Registration Dossier
Registration Dossier
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EC number: 204-010-8 | CAS number: 112-85-6
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).
Persistence (P) Assessment:
The substance is readily biodegradable according to OECD criteria (75% after 28 d, OECD 301B). Thus, the test substance does not meet the screening criterion for persistency and it is not considered to be P or vP.
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 (including docosanoic acid) that could all demonstrate the ready biodegradability of the substances within 28 days.
Therefore, docosanoic acid (CAS 112 -85 -6) does 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 surrogate substance C12 fatty acid sodium laurate (CAS 629-25-4) is below the bioaccumulation criterion of BCF > 2000. In addition, rapid metabolism of fatty acids 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 - Chapter R. 11: PBT Assessment", fatty acids are considered unlikely to be bioaccumulative (B) or very bioaccumulative (vB).
Toxicity (T) Assessment:
Environmental Toxicity (T):
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. Data for long term toxicity on algae, invertebrate and fish are available showing no effects up to the limit of water solubility.
Therefore docosanoic acid (CAS 112 -85 -6) is not considered as a toxic substance regarding ecotoxicological endpoints.
Human Health Hazards Assessment (T):
The substance is not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any other evidence for chronic toxicity according to Regulation (EC) No. 1272/2008 (2nd ATP). The criteria for “T” based on mammalian effects are therefore not met.
Thus, docosanoic acid (CAS 1412 -85 -6) does not meet the Toxicity (T) criteria set out in Annex XIII of Regulation (EC) No. 1907/2006.
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