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PBT assessment

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PBT assessment: overall result

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

The PBT assessment for C14-16AS NA (CAS 91648-54-3) 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:

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). Studies using standardized test guidelines available for C14-16AS NA (CAS 91648-54-3) demonstrated the ready biodegradability of the substance (> 69%) after 30 days based on O2 consumption (OECD 301D). Therefore, C14-16AS NA (CAS 91648-54-3) does not meet the Persistent (P) or very Persistent (vP) criteria.

 

Bioaccumulation (B) Assessment:

The value of log Pow was determined to be 2.9. Available data indicate that C14-16AS NA (CAS 91648-54-3) has a low potential for bioconcentration and the substance will not accumulate to significant levels in the aquatic environment. Therefore, C14-16AS NA (CAS 91648-54-3) does 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. The lowest NOEC value based on chronic experimental data was 0.072 mg/L (Daphnia, reproduction). This value exceeds the toxicity criterion and therefore, C14-16AS NA (CAS 91648-54-3) is not considered as a toxic substance regarding ecotoxicological endpoints.

Human Health Toxicity:

Carcinogenicity: the available data on C14-16AS NA (CAS 91648-54-3) do not warrant classification for carcinogenicity under GHS/CLP.

Mutagenicity: the available data indicate that C14-16AS NA (CAS 91648-54-3) is not genotoxic or mutagenic and do not warrant classification for carcinogenicity under GHS/CLP.

Reproductive Toxicity: there is no evidence that C14-16AS NA (CAS 91648-54-3) causes reproductive or developmental toxicity. The available data indicate that members of the alkyl sulfate category are not toxic to reproduction and do not warrant classification under GHS/CLP.

Chronic toxicity: due to the results of the relevant mammalian toxicity studies C14-16AS NA (CAS 91648-54-3) is not classified as STOT RE.

Therefore it can be concluded that the substance does not meet the T criteria.

 

The substance is considered not to be PBT or vPvB on the basis of the provided relevant data.