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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 Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt 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). The key study using standardized test guideline is available that could demonstrate the ready biodegradability of the substance (100% biodegradation after 30 days based on CO2 evolution, OECD 301 B). Therefore, Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt does not meet the Persistent (P) or very Persistent (vP) criteria.

 

Bioaccumulation (B) Assessment:

The value of log Pow was determined to be 1.0. The available data indicates that Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt has a very low potential for bioconcentration and the substance will not accumulate to significant levels in the aquatic environment. Therefore, Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt 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 on algae was EC10 of 0.95 mg/L. This value exceeds the toxicity criterion and therefore, Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt is not considered as a toxic substance regarding ecotoxicological endpoints.

Human Health Toxicity:

Carcinogenicity: the available data on Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt do not warrant classification for carcinogenicity under GHS/CLP.

Mutagenicity: the available data indicate that Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt is not genotoxic or mutagenic and do not warrant classification for carcinogenicity under GHS/CLP.

Reproductive Toxicity: There is no evidence that Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt 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, Sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt is not classified as STOT RE.

 

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