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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

The PBT assessment of C9-12AS Na is based on the criteria set out in the "Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment" (ECHA, 2014).

 

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 test guidelines could demonstrate the ready biodegradability of the substance (95% biodegradation after 28 days based on CO2 evolution, OECD 301 B). Therefore, C9-12AS Na does not meet the Persistent (P) or very Persistent (vP) criteria.

 

Bioaccumulation (B) Assessment:

The value of log Pow was determined to be 0.581. The available data indicates that C9-12AS Na has a very low potential for bioconcentration and the substance will not accumulate to significant levels in the aquatic environment. Therefore, C9-12AS Na 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/EC10 values for aquatic organisms are lower than 0.01 mg/L. The lowest chronic value based on experimental data with aquatic invertebrates was 1.1 mg/L. This value exceeds the toxicity criterion and therefore, C9-12AS Na is not considered as a toxic substance regarding ecotoxicological endpoints.

Human Health Toxicity:

Carcinogenicity: the available data on C9-12AS Na do not warrant classification for carcinogenicity under GHS/CLP.

Mutagenicity: the available data indicate that C9-12AS Na is not genotoxic or mutagenic and do not warrant classification for carcinogenicity under GHS/CLP.

Reproductive Toxicity: There is no evidence that C9-12AS Na 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 GHS/CLP.

Chronic toxicity: due to the results of the relevant mammalian toxicity studies, C9-12AS Na is not classified as STOT RE. Therefore, C9-12AS Na does not meet the (T) criteria.

 

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