolism of fatty acid within the organism is expected. Therefore, based on the screening criteria for bioaccumulation stipulated in the ECHA‘s Guidance on information requirements and chemical safety assessment - Part C: PBT Assessment (2008), fatty acids are considered unlikely to be bioaccumulative.

Toxicity (T) Assessment:

Environmental Toxicity:

According to Annex XIII of REACH Regulation (EC) No 1907/2006, a substance is considered to be toxic in terms of PBT criteria if long-term NOEC values for aquatic organisms are lower than 0.01 mg/L. For palmic acid, no effects within the range of water solubility were observed. Thus, stearic acid (CAS 57-11-4) is not considered as a toxic substance regarding ecotoxicological endpoints.

Human Health Hazards Assessment (T)

Carcinogenicity:

The available data on stearic acid (CAS 57-11-4) do not warrant classification for carcinogenicity under Dir 67/548/EEC or GHS/CLP.

Mutagenicity:

The available data indicate that stearic acid (CAS 57-11-4) are not genotoxic or mutagenic and do not warrant classification for carcinogenicity under Dir 67/548/EEC or GHS/CLP.

Reproductive Toxicity:

There is no evidence that stearic acid (CAS 57-11-4) cause reproductive or developmental toxicity. The available data indicate that members of the fatty acids category are not toxic to reproduction and do not warrant classification under Dir 67/548/EEC or GHS/CLP.