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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 for C9-11 (CAS 84501-49-5) 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). Studies using standardized test guidelines available for C9-11 (CAS 84501-49-5) demonstrated the ready biodegradability of the substance (95%) after 28 days based on O2 consumption (OECD 301B). Therefore, C9-11 (CAS 84501-49-5) does not meet the Persistent (P) or very Persistent (vP) criteria.

 

Bioaccumulation (B) Assessment:

The value of log Pow was determined to be 1.057. Available data indicate that C9-11 (CAS 84501-49-5) has a very low potential for bioconcentration and the substance will not accumulate to significant levels in the aquatic environment. Therefore, C9-11 (CAS 84501-49-5) 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 value based on chronic experimental data on algae was an EC10 of 0.95 mg/L. This value exceeds the toxicity criterion and therefore, C9-11 (CAS 84501-49-5) is not considered as a toxic substance regarding ecotoxicological endpoints.

Human Health Toxicity:

Carcinogenicity: the available data on C9-11 (CAS 84501-49-5) do not warrant classification for carcinogenicity under GHS/CLP.

Mutagenicity: the available data indicate that C9-11 (CAS 84501-49-5) is not genotoxic or mutagenic and do not warrant classification for carcinogenicity under GHS/CLP.

Reproductive Toxicity: there is no evidence that C9-11 (CAS 84501-49-5) 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 C9-11 (CAS 84501-49-5) is not classified as STOT RE.

 

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