Registration Dossier
Registration Dossier
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EC number: 204-669-1 | CAS number: 123-99-9
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for Nonanedioic acid (CAS 123-99-9) is based on the criteria set out in the "Guidance on information requirements and chemical safety assessment, Chapter R. 11: PBT Assessment" (ECHA 2012).
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 substances within 28 days.
Therefore, Nonanedioic acid (CAS 123-99-9) 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 read across substances (fish, aquatic invertebrates and algae) are available all showing values above 0.01 mg/L. Therefore Nonanedioic acid (CAS 123-99-9) 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 Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (2nd ATP). The criteria for “T” based on mammalian effects are therefore not met.
Thus, Nonanedioic acid (CAS 123-99-9) does not meet the Toxicity (T) criteria set out in Annex XIII of Regulation (EC) No. 1907/2006.
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