Registration Dossier
Registration Dossier
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EC number: 939-582-4 | CAS number: 1471315-26-0
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT assessment of Fatty acids, C16-18 (even numbered), aluminum salts is based on the criteria set out in the "Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment" (ECHA, 2008).
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). One study using standardized test guideline is available for fatty acids, C16-18 (even numbered), aluminum salts that could demonstrate the ready biodegradability of the substance (81.2% after 29 days based on CO2 evolution, OECD 301 B). Therefore, fatty acids, C16-18 (even numbered), aluminum salts do not meet the Persistent (P) or very Persistent (vP) criteria.
Bioaccumulation (B) Assessment:
The log Pow value could not be determined because the substance has very low water solubility. Nevertheless, the bioaccumulation test with fish available for a read-across substance indicates that fatty acids, C16-18 (even numbered), aluminum salts have a low potential for bioconcentration and the substance will not accumulate to significant levels in the aquatic environment. Therefore, fatty acids, C16-18 (even numbered), aluminum salts do not meet the Bioaccumulative (B) or very Bioaccumulative (vB) criteria.
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. Based on the experimental data for the read-across substances it can be concluded that no chronic toxicity is expected data up to the water solubility limit (0.15 mg/L). This value exceeds the toxicity criterion and therefore, fatty acids, C16-18 (even numbered), aluminum salts are not considered as a toxic substance regarding ecotoxicological endpoints.
Human Health Toxicity:
Carcinogenicity: the available data on fatty acids, C16-18 (even numbered), aluminum salts do not warrant classification for carcinogenicity under Directive 67/548/EEC or GHS/CLP.
Mutagenicity: the available data indicate that fatty acids, C16-18 (even numbered), aluminum salts are not genotoxic or mutagenic and do not warrant classification for carcinogenicity under Directive 67/548/EEC or GHS/CLP.
Reproductive Toxicity: There is no evidence that fatty acids, C16-18 (even numbered), aluminum salts causes reproductive or developmental toxicity. The available data indicate that fatty acids, C16-18 (even numbered), aluminum salts are not toxic to reproduction and do not warrant classification under Directive 67/548/EEC or GHS/CLP.
Chronic toxicity: due to the results of the relevant mammalian toxicity studies, fatty acids, C16-18 (even numbered), aluminum salts are not classified as Xn, R48 or STOT RE.
The substance is considered not to be PBT or vPvB on the basis of the provided relevant data.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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